QuERY
Quality Improvement, Evidence Based Practice,
Research & You
Part 2: Research Processes
Presented by:
Karen Gabel Speroni, BSN, MHSA, PhD, RN
-Director, Nursing Research & Chair, Research Council
Inova Loudoun Hospital & Inova Fair Oaks Hospital: Virginia
-Co-Chair, Inova Health System Nursing Research Council: Virginia
-Chair, Shore Health System Nursing Research Council: Maryland
12 November 2011
OBJECTIVES
• Review of day 1: Provide examples of
quality improvement (QI) activities,
evidence based practice (EBP) projects,
research studies and innovations
– Day 2 focus:
• Research and innovation examples focus
• Review of steps from study idea inception to
dissemination of findings
• Review definitions of QI, EBP and
research
Karen Gabel Speroni, 11/12/11
QI, EBP & Research
• What is Quality Improvement?
– Activity
• What is Evidence Based Practice?
– Project
• What is Research?
– Systematic nursing research
Karen Gabel Speroni, 11/12/11
3
Quality Improvement
• Systematic, data guided activities
designed to bring about immediate
improvement in health care delivery in
particular settings
– ANCC, 2008. Magnet Recognition Program Application Manual
Karen Gabel Speroni, 11/12/11
4
The QI Report
SQUIRE: Standards for QUality Improvement Reporting Excellence
•
•
Problem or purpose, and aims of the proposed change
Methods
– Context of the organization or setting
– Intervention
– Process for change
– Measures
– Analytic methods
• Results
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How the change evolved and adjustments that were made
Outcomes
Impact of the change on the organization
Challenges
• Discussion
www.squire-statement.org
Karen Gabel Speroni, 11/12/11
5
Evidence Based Practice
• The conscientious use/integration of the best
research evidence with clinical expertise and
patient preferences in nursing practice
– Adapted from Sackett et al.,2000
• The utilization of clinical expertise, clinical
judgment, and best research/practices to
improve patient outcomes
– Inova Loudoun Hospital, 2010
Karen Gabel Speroni, 11/12/11
6
Evidence Based Practice
Nursing Models
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Iowa Model
Stetler’s Model
Rosswurm and Larrabee’s Model
John Hopkins Nursing Model
ACE Star Model of Knowledge and
Transformation (Academic Center for Evidence Based Practice)
• ARCC Model (Advancing Research & Clinical Practice through
Close Collaboration)
• PARiHS Framework (Promoting Action on Research
Implementation in Health Services)
Karen Gabel Speroni, 11/12/11
7
Research
• A systematic investigation, including
research development, testing, and
evaluation, designed to develop or
contribute to generalizable knowledge
– U.S. Department of Health and Human
Services, nd., [45 CFR 46,102(d)]
Karen Gabel Speroni, 11/12/11
8
Nursing Research
• A systematic search for knowledge about
issues of importance to the nursing
profession
– Polit and Hungler, 1995
Karen Gabel Speroni, 11/12/11
9
Innovation
• Innovation in service delivery and
organization [is] a novel set of behaviors,
routines, and ways of working that are
directed at improving health outcomes,
administrative efficiency, cost
effectiveness, or users’ experiences and
that are implemented by planned and
coordinated actions
– Greenhalgh, 2004
Karen Gabel Speroni, 11/12/11
10
Nurses are Scientists!!
Karen Gabel Speroni, 11/12/11
11
QI, EBP AND RESEARCH
• How do you integrate the 3
• How do we better understand the
differences between the 3
• Thru the QuERY process:
Quality Improvement, Evidence Based
Practice, Research & You
Karen Gabel Speroni, 11/11
QuERY CONCEPT
• Developed to help hospital nurses become
knowledgeable about each unit’s best
– QI activity
– EBP project
– Research study
• Provides opportunity for nurses from each hospital unit
to showcase their best QI, EBP and research work
during the last year
– OR, to identify strategic planning needs
• Through the QUERY work and seminar presentations,
hospital nurses are exposed to QI, EBP and research
concepts, unit best examples, and unit needs to improve
patient outcomes
Karen Gabel Speroni, 11/11
QuERY CONTEST
• Annually contest judged by nurses
selecting the best QI, EBP and research
work that improves
– Standard operating procedure
– Patient outcomes
– Care delivery
• Electronic contest
– List definitions
– List each units QI, EBP and research work
• Award prizes
Karen Gabel Speroni, 11/11
Publications 2011: ILH
• Speroni, K.G., Lucas, J., Dugan, L., O’Meara-Lett, M.,
Putman, M., Daniel, M. & Atherton, M. Comparative
Effectiveness of Standard Endotracheal Tubes versus
Endotracheal Tubes with Continuous Subglottic Suctioning
on Ventilator-Associated Pneumonia Rates (2011) Journal
of Nursing Economic$. 29(1): 15-21.
• Book contribution: McLaughlin, M & Bulla, S. Real
Stories of Nursing Research: A Quest for Magnet.
2009. Jones and Bartlett Publishers, Los, Angeles.
[Chapter 30, O’Meara-Lett, M. See
http://www.jbpub.com/catalog/9780763761660/
• Improvement: Use of the Hi-Lo Evac tube for all
intubations throughout the hospital except in the OR
Speroni, 2011
Publications 2011:
(continued):
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AHRQ Health Care Innovations Exchange. Innovation Profile/Attempt: [NurseLed Weekly Educational Program for Children Focuses on Physical Activity
and Food Choices, Leading to Healthier Behaviors, Lower Body Mass Index]
([Karen Gabel Speroni, Inova Loudoun Hospital]). In: AHRQ Health Care
Innovations Exchange [Web site]. Rockville (MD): [cited 2009 Apr 13 & updated
2011 July 20]. Available: http://www.innovations.ahrq.gov/content.aspx?id=2406.
– Improvement: Implementation of hospital-based Living Fit program for
hospital employees and community members
Speroni, K.G. (2011) Prospective Evaluation of the Effect of the Nurses Living
Fit™ Intervention versus No Intervention on Body Mass Index of Nurses.
JOGNN, 40, S86–S87.
Speroni, K.G., Earley, C., Seibert, D., Kassem, M., & Williams, D. (2011).
Prospective Evaluation of the Effect of the Nurses Living Fit™ Intervention
Versus No Intervention on Body Mass Index of Nurses. Journal of Women’s
Health, 20(3), 480-481.
Speroni, 2011
Publications 2010: ILH
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Dawson, E., Speroni, K.G., Salisbury, M., & Atherton, M. (2010). Effect of
the Workforce Initiatives Safe Handling Minimal Lift Program on Patient
Care Provider Injuries, Attributable Costs, and Satisfaction. Journal of the
Association of Occupational Health Professionals. XXX(3); 22-26.
O’Neil, S., Speroni, K.G., Dugan, L, & Daniel, M. (2010). A Two-tier Study
of Direct Care Providers Assessing the Effectiveness of the Red Rule
Education Project and Precipitating Factors Surrounding Red Rule
Violations. Journal of Quality Management in Health Care, 19:3, 1-6.
Harrison, G., Speroni, K.G., Dugan, L., & Daniel, M.G. (2010). A
comparison of the quality of blood specimens drawn in the field by
Emergency Medical Services verses specimens obtained in the Emergency
Department. Journal of Emergency Nursing. 36(1); 16-20.
• Improvement: Policy change to allow blood drawn by EMS.
Speroni, 2011
Publications 2010-2011: IFOH
•
2011
– Suchicital, L.G., Gujral, H., Speroni, K.G., Eldridge, D. & Atherton, M. (2011).
Prospective, Randomized, Pilot Study Evaluating the Effect of Ice Chip
Administration versus None on the Bitterness of Crushed Medications in Post
Operative Bariatric Patients. Journal of Bariatric Nursing and Surgical Patient
Care. 6(1): 15-20.
• Improvement: Evaluate procedures for provision of ice chips procedure prior to
medication administration
•
2010
– Bergin, C., Kelly, K., Travis, T. & Speroni, K.G. (2010). Interim Analysis of the
Pre-Operative Incentive Spirometry Education (POISE) Intervention. Journal of
Perianesthesia Nursing, vol 25, No. 3 (June); pp 196-198.
• Improvement: Documentation in the medical record of pre-operative incentive
spirometry levels
– Dunn, K.D., Speroni, K.G., & Kassem, M. Stress Reduction Through Yoga.
Advance for Nurses. Posted on: January 26, 2010. www.advanceweb.com
Retrieved from: http://nursing.advanceweb.com/Student-and-New-GradCenter/Student-Top-Story/Stress-Reduction-Through-Yoga.aspx?rpid=14
Speroni, 2011
Publications 2011: SHS
•
•
2011
– Hanlon, L., Punzo, A., Jones, R.A., & Gabel Speroni, K. G. (2011).
Cardiopulmonary Complication Rates in Patients Undergoing Total Knee
Arthroplasty and Reinfusion of Shed Blood. Journal of Orthopaedic Nursing. 30
(5): 307-311.
• Improvement: Stopped usage of reinfusion device
– Stagg, S., Sheridan, D., Jones, R. A., & Speroni, K. G. Evaluation of a Workplace
Bullying Cognitive Rehearsal Program in a Hospital Setting. (2011) The Journal
of Continuing Education in Nursing, 42(9), 395-403.
In press
– Trinkley, D., Bryan, S., Speroni, K.G., Jones, R.A., & Allen, H. Evaluation of
Domestic Violence Screening and Positive Screen Rates in Rural Hospital
Emergency Departments. In November, 2011, Online Journal of Rural Nursing
and Health Care.
– Ganter-Ritz, V., Speroni, K.G, & Atherton, M. A Randomized Double Blind Study
Comparing Intradermal Anesthetic Tolerability, Efficacy, and Cost-Effectiveness
of Lidocaine, Buffered Lidocaine and Bacteriostatic Normal Saline for Peripheral
Intravenous Insertion. In Press, March/April 2012, Journal of Infusion Nursing.
Speroni, 2011
Selected Publications: 2005-2009
•
Speroni, K.G., Tea, C., Earley, C., Niehoff, V., & Atherton, M. (2008). Evaluation of a Pilot
Hospital-Based Community Program Implementing Fitness and Nutritional Education for
Overweight Children. Journal for Specialists in Pediatric Nursing, 13(3), 144-153.
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Improvement : Hospital provision of exercise/nutrition classes for children at Inova Fair Oaks
Hospital
Bowers L., Speroni K.G., Jones L., & Atherton M. (2008). Comparison of Occlusion Rates by
Flushing Solutions for Peripherally Inserted Central Catheters with Positive Pressure LuerActivated Devices. Journal of Infusion Nursing, 31(1), 22-27.
Speroni K.G., Earley, C., & Atherton, M. (2007). Evaluating the Effectiveness of the Kids Living
Fit™ Program: A Comparative Study. Journal of School Nursing, 23(6), 329-336.
– Also see http://www.loudountimes.com/news/2007/dec/22/Speroni-Inova-obesity-nutrition/
for newspaper article covering research: Solinger, S. Learning to eat: Inova researcher
says education is key to solving childhood obesity. Loudoun-Times Mirror. December 22,
2007; updated December 28, 2007.
Speroni, K.G. (2006). A hospital nursing community outreach program on childhood obesity.
Nursing Spectrum. Retrieved June 19, 2006, from
http://community.nursingspectrum.com/MagazineArticles/article.cfm?AID=22247
– Companion article to: Hawke, M. (2006). Taking Research to the Bedside. Nursing
Spectrum. Retrieved June 19, 2006, from
http://community.nursingspectrum.com/MagazineArticles/article.cfm?AID=22054.
Speroni, 2011
Selected Publications: 2005-2009 (continued)
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Leonard Y., Speroni K.G, Atherton M. & Corriher J. (2006) Evaluating use of flash
sterilization in the OR with regard to postoperative infections. Journal of the
Association of peri-Operating Room Nurses, 83(3), 672-680.
Speroni K.G, Dawson E., Atherton, M., & Corriher J. (2005). Influenza
vaccination, incidence of symptoms and resulting absenteeism in hospital
employees. American Association of Occupational Health Nurses Journal, 53
(11), 477-483.
Speroni K.G, Hannah, J., Corriher, J., & Atherton, M. (2005). Evaluation of
demographic, behavioral, and procedural factors on pain perception by patients
undergoing colonoscopy and moderate sedation. Gastroenterology Nursing
Journal, 28(6), 502-508. [Nominated for Best Author award]
Dugan L., Leech L., Speroni K.G., & Corriher J. (2005). Factors affecting
hemolysis rates in blood samples from newly placed IV sites in the Emergency
Department. Journal of Emergency Nursing, 31(4), 338-345.
Improvement: Eliminated use of 22G or smaller catheter when drawing
blood
Speroni, 2011
Speroni’s Steps:
From Study Idea Inception
to Publishing Research
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Step 1: Study Idea
• Discuss your study idea with
– Nurse peers
– Nurse manager / unit director
– Research mentor
• Present your study idea to Research
Council (RC)
– Follow Standard Operating Procedure
(SOP) for documenting study idea
– Complete a contest card
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Speroni, 2011
Step 2: Literature Review
• Conduct literature review
– Email hospital librarian with your study title, study
purpose/objective, proposed search terms and
request search over last 10 years
– Document search terms, databases searched and
years searched
– Utilize standardized literature review tool to review
article
• Draft a 1-2 page summary for the protocol
introduction section
– Specify from an evidence based practice perspective
how research results could improve standard of care,
care delivery and patient outcomes
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Speroni, 2011
Step 2 (continued)
• Keep electronic copy of all articles referenced in
introduction / background section of protocol
• Determine target journal for dissemination of
findings to facilitate writing style of introduction,
search terms, and reference formatting in text
and the reference listing
• Present findings to RC to verify if evidence
sufficient to answer best practice question or if
research should be conducted
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Speroni, 2011
Step 3: Confirm Study Team
• Study team member types
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Principal Investigator
Sub-investigators
Hospital contact
Statisticians
Administrative support
Other multidisciplinary team members needed to
complete research
• Ensure team completes human subjects
protection coursework
• Specify requirements for authorship with study
team following Authorship SOP
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Speroni, 2011
Step 4: Draft Research Protocol
• Draft the research protocol
–Follow RC template
–Append survey instrument(s)
subject completes
• Surveys patients/subjects touch are
appended to the protocol
• Pilot electronic surveys before
submitting to Institutional Review
Board (IRB)
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Speroni, 2011
Step 5: Draft Case Report Forms
• Draft data collection tool
–Follow RC template
–Case Report Form (CRFs)
•Patients / subjects do not
touch
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Speroni, 2011
Step 6: Draft Study logs
• Draft study logs
–Follow RC template
• Randomization or observation log
• Screen Failure Log
• Protocol Deviation Log
• Early Termination Log
• Other logs specific to study
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Speroni, 2011
Step 7: Draft Table Shells
• Table shells
–Follow RC template
–Track to each
• Protocol data collection point
• CRF item
• Survey item
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Step 8: Statistician
• Identify statistician
– Work thru RC
• Provide to statistician draft study documents
– Protocol / survey instrument
– CRFs
– Table shells
• Ask them to review / write
– Sample size calculation
– Data analysis methods
• Confirm database software statistician will use for
analysis
• Design database
– Receive statistician approval of database
Speroni, 2011
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Speroni, 2011
Step 9: Evaluate Grant Opportunities
• Review affiliated associations request
for proposals
• Work with Grants Management Office
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Step 10: Draft IRB Documents
• Draft IRB documents
•
•
•
•
IRB application
Other required IRB documents
Informed Consent Form
Investigator information
• Send to research mentor for review
– IRB documents
– Final Study documents
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•
•
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Protocol
Case Report Forms
Study logs
Table shells
• Follow IRB SOPs in preparation for research
• Obtain required signatures
Speroni, 2011
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Step 11: Plan Study Initiation Meeting
• During IRB review create Study Initiation Meeting (SIM)
document
– Agenda
– Protocol
• Study procedures
• Chart documentation
– Informed Consent
• IRB approved Informed Consent Form
• IRB ICF SOPs
– Case Report Forms
– Study Logs
– Table shells
– Study requirements
• RC SOPs
• Reporting to RC
• Study files maintenance
• Database entry
– Authorship requirements / team assignment
– Study timeline
Speroni, 2011
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Speroni, 2011
Step 11: Plan Study Initiation Meeting
(continued)
• Finalize SIM document with research
mentor
• Schedule SIM based upon date after
expected IRB review
• Include all investigators & study team
members participating in daily research
• Email invite for SIM meeting
