The National Association of Clinical Nurse Specialists Alarm Fatigue Strategies to Safely Manage Clinical Alarms and Prevent Alarm Fatigue NACNS Alarm Fatigue Task Force Alarm Fatigue Task Force 2013 -2014 JoAnne Phillips (Chair), MSN, RN, CCRN, CCNS, CPPS Informatics Professional Development Specialist The University of Pennsylvania Health System Philadelphia, PA Joanne.phillips@uphs.upenn.edu Jacob Ainsworth, MSN, RN, ACNS-BC, NP-C, CCRN-CMC Cardiology Clinical Nurse Specialist, Spectrum Health, Grand Rapids, MI Jacob.ainsworth@spectrumhealth.org Rachel Catinella, MSN, RN, CCRN, CNRN (literature table contributor) Michigan State University CNS Student, Grand Rapids, MI Rachel.catinella@spectrumhealth.org Carolyn Crumley DNP RN ACNS-BC CWOCN Clinical Nurse Specialist-Adult Health/WOC Nurse St. Mary's Medical Center Blue Springs, MO ccrumley@carondelet.com Kathleen Ellstrom, PhD, RN, ACNS-BC Pulmonary Clinical Nurse Specialist, VA Loma Linda Healthcare System Loma Linda, CA Kathleen.ellstrom@va.gov Rhonda Fleischman, MSN, RN-BC, CNS, CCRN-CMC Clinical Education Specialist, Cardiac Care Unit, Aultman Hospital, Canton, OH rfleischman@aultman.com Brenda Moffitt MSN, APRN, CNS-BC Director, Education and Organizational Development, Stormont-Vail Health Care Topeka, Kansas bmoffitt@stormontvail.org Patti Radovich, PhD, CNS, FCCM Nursing Clinical Practice Chair Manager Nursing Research Loma Linda University Medical Center, Loma Linda, CA pradovich@llu.edu Anita White MSN, RN, ACNS-BC, CCRN Clinical Nurse Specialist MICU, Cleveland Clinic, Cleveland, Ohio Whitea2@ccf.org NACNS Alarm Management Toolkit I. Introduction and Instructions Alarm Safety has been named by ECRI the number one technology safety hazard six out of the last eight years. The number and types of clinical alarms generated by medical devices can be overwhelming for clinicians, patients and families. “Alarm fatigue,” occurs when clinicians become desensitized and nonreactive to the sensory overload created by an overwhelming number of alarms, many of which are nuisance or non-actionable alarms. Delayed response and silenced alarms constitute significant threats to patient safety. Alarm fatigue has been implicated as the lead contributing factor in sentinel events related to alarm safety (Sentinel Event Alert, 2013). In 2014, The Joint Commission established a National Patient Safety Goal to improve the safety of clinical alarm systems. Clinical alarms may be associated with physiologic and equipment monitors (e.g., cardiac monitors and IV pumps) or physical-safety alarms (e.g., bed exit alarms). Clinicians may be exposed to hundreds of alarms per patient per day. There are complex reasons for the overwhelming number of alarms, including technology issues, human factors, staffing, and environment. Appropriate alarm management is a complex, yet essential component of clinical practice. When alarms are not set or responded to appropriately, clinicians are more likely to develop alarm fatigue. Patients, families and staff can suffer undue anxiety. Eighty five to ninety nine percent of alarms do NOT require clinical intervention (Cvach, 2012; Feder & Funk, 2013; Gorges, Markewitz, & Westenskow, 2009; Graham & Cvach, 2010; Sendelbach & Funk, 2013). It is essential that clinicians mitigate the risks associated with ineffective alarm management. There are a number of solutions to managing alarms more effectively and safely. Effective alarm management is influenced by unit culture, infrastructure, nursing practice and technology. The Clinical Nurse Specialist (CNS) role is uniquely positioned to understand the variables that facilitate appropriate alarm management and assist staff in implementing strategies for safe and effective alarm management. The CNS practices within the spheres of influence of patient/client; nurses and nursing practice; and organizations /system. The CNS will be able to work collaboratively with an inter-professional team to assess the clinical environment; and to develop, implement and evaluate appropriate interventions to mitigate risks associated with ineffective alarm management. These interventions will impact the patient’s environment, the nurse’s workplace, and the overall clinical environment (Urden & Stacy, 2011). This toolkit serves as a repository of resources and strategies to effectively and safely manage alarms and is intended for use by the CNS working to decrease alarm fatigue and promote safe, effective alarm management in the clinical setting. References Cvach, M. (2012). Monitor alarm fatigue: An integrative review. Biomedical Instrumentation & Technology, 46(4), 268-277. Feder, S., & Funk, M. (2013). Over-monitoring and alarm fatigue: For whom do the bells toll? Heart & Lung: The Journal of Acute and Critical Care, 42(6), 395-396. Görges, M., Markewitz, B. A., & Westenskow, D. R. (2009). Improving alarm performance in the medical intensive care unit using delays and clinical context. Anesthesia & Analgesia, 108(5), 1546-1552. Doi:10.1213/ane.0b013e31819bdfbb Graham, K. C., