PRESCRIBING COMPETENCIES FOR AUTONOMOUS APRN PRESCRIPTIVE AUTHORITY: WHAT DO NURSE PRESCRIBERS NEED TO KNOW? By TRACY KLEIN A dissertation submitted in partial fulfillment of the requirements for the degree of DOCTOR OF PHILOSOPHY WASHINGTON STATE UNIVERSITY College of Nursing MAY 2011 © Copyright by TRACY KLEIN, 2011 All Rights Reserved © Copyright by TRACY KLEIN, 2011 All Rights Reserved To the Faculty of Washington State University: The members of the Committee appointed to examine the dissertation of TRACY KLEIN find it satisfactory and recommend that it be accepted. ___________________________________ John Roll, Ph.D., Chair ___________________________________ Louise Kaplan, Ph.D., ARNP, FAANP ___________________________________ Renee Hoeksel, Ph.D., RN ___________________________________ Linda Eddy, Ph.D., RN, CPNP ii ACKNOWLEDGMENT The author would like to acknowledge the members of the dissertation committee: Dr. John Roll, Dr. Louise Kaplan, Dr. Renee Hoeksel, and Dr. Linda Eddy. Your kindness, scholarly attention, and support as I explored the nebula of competency development and assessment was remarkable and much appreciated. Additional support throughout the dissertation process was provided by Dr. Katherine Crabtree, Dr. Jill Budden from the National Council of State Boards of Nursing, and the staff and members of the Oregon State Board of Nursing. Special thanks to Dr. Ruth Bindler, who graciously accepted my transfer to this program knowing my desire to incorporate public policy into graduate nursing study, and to Eileen Swalling who kept me connected to the home campus even though I live in Oregon. Much appreciation is extended to Jessie Dahl for her editorial work on this manuscript. Finally, thank you to my parents who always encouraged my studies and supported my interests in continuing them well beyond my teenage years, to Dr. Helen Turner, who completed the first prescribing practicum in Oregon as a Clinical Nurse Specialist, to Dr. Peter Collier who introduced me to role socialization theory, and to my husband Mark who rarely tires of nursing policy discussions and learned to like Spokane. iii PRESCRIBING COMPETENCIES FOR AUTONOMOUS APRN PRESCRIPTIVE AUTHORITY: WHAT DO NURSE PRESCRIBERS NEED TO KNOW? Abstract Tracy Klein, Ph.D Washington State University May 2011 The United States currently has no reliable and valid model for assessing entry-level autonomous prescriptive competency for advanced practice nurses, despite a decade of legislative expansion in scope and autonomy. Klein and Kaplan (2007) surveyed Washington and Oregon nurse practitioners with prescriptive authority, clinical nurse specialists with and without prescriptive authority; and nurse practitioner students, their preceptors and faculty about the relative importance of prescribing specific competencies (n=180). The original survey used an instrument from the Oregon State Board of Nursing, titled Clinical Practicum in Pharmacological Management Evaluation, containing 31 competencies. The present study used mixed methods to further confirm essential entry-level outcomes used to meet requirements for autonomous prescriptive authority. Three steps of analysis were conducted to determine final domain and competency recommendations: content analysis of original survey comments, principle component analysis (PCA) of competency ratings, and final Q-Sort of revised competencies using Subject Matter Experts (SMEs) with prescriptive authority licensed as CNSs, NPs, or both. PCA of the 31 original competencies identified 4 factors containing 30 items accounting for loadings of .40 or greater for all items. Removal of 1 competency as suggested by content and factor analysis resulted in a Cronbach’s alpha of .959, indicating item internal consistency. Two contextually similar items were combined for the final Q-sort analysis resulting in the final 29 competencies in 4 domains titled: Safety, Patient Specific Assessment, Clinical iv Reasoning, and Clinical Management. Q-Sort by SMEs clearly placed 8 competencies into the Safety domain, 3 between Safety and Patient Specific Assessment, 7 into Patient Specific Assessment, 1 between Patient Specific Assessment and Clinical Reasoning, 2 into Clinical Reasoning, 3 between Safety and Clinical Reasoning, 1 into Clinical Management and 4 in more than two categories. SMEs confirmed item validity but did not confirm discrete domain placement for 11 competencies, indicating a need for further analysis and revision of domain categories in order to confirm regulatory sufficiency. v TABLE OF CONTENTS Page ACKNOWLEDGEMENTS………………………………………………………………………iii ABSTRACT................................................................................................................................ iv-v LIST OF TABLES......................................................................................................................... xi LIST OF FIGURES ...................................................................................................................... xii CHAPTER 1. INTRODUCTION .........................................................................................................1 Statement of the Problem .......................................................................................1 Statement of Purpose .............................................................................................2 Specific Aim and Sub Aims ..................................................................................2 Significance and Rationale ....................................................................................3 Nurse practitioner prescribing competencies in the United States ............3 Clinical nurse specialist prescribing ..........................................................4 Rationale for a prescribing specific instrument .........................................5 Prescribing competencies and state regulation ......................................... 7 Instrument development process and rationale .........................................8 2. REVIEW OF THE LITERATURE ..............................................................................11 Definitions ............................................................................................................11 Competencies ...........................................................................................11 Prescribing ...............................................................................................11 Advanced practice registered nurse (APRN) ...........................................11 Search Strategy..................................................................................................... 12 vii Prescribing Competencies: Health Professionals .................................... 12 Validation of competencies ..................................................................................14 Competency development: Purpose .....................................................................15 Controversies in competency assessment............................................................. 16 Methods of validation........................................................................................... 18 Theoretical framework and model........................................................................ 19 The Harden Model................................................................................... 19 The Regulatory Context of Prescribing Privileges................................................22 U.S. Prescriptive Authority...................................................................... 22 Prescribing Competencies: Nursing......................................................... 23 International Prescribing Perspectives......................................................26 3. RESEARCH, DESIGN, AND METHODOLOGY......................................................28 Original Study.......................................................................................................28 Results...................................................................................................................30 Present Study: Methodology.................................................................................31 Content Analysis...................................................................................................32 Method .....................................................................................................32 Data Collection ........................................................................................ 32 Validity..................................................................................................... 33 Analysis ....................................................................................................34 Principle Component Analysis ............................................................................ 35 Method .....................................................................................................35 Reliability .................................................................................................36 viii Analysis ....................................................................................................37 Q Sort ...................................................................................................................38 Method .....................................................................................................38 Data Collection .........................................................................................39 Analysis ....................................................................................................40 4. RESULTS ....................................................................................................................42 Sample Description ..............................................................................................42 Content Analysis Findings ...................................................................................44 Original Survey: Reflections of Faculty and Participants .......................44 Faculty Specific Responses .................................................................................47 Independent Review Using Two Experts ............................................................49 Coder Reliability ..................................................................................... 51 Principle Component Analysis Findings .............................................................54 Q Sort Findings ....................................................................................................61 SME Comments ...................................................................................................67 5. DISCUSSION ...............................................................................................................74 Theoretical Framework ........................................................................................74 Competency Concepts .............................................................................74 Domains ...................................................................................................76 Implementation and Assessment ..........................................................................80 Limitations ...........................................................................................................82 Recommendations for Future Research ............................................................. 84 Regulatory Implications ..................................................................................... 86 ix REFERENCES .............................................................................................................................89 APPENDIX A. CLINICAL PRACTICUM IN PHARMACOLOGICAL MANAGEMENT EVALUATION INSTRUMENT............................................................................................................... 107 B. WSU IRB APPROVAL LETTERS ............................................................................108 C. RECRUITMENT OF SUBJECT MATTER EXPERTS LETTER............................ 110 D. INFORMED CONSENT TO PARTICIPATE IN Q SORT LETTER .......................111 x LIST OF TABLES 1. Demographic Information: Subject Matter Experts..................................................................42 2. Comments: All Participants ......................................................................................................44 3. Faculty Specific Additional Questions .....................................................................................47 4. Tone Score Comparisons ..........................................................................................................50 5. Content Code Description with Frequency of Use ...................................................................52 6. Cronbach’s Alpha All Items .....................................................................................................54 7. Cronbach’s Alpha with Ownership Competency Removed .....................................................54 8. Initial Factors in Principle Component Analysis with Loadings ............................................. 56 9. Final Domains and Competencies ............................................................................................59 10. Q Sort Results ..........................................................................................................................61 11. SME Interview Responses .......................................................................................................68 12. Comparison of Original Communication Domain and New Safety Domain ..........................69 13. Final Revised Domains and Competencies..............................................................................71 xi LIST OF FIGURES 1. Figure 1; Harden 3 Circle Model ...............................................................................................20 xii CHAPTER 1 INTRODUCTION Statement of the Problem An improved regulatory environment has increased the number and scope of Advanced Practice Registered Nurse (APRN) prescribers (Pearson, 2010; Lugo, O’Grady, Hodnicki, & Hanson, 2007; Christian, Dower, & O’Neil, 2007). However, there are no US regulatory models that identify and validate prescribing specific outcomes for the purpose of granting initial autonomous prescriptive authority either for new graduates or an already licensed APRN. Entrylevel preparation cannot always anticipate scope of practice changes (“Changes in Health Care,” 2007). It is therefore important to facilitate readiness for change that incorporates APRN full autonomy in the prescribing role (Kaplan & Brown, 2008). Role and scope of practice expansion makes it increasingly likely that more APRNs will seek prescriptive authority. Health regulatory Boards need to devise systems to evaluate and confirm that prescribing competencies have been met. A particular gap is the lack of models for attainment of prescribing competencies after completion of graduate education and initial APRN licensure. In order to evaluate prescribing outcomes it is necessary to develop and validate a set of prescribing specific competencies for autonomous practice. The primary document addressing prescribing specific competencies for nurses was published over a decade ago (Yocom, Busby, Conway-Welch, & Veins, 1998). Curriculum Guidelines and Regulatory Criteria for Family Nurse Practitioners Seeking Prescriptive Authority to Manage Pharmacotherapeutics in Primary Care (Yocom, Busby, Conway-Welch, & Veins, 1998) was developed specifically to address one APRN role (nurse practitioner) and one population focus (family). Since that time, the availability of prescriptive authority has 1 expanded to include all APRN roles and multiple population foci. More states have also obtained the authority for scheduled drug prescribing, now possible for APRNs in all but two states (Pearson, 2010). There are no published prescribing specific competencies for nurse midwives, clinical nurse specialists, or certified registered nurse anesthetists in the US. General competencies for nursing incorporate practice across the spectrum that may or may not include prescriptive authority. Specific competencies for advanced practice nurses, such as the NONPF Core Competencies (2006) incorporate prescribing as a very limited component of overall practice. Prescriptive authority is an integral part of autonomous practice ability. It is therefore the position of APRN representatives from licensure, accreditation, certification and education in the APRN Consensus Paper (APRN Joint Dialogue, 2008) that prescribing medication is substantial part of the APRN role that distinguishes its scope from that of the basic registered nurse. Preparation to prescribe, regardless of current legal authority, should therefore be required as a competency for all APRN roles (APRN Joint Dialogue, 2008). Statement of the Purpose The purpose of this study is to identify competencies and domains for use by regulators charged with granting prescriptive authority. Study findings will be used to promote a refined instrument for use by state regulators as a model for authorizing autonomous prescriptive authority. Specific Aim and Sub Aims The specific aim of this study is to identify prescribing competencies and domains in the Clinical Practicum in Pharmacological Management Evaluation instrument that accurately 2 reflect essential entry-level autonomous prescriber outcomes. There are three sub aims to this study: Sub Aim 1. Identify prescribing competencies that may be removed or modified to strengthen the reliability of the Clinical Practicum in Pharmacological Management Evaluation instrument. Sub Aim 2. Revise the domains into which the competencies can be categorized Sub Aim 3. Confirm appropriate categorization of the competencies into representative domains. Significance and Rationale Nurse practitioner prescribing in the United States. In Fiscal Year 1993, Senate Appropriations Committee report 102-397 urged the Agency for Health Care Policy and Research to work with the Health Resources and Services Administration to develop an advanced practice curriculum with guidelines to prepare nurse practitioners (NPs) for prescriptive privileges (Clancy & Gelot, 1999). Under a 16- month grant funded process, the National Council of State Boards of Nursing (NCSBN) and the National Organization of Nurse Practitioner Faculties (NONPF) developed curriculum guidelines for pharmacology/pharmacotherapeutics courses appropriate for use in master’s level family nurse practitioner (FNP) programs. These guidelines were to be used in conjunction with regulatory guidelines for state Boards of Nursing charged with granting prescriptive authority for the FNP (Model Pharmacology/Pharmacotherapeutics, 1998). The guidelines also cite documents appropriate to the time as reference resources for competency development, including the American Association of Colleges of Nursing’s The Essentials of Master’s Education for Advanced Practice Nursing (AACN, 1996). The final document, titled Curriculum Guidelines 3 and Regulatory Criteria for Family Nurse Practitioners Seeking Prescriptive Authority to Manage Pharmacotherapeutics in Primary Care (Yocom, Busby, Conway-Welch, & Veins, 1998), subsequently referred to as Curriculum Guidelines, included both regulatory and curricular recommendations, and provided end-of-course competencies for a model pharmacology course. At the time of development of the Curriculum Guidelines, the FNP program focus was chosen as it had the broadest scope of practice. In 1998, there were several states without prescriptive authority for NPs. In 2010, although regulation of NPs still varies from state to state, all states have prescriptive authority (Pearson, 2010). Ironically, the revised 2006 NONPF core competencies include only one specifically related to prescribing: “prescribes medications within legal authorization” (NONPF, 2006). Clinical Nurse Specialist prescribing. Clinical Nurse Specialists are gaining regulatory recognition and prescribing authority similar to that of nurse practitioners. It is therefore of particular interest to develop and evaluate prescribing competencies inclusive of an APRN role like the Clinical Nurse Specialist (CNS). The CNS has prescriptive authority in 34 states (NCSBN, 2010) but most have not been educated to have prescriptive authority as part of their role. Preparation for prescriptive authority includes attainment of the knowledge, skills and ability to use differential diagnosis, identify pharmacologic intervention, and manage individual patients. Perhaps due to existing legal barriers to implementation of prescribing competencies in educational coursework and clinical preparation, the National Association of Clinical Nurse Specialists (NACNS) distinguishes between advanced pharmacology included in all CNS educational curricula and the knowledge needed for prescriptive authority. The regulatory requirements for prescriptive authority consequently mandate many CNSs to pursue additional 4 education to prescribe (NACNS, 2005; Delaney, Hamera & Drew, 2009). Regulatory Boards may confront the dilemma of developing a framework to evaluate initial competency to prescribe in APRNs not prepared through traditional educational means. Prescribing specific competencies should be developed to address the needs of practice expansion for otherwise experienced nurses. Rationale for a prescribing specific instrument. Educational programs that prepare students for prescriptive authority and to be safe competent prescribers do not always meet that goal. Delaney et al. (2009) conducted a comprehensive national survey of psychiatric mental health APRNs (n= 1, 899) regarding the adequacy of their educational preparation for practice. The study revealed that a majority of psychiatric mental health APRNs (CNS or NP) spends over one- third of their week prescribing (Delaney et al., 2009). While 70% were satisfied with their initial program preparation, 534 participants responded to open ended questions regarding areas of preparation in their programs and identified inadequate preparation in psychopharmacology and in pharmacologic management of patients. The third most common response to an openended question regarding program preparation identified a mismatch between educational preparation and regulatory requirements, resulting in the need to return to school to meet requirements for prescribing authority and/or national certification. The majority of states require national certification for initial licensure and many mandate prescriptive authority (Pearson, 2010). This finding represents a significant disconnect between curricular design and regulatory requirements. Competencies developed for novice use, such as the Curriculum Guidelines and NONPF Core Competencies (2006) have not been evaluated for regulatory purposes. Furthermore, they do not encompass the experienced APRN who returns to obtain prescriptive authority. 5 APRNs continue to increase their legal autonomy. This autonomy includes greater ability to prescribe controlled substances, dispense medications, increase the scope of legend drugs prescribed, and practice without physician supervision or collaboration (Kaplan, Brown, Andrilla & Hart, 2006; Pearson, 2010). It is important to prepare NPs for a new scope of practice such as expanded prescribing, even before it occurs in order to validate their socialization to the role and their safety in practice (Kaplan & Brown, 2008). Little unified political or financial support was generated to further research nurse prescribing competencies as the role was being developed and practiced. From 1955 until 1970 the American Nurses Association Model Nurse Practice Act explicitly prohibited prescriptive authority of nurses, although nurses had long taken on the role of medication dispensing, administration, and monitoring of patient responses to pharmaceutical effects (O’Malley & Mains, 2003). Many states still grant APRN practice authority without prescriptive authority, which potentiates challenges for state Boards responding to requests to add prescriptive authority long after the student role is finished and clinical practice has been established. Lyon (2003) cites multiple surveys of CNSs in practice who neither require nor desire to gain prescriptive authority. It is the position statement of the National Association of Clinical Nurse Specialists (National Association, 2005) that prescriptive authority should be optional under state law and should not be mandated in the educational curriculum as a presumption. The sole statement on prescriptive authority located on the website of the American Association of Nurse Anesthetists (Blumenreich, 1988) identifies prescribing as primarily the act of filling out a prescription, and therefore not necessary for the CRNA working in an inpatient setting administering medications. 6 Prescribing competencies and state regulation. The Institute of Medicine (IOM, 2003) identified the need for significant changes in health professional education. Among many recommendations, the IOM (2003) stressed the need to integrate competencies into oversight processes including licensure. Oregon serves as an example of how scope of practice change generates the need for validated prescribing competencies. Nurse Practitioners and Nurse Midwives in Oregon have a long history of independent practice and prescribing medications, beginning with legislative recognition in 1977 and prescriptive authority in 1979 (Oregon Nurse Practice Act, 1953/2010). Recognition of CRNAs occurred in 1997 and of Clinical Nurse Specialists in 2002 (Oregon Nurse Practice Act, 1953/2010). In 2004, Oregon legislation added prescriptive authority to the scope of practice for CNSs. The new statute was broad and modeled existing Oregon statutes that provide for autonomous NP prescribing and dispensing of medications including Schedule II-V narcotics. Implementation of the law presented a regulatory challenge. Not all CNS programs prepare students to prescribe. Furthermore, the mandate did not include additional funding for resources to develop educational programs or curricular models that could facilitate CNSs in current practice without such authority. Frequently, states in the same position find themselves short on resources and models with which to accommodate legislative changes to the APRN scope of practice. It was also difficult to estimate the numbers of CNSs who would see prescriptive authority, and their individual experiences with prior practice or coursework in preparation for expanded authority. As of January 1, 2011, nine nurses have completed the practicum in order to be granted prescriptive authority in Oregon. Applicants were required to complete the practicum of 150 supervised prescribing hours either because their initial program either did not contain clinical 7 hours or courses specific to prescribing or because they had an extended gap in practice. The Clinical Practicum in Pharmacological Management Evaluation instrument was developed by the Oregon State Board of Nursing’s Advanced Practice Consultant for preceptors to use when evaluating completion of a supervised prescribing practicum, as required in law. Instrument Development Process and Rationale The current instrument used in Oregon was developed to evaluate a prescribing specific practicum by Board of Nursing staff. The prescribing practicum regulations which determined the number of hours, required courses, and process for licensure were written in conjunction with a task force of CNSs, NPs, and a pharmacist who met monthly for one year. The regulatory purpose of the prescribing practicum was to confirm safety to prescribe for CNSs who did not have a supervised prescribing practicum in their initial educational program and subsequently applied for prescriptive authority. Passage of legislation authorizing Clinical Nurse Specialists (CNSs) to obtain autonomous prescribing authority generated the initial need for this practicum. The process of adopting prescribing regulations moved requirements for NPs into a new section of the Oregon Nurse Practice Act that could apply to all nurse prescribers. This facilitated the statutory requirement that a CNS complete “Clinical education in patient management, including pharmacotherapeutics, comparable to the requirements for completion of a nurse practitioner program” (Oregon Nurse Practice Act, 1953/2010). It also created a placeholder for CRNAs if legislation changes enabling them to obtain prescriptive authority. Nurse Midwives are licensed as NPs in Oregon and are therefore incorporated into all NP regulations. The task force used a comprehensive survey of all NP programs completed in 2000-2001 (n=275, 85% response rate) conducted by the American Association of Colleges of Nursing (AACN) and NONPF to identify regulatory requirements for curricular content comparable to requirements 8 for an NP program (Berlin, Harper, Werner, & Stennet, 2002). Faculty on the task force further estimated that 150 hours would be an accurate minimum percentage of the total prescribing focused clinical time in the average 500- to 600 hour NP program. The Clinical Practicum in Pharmacological Management Evaluation instrument (see Appendix A for more details) was developed to provide the Oregon State Board of Nursing with documentation of successful completion of a supervised 150 hour prescribing practicum. Although not designed initially to evaluate NPs, evaluation criteria were generated from the statutory mandate that the practicum be comparable to that completed by NPs prepared to prescribe. A search of current regulatory models that incorporate a prescribing practicum revealed limited guidelines for or use with Oregon’s scope of autonomous APRN practice. Models for obtaining prescriptive authority vary significantly from state to state in consideration of regulatory context and legislative mandate. All states require completion of a 30 to 45 hour pharmacology course for authority to be granted (NSCBN, 2009). Beyond this requirement, some require a period of supervision before prescriptive authority is granted, including Colorado, Maine, and California (Pearson, 2010; NCSBN, 2009). This externship may be extensive, as in Ohio where applicants must complete a 1500 to1800 hour supervised externship under a physician and may not do so under an APRN who already has prescriptive authority (Ohio, 2010). Colorado requires an 1800- hour practicum under the supervision of a physician for any NP, including new graduates, unless they have prescribed at least that many hours autonomously in the past (Colorado Division, 2008). There is little evidence to support the number of supervised hours required to develop prescribing competency, and none to validate whether socialization to the role under an experienced nurse prescriber is an important component. As of 9 2010, Maine and Colorado grant autonomous authority upon completion of the physiciansupervised practicum, but California and Ohio do not. Initial evaluation of the competencies by Oregon and Washington NPs, CNSs, faculty, students, and preceptors was the subject of a study by Klein and Kaplan (2010). Results of the study indicated a need for further analysis of which prescribing competencies are required for autonomous prescriptive authority. Rigorous instrument development and validation is a task rarely accomplished by regulatory Boards. Nurse regulators face barriers to development of evidence based practice tools, including lack of educational preparation, inability to find time to write and publish their findings, and difficulty obtaining financial support (Spector, 2010). Additionally, resources for conducting research or collecting data is rarely considered a priority for nursing Boards and unlikely to be measured by benchmarking data to which Boards are accountable (Spector, 2010; Ridenour, 2009). The use of the tool for various experience levels and APRN roles in nursing is an example of what Simon (1995) identifies as bounded rationality. Law is often passed without infrastructure such as available coursework and validated outcomes. Structure is then built to accommodate it during the process of implementation and evaluation in practice. Simon (1995) provides an example of the framers of the US Constitution, who did not have before them a “menu of all possible constitutional provisions. Instead, they invented some provisions as they went along.” (p. 47). Further evolution of the tool and the gathering of informed data on autonomous prescribing will therefore strengthen the instrument for broader regulatory use. 10 CHAPTER 2 REVIEW OF THE LITERATURE Definitions Competencies. For the purpose of this analysis “competencies” refer specifically to measurable outcomes consisting of a mixture of knowledge, skills, abilities, motivation, beliefs, values, and interests (Fleishman, Wetrogen, Uhlman, & Marshall-Mies, 1995). Integration of competencies into a professional role also incorporates additional role specific competencies, such as those necessary to become a safe APRN prescriber, or specific legal requirements for valid prescriptive authority. Prescribing. As this is a study of the Clinical Practicum in Pharmacological Management Evaluation instrument used by the OSBN the Oregon statutory definition of “prescribe” is used. Prescribing involves instruction related to a medication or preparation for use by human beings “to direct, order, or designate the preparation, use of or manner of using by spoken or written words or other means” (Oregon Nurse Practice Act, 1953/2010). This definition was adopted initially for nurse practitioner prescribers, and then amended in 2005 to add CNS authority to prescribe and dispense medications (Oregon Nurse Practice Act, 1953/2010). CRNAs do not have prescriptive authority in Oregon currently. Advanced Practice Registered Nurse (APRN). The Consensus Model for APRN Regulation: Licensure, Accreditation, Certification and Education (APRN Joint Dialogue, 2008) represents a document endorsed by forty-four nursing organizations with the authority to implement it (ANA, 2009). The model is a significant step towards consistency in how advanced 11 practice registered nurses (APRNs) are prepared and recognized for practice. The first step in the development of the Consensus Paper (APRN Joint Dialogue, 2008) was to define the term and meaning of APRN. Prior to the Consensus Paper (APRN Joint Dialogue, 2008) there was great divergence regarding what constituted “advanced nursing practice.” As one example, public health nurses considered what they do as “advanced practice” and objected to the characterization of advanced nursing practice in the Vision Paper (NCSBN, 2006) because it limited advanced practice to the direct care of individuals and use of pharmacologic interventions (Levin, Cary, Kulbok, Leffers, Molle & Polivka, 2008). The final Consensus Paper defines four APRN roles as requiring specific advanced preparation and licensure: certified nurse practitioner (CNP), certified nurse midwife (CNM), certified registered nurse anesthetist (CRNA) and clinical nurse specialist (CNS). Search Strategy Prescribing competencies: Health professions. The act of prescribing crosses legal professional boundaries of medicine, pharmacy, and nursing. Initial database searches for competencies and outcomes used the terms “prescribing” and “prescribing competencies” in conjunction with “nurse prescribers,” “APRN,” “nurse practitioners,” “clinical nurse specialists,” “nurse midwives,” and “certified registered nurse anesthetists” in EBSCO (Academic Search Complete), CINAHL, JSTOR, ERIC, and SOCIAL SCIENCES INDEX. Clinical psychologists have been granted prescriptive authority in New Mexico and Louisiana, so a search was expanded to include the search terms “clinical psychology” and “clinical pharmacology” with the terms “prescribing” and “prescriptive authority.” Google search engine was used to scan professional educational accreditation websites for medicine and pharmacy to identify educational competencies, since both fields integrate pharmacotherapeutics application 12 throughout the educational process (Introductory, 2008; Aronson, 2006; Tonkin, Taverner, Latte, and & Doecke, 2006; Maxwell & Walley, 2002) with graduate medical education in the US having adopted prescribing competencies for medical residents in 1999 (Scott Tilley, 2008). Research related to prescribing competencies in countries outside of the US was considered for the purpose of secondary analysis, but was not utilized in original instrument development due to significant differences in regulation, scope of practice, and implementation of prescriptive authority for non-US nurse prescribers. Research related to competency assessment, continued competency, and regulatory assessment was primarily obtained through both the public and members only sections of the website for the National Council of State Boards of Nursing. At the suggestion of Dr. Jill Budden from National Council of State Boards of Nursing, a search was initiated using the term “competency modeling” to obtain additional information on methodology used in occupational and psychological literature. Other resources included Dissertations and Theses A & I databases and personal communications with nursing leaders and scholars including Dr. Katherine Crabtree and Dr. Christine Tanner from Oregon Health and Sciences University. The field of basic nursing competency assessment itself is still at the concept analysis stage (Scott Tilley, 2008). Literature specific to the concept of the nurse prescriber is rare, and role competency literature primarily focuses on nursing at the basic level of education. Therefore, the literature search was broadened to incorporate terms such as “role transition,” “expertise,” “role identity,” and “role socialization” to clarify the role mastery piece of becoming a nurse prescriber. Role socialization literature was found primarily in social psychology (Brewer, 1991) or education (Kennedy, 1987), but there were also articles in medical journals that focused on the development of clinical diagnostic reasoning as one moves from novice to 13 expert (Norman, 2006; Bowen, 2006; Harden, Crosby & Friedman, 1999). Nurse specific role transition focused in one of three areas: basic level RN novice to expert literature (Benner, 1982), role socialization of the nurse practitioner which did not focus on prescribing (Lurie, 1981), or transition to the APRN role outside of the US health system (McKenna, 2006; Offredy, Kendall, and& Goodman, 2008). Current National Council of State Boards of Nursing initiatives on transition to practice focus on the registered nurse and do not therefore address prescribing medications (NCSBN, 2009). In 2007, NCSBN completed a comprehensive role delineation study comparing NPs and CNSs who were asked to rate the frequency (“criticality”) of their activities in actual practice. The highest criticality ratings from NPs that were not highest for CNSs involved both prescribing and adjusting medications (NSCBN, 2007). CNSs who choose to prescribe may experience a different transition to practice than NPs or NP students, especially if they lack role models or mentors. Validation of Competencies There is no nationally accepted method for validation of competencies at the advanced nursing level (NACNS, 2005) and no one good method for assessing competence in practice (Hodges, 2006; NCSBN, 2005). The most widely used methods are expert consensus panel validation in conjunction with broader expert opinion. These may be confirmed by a number of additional methods. The highest level of rigor is obtained by a variable combination of mixed multiple methods reflective of setting, target populations, and intended application (Shippmannn et al., 2000). The process for validation of the original Curriculum Guidelines (Yocom et al., 1998) involved: (a) appointment of an eleven person advisory committee representing nursing, medicine and pharmacy; (b) literature search of existing curricula and outcomes specific to prescribing including those for Physician Assistants; (c) expert panel appointment of eight 14 persons representing medicine, FNP education and clinical practice, pharmacy and medical/legal perspectives to identify competencies and the outline of topics for the curriculum guideline component; and (d) document review and revision through distribution of the draft document and consideration of 140 comments received in the first two drafts. Regulatory criteria incorporated into the document were evaluated following a similar process but additionally distributed through eight national nurse practitioner meetings and comments were received (approximately 70) from Boards of Nursing. Because competencies for health professions are designated for use in a licensed employment role, the use of job analysis can enhance role specific competencies for practice as well as differentiate competencies for specific APRN roles (NACNS, 2005; NCSBN, 2007). Competency models may be developed using a wide variety of formats depending upon organizational needs (Marrelli, Tondora, & Hoge, 2005). Standards used for evaluating and measuring competencies also vary depending upon whether their intended function has a legal or regulatory component (Marrelli, et al., 2005). A conceptual framework for development should identify how representation of the construct can be distinguished from other constructs and is shaped by the way in which the scored competencies will be used (Joint Committee on Standards, 2004). Competency Development: Purpose Competency based assessment can be used for educational, employment, or regulatory purposes. Public-corporate models for education that adopt job specific competencies into the educational curriculum appeal to employers (Paulson, 2001). However, competencies must also incorporate attitudinal and personal characteristics and not just functional skills (Marrelli et al., 2005). The ultimate goal of enforcing competency based professional education is significant 15 reduction or elimination of error (IOM, 2003; Davenport, Davey, & Ker, 2005). Medication errors are attributed to multiple conditions including attitude of the prescriber, particularly if prescribing is perceived as low importance compared to other job responsibilities (Dean, Schachter, Vincent, & Barber, 2002; O’Malley, 2007). Dean et al. (2002) emphasize that safe prescribing requires creating and enforcing a culture that sees prescribing as important. The goal of any requirement incorporated into nursing regulation should be public protection (Ridenour, 2009). Shippmann et al. (2000) conducted an extensive two-year review of the practice of competency modeling and its methodological range in practice under the sponsorship of the Society for Industrial and Organizational Psychology. Their process included an extensive literature search and in depth interviews with 37 subject matter experts (SMEs) specializing in the development and use of competency models. Descriptive findings included a wide variety of definitions of the term and use of “competencies” with the concept of the “core competency” emerging in the US business landscape during the early 90’s for human resource purposes. An interesting finding from the SME discussion was that the majority felt job analysis is task focused and competency modeling is worker focused (Shippmann et al., 2000). A job analysis may be used to enhance competency development but should not substitute for evaluation of individual traits and intelligences. Controversies in Competency Assessment Competencies purport to quantify desirable traits that result from a synthesis of education, socialization, and inherent qualities. These traits are then used to evaluate and assure some measure of competence in practice. Despite the acceptance and incorporation of competency-based assessment into health professional education, there are several cautions 16 found in the literature regarding their widespread usage. Rees (2004) sees outcome based learning tools as directly countering the pedagogy of problem based learning because their expert development enforces the dominant paradigm and dis-empowers learners who might innovate or generate new knowledge. Talbot (2004, p. 588) notes that in developing measurable competencies “the danger is always that we ask questions related to those things that might be more easily measured, instead of asking the difficult questions.” Models that are overly broad do little to ensure individual safety and competency in practice; however, there are no specific rules to guide level of detail for either competency modeling or job analysis (Shippman et al., 2000). Incorporation of competency based testing and evaluation in the regulatory sphere involves minimum level assessment, whereas in the educational sphere it concentrates on assessment for improvement and learning (Erwin & Wise, Summer 2001). The ultimate goal of enforcing competency based professional education is significant reduction or elimination of error (IOM, 2003; Davenport, Davey & Ker, 2005). However, legislatures and the public, as primary constituents of regulatory Boards, request competency assessment for greater accountability but not necessarily improvement (Nettles, Cole, and Sharp, 1997). Development of competencies to reflect discipline specific goals has hindered the use of common terminology and inter-professional models of practice (CICH, 2007). This conflicts with recommendations from the Institute of Medicine (IOM, 2001; 2003) that all health professionals receive education in patient centered care that emphasizes use of interdisciplinary teams and related core competencies. Hodges (2006) identifies four types (“discourses”) of competency models in use and their respective pitfalls when used for measurement of competence. The first is the assessment of competence-as-knowledge, which when overemphasized leads to potential lack of interpersonal 17 skills and poor integration of knowledge with performance. The second is competence-asperformance which developed as a reaction to the former. Competence-as-performance generated an interest in quantifying observed skills through use of simulated patients and Objective Structured Clinical Examination (OSCE) formats. Hodges (2006) states that excessive reliance on this teaching process can lead to hidden incompetence through lack of authentic connection to patients and inability to integrate content specific knowledge. The third is competence-as-reliable test score, focusing on the psychometric reliability of measurement tools to generate high stakes examinations for measurement of competency. Competence-as-reliabletest-score results in the concern that programs preparing students will teach to the test rather than the desired outcomes. Hodges (2006) also observes that higher-level skills needed for clinical practice such as pattern recognition, integration and synthesis do not measure well on standardized testing. Finally, Hodges (2006) addresses the use of internal reflection and selfreflection in competency frameworks. He cites the work of Kruger and Dunning (1999) who identified the wide gap in accuracy of self assessment for those who perform poorly, while persons doing well tend to devalue their own efficacy. In a later article Dunning, Johnson, Erhlinger & Kruger (2003) call into question whether incompetent people can be expected to identify their deficits due to insufficient meta-cognitive skills. Methods of Validation Complex knowledge required for higher-level actions can be difficult to measure (Marrelli, Tondora & Hoge, 2005; Tanner, 2006) regardless of job title or description. Measurement of nursing regulatory models does not fit with the established evidence based biomedical framework (Spector, 2010). Spector (2010) argues for adoption of a pragmatic model developed by Evans (2003) that incorporates effectiveness, appropriateness and feasibility 18 criteria into a new hierarchy of evidence. Policy implementation, while difficult to validate with randomized controlled studies, can be validated using program evaluation, audits, and other methods of confirmation in addition to psychometric methods. Theoretical Framework and Model Development of the Clinical Practicum in Pharmacological Management Evaluation instrument required use of already established nursing domains to meet time and resource constraints. The initial model for the instrument was created using domains published in the American Nurses Association (ANA) Nursing: Scope and Standards of Practice. The domains were developed for all aspects of nursing practice and incorporate prescribing as a small component. The ANA Scope and Standards of Practice (2004) identifies one standard (5D) related to prescriptive authority that has six measurement criteria. The overarching standard identified by ANA is that “the advanced practice registered nurse uses prescriptive authority, procedures, referrals, treatments and therapies in accordance with state and federal laws and regulations” (p. 30). All standards related to prescriptive authority under the domain titled Implementation. This categorization conceptualizes prescribing as a discrete and episodic skill rather than an ongoing complex management skill. While useful for initial development of the instrument, results of the initial study indicate the need for refinement. The Harden model (1999) will be used as the primary conceptual framework of this study, in order to articulate and simplify the validation of prescribing competencies needed by an autonomous prescriber. The Harden Model. The Harden model is based upon his educational expertise in training physicians. However, Harden et al (1999) observe that preliminary studies suggest that a similar framework can be applied to other professions and that if this is done his work could 19 facilitate development of inter-professional educational programs. Harden uses a three-circle model to classify learning outcomes (Figure 1). Figure 1. The Three-Circle Model for Outcome-Based Education. Adapted from “AMEE Guide No 14: Outcome-based education, part 5: From competency to meta-competency: a model for the specification of learning outcomes, by R.M. Harden, J.R. Crosby, M. H. Davis, & M. Friedman, 1999, Medical Teacher, 21, p. 547. The Harden medical model was selected for several reasons related to the lack of an appropriate nursing model. The first is the dearth of nursing competency assessment frameworks to use with autonomous prescribing and prescriptive authority. In contrast, the ability to competently and autonomously prescribe medications is assumed as a mandatory component of medical education and residency. The second reason is the focus of practice transition models and frameworks for nurses on either administration of medication or episodic prescribing rather than extended pharmacologic management (NCSBN, 2009; ANA, 2004). The third reason is that models that evaluate clinical decision-making at a complex level of practice were developed and evaluated through observation of basic rather than advanced nursing practice (Tanner, 2006; C. 20 Tanner, personal communication August 17, 2009). The Harden model was also selected for its simplicity, utility, and potential application to multiple roles and levels of educational preparation. Harden et al. explicitly articulate use of the model for both other healthcare professionals and for all phases of education including undergraduate, post-graduate and continuing education. The model anticipates transition from one phase to the next as well as life long learning (Harden et al., 1999). A model that can be used for various roles and levels of entry into practice could be useful for implementing competencies developed in response to scope or regulatory changes. A feasible, pragmatic model such as Harden’s may help address the regulatory quandary of how to evaluate a prescribing practicum developed for multiple roles and levels of clinical experience. Harden incorporates twelve outcome competencies into the three-circle model. Seven are task based and are demonstrations of the inner circle. Three describe the approach inherent to the practitioner as he or she enact the inner circle tasks, and are represented in the middle circle. The outer circle represents professionalism and “professional intelligences.” Harden identified his competencies as the following: • Clinical skills. • Practical procedures. • Patient investigation. • Patient management. • Health promotion and disease prevention. • Communication. • Appropriate information handling skills. • Understanding of social, basic and clinical sciences and underlying principles. 21 • Appropriate attitudes, ethical understanding and legal responsibilities. • Appropriate decision-making skills, and clinical reasoning and judgment. • Role of the doctor within the health service. • Personal development. Harden et al. observe that the competencies can be evaluated using flexible methods such as a portfolio or an Objective Structured Clinical Examination (OSCE). The latter is operationalized in the specific curriculum designed by Harden for Dundee, Scotland. Harden is credited with initial development of the OSCE exam (Major, 2005). The OSCE has been used to evaluate student nurses for over 12 years in the United Kingdom (Major, 2005) and is used as a licensure requirement for NPs in British Columbia. The outcome model and its competencies have also been used specifically for a learning initiative in prudent prescribing designed to teach safe and appropriate prescribing of antibiotics (Davenport et al., 2005). The Regulatory Context of Prescribing Privileges U.S. Prescriptive Authority. The regulatory process for granting prescriptive authority in the US is state based and widely divergent. Physicians are always granted prescriptive authority with initial licensure. No research supports or refutes the current regulatory process of granting prescriptive authority to nurses with varying educational requirements, sometimes after years of practice without it. Most states address the perceived discrepancy in educational preparation and prescribing practice experience for health professionals other than physicians by requiring some form of physician supervision or collaboration (Pearson, 2009; Christian, Dower, & O’Neil, 2007; O’Malley & Mains, 2003) though there is no research to support its need. Levels of evidence are defined for the purpose biomedical research by levels in descending order I-V for rigor. Lack of level I (likely reliable) and II (mid-level) studies related to assessment of 22 competence to practice is noted in studies which relate to both medicine and nursing (Vess, 2007), which does not support physician supervision as a proxy for assessing prescribing competency in nurse prescribers. Clinical psychologists have published model guidelines for a postdoctoral experience that includes pharmacology education and supervised clinical practice (APA, 2007) in order to objectively evaluate competency in prescribing. These guidelines were developed in anticipation of expansion of prescriptive authority through legislative changes in scope of practice. There is conflict within the psychology profession, however, regarding whether these guidelines appropriately prepare for autonomous prescriptive authority as opposed to supervised practice (Heiby, 2010). There have been no published validation studies of graduates who added prescriptive authority in autonomous practice to determine if the standards and training are congruent (Heiby, 2010). Prescribing competencies: Nursing. APRN prescribers function in four roles: Certified Nurse Practitioner, Certified Nurse Midwife, Clinical Nurse Specialist, and Certified Registered Nurse Anesthetist (APRN Joint Dialogue, 2008). Nurse prescribers have been authorized in the US for over thirty years, yet there are limited data regarding the important transition to the prescriber role that is specific to nurses. Prescriptive authority legislation was adopted state by state in a piecemeal fashion, often in response to a specific geographic, financial, or political pressure. The most common requirement for obtaining prescriptive authority is completion of a 30 to 45 contact hour pharmacology course (National Council, 2008). The presence of a separate dedicated pharmacology course within current NP programs is evaluated through the degree accreditation process, but is not currently required for the education of nurse midwives. CNS programs may or may not contain pharmacology specific to prescribing. Current American 23 Association of Colleges of Nursing (AACN) guidelines and Commission on Collegiate Nurse Education (CCNE) accreditation criteria do not specify the extent to which programs must demonstrate application of prescribing principles within the educational program (AACN, 1996; CCNE, 2009). National core competencies in all the APRN specialties do not reflect the primacy of prescribing to the APRN role, and are therefore inconsistent with its emphasis in the APRN Consensus Paper (APRN Joint Dialogue, 2008). While practice differs based on individual role, scope and geography, health care reform increases the likelihood that APRNs will play a primary role in their patients’ healthcare, including prescribing (Stanley, Werner, & Apple, 2009). Currently, not all APRNs prescribe and not all see it as a functional role competency. A job analysis comparing the NP and CNS roles was published by the National Council of State Boards of Nursing (NCSBN, 2007) as part of a role delineation study. As of 2007, NPs were far more frequently engaged in all five identified activities related to prescribing and monitoring medications. When asked to rank their activities related to its priority in their practice, NPs ranked four of the five prescribing competencies in their top ten of all activities critical to the performance of their role. CNSs, by comparison, ranked “prescribes medications using principles of pharmacokinetics, drug dosage and routes, indications, interactions and side/adverse effects” as sixty-fourth in importance, and “writes and transmits correct prescriptions to minimize the risk of errors” as sixty-seventh. These differences were statistically significant between the roles and consistently reflected in the job analysis, which included a total of 92 job essential functions (NCSBN, 2007). National consensus core competencies for CNSs from the profession (Baldwin, Clark, Fulton and Mayo, 2009) identify 75 competencies for clinical practice in the role without 24 including one that addresses prescribing, dispensing, administering or even evaluating medications used by individual patients. While this may reflect regulatory ambivalence, CNSs themselves, when given the opportunity to respond to an open ended question asking for recommendations about additional core competencies which should be included, identified that competencies related to prescriptive authority were needed (Baldwin et al., 2009) as did CNSs who practice in psychiatric mental health queried in a large survey of behalf of the American Psychiatric Nurses Association (Delaney et al., 2009). CRNAs also do not have uniform legal recognition of prescriptive authority. In Oregon, as an example, CRNAs may select and administer medications, as well as be the primary person responsible for development of the anesthesia plan, but they do not have prescriptive authority (Oregon Nurse Practice Act 1953/2010). The American Association of Nurse Anesthetists (AANA) is the professional organization responsible for setting professional and practice standards for the CRNA role. CRNAs have a long history of administration and management of medications that often are controlled substances and have a narrow window of safety. While clearly functioning in an autonomous role in most states, CRNAs do not uniformly support prescriptive authority or legal autonomous practice. Perhaps as evidence of this conflict within the role, the most recent position statement on the AANA website which addresses prescriptive authority was written in 1988 (Blumenreich, 1988) and clearly states that what CRNAs do in their daily practice is not “prescribing,” but instead “administering” medications. There are no nationally adopted prescribing competencies for CRNAs. Finally, despite the long history of prescribing by Nurse Practitioners, core competencies which focus on prescribing were reduced in the National Organization of Nurse Practitioner Faculties’ (NONPF) most recent core competency document to one competency: “prescribes 25 medications within legal authorization” (NONPF, 2006). A prior document prepared jointly by the National Council of State Boards of Nursing and the NONPF (Yocom, et al., 1998) identified end of course and end of program competencies in pharmacotherapeutics for new graduates of Family Nurse Practitioner programs only. International prescribing perspectives. Competencies are used as outcomes to guide curricula (Center for Health Policy, March 2008), licensing, and performance evaluation. A literature search was initiated to identify published evidence-based models that addressed the addition of prescribing authority through post-educational attainment of identified competencies. Results revealed data from other countries regarding nurse prescribing, particularly specific to the nurse practitioner role being enacted in Australia, Canada (Registered Nurses Association, 2003), the United Kingdom (U.K.) (Latter, Maben, Myall, and Young, 2007) and New Zealand (Spence & Anderson, 2007). This research was being validated as the prescribing process was being implemented in order to support expansion of practice. No research from other countries was located which described prescribing competencies for the CNS role, though prescriptive authority is available for CNSs in the U.K. (Dean et al., 2004). A difficulty in evaluation of international literature is the discrepancy in role titling and recognition from the APRN role in the U.S. Differences in health care delivery and regulatory structure further support research on evidence-based prescribing in other countries. Data collection is facilitated by single payer government models which use nationalized prescribing networks and formularies. However, despite the advantages that these systems might offer for tracking prescribing patterns and identifying areas for competency development, limitations are still identified by critics. The nurse prescriber role is relatively new to countries outside of the U.S. Maxwell & Walley (2003) 26 describe weaknesses in the prescribing curriculum for physicians in the U.K. resulting from complete integration of clinical pharmacology and therapeutics under curriculum reform in the 1990s. This integration, while useful for promoting interdisciplinary clinical experiences, resulted in a lack of clear learning outcomes and effective assessment specific to safe and effective prescribing. Literature regarding nurse prescribing outside of the U.S. rarely reflects experiences with autonomous nurse prescribing analogous to the U.S. nurse practitioner role. Pulcini, Jelic, Gul & Loke (2010) surveyed ninety one nurses from thirty two countries regarding advanced practice nursing, education, practice and regulation. The survey revealed that while fifteen countries allowed nurses to prescribe, the authority to do so varied widely, and ranged from autonomous prescriptive authority to delegated, site based, or institutional authority. As with the U.S., prescriptive authority has expanded beyond physicians and dentists in other countries. In the U.K. Aronson (2006) discusses the governmental efforts to increase patient access to medications that led to Patient Group Directions. This process is similar to a collaborative agreement that permits pharmacists and nurses to supply medications to patient under a protocol, sometimes without a generated prescription. 27 CHAPTER THREE RESEARCH, DESIGN, AND METHODOLOGY This is an exploratory study designed to identify prescribing competencies for APRNs for the purpose of instrument development and refinement. It involves further analysis of survey data collected by Klein and Kaplan in 2007 to 2008. The further analysis uses both quantitative and qualitative exploratory approaches that allow for across-method triangulation to address research aims and increase the likelihood of uncovering additional constructs specific to prescribing (Williamson, 2005; Lev, 1995). The quantitative component uses data from respondents including nurse educators, NP students, clinical preceptors, NPs with prescriptive authority, and CNSs with and without prescriptive authority. The qualitative component uses both solicited and unsolicited comments from the survey for further content analysis. The final methodology is a Q sort, which provides quantification of subjective evaluation (Brown, et al., 2008). The Q sort is a new component of the research that uses Subject Matter Experts (SMEs) representing regulators, prescribing clinicians, and faculty with expertise in pharmacologic management. Original Study The original study was a quantitative descriptive exploratory study that utilized survey methodology. The sample included faculty, students and clinical preceptors from the Washington State University FNP program; all CNSs licensed in Oregon, most of whom did not have prescriptive authority; and attendees at a NP conference in Oregon who had prescribing experience. The Clinical Practicum in Pharmacological Management Evaluation instrument (see Appendix A for more detail) was developed by this researcher for use in her role as the 28 Advanced Practice Consultant for the Oregon State Board of Nursing. Instrument development was based on a literature review that was expedient and cost efficient for regulatory purposes. Using already validated domains from the American Nurses Association’s Scope and Standards of Practice (2004), pharmacotherapeutic specific competencies were identified from existing U.S. based recommendations for CNSs (Tucker & Rhudy, 2003; NACNS, 2005), NPs (ANCC, 2004; Lecuyer, Desocio, Brody, Schlick & Menkens, 2005); and pharmacists (American Pharmacists Association, 2005; National Association of Boards of Pharmacy, 2006), as well as competencies adopted for national use by pharmacist and nurse prescribers in the U.K. (National Prescribing Centre, 2004). The instrument follows a format already in use by the OSBN to verify completion of a re-entry practicum for registered nurses. The instrument was used as the basis to develop a 42- item questionnaire containing 11 demographic questions and the instrument’s 31 competencies. While the domains identified on the OSBN instrument group the competencies according to seven domains from the ANA Nursing Scope and Standards of Practice (2004), the survey questionnaire listed each competency without identified domains. The version distributed to faculty members contained 10 reverse worded questions and additional comment space soliciting specific input on the instrument itself and its utility. The intent of wording items in the same scale both positively and negatively is to avoid acquiescence, affirmation or agreement bias (DeVellis, 2003). After receiving IRB approval through Washington State University (#09797) (see Appendix B for complete letter), the original survey was mailed to the WSU graduate nursing faculty. Subsequently, the survey was mailed to WSU FNP students and their preceptors, as well as all licensed Oregon CNSs. A second mailing was done one month later to increase the response rate. The survey was later distributed at a regional Nurse Practitioner conference. Study 29 participants were asked to evaluate prescribing competencies using a 5-point Likert scale with responses of not at all essential, neutral, somewhat essential, very important and mandatory. “Mandatory” was defined as: “a nurse should not be granted prescriptive authority without it” (Klein & Kaplan, 2010). Participants were asked to rate the importance of each prescribing competency for safe effective prescribing. One hundred and eighty surveys were returned and included participants from Oregon and Washington. Respondents included CNSs with and without prescriptive authority (n= 88, 59% response rate), NP Faculty (n= 9, 69% response rate), FNP students (n=7, 27% response rate), FNP preceptors (n=20, 39% response rate), and NPs with prescriptive authority (n=56). Results Descriptive statistics were combined to create a content validity index used to rank the competencies in order of identified importance. Once the competencies were ranked, the domains in which the most and least important competencies occurred were analyzed. Comparison between groups was also conducted using the ratings and the rankings (Klein & Kaplan, 2010). Overall, the competencies were assessed within the “very important” range (range= 3.25-3.85). The lowest responses were in the “neutral” range identified for 16 of the competencies. No competency was ranked as “not at all essential.” Descriptive statistics and rankings of competencies in the tool have been published (Klein & Kaplan, 2010). The five highest-ranking competencies included: 1. Determines appropriate drug therapy. 2. Writes clear, legible and complete prescriptions. 3. Prescribes in accordance with current professional codes. 4. Demonstrates competency in drug dosage calculations. 30 5. Interprets tests and identifies client-specific factors. The five lowest ranking competencies were: 1. Assesses client health care risks. 2. Evaluates own practice for continuous improvement. 3. Assesses the client’s therapeutic self-management. 4. Adapts communication style to meet needs of the client. 5. Demonstrates effective working relationship with the health care team. Results indicated differences between CNSs and NPs regarding their valuation of prescribing competencies, and overall lower rankings for the communication domain. The latter finding is of particular concern given the pivotal role that miscommunication plays in medication errors (Board on Health Care Services, 2006). Present Study: Methodology The present study incorporates additional methodology to confirm the previously identified prescribing competencies and their domain placement. Incorporation of qualitative and quantitative (mixed methods) of investigation enhances the feasibility of the instrument for applied regulatory use. Inclusion of feasibility as a criterion is critical for regulation of scope changes (Spector, 2010). Shippmann et al (2000) identify five levels of rigor when evaluating the quality of competency modeling processes. The highest level of methodological investigation includes a variable combination and logically selected mix of multiple methods reflective of the research setting, target population, and intended application (Shippmann et al., 2000). Mixed methods are used widely for tool validation (Benzein et al., 2008; Weis & Schank, 2009; Fisher, King, & Tague, 2001). The current study therefore incorporates principle component analysis (PCA) and the Q Sort as quantitative methodologies and content analysis as a qualitative 31 methodology to further analyze prescribing competencies in the Clinical Practicum in Pharmacological Management Evaluation instrument. A concurrent triangulation strategy incorporates both methodologies equally into analysis of the prescribing competencies (Creswell, 2009). Subject matter experts are used to confirm the revised domains for potential regulatory use. Feasibility analysis is achieved by content analysis of solicited questions specific to the instruments application, which were asked of nursing faculty in the original survey and SMEs in the current study. Content Analysis Method. Content analysis of solicited and unsolicited comments on the original survey contributes to completion of the overall study aim of identifying prescribing competencies that accurately reflect essential entry-level autonomous prescriber outcomes. Content analysis also contributes to competency revision (Sub Aim 2) following PCA, and feasibility analysis of instrument application. Once completed, a final list of competencies and domains are further confirmed under Sub Aim 3 using SME and the Q Sort method. Content analysis is a method that can strengthen validation of prescribing competencies in conjunction with quantitative analysis methods (Marshall & Rossman, 2006; Doyle et al., 2009). Content analysis assists in confirming prescribing competencies by analyzing faculty expert input and the unsolicited comments submitted on the survey instrument. Unsolicited comments contribute to content validation by serving as negative case sampling (Johnson, 1997). Content analysis of the prescribing competencies using feedback provided by APRNs and their preceptors or teachers enhances interpretive validity of the study (Johnson, 1997). Data collection. As noted above, in the original study, WSU faculty were asked to identify whether the competencies listed were at least entry level for advanced practice, whether 32 they were discrete in their wording, and whether there were any competencies missing from the instrument. They were also asked questions specific to utilization of the instrument to evaluate prescribing competency. Suggestions were solicited for refining or modifying the tool for use. Data included both closed and open-ended response items. Participants other than the WSU graduate nursing faculty did not have a comment space for reflective observations and were not asked to comment on the questionnaire itself or the text of the competencies. However, there were a number of unsolicited comments. A total of 45 solicited and unsolicited comments were obtained but not analyzed in the initial analysis of the original study. Validity. Lincoln and Guba (1985) identify four criteria for establishing trustworthiness of data: credibility, dependability, confirmability, and transferability. Credibility of the original survey data was established in several ways. The first was generating a research partnership between experts at Washington State University and the Oregon State Board of Nursing. The second was method triangulation using both quantitative and qualitative data collection. The third was the study sampling technique that explored perspectives on prescribing by soliciting input from prescribers, non-prescribers, faculty, preceptors and students, all of whom had a potentially different view and experience of prescribing. Dependability of the data is addressed through content analysis for thematic congruency. Confirmability and transferability is addressed through tool revision and recommendations for further study. Content analysis addresses the overall Study Aim, Sub Aim 2, and contributes to development of the Q sort process. Content analysis is a method that can strengthen validation of prescribing competencies in conjunction with quantitative analysis methods (Marshall & Rossman, 2006; Doyle et al., 2009). Content analysis also assists in confirming prescribing 33 competencies by analyzing faculty expert input and the unsolicited comments submitted on the survey instrument. The inclusion of unsolicited comments contributes to content validation by serving as negative case sampling since participants felt strongly enough about wording or content of specific survey items that they submitted comments about them even when they were not asked for their opinion (Johnson, 1997). Content analysis of the prescribing competencies using feedback provided by APRNs and their preceptors or teachers also enhances interpretive validity of the study (Johnson, 1997). Validation can be viewed as supporting potential use and interpretation of the prescribing competencies and their relevance to proposed use. As validation proceeds, revision to the instrument may be indicated, as well as to the conceptual framework that shapes it (American Educational Research Association, American Psychological Association & National Council on Measurement in Education, 1999). Analysis. The solicited and unsolicited comments were entered verbatim into a Word document. The comments were further sorted into thematic categories for analysis by the researcher in conjunction with the dissertation committee. Final category placement was done through e-mail consultation with two qualitative methods researchers who conduct research on APRNs and prescribing. Each was initially asked to individually review the researcher’s established categories with the option of providing additional categories if none were appropriate. The researcher did revision of the categories, with a final coding process using the two consultants to independently code the comments into the thematic categories provided. In addition to content coding, Consultants were also asked to independently analyze comments for 34 “feeling tone” to incorporate a dimension of the latent level (non-verbatim) of participant response (Fox, 1976; Hseih & Shannon, 2005). Accuracy of content analysis is dependent upon checking reliability of the coding process (Bowen & Bowen, 2008). Stability and reproducibility are the primary types of reliability that can be calculated through identification of observed agreement (Bowen & Bowen, 2008). Final analysis is documented in a narrative format with percentage agreement calculations provided. A kappa coefficient of greater than 0.61 indicates substantial strength of agreement (Bowen & Bowen, 2008), however, there is no set agreement regarding how much inter-coder agreement is “enough” (Bernard & Ryan, 2010). Fair to moderate agreement of kappa (0.21-0.60) may be adequate for the purpose of contributing to tool revision for further analysis by a wider number of experts. Principle Component Analysis Method. The primary study aim is to identify prescribing competencies and domains that accurately reflect entry-level autonomous prescriber outcomes. Sub Aim 1 is to identify prescribing competencies that may be removed or modified to strengthen the reliability of the instrument. Both are addressed through principle component analysis. Principle component analysis (PCA) is generally identified as a type of factor analysis but there are important differences between the two as analytic techniques (DeVellis, 2003). The primary goal of PCA is to represent a large set of observed variables by a smaller set while still preserving the essential original information (Zwick & Velicer, 1982). This is achieved by reducing the total number of factors (Julnes, 2008; Zwick & Velicer, 1982). PCA is used to reorganize variables into actual items. In this study, variables are the previously identified 31 prescribing competencies. The items obtained through PCA were subsequently 35 renamed and organized into domains. Factor analysis, in contrast, is an estimate of a hypothetical variable ranking and does not reflect real items (DeVellis, 2003). While both can be used to analyze domain placement of competencies, the use of factor analysis in this study could result in categorizing variables together because they are equally “important” in the eyes of the expert panel, rather than because they each represent the same actual domain construct. Another significant difference is that in PCA all sources of variability are analyzed for each observed variable, whereas in factor analysis only shared variability is analyzed and unique and error variance is ignored (Mertler & Vannatta, 2002). PCA is the preferred method when the focus of analysis is exploratory (Mertler & Vannatta, 2002). PCA further contributes to Sub Aim 2, revising the domains into which prescribing competencies can be categorized, by identifying items that do not clearly represent the construct for domain inclusion. Items are selected for domain inclusion based upon their numerical scores under each factor heading. Items whose scores split equally between two factors (cross loading) or have a weak factor loading likely do not adequately reflect their construct and should be removed or revised (Thompson & Daniel, 1996). Final determination of domains requires synthesis of analytic data and subject matter expert (SME) input in order to address Sub Aim 3 and is discussed below. As noted by Julnes (2008), choosing the number of principle components to include in the analysis is not objective “and represents a tension between parsimony and retention of the information contained in the original variables.” Reliability. Components with four or more loadings above .60 in absolute value are reliable, regardless of sample size (Stevens, 1992). Components with approximately 10 or more low loadings defined as less than .40 are reliable as long as the sample size is greater than 150 (Stevens, 1992). In this study, the survey sample size of 170 supports use of .40 as the lowest 36 cutoff point for factor loading, since the final number of components is unknown. Zwick and Velicer (1982) and Linn (1968) support .40 as the lowest limit for factor loading, therefore those items scoring below .40 are too weak for domain placement. Bartlett’s sphericity test should also be used if sample sizes are small (Mertler & Vannatta, 2001). Reliability can be further assessed through evaluation of the internal consistency of the scale using Cronbach’s alpha. Items that rate lower than .70 should be dropped from the final SME analysis. DeVellis (2003) also observes that multiple items much above .90 should invite consideration of shortening the scale, though scales intended for employment or academic purposes should have a higher level of reliability “in the mid-90s.” Analysis. PASWStatistics 18.0 was used to conduct PCA for initial variable reduction and to prepare for SME domain categorization. Mertler & Vannatta (2001) identify four criterion for factor retention: (a) Eigenvalues greater than one; (b) a scree test that identifies eigenvalues in descent before a visual leveling off; (c) factors that account for at least 70% of total variance; and (d) path analysis for goodness of the model fit. Mertler & Vannatta (2001) advise using more than one criterion to achieve maximal parsimony. Orthogonal varimax rotation was also used due to the exploratory nature of the data (Mertler & Vannatta, 2001). Initial factor extraction provided eigenvalues and a scree plot. The scree plot results determine how many factors to submit to factor rotation, suggesting retention of all factors in sharp descent before the eigenvalues level off (Green & Salkind, 2008). Retained factors were submitted to varimax rotation and Bartlett’s sphericity testing. A correlation matrix was also generated to provide visual representation of the 31 competencies for analysis and reduction of factors (Green & Salkind, 2008). Final correlations were calculated using Cronbach’s alpha. 37 Items greater than .70 were retained, with repeat analysis of Cronbach’s after removal of outliers (DeVellis, 2003). Final Cronbach’s reliability criteria are discussed in the results section. The final number of factors was initially represented in a grid using a numerical title: Factor 1, Factor 2, etc. A list of the competencies with their accompanying loading percentage number from the PCA results, minus those that have been deleted as unreliable or weak per the stated criteria was generated under each heading. A suggested domain name was then provided for each factor by the researcher according to theoretical categorization that is thematically grouped. There is no standardized method to conduct this process as its initial methodology is subjective (J. Budden, personal communication, July 9, 2010; Mulaik, 1987; Bowen & Bowen, 2008). Category generation for this study is grounded in competency and clinical decisionmaking theory found in review of both nursing and medical literature. Members of the dissertation committee served as expert reviewers and were asked via Survey Monkey ™ to confirm three criteria: (a) agreement that domain names represent discrete concepts; (b) agreement that domain names represent role appropriate categories for prescribers generally; and (c) agreement that domain names are desired traits for prescribers. Results of the Survey Monkey ™ were used in conjunction with content analysis to develop the Q sort survey including final domains and revised competencies for SME review. Q Sort Method. Using Q sort methodology, Subject matter experts (SMEs) were asked to evaluate the prescribing competencies that remained after PCA and content analysis. The purpose was to confirm sorting of competencies into appropriate domains (Sub Aim 3). The Q sort methodology involves the following components: (a) identification of the topic of interest; (b) creating a sample of the concourse of the topic; (c) selecting the people of interest to carry 38 out the sort; (d) administering the sort; (e) conducting a statistical analysis of the completed sort; and (f) interpreting the Q factors that emerge from the analysis (Brown, Durning & Seldon, 2008). Content for the Q sort consists of revised competencies and domains determined during the current study’s qualitative and quantitative analyses. Results were further analyzed to confirm or correct domain placement using descriptive analysis. Data collection. A diverse panel of subject matter experts (SME) was recruited initially by email to verify their inclusion criteria and interest in participation. The selection process yielded a purposive sample of SME with pharmacologic and/or prescribing expertise outreach to members of the American Academy of Nurse Practitioners Fellows and NCSBN APRN internal list serves. Additional experts were identified through an internal list serve for experienced faculty teaching NP certification review and continuing education courses, including pharmacology. Confirmation of expert panel participation was done by the researcher in consultation with the dissertation committee, by sending identified subject matter experts an email attachment letter confirming their eligibility to participate (see Appendix C for complete letter). Representation on the panel included two regulators affiliated with state boards of nursing and familiar with authorization of prescriptive authority for APRNs; two nurse practitioner educators who teach pharmacology to family or adult NP students; and four expert clinicians who have been prescribing medications for a minimum of five years. Some participants met more than one category of inclusion, as indicated on their demographic profile. For example, a nurse regulator could also have a clinical practice in which they actively prescribed. Inclusion criteria specified that all participants were required to indicate that they hold current unencumbered prescriptive authority, and have had prescriptive authority as an APRN for at least five years. 39 The researcher entered revised domains and the final 29 competencies that remained after revision and PCA into the Q-Assessor online program. The Q-Assessor survey was piloted with the dissertation committee and with Dr. Jill Budden, a psychometrician from the National Council of State Boards of Nursing. Participants were then sent a letter of consent (see Appendix D for complete letter), and provided a dedicated email link to Q-Assessor (http://q-assessor.com) to individually complete a series of questions regarding the revised competencies and the revised domains. Q-Assessor was configured to capture basic demographic questions as well as three open ended responses. Additionally, Q sort technique (Cross, 2005) was used to ask experts to re-sort the competencies into identified domains using a forced sort technique for goodness of fit. Experts were asked if there were any aspects of the competencies or domains missing using the open-ended response option. The process is not iterative and does not require consensus. Analysis. The final data analysis of SME input is critical to interpretation of the PCA and content analysis. One of the primary criticisms of PCA as a methodology is its indeterminacy. However, such indeterminacy need not be a flaw (Mulaik, 1987). Exploration of appropriate prescribing outcomes will be bounded in the context of role and practice, and their identification is therefore by nature exploratory as scope of practice evolves for nurse prescribers. The nature of the data itself involves attitudinal assessment and judgment. As noted by Mulaik (1987), the focus of analysis is that whatever inferences we do form from data with inductive methods must be evaluated with additional confirmation. Q methodology can be used to extract subjective opinion and evolved from factor analytic theory (Cross, 2005). Analysis of the Q sort involves interpretation of resulting positioning of competencies into domains. Descriptive statistics were obtained through Q-Assessor data. Results are presented in table format with final domain categories and competencies. Comparative analysis 40 includes agreement between researcher and expert domain placement, and comparison of perspectives between experts. Several comments obtained from SMEs were incorporated into recommendations for further instrument refinement. 41 CHAPTER 4 RESULTS Sample Description Participants were solicited for two parts of the present study: content analysis and Q sort analysis. Content analysis was achieved using two experts with extensive expertise in research on APRN prescribing as well as teaching nurse prescribers at the university level. Both are Washington licensed ARNPs in active clinical practice, each having over 20 years of experience as a prescribing nurse practitioner. One expert is certified as a family nurse practitioner and has specialty training as a women’s health care nurse practitioner, while the second is a family nurse practitioner. Content analysis of overall participant comments was also utilized by the researcher for final domain revision. Q sort analysis was done as the final stage of the study using experts solicited for their expertise in one or more areas of pharmacotherapeutics. Consent to participate was obtained (see Appendix D for complete letter) and participants were informed of criteria which would make them ineligible to participate in the study. All experts were required to have expertise in one or more areas of pharmacology and have current unencumbered prescriptive authority. Experts could have expertise in more than one area (such as regulation and teaching). Table 1 Demographic Information: Subject Matter Experts (n=8) Mean= 54.8 years Age Sd= 7.3 years Range= 44-65 42 APRN Licensure NP= 6 NP and CNS= 2 Total Number of Years of Clinical Mean= 19 years Practice Sd= 6.4 years Range= 10-27 years Total Number of Years of Prescriptive Mean= 18.75 Authority Sd= 5.4 years Range= 12-27 years DEA Number (Yes/No) Yes= 6 No= 2 State(s) of current licensure State(s) of current practice Licensed Practice Alaska 1 1 Arizona 2 1 Idaho 1 1 Iowa 1 1 Massachusetts 1 1 Oregon 1 1 Texas 1 1 Department of Defense a 1 a SME is licensed in Arizona but may practice within the Department of Defense in multiple states under one license as per federal law. 43 Area of Expertise Nursing regulation n=2 Research n=0 Prescribing law/policy n=2 Pharmacologic management of n=7 patients n=4 Teaching pharmacology to APRNs n=5 Faculty supervision of APRN students seeking prescriptive authority n=2 Other • Faculty for pharmacy and family practice medicine residents • Department of Defense Military Content Analysis Findings Original survey: Reflections of faculty and participants. Comments were distributed across the survey as follows. Questions specific to tool design and use were asked on the faculty questionnaire only and are noted as 1-10A. All participants were asked to rate the competencies for level of importance to autonomous prescriptive authority. Table 2 Comments: All Participants Competency Accurately performs a comprehensive, problemfocused, or interval medical history including current and previous diseases or conditions. 44 Number of Comments 1 Assesses client health care risks including environmental, cultural, educational and other risks which may impact therapeutic decision-making. Collects and documents data appropriate to individual client’s health needs. Assesses the client’s therapeutic self-management including any use of complementary/alternative therapies. Documents and validates data from patient interview and comprehensive evaluation of available clinical information regarding client’s physical and overall health status. Establishes and documents medical diagnosis and appropriate differential diagnosis to serve as basis for pharmacological management. Interprets client information including laboratory and diagnostic testing and identifies client-specific factors which determine pharmacologic management planning. 1 Interprets and applies pharmacokinetic, pharmacodynamic, and pharmacogenomic principles in evaluation and selection of drug therapy. Critically analyzes prescribing standards, references, and decision support tools to provide evidence-based recommendations to clients which optimize clinical efficiency. Plans drug regimens which consider interactions, expected effects and potential side effects, client characteristics, illness and co-morbidity, absorption, distribution, metabolism and excretion and cost or accessibility to patient. 4 Determines appropriate drug therapy including dose, dosage form, route and frequency of administration. 1 Considers no treatment, non-drug and drug treatment options and refers as indicated. 0 Identifies and validates client-specific needs while incorporating informed consent from client or health care representative regarding treatment planning. 0 45 0 1 1 2 1 4 1 Prioritizes and develops treatment plan in accordance with mutually agreed upon client/provider goals. 0 Writes clear, legible, and complete prescriptions which comply with state and federal regulations. 1 Demonstrates competency in drug dosage calculation. 4 Uses appropriate references and consultation to implement drug regimens (may include collaboration as appropriate). 0 Prescribes based on knowledge of pharmacological and physiological principles. 0 Provides client specific education regarding use of medication and anticipated effects including cautions. 1 Monitors the safety and efficacy of drug therapy treatment plan. 1 Modifies treatment plan as appropriate based upon therapeutic outcome and response. 1 Incorporates and orders periodic lab testing or monitoring as indicated. 1 Demonstrates effective working relationship with other members of healthcare team including collaboration, consultation, and referral resources. 0 Demonstrates ownership of and responsibility for the welfare of the client by providing safe, effective, and appropriate care specific to the Nurse Practitioner or Clinical Nurse Specialist role and scope of practice. 8 Evaluates own practice for continuous improvement opportunities. 0 Provides ethical care for clients including but not limited to incorporating principles of confidentiality, patient self-determination, and 2 46 Provides ethical care for clients including but not limited to incorporating principles of confidentiality, patient self-determination, and issues related to use of information technology. 2 Prescribes in accordance with current professional codes of practice and standards. 0 Adapts communication style to meet the needs of the client regarding pharmacologic treatment and recommendations. 0 Gives clear written and/or verbal instruction to clients regarding obtaining, using, and monitoring their medications. 0 2 Protects sensitive client communications while enhancing therapeutic information sharing. Accurately and promptly records clinical notes which reflect client assessment and pharmacological management plan. 0 General Comments 5 Total 48 Faculty Specific Responses The graduate nursing faculty from WSU (n= 9) received an additional section in the original survey (1A-10A) for solicited comments that focused specifically on the content of the competencies and the utility of the tool. They were asked to rate each question on a scale of 1-5 with 5 being strong agreement and 1 being strong disagreement. Responses were as follows: 47 Table 3 Faculty Specific Additional Questions Question Response 1A. The tool will be useful for evaluation of students. Strongly Agree= 2 Agree= 4 Not Sure= 3 Disagree=0 Strongly Disagree= 0 Strongly Agree= 2 Agree= 2 Not Sure= 4 Disagree= 1 Strongly Disagree=0 Strongly Agree= 3 Agree= 2 Not Sure= 3 Disagree= 1 Strongly Disagree=0 Strongly Agree= 2 Agree= 6 Not Sure= 1 Disagree= 0 Strongly Disagree=0 Strongly Agree= 0 Agree= 5 Not Sure= 1 Disagree= 2 Strongly Disagree=1 Strongly Agree= 1 Agree= 5 Not Sure= 2 Disagree= 1 Strongly Disagree=0 Strongly Agree= 0 Agree= 5 Not Sure= 0 Disagree= 4 Strongly Disagree=0 Strongly Agree= 1 Agree= 7 Not Sure= 1 Disagree= 0 Strongly Disagree=0 2A. The tool will be useful for already practicing Nurse Practitioners seeking prescriptive authority. 3A. The tool will be useful for already practicing Clinical Nurse Specialists seeking prescriptive authority. 4A. The tool is easy to administer. 5A. The tool has too many items for evaluation. 6A. The competencies can be evaluated through direct observation of the student or Advanced Practice Nurse. 7A. The competencies listed in the tool contain many similar items which are not clear and distinct from one another. 8A. Competencies reflect at least entry level prescribing skills and behaviors. 48 Weighted mean 3.8 3.5 3.8 4.1 3.1 3.6 3.1 4.0 9A. The competency checklist will take too long for users to complete. 10A. There are important competencies for prescribing which are missing from the tool. Strongly Agree= 0 Agree= 3 Not Sure= 1 Disagree= 5 Strongly Disagree=0 Strongly Agree= 0 Agree= 0 Not Sure= 3 Disagree= 5 Strongly Disagree=0 Missing= 1 2.7 2.4 Independent Review Using Two Experts Two data points, content and tone of comments, were obtained from the independent reviewers further analyzing verbatim feedback on the survey instrument. Comments were reflected as obtained from both faculty and participant input, and therefore contained opinions of both the content of the competency and the use of the tool. Using a coding key representing both content and tone, each rater was asked to use the supplied code and was given the option of suggesting a new code if she determined it necessary to describe the content. Each rater was supplied with a code for tone ranging from 1-5 with the following legend: • 1= positive • 2= positive and negative (mixed) • 3=neutral • 4= negative • 5= unable to determine When coding for tone of survey responses, there were a total of 50 usable codes with 72% (n=36) agreement. The majority of comments were coded as “neutral” (n= 28). There was 49 minimal discordance related to tone when the reviewers disagreed, with the bulk of variance between neutral and negative (n=7). Kappa = .70 indicating very high inter-rater agreement. Codes were broken down as follows: Table 4 Tone Score Comparisons Score 3/3 3/4 4/4 4/3 3/2 1/1 1/2 2/2 5/4 Total Number 28 7 5 3 2 2 1 1 1 Content coding was done independently by each reviewer using a coding sheet provided by the researcher. Reviewers were asked to provide additional codes if they felt the provided codes were not an accurate fit. Eleven topic codes were offered with an additional ten codes generated by the reviewers for a total of 21. The results were calculated as a free marginal Kappa with a total of 0.36, indicating fair agreement on the initial coding run. A list of new and old topic codes was developed in order to refine the coding schema. Initial exclusion decisions for coding included codes which were not used by either reviewer (n=0) or codes that had zero use by at least one reviewer (n=4). Based upon initial categorization the following topic codes were identified as the most discordant between the two reviewers:  Not all parts equally important  May require assistance from colleagues  Reflection on competence of others  Reflection on legal authority 50 Initial independent coding by two content experts resulted in the generation of 11 new codes. The following new codes were suggested by reviewers, and were analyzed further for congruence with the original thematic categories:  Elaborating the competencies in a supportive way  Multiple competencies in item  Grammatical correction  Affirming importance  Pertains to some specialties but not others  Questioning accuracy of the tool  Questions/challenges use of the tool  Explanatory comment  Emphatic agreement  Delegation  Collaboration Coder Reliability. Codes were selected for revision. The first step was to identify codes that received no selection by at least one expert. These codes were marked for recoding into an existing concept, a newly suggested concept, or potential removal if both experts did not use them at all. Tone codes were not repeated in the second code run since they achieved a substantial Kappa of 0.70 in the first run. Recoding also involved determination by the researcher regarding the subject themes of the codes generally. New and revised codes were examined to see if they fit into the initially identified themes of comments:  Question itself 51  Tool  Competency  Reflective observation on prescribing practice All revised codes were congruent with the original theme areas, however, there were unique concepts identified by the researcher that were monitored for further analysis, including those of “delegation” and “collaboration” which were identified by the original survey participants as notations on the competencies which seemed to imply they should be added. A set of revised codes was then supplied to each reviewer for a second round of independent coding. Table 5 Content Code Description with Frequency of Use Code Reviewer 1 QW- Question uses poor 9 wording or grammar CC-Disagreement with a 7 concept in the competency Reviewer 2 10 CU- Competency is unrealistic CD-Competency may require collaboration or delegation CS-Competency pertains to some specialties but not others CA-Competency is missing CNP-Competency not limited to prescribing CMI- Competency contains multiple concepts/ideas RCS-Reflection: evaluating own competence 6 4 0 6 2 2 0 0 2 3 5 5 1 1 5 52 REA- Reflection: emphatic agreement RAI- Reflection: affirming the importance of the competency RES- Reflection: elaborating the competency in a supportive way REC- Reflection: explanatory comment TA- Questioning tool accuracy TU- Questioning tool utility TI- Questioning tool practicality 1 (marked REA/CA) 0 3 7 3 0 9 6 0 0 3 1 2 2 The greatest discrepancies between reviewers were for the concepts expressed in CD (0/6), RAI (3/7), RES (3/0), REC (9/6) and TU (3/1). Of particular note is that one reviewer did not use CD or RES at all. Comments coded CD (Competency may require collaboration or delegation) by the first reviewer were coded by the second reviewer as CC (1), RES (2) or REC (3). Competencies coded RES by the first reviewer were coded CD (2) or RAI (1) by the second reviewer. The code RAI (“Reflection: Affirming importance of the competency”) was established as a way to express a supportive stance towards incorporation of the competency. However, experts differed in 6 instances regarding their interpretation of when this was the emergent concept in comments. The code REC (“Reflection: Explanatory comment”) was frequently chosen by both reviewers but differed in 7 instances. Finally, the code TU (“Questioning tool utility”) was used with 2 instances of disagreement out of the 3 times noted. The following code was not used by either reviewer: TA (“Questioning tool accuracy”). The repeat free-range kappa was 0.40, an increase of 0.04 points from the first run. By most 53 agreement standards this still ranks in the “fair” (0.21-0.40) category (Bernard & Ryan, 2010) but is not a significant increase from the first coding run. Principle Component Analysis Findings PCA contributes to both reduction and placement of competencies into domains. Reliability statistics were initially evaluated for all items using Cronbach’s alpha. In the content analysis phase of this study one competency was repeatedly identified by participants as problematic (n=8 comments) and was therefore identified for removal: “Demonstrates ownership of and responsibility for the welfare of the client by providing safe, effective, and appropriate care specific to the Nurse Practitioner or Clinical Nurse Specialist role and scope of practice.” Participants particularly objected to the term “ownership” and the tone of the competency wording which some felt was “paternalistic.” No item individually ranked lower than .70. Table 6 Cronbach’s Alpha All Items Cronbach's Alpha .878 Cronbach's Alpha Based on Standardized Items .958 N of Items 31 Table 7 Cronbach’s Alpha with Ownership Competency Removed Cronbach's Alpha Cronbach's Alpha Based on Standardized Items .959 .961 N of Items 30 54 Although a Cronbach’s of .878 is considered acceptable, the decision was made to acknowledge the potential regulatory impact of the competency use in targeting a range of the 90s for acceptable reliability. As previously noted, DeVellis (2003, p.96) states that multiple items much above .90 should invite consideration of shortening the scale, though scales intended for employment or academic purposes should have a higher level of reliability “in the mid-90s.” The final decision to remove the problematic competency achieved a Cronbach’s of .959 with a total of 30 items remaining. Principle Component Analysis was then conducted using PASWStatistics 18.0. Using prior identified criteria of factor component retention for those factors which are .40 or higher (Zwick & Velicer 1982; Linn, 1968), a matrix of factors was developed for review with the dissertation committee with headings and factor loading scores. There were four competencies that cross loaded between two domains: 1. Monitors the safety and efficacy of drug therapy treatment plan. (.548, Factor 1; .545 Factor 3) 2. Protects sensitive client communications while enhancing therapeutic information sharing. (.570, Factor 1; .568 Factor 2) 3. Plans drug regimens which consider interactions, expected effects and potential side effects, client characteristics, illness and co-morbidity, absorption, distribution, metabolism and excretion and cost or accessibility to patient. (.522 Factor 2; .583 Factor 3) 4. Prescribes based on knowledge of pharmacological and physiological principles. (.505, Factor 3; 507, Factor 4) 55 SurveyMonkey ™ was used with the dissertation committee to determine if cross loading factors should be retained, reworded, or reorganized within their domains. Domain names were initially developed by the researcher and then confirmed by the committee after the PCA had been completed. Based upon committee feedback, one domain was reworded to less resemble its preceding domain. See Table 9 for final competencies and domains after completion of PCA. Changes made to the competencies included reduction and wording clarification. Changes made to the domains included domain naming, and domain relocation for competencies which loaded similarly between two domains. Competencies were ordered in placement for sequential flow, with the understanding that the Q sort results would revise and reorder the competencies based upon SME input. The dissertation committee identified too much similarity between “clinical reasoning” (Factor 3) and “clinical decision-making” (Factor 4) in the initial naming process. The domain name “clinical decision-making” was subsequently changed to “clinical management” to help distinguish the two domains and emphasize that pharmacologic prescribing includes ongoing management and evaluation (Davenport et al, 2005; Harden et al, 1999; DeVries, Henning, Hogerzeil & Fresle, 1994). Table 8 Initial Factors in Principle Component Analysis with Loadings Factor Adapts communication style to meet the needs of the client regarding 1 pharmacologic treatment and recommendations. (.677) Writes clear, legible, and complete prescriptions which comply with state and federal regulations. (.572) Provides client specific education regarding use of medication and anticipated effects including cautions. (.510) Monitors the safety and efficacy of drug therapy treatment plan. (.548) Evaluates own practice for continuous improvement opportunities. (.653) 56 Provides ethical care for clients including but not limited to incorporating principles of confidentiality, patient self-determination, and issues related to use of information technology. (.653) Prescribes in accordance with current professional codes of practice and standards. (.677) Gives clear written and/or verbal instruction to clients regarding obtaining, using, and monitoring their medications. (.668) Accurately and promptly records clinical notes which reflect client assessment and pharmacological management plan. (.760) Protects sensitive client communications while enhancing therapeutic information sharing. (.570) Demonstrates effective working relationship with other members of healthcare team including collaboration, consultation, and referral resources. (.710) 57 Factor Critically analyzes prescribing standards, references, and decision support tools to 2 provide evidence-based recommendations to clients which optimize clinical efficiency. (.546) Assesses client health care risks including environmental, cultural, educational and other risks which may impact therapeutic decision-making. (.506) Collects and documents data appropriate to individual client’s health needs. (.504) Assesses the client’s therapeutic self-management including any use of complementary/alternative therapies. (.550) Documents and validates data from patient interview and comprehensive evaluation of available clinical information regarding client’s physical and overall health status. (.678) Plans drug regimens which consider interactions, expected effects and potential side effects, client characteristics, illness and co-morbidity, absorption, distribution, metabolism and excretion and cost or accessibility to patient. (.522) Identifies and validates client-specific needs while incorporating informed consent from client or health care representative regarding treatment planning. (.605) Prioritizes and develops treatment plan in accordance with mutually agreed upon client/provider goals. (.651) Protects sensitive client communications while enhancing therapeutic information sharing. (.568) Factor Plans drug regimens which consider interactions, expected effects and potential side 3 effects, client characteristics, illness and co-morbidity, absorption, distribution, metabolism and excretion and cost or accessibility to patient. (.581) Accurately performs a comprehensive, problem-focused, or interval medical history including current and previous diseases or conditions. (.547) Interprets client information including laboratory and diagnostic testing and identifies client-specific factors which determine pharmacologic management planning. (.735) Interprets and applies pharmacokinetic, pharmacodynamic, and pharmacogenomic principles in evaluation and selection of drug therapy. (.419) Establishes and documents medical diagnosis and appropriate differential diagnosis to serve as basis for pharmacological management. (.454) 58 Prescribes based on knowledge of pharmacological and physiological principles. (.505) Determines appropriate drug therapy including dose, dosage form, route and frequency of administration. (.690) Monitors the safety and efficacy of drug therapy treatment plan. (.545) Factor Demonstrates competency in drug dosage calculation. (.504) 4 Uses appropriate references and consultation to implement drug regimens (may include collaboration as appropriate). (.645) Prescribes based on knowledge of pharmacological and physiological principles. (.507) Modifies treatment plan as appropriate based upon therapeutic outcome and response. (.517) Incorporates and orders periodic lab testing or monitoring as indicated. (.536) Considers no treatment, non-drug and drug treatment options and refers as indicated. (.658) Delete Demonstrates ownership of and responsibility for the welfare of the client by providing safe, effective, and appropriate care specific to the Nurse Practitioner or Clinical Nurse Specialist role and scope of practice. 59 Table 9 Final Domains and Competencies Factor 1: Writes clear, legible, and complete prescriptions that comply with state and federal regulations. Safety Prescribes in accordance with current professional codes of practice and standards. Demonstrates ethical care for clients regarding confidentiality, self-determination, and issues related to use of information technology Prescribes based on knowledge of pharmacological and physiological principles. Demonstrates competency in drug dosage calculation. Provides client specific education regarding obtaining, using, and monitoring of medication including cautions or anticipated side effects. Adapts communication style to meet the needs of the client regarding pharmacologic treatment and recommendations. Accurately and promptly records clinical notes that reflect client assessment and pharmacological management plan. Demonstrates effective working relationship with other members of healthcare team including collaboration, consultation, and referral. Monitors the safety and efficacy of drug therapy treatment plan. Factor 2: Client Specific Assessment Evaluates own practice for continuous improvement opportunities. Critically analyzes prescribing standards, references, and decision support tools to provide evidence-based recommendations to clients which optimize clinical efficiency. Assesses client health care risks including environmental, cultural, educational and other risks that may impact therapeutic decision-making. Assesses the client’s therapeutic self-management including any use of complementary/alternative therapies. Collects and documents data appropriate to individual client’s health needs. Identifies and validates client-specific needs while incorporating informed 60 consent from client or health care representative regarding treatment planning. Documents and confirms data from patient interview and comprehensive evaluation of available clinical information regarding client’s overall health status. Prioritizes and develops treatment plan in accordance with mutually agreed upon client/provider goals. Protects sensitive client communications while enhancing therapeutic information sharing. Factor 3: Clinical Reasoning Accurately performs a comprehensive, problem-focused, or interval medical history including current and previous diseases or conditions. Interprets client information including laboratory and diagnostic testing and identifies client-specific factors which determine pharmacologic management planning. Establishes and documents medical diagnosis and appropriate differential diagnosis to serve as basis for pharmacological management. Interprets and applies pharmacokinetic, pharmacodynamic, and pharmacogenomic principles in evaluation and selection of drug therapy. Plans drug regimens which consider individual patient characteristics such as absorption, distribution, metabolism and excretion, comorbidity, drug cost or accessibility. Determines appropriate drug therapy including dose, dosage form, route and frequency of administration. Factor 4: Uses appropriate references and consultation to implement drug regimens (may include collaboration as appropriate). Clinical Management Modifies treatment plan as appropriate based upon therapeutic outcome and response. Incorporates and orders periodic lab testing or monitoring as indicated. Considers no treatment, non-drug and drug treatment options and refers as indicated. 61 Q Sort Findings The Q sort was conducted using the online program Q-Assessor. Participants were sent a dedicated link which enabled them to sort competencies into the four categories. The results of the Q sort provided descriptive data as well as open-ended responses. The process of Q sorting followed a forced sort process where participants were provided a set number of domain spaces based upon PCA results. In accordance with the PCA results, domain placement was not forced into a normal distribution pattern. Each participant was instead instructed to sort the competencies one by one into the “best” fit while using all provided domain spaces as a forced sort configuration. Table 10 Q Sort Results Competency Original Domain Expert Domains Writes clear, legible, and complete prescriptions that comply with state and federal regulations. Safety Safety Assessment Reasoning Management 6 0 0 2 Prescribes in accordance with current professional codes of practice and Safety Safety Assessment Reasoning Management 2 0 5 1 62 Expert Agreement with Original Domain/ Agreement Among Experts 75%/75% New Domain 25%/62% Reasoning Safety standards. Demonstrates Safety ethical care for clients regarding confidentiality, self-determination, and issues related to use of information technology Safety 0 Assessment 2 Reasoning 4 Management 2 0%/50% Reasoning Assessment/ Management Prescribes based on knowledge of pharmacological and physiological principles. Safety Safety 5 Assessment 0 Reasoning 2 Management 1 62%/62% Safety Demonstrates competency in drug dosage calculations. Safety Safety 8 Assessment 0 Reasoning 0 Management 0 100%/100% Safety Provides client specific education regarding obtaining, using, and monitoring of medication including cautions or anticipated side effects. Adapts communication style to meet the needs of the client regarding pharmacologic treatment and recommendation. Accurately and promptly records clinical notes that reflect client assessment and pharmacological Safety Safety 6 Assessment 0 Reasoning 1 Management 1 75%/75% Safety Safety Safety 1 Assessment 6 Reasoning 1 Management 0 12.5%/75% Assessment Safety Safety 3 Assessment 4 Reasoning 1 Management 0 37%/50% Assessment/ Safety 63 management plan. Demonstrates effective working relationship with other members of healthcare team including collaboration, consultation, and referral. Safety Safety 0 Assessment 0 Reasoning 2 Management 6 0%/75% Management Monitors the Safety safety and efficacy of drug therapy treatment plan. Safety 5 Assessment 1 Reasoning 1 Management 1 62%/62% Safety Evaluates own practice for continuous improvement opportunities Safety Safety 2 Assessment 0 Reasoning 5 Management 1 25%/62% Reasoning Critically analyzes prescribing standards, references, and decision support tools to provide evidence-based recommendations to clients which optimize clinical efficiency. Client Specific Assessment Safety 4 Assessment 0 Reasoning 3 Management 1 0%/50% Safety/ Reasoning Assesses client health care risks including environmental, cultural, educational and other risks that may impact therapeutic decision-making. Client Specific Assessment Safety 2 Assessment 5 Reasoning 0 Management 1 62%/62% Assessment 64 Assesses the client’s therapeutic selfmanagement including any use of complementary/alt ernative therapies. Client Specific Assessment Safety 2 Assessment 5 Reasoning 0 Management 1 62%/62% Assessment Collects and documents data appropriate to individual client’s health needs. Client Specific Assessment Safety 5 Assessment 3 Reasoning 0 Management 0 37%/62% Safety Identifies and validates clientspecific needs while incorporating informed consent from client or health care representative regarding treatment planning. Client Specific Assessment Safety 1 Assessment 5 Reasoning 0 Management 2 62%/62% Assessment Documents and confirms data from patient interview and comprehensive evaluation of available clinical information regarding client’s overall health status. Prioritizes and develops treatment plan in accordance with mutually agreed upon client/provider goals. Client Specific Assessment Safety 1 Assessment 5 Reasoning 2 Management 0 62%/62% Assessment Client Specific Assessment Safety 0 Assessment 6 Reasoning 1 Management 1 75%/75% Assessment 65 Protects sensitive client communications while enhancing therapeutic information sharing. Client Specific Assessment Safety 0 Assessment 7 Reasoning 0 Management 1 87%/87% Assessment Accurately Clinical performs a Reasoning comprehensive, problem-focused, or interval medical history including current and previous diseases or conditions. Safety 4 Assessment 2 Reasoning 2 Management 0 25%/50% Safety Assessment/ Reasoning Interprets client information including laboratory and diagnostic testing and identifies client-specific factors which determine pharmacologic management planning. Clinical Reasoning Safety 4 Assessment 3 Reasoning 0 Management 1 0%/50% Safety/ Assessment Establishes and documents medical diagnosis and appropriate differential diagnosis to serve as basis for pharmacological management. Clinical Reasoning Safety 1 Assessment 3 Reasoning 3 Management 1 37%/37% Assessment/ Reasoning Interprets and applies pharmacokinetic, pharmacodynamic Clinical Reasoning Safety 4 Assessment 0 Reasoning 4 Management 0 50%/50% Safety/ Reasoning 66 and pharmacogenomic principles in evaluation and selection of drug therapy. Plans drug regimens which consider individual patient characteristics such as absorption, distribution, metabolism and excretion, comorbidity, drug cost or accessibility. Determines appropriate drug therapy including dose, dosage form, route and frequency of administration. Clinical Reasoning Safety 4 Assessment 3 Reasoning 1 Management 0 12.5%/50% Safety/ Assessment Clinical Reasoning Safety 6 Assessment 0 Reasoning 1 Management 1 12.5%/75% Safety Uses appropriate references and consultation to implement drug regimens (may include collaboration as appropriate). Clinical Management Safety 3 Assessment 0 Reasoning 3 Management 2 25%/37% Safety/ Reasoning Modifies treatment plan as appropriate based upon therapeutic outcome and response. Clinical Management Safety 0 Assessment 4 Reasoning 2 Management 2 25%/50% Assessment Reasoning/ Management 67 Incorporates and orders periodic lab testing or monitoring as indicated. Clinical Management Safety 5 Assessment 2 Reasoning 1 Management 0 0%/62% Safety Considers no treatment, nondrug and drug treatment options and refers as indicated. Clinical Management Safety 2 Assessment 0 Reasoning 2 Management 4 50%/50% Management Safety/ Assessment SME Comments Experts were provided with several options to give feedback during the Q-sort, in addition to domain placement. The Q-Assessor tool posed the following questions: • Should any of the competencies be eliminated? • Should any of the domains be eliminated? Participants were given the option of responding: “yes,” “no,” or “no but should be reworded.” They were then given several open field areas with which they could respond to the following queries: • Please comment regarding suggested rewording of domains or competencies • Please comment regarding any competencies you think are missing and should be added • Please comment regarding any domains you think are missing and should be added One participant felt that competencies should not be eliminated but should be reworded. The same participant also stated that it may be possible to eliminate one of the two final domains due to the overlap perceived between “clinical reasoning” and “clinical management.” A second 68 participant felt that the domain “safety” should be reworded to state “patient safety” in order to emphasize that competencies are in place to protect the public from unsafe prescribing. Table 11 SME Interview Responses Question Yes No Should any of the competencies be eliminated? 0 7 Should any of the domains be eliminated? 1 6 No, but Comment should be reworded 1 • All of the individual statements are appropriate, it is the overlap in category placement that posed difficulty. 1 • Hard to separate clinical reasoning and clinical management because there is overlap. I felt that some components were duplicate and due to the limited options for placement, clinical reasoning and clinical management could have some overlap. • Would suggest rewording safety to say patient safety. It is important to point out that the competencies are not there to ensure provider safety. • Probably prescribing in accordance with current professional codes & standards covers this, but what about consideration of promotion of information sharing or prescribing sharing when two or more prescribers are treating Please comment on any domains or competencies you think should be added. 69 • the client concurrently? Recognition of personal limitations related to scope of practice and personal knowledge, skills and abilities. It was anticipated that a category called “Safety” would incorporate a significant communication component to experts in the Q sort follow-up, based upon literature review of medication error and safety initiatives to which expert prescribers would likely have been exposed (Kohn, Corrigan & Donaldson, 1999; Joint Commission, 1999). Once renamed “Safety” and submitted for expert review however, the SMEs viewed this category as much more prescriber task focused, which Harden calls “technical intelligences” in the domain of “doing the right thing.” Only one competency from the original communication domain fell clearly into the new Safety domain (Table 9). Eight other competencies clearly fell within the Safety domain according to SMEs, while 6 more fell between safety/assessment or safety/reasoning. The following were clearly placed in the “Safety” domain: Table 12 Comparison of Original Communication Domain and New Safety Domain Revised Safety Competencies Original Communication Competencies (*with new categories of classification) Writes clear, legible, and complete Accurately and promptly records clinical prescriptions that comply with state and federal notes which reflect client assessment and regulations. pharmacological management plan. (*Safety/Assessment) Prescribes based on knowledge of pharmacological and physiological principles. Adapts communication style to meet the needs of the client regarding pharmacologic treatment and recommendations. (*Patient Specific Assessment) 70 Demonstrates competency in drug dosage calculations. Provides client specific education regarding obtaining, using, and monitoring of medication including cautions or anticipated side effects. Protects sensitive client communications while enhancing therapeutic information sharing. (*Patient Specific Assessment) Gives clear written and/or verbal instruction to clients regarding obtaining, using, and monitoring their medications. (*Eliminated, combined with “Provides client specific education” to form one competency) Monitors the safety and efficacy of drug therapy treatment plan. Collects and documents data appropriate to individual client’s health needs. Determines appropriate drug therapy including dose, dosage form, route and frequency of administration. Incorporates and orders periodic lab testing or monitoring as indicated. The “Safety” domain did not include any of the previously identified professional role competencies. The competency in the OSBN instrument that closely matches Harden’s “personal intelligences” or professional role competency is the competency “evaluates own practice for continuous improvement opportunities.” Experts placed this competency under the domain of “Clinical Reasoning.” Conceptually, SMEs identified “Clinical Reasoning” not as the development of a diagnosis or treatment plan, but as the incorporation of professional role behaviors. This is illustrated by including the second competency in this category “prescribes in accordance with current professional codes of practice and standards.” One expert commented that it might be important to add a competency that incorporates “recognition of personal limitations related to scope of practice and personal knowledge, skills and abilities.” 71 Table 13 Final Revised Domains and Competencies Factor 1: (Patient) Writes clear, legible, and complete prescriptions that comply with state and federal regulations. Safety Prescribes based on knowledge of pharmacological and physiological principles. Demonstrates competency in drug dosage calculations. Provides client specific education regarding obtaining, using, and monitoring of medication including cautions or anticipated side effects. Monitors the safety and efficacy of drug therapy treatment plan. Collects and documents data appropriate to individual client’s health needs. Determines appropriate drug therapy including dose, dosage form, route and frequency of administration. Incorporates and orders periodic lab testing or monitoring as indicated. Safety/Assessment Accurately and promptly records clinical notes that reflect client assessment and pharmacological management plan. Interprets client information including laboratory and diagnostic testing and identifies client-specific factors which determine pharmacologic management planning. Plans drug regimens which consider individual patient characteristics such as absorption, distribution, metabolism and excretion, comorbidity, drug cost or accessibility. 72 Factor 2: Patient Specific Assessment Adapts communication style to meet the needs of the client regarding pharmacologic treatment and recommendations. Assesses client health care risks including environmental, cultural, educational and other risks that may impact therapeutic decisionmaking. Assesses the client’s therapeutic self-management including any use of complementary/alternative therapies. Identifies and validates client-specific needs while incorporating informed consent from client or health care representative regarding treatment planning. Documents and confirms data from patient interview and comprehensive evaluation of available clinical information regarding client’s overall health status. Prioritizes and develops treatment plan in accordance with mutually agreed upon client/provider goals. Protects sensitive client communications while enhancing therapeutic information sharing. Assessment/Reasoning Establishes and documents medical diagnosis and appropriate differential diagnosis to serve as basis for pharmacological management. Factor 3: Prescribes in accordance with current professional codes of practice and standards. Clinical Reasoning Evaluates own practice for continuous improvement opportunities Safety/Reasoning Critically analyzes prescribing standards, references, and decision support tools to provide evidence-based recommendations to clients which optimize clinical efficiency. Interprets and applies pharmacokinetic, pharmacodynamic, and pharmacogenomic principles in evaluation and selection of drug therapy. Uses appropriate references and consultation to implement drug regimens (may include collaboration as appropriate). 73 Factor 4: Demonstrates effective working relationship with other members of healthcare team including collaboration, consultation, and referral. Clinical Management More than two categories Demonstrates ethical care for clients regarding confidentiality, self-determination, and issues related to use of information technology. Accurately performs a comprehensive, problem-focused, or interval medical history including current and previous diseases or conditions. Modifies treatment plan as appropriate based upon therapeutic outcome and response. Considers no treatment, non-drug and drug treatment options and refers as indicated. 74 CHAPTER 5 DISCUSSION Evans (2003) proposes a hierarchy of evidence for evaluation of healthcare interventions which Spector (2010) suggests might be more appropriate for nursing regulation than classical evidence based approach: effectiveness, appropriateness, and feasibility. It is evident from this and other studies that there is no one “right way” to develop and evaluate competencies. Utility, clarity, and defensibility are important components if the instrument will be adapted for regulatory use. Using a 5 point scale (see Table 3 for more detail), initial faculty input on the Oregon State Board of Nursing’s instrument did confirm that faculty felt the original competencies were appropriately leveled for the beginning prescriber (4.0), and that the tool was easy to use (4.1). They were somewhat less certain regarding use of the tool with students (3.8) or CNSs seeking prescriptive authority (3.8) with 4.0 indicating “agreement” and 3.0 indicating “not sure.” SMEs also confirmed the reliability and consistency of the competency items, however, they did not agree regarding the appropriate domains when compared to those selected by the researcher. Further testing of the revised tool with Boards of Nursing outside of Oregon is advised to determine sufficiency for regulatory use. Theoretical Framework Competency concepts. Under Harden’s model a discrete domain describes the doctor as a professional who encompasses “personal intelligences” which contains two competencies (Harden et al., 1999). Harden defines these as the “role of the doctor within the health service” and “personal development” (p. 548). In the circle model (Figure 1) this has the overall description of “the right person doing it” generally understood as role socialization. The 75 competencies identified in the original Oregon State Board of Nursing’s instrument which pertain to role/professional components are the following: • • Demonstrates effective working relationship with other members of healthcare team including collaboration, consultation, and referral resources. (Factor 1) • Demonstrates ownership of and responsibility for the welfare of the client by providing safe, effective, and appropriate care specific to the Nurse Practitioner or Clinical Nurse Specialist role and scope of practice. (Eliminated) • Evaluates own practice for continuous improvement opportunities. (Factor 1) • Provides ethical care for clients including but not limited to incorporating principles of confidentiality, patient self-determination, and issues related to use of information technology. (Factor 1) • Prescribes in accordance with current professional codes of practice and standards. (Factor 1) All of the previously identified professional role competencies factored into Factor 1 in the analysis of the original survey. However, they did not appear to be a discrete category as they were in the Harden model. Instead, Factor 1 also included all the competencies that were previously identified in the communication domain: • Adapts communication style to meet the needs of the client regarding pharmacologic treatment and recommendations. (.677) • Gives clear written and/or verbal instruction to clients regarding obtaining, using, and monitoring their medications. (.668) • Accurately and promptly records clinical notes which reflect client assessment and pharmacological management plan. (.760) • Protects sensitive client communications while enhancing therapeutic information sharing. (.570) 76 The additional competencies in Factor 1 included: • Writes clear, legible, and complete prescriptions which comply with state and federal regulations. (.572) • Provides client specific education regarding use of medication and anticipated effects including cautions. (.510) The final competency in Factor 1 that also factored equally into Factor 3 so was not strongly identified as one of the professional or communication domains: “Monitors the safety and efficacy of drug therapy treatment plan.” The Harden model includes communication competencies under two domains: Communication and Appropriate Information Handling Skills. Harden also includes competencies which did not appear until recently within nursing specific domains such as “communication with media/press” (Harden et al, 1999). Information handling is captured in two competencies in the OSBN instrument “protects sensitive client communications while enhancing therapeutic information sharing” (placed by experts into “patient specific assessment”) and “demonstrates ethical care for clients regarding confidentiality, selfdetermination, and issues related to use of information technology.” Experts placed the latter across more than one category, possibly indicating that information handling is seen as an overarching concept. As APRNs play a greater role in policy development, the importance placed upon communication competencies may change and be further related to prescribing specific issues. Emerging issues such as pharmaceutical marketing require that APRNs who prescribe are adept at evaluating media influence strategies (Crigger, Barnes, Junko, Rahal & Sheek, 2009). Domains. The Harden model (Harden et al, 1999) presumes that domains represent 77 “discrete components of competence and can be taught as such and evaluated in performance assessments” (p. 550). However, SMEs did not confirm discrete domains as re-conceptualized by the researcher using further analysis including PCA. Several interesting results emerged from the forced Q sort. While it was clear that the domain “Safety” was well populated by prescribing competencies (14 of the competencies fit into the Safety domain in some manner) the domains of Clinical Reasoning and Clinical Management confounded the experts. As discussed, experts seemed to view Clinical Reasoning as incorporating professional behaviors rather than diagnostic synthesis and planning. One expert commented that the domain names seemed to signify overlapping concepts “Hard to separate clinical reasoning and clinical management because there is overlap. I felt that some components were duplicate and due to the limited options for placement, clinical reasoning and clinical management could have some overlap.” This finding is inconsistent with the literature review that defines clinical reasoning as a distinct concept in both nursing and medicine (Tanner, 2006; Bowen, 2006) and pharmacologic prescribing as including ongoing management and evaluation (Davenport et al, 2005; Harden et al, 1999; DeVries, Henning, Hogerzeil & Fresle, 1994). The absence of clear placement of competencies into the Management domain is concerning and indicates need for further analysis and research to determine if these results indicate a lack of clarity with the competency content, the domain name, or the conceptualization of “Clinical Management” itself. The latter is particularly problematic for several reasons. The first is the fact that the original instrument was designed in order for the Oregon State Board of Nursing to evaluate a clinical practicum in pharmacological management [emphasis added] as required by Oregon statute. Clinically and conceptually, management of the patient connotes ongoing responsibility for the patients’ treatment and outcomes resulting from autonomous 78 prescribing actions. Harden et al (1999) identify “patient management” as a discrete technical intelligence that demonstrates that the competent and reflective practitioner knows how to “do the right thing” Experts identified only one competency as fitting discretely into this domain: “Demonstrates effective working relationship with other members of the healthcare team including collaboration, consultation, and referral.” This competency, which in the original instrument was identified in a domain called Professional Behavior (see Appendix A) was identified by 75% of SMEs as a clinical management specific behavior. One SME also specifically commented on the task of comanagement as conceptually important for prescribing: “Probably prescribing in accordance with current professional codes & standards covers this, but what about consideration of promotion of information sharing or prescribing sharing when two or more prescribers are treating the client concurrently?” It is possible that nurses, as opposed to other types of prescribers, view the concept of patient management as more team oriented. Recently educated APRNs are exposed to concepts such as inter-professional educational competencies, which were recommended in 2003 by the Institute of Medicine (IOM, 2003) and subsequently adapted into curricular competencies (AACN, 2006). However, Flavell, Vanstolk, Bainbridge & Nasmith (2009) found that the concept of inter-professional collaboration as a competency is poorly defined and therefore difficult to incorporate consistently into competency based education, so conceptualization of patient management may also be influenced by practice setting. Teamwork may also imply a more subordinate role to nurses. Clinical Nurse Specialists in the original survey (most of whom did not have prescriptive authority) made several observations regarding the use of the pharmacist or other members of a team for medication provision, which was noted in the content 79 analysis. Even when instructed that the competencies were designed to grant legal autonomous prescriptive authority, CNSs referred to delegation or collaboration as a necessary component of prescribing. Views of teamwork and collaboration differ among different levels of nursing as well as among nursing roles. Cott (1998, p. 852) reported that physicians viewed teamwork as a form in which registered nurses were subordinate, while nurses viewed it as a way of directly influencing patient care and as a ‘means of gaining status’. Nurse Practitioners demonstrate a high level both collaboration and high levels of autonomy (Maylone, Ranieri, Quinn Griffin, McNulty & Fitzpatrick, 2011), as compared to CRNAs who most frequently use a compromising mode when working with other professionals (Alves, 2005). Xyrichis & Ream (2007, p. 238) did an extensive concept analysis of published research on teamwork as understood across disciplines and proposed the following definition: A dynamic process involving two or more health professionals with complementary backgrounds and skills, sharing common health goals and exercising concerted physical and mental effort in assessing, planning, or evaluating patient care. This is accomplished through interdependent collaboration, open communication and shared decision-making. This in turn generates value-added patient, organizational and staff outcomes. The above complements the comments from an SME who identified the need for two or more prescribers to collaborate in order to determine the best plan of care for patient co-management. Further examination of the conceptual meaning of “Clinical Management” is warranted in order to understand its meaning in the context of nurse prescribers, particularly as they legislatively move towards an autonomous prescribing role. 80 Implementation and assessment One of the challenges of implementing the Oregon instrument was its use for persons obtaining prescriptive authority after many years of clinical practice. The Harden model presumes use of tools such as the Objective Structured Clinical Examination (OSCE) that was developed by Dr. Harden in the 1970s. As of 2009 the OSCE is required for at least one clerkship and the final comprehensive examination for 101 medical schools in the US (Barzansky & Etzel, 2011), but is not required for graduation from APRN programs. Use of the OSCE for professionals seeking to add a new competency after many years of practice has not been evaluated. The Harden model (Harden et al, 1999) was further evaluated by Davis and Harden (2003) once it was implemented into the medical curriculum. Assessment in the Dundee medical school where Harden teaches incorporates a portfolio assessment as part of the final exam, in addition to the use of OSCE and self-assessment methods throughout the program. There are several recommendations that Davis and Harden (2003) make based upon data collected through student diaries and examination data, formal accreditation review, external examiner reports, and faculty evaluation. One change that was implemented was transferring pharmacology teaching to an earlier phase (first year) of the curriculum. A second was establishing an introductory course at each phase of the curriculum that introduced new learning outcomes for the exit learning outcomes for the overall courses. The authors note that, though conceptually appealing, the logistics of organizing a clinical assessment at the end of each course in form of an OSCE was too difficult and was abandoned (Davis & Harden, 2003). They also discuss many of the logistic issues in implementing curricular change in terms of funding, administrative and faculty support. Integration of prescribing competencies into a curriculum requires thoughtful mapping and 81 agreement regarding assessment methods, particularly when implementation cannot presume a novice practitioner as with Harden’s medical school curriculum. Morris et al (2001) evaluated faculty incorporation of the only published nurse specific prescribing competencies in the US, those developed by NONPF and NCSBN in 1998 (Yocom et al, 1998). These competencies were not used for regulatory purposes, though their introduction suggested utility for development of model rules and standards (Yocom et al, 1998). Evaluation strategies were described by respondents as multiple choice exam questions, short answer exam questions, oral case studies, written case studies, and other written assignments (Morris et al., 2001). Respondents were not asked about achievement of the end of course competencies specified in the guidelines (Morris et al., 2001). The Clinical Practicum in Pharmacological Management Evaluation instrument does not specify an evaluation methodology. Further research in this area is recommended, particularly if the tool will be used for applicants of diverse backgrounds, roles, and clinical preparation. The Oregon practicum mandated in conjunction with the tool is accomplished under a limited license that specifies direct supervision of all clinical practice hours related to prescribing. However, emerging technologies are challenging the boundaries of what constitutes direct supervision for regulatory and educational purposes. Technology such as videoconferencing, email, simulation, and telemedicine generally will continue to reshape how evaluation and supervision are addressed in regulation. Electronic prescribing may obviate or change the competency currently articulated as “writes clear, legible, and complete prescriptions that comply with state and federal regulations.” In the original survey, a nursing faculty member expressed concern regarding how the tool might be implemented to evaluate prescribing within the educational program for eventual licensure because attainment of all the competencies originally listed might be 82 unrealistic “if they are expected to accomplish the competencies within their clinical practicum in an educational program” (Table 2). Despite concerns about the breadth of the curriculum, APRN faculty are currently expected to verify to both licensing agencies and national certifiers that their graduates are fully prepared to prescribe medications for their target population, practice competently in states which currently do not require supervision, collaboration, or a mandated practicum. The emergence of the Doctor of Nursing Practice (DNP) as entry into practice has potential to further expand the number of hours of prescribing practice that are integrated into the curriculum, with graduates completing 1000 instead of 5-600 hours of clinical practice. However, the current definition of hours for the DNP does not necessarily include direct patient care or prescribing practice and does not therefore assure achievement of autonomous prescribing competencies (AACN, 2006). Limitations Competency development and evaluation is frequently done using expert panels (NONPF, 2006; Yocom et al., 1998), as is instrument review and revision (Davis, 1992). Experts were used in the current study to analyze content and to confirm domain placement. Experts were selected for their broad expertise in nursing regulation, practice, or faculty roles related to pharmacology and prescribing. All but one expert is active in current clinical practice with individual patients. None had less than 12 years of prescribing experience, and most had practiced or were currently practicing under autonomous prescriptive authority (10/12 or 83%). Although representing a wealth of expertise on the topic of prescribing, there are challenges in using expert panels to draw representative conclusions. Harden et al. (1999, p. 547) caution that the outcomes anchored in the inner circle he calls “doing the right thing” are anchored in the past and may have to be unlearned when circumstances change. He and his colleagues also stress that 83 adaptation and reflection are critical components for a good practitioner: “A student or trainee may have all the technical competences in the inner circle, but not be a good doctor. The outcomes in the middle and outer circles mean that the student has to think as a doctor”. The original survey solicited evaluation of the competencies by FNP students, FNP faculty, practicing NPs and CNSs with and without prescriptive authority. As the target of the newly passed prescriptive authority in Oregon, CNSs were over-represented in the original survey and their views of competency to prescribe were not well-known. Lack of national agreement regarding the need to prescribe for the CNS role complicated the ability to locate and evaluate prescribing specific competencies, or research on prescribing practices, when developing the original competencies (Lyon, 2003; NACNS, 2005). Current study experts, even those licensed or experienced as CNSs, had the majority of their prescribing experience as NPs. This is not surprising, since many states do not offer prescriptive authority to CNSs or provide it as an optional status as in Oregon (NCSBN, 2010). The lack of published information and diverse prescribing among CNSs, many of who practice in clinical subspecialties (Baldwin et al., 2009) limits the availability of expert members with CNS prescribing expertise. Certified Nurse Midwives and Certified Registered Nurse Anesthetists were also underrepresented in the expert panel. As practitioners who have role specific rather than population based practice competencies, nurse anesthetists and nurse midwives may have role specific competencies for prescribing which do not exist for other prescribers (ACNM, 2008; AANA, 2007). However, a review of both ACNM and AANA competencies does not identify competencies which include the word “prescribe” or “pharmacologic management.” AANA competencies address medication administration (AANA, 2007), while ACNM (2008) mentions use of therapeutics in the management of specific conditions, but does not specify whether 84 therapeutics are pharmacologic or non-pharmacologic. Based upon the current lack of core competencies and core licensing requirements for prescriptive authority, prescribing specific regulatory criteria is difficult to evaluate for all APRNs, but more so for CNSs, CRNAs, and CNMs than for NPs. Further research regarding role specific prescribing competencies within each of the individual APRN roles may yield valuable information which can contribute to the development of an overall document for APRN autonomous prescriptive authority. Recommendations for Future Research Final analysis includes recommendations for further research using the refined instrument. Recommendations for further instrument development include potential modifications to the theoretical framework, content of competencies and domains, and identification of additional previously unidentified competencies. A meta-analysis done of competency based medical or medicine articles published from 1966 to 2002 defined four steps to competency development: 1. Competency identification, 2. Determination of competency components and performance levels, 3. Competency evaluation, and 4. Overall assessment of the process (Carraccio, Wolfsthal, Englander, Ferentz & Martin, 2002). However, the authors found little evidence to support one methodology of competency identification over the other, and few models which evaluate and compare specific outcome measurement tools (Carraccio, et al, 2002). The development of this instrument and its validation for the Oregon State Board of Nursing satisfies step one. Further work is needed to determine the 85 appropriate evaluation assessment tools, particularly when incorporating the competencies for different APRN roles, settings, and levels of prior clinical and educational preparation. Ideally, incorporation of prescribing competencies into educational preparation would be accompanied by increasing their presence in either licensure or certification testing plans. As an example, the test plan for the American Nurses Credentialing Center’s Family Nurse Practitioner certification exam includes content in “knowledge of pharmacology,” “skill in managing conditions with pharmacological and non-pharmacological interventions,” and “evaluating the effectiveness of pharmacological and non-pharmacological interventions” (ANCC, 2010). It does not, however, evaluate whether an applicant can write or electronically transmit a legible legal prescription, which was unanimously evaluated by Subject Matter Experts as an essential competency for safety in prescribing. Clinical Nurse Specialists, have prescriptive authority in 34 states (NCSBN, 2010) but are not tested on prescribing specific competencies when obtaining national certification, unless they are seeking certification as an adult psychiatric mental health CNS (ANCC, 2011). Many CNSs have found it clinically expedient to become licensed and educated as a Nurse Practitioner in addition to their CNS preparation if they want to have full prescriptive authority. One SME stated that she practiced as a CNS for twelve years before obtaining her NP license, as she practices in a state that does not grant prescriptive authority to CNSs. A second SME in Idaho has a license and prescriptive authority as both a CNS and an NP and is certified nationally in each role. The use of competency based evaluation serves a policy purpose. Outcomes based education provides benchmarks that help inform decisions regarding funding, public safety initiatives, and workforce skill assessment (Carraccio, et al, 2002; Shippmann, et al, 2000). The ability to verify by objective assessment the APRN competency to prescribe autonomously has 86 significant implications for licensing law, which currently restricts many APRNs to prescribing under physician supervision or collaboration, within a prescribed formulary, or without categories of necessary drugs such as controlled substances. There is little research to validate restrictive prescribing law as protective of public health and safety. Nevertheless, expansion of autonomy requires responsive change in how APRNs are licensed, educated, and certified; and in how their programs are accredited (APRN Joint Dialogue, 2008). Regulatory Implications Prescribing specific curricula has been developed using the Harden model (Davenport et al, 2005). The only US document to date that articulates nurse prescribing specific competencies, in this case for family nurse practitioners, was published by NONPF and NCSBN in 1998 (Yocom, et al., 1998) and is accompanied by a model curriculum. Development of prescribing specific competencies requires integration into the curriculum that prepares prescribers. However, Harden and others identified barriers to this process. A study by Morris, Possidente & Muskus (2001) evaluated integration of the model curriculum published by NONPF and NCSBN in 1998 (Yocom, et al, 1998) and found that 85% of programs had not yet evaluated the model curriculum three years after its publication. Common themes which were reported included too much content to address in a 3 or 4 credit course and the difficulty of meeting the needs of a diverse group of students who have varied knowledge levels, interests, and clinical backgrounds (Morris et al., 2001). Another difficulty identified by faculty was the student’s inadequate understanding of physiology and pathophysiology (Morris et al., 2001). NP and CNS applicants to Oregon for prescriptive authority are required to demonstrate completion of pharmacology, pathophysiology, and physical assessment before they are granted prescriptive authority. Those needing to complete the prescribing practicum because they do not meet the clinical hours 87 requirement, either because they did not have it in their original program or their practice experience is too old, must demonstrate completion of the courses as well but there are no mandated requirements for order of completion before starting the practicum. The Morris et al (2001) study suggests that regulatory Boards may want to consider further guidance regarding appropriate course sequencing for applicants who want to add prescribing to their scope of practice, and work in conjunction with graduate educational institutions preparing licensees for the APRN roles. More is known about NP prescribing than the three other APRN roles of CNS, CRNA, and CNM. Until prescriptive authority is both mandatory and consistently documented as a unique authority in licensing statistics, it is difficult to evaluate whether differences exist between the roles. Variability of state authority, titling, and regulatory transparency limit data gathering specific to APRN prescribing on a national level. Practice environment for APRNs are influenced by multiple regional and contextual factors. As an example, many CRNAs choose not to prescribe despite the legal option to do so (Kaplan, Brown & Simonson, 2011). Lyon (2003) asserts that this is also true of CNSs, though more recent data is lacking regarding trending for this role related to prescribing practices. As with Oregon, many states license Nurse Midwives as NPs, which confounds data collection specific to CNM prescribing habits and competence. Benner (2001) cautions that nursing is faced with two conflicting mandates: to individualize patient care, and to minimize error. Nowhere is this more apparent than in the act of prescribing medications for individual patients. However, Benner (2001) also observes that efforts to standardize practice through mechanisms such as identifying competencies for practice can “at the same time prevent the individualization of that care” by expert practitioners (p. 176). 88 She emphatically states that expert practice always involves a level of discretionary judgment and often risk as well, and that such expertise is difficult to quantify or standardize. Nonetheless, Nursing Boards have been charged with establishing and enforcing a standard level of competence in order to protect the public. Regulators must first determine if prescriptive authority is a mandatory part of the APRN role in order to establish objective perimeters for competence. While prescribing is not the only function that differentiates the APRN from the registered nurse, all APRNs of the future will be prepared to prescribe for individual patients (APRN Joint Dialogue, 2008). Regulatory boards will then be charged not only with establishing initial competency to prescribe, but also evaluating continued competency using defensible instruments and criteria. The Oregon State Board of Nursing’s Clinical Practicum in Pharmacological Management Evaluation instrument has been tested using long term autonomous prescribers, novice prescribers, faculty and non-prescribers who may or may not seek this authority. APRNs seeking to expand their authority may already be competently prescribing under mandated legal constraints that merely serve to hamper their mobility and service to their patients. 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