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Step 12: Hold SIM
• Review content of SIM
• Discuss authorship, follow authorship SOP and
targeted journal authorship requirements if specified
by journal
– Register with www.clinicaltrials.gov if randomized
study / journal requires
• Document attendance
• Review database entry procedures
• Document and address all study process issues
identified during SIM
• Email team when recruitment / study work will begin
Speroni, 2011
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Step 13: Initiate / Conduct Study
• Submit monthly update to RC Chair
• Attend each RC meeting
• Ensure ongoing completion of study
documents
• Track IRB continuing review due dates
• Ensure research conducted following IRB
SOPs
• Notify IRB of human subjects protection
issues, serious adverse events and
protocol deviations
Speroni, 2011
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Step 14: Database Entry
• Ensure ongoing data input
• Once final data obtained, conduct 100%
quality assurance (QA) review of
database
• Document fixes to database, apply fixes
and conduct QA of fixes
• Lock database
• Provide locked database to research
mentor for verification prior to sending to
statistician
Speroni, 2011
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Speroni, 2011
Step 15: Data Analysis
• Using locked database, analyze data per
protocol data analysis methods
• Populate table shells
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Step 16: Report Writing
• Review authorship SOP and journal authorship
requirements if specified
• Verify target journal
• Review authorship guidelines
• Copy FROM PROTOCOL, abstract, introduction,
methods and references to manuscript
– Update literature search using same search terms and
databases for only new years
• Update introduction if new literature
– Update references as needed
– Change future tense to past tense in introduction and
methods
– Draft results
Speroni, 2011
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Step 16: Report Writing (continued)
• Write discussion
– Contrast your findings to literature cited findings
– Specify your limitations
• Write conclusions
– Include the ‘so-what’ factor
• Based upon the results of this research and the
evidence in the literature, the hospital standard of
care [or SOP or nursing practice] has been
modified from xx to xxx
• Based upon the results of this research and the
evidence in the literature, care delivery has been
modified from xx to xxx
• As a result of this research patient outcomes xxx
has xxxx
Speroni, 2011
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Step 17: Dissemination of Findings
• One per study
– Manuscript
– Poster
– Podium presentation
• Update RC research outcomes table
– Dissemination of findings
– How research findings impacted standard of
care, care delivery and patient outcomes
Speroni, 2011
Karen Gabel Speroni, 2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
Karen Gabel Speroni, November
2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
43
Last Step:
REJOICE IN YOUR
ACCOMPLISHMENTS
• Authors Happy Hour
Karen Gabel Speroni,
Speroni, 2011
2011
Contact Kgabelsperoni@smartneighborhood.net to request permission for use
SUMMARY
• Before submitting to the IRB
– Write the protocol as if it were the manuscript
• Include an abstract with headings
• Write ~ 1 - 1.5 page introduction
– From an evidence based practice perspective,
results of this research can be used by
administration to xxxxxxx
• Summarize literature search including specifying
search terms, years searched and databases
searched
– Draft the table shells that guide THE END / how you
will present your data
Speroni, 2011
SUMMARY (continued)
• After the research has been completed
– Copy FROM PROTOCOL, abstract, introduction,
methods and references to manuscript
• Update literature search using same search terms
and databases for only new years
– Update introduction if new literature
• Change future tense to past tense in introduction
and methods
• Draft results
Speroni, 2011
SUMMARY (continued)
• Write discussion
– Contrast your findings to literature cited findings
– Specify your limitations
• Write conclusions
– Include the ‘so-what’ factor
• Based upon the results of this research and the
evidence in the literature, the hospital standard of
care [or SOP or nursing practice] has been
modified from xx to xxx
• Based upon the results of this research and the
evidence in the literature, care delivery has been
modified from xx to xxx
• As a result of this research patient outcomes xxx
has xxxx
Speroni, 2011
Speaker Contact Information
Karen Gabel Speroni, PhD, RN
• Director, Nursing Research & Chair, Research Council
– Inova Loudoun Hospital
– Inova Fair Oaks Hospital
• Chair, Nursing Research Council, Shore Health System
• Clinical Scientist, Institutional Review Board
– Inova Research Center
– George Mason University
– Chesapeake Research Review
E-mail:
kgabelsperoni@smartneighborhood.net
Speroni, 2011
48
Questions & Answers
Speroni, 2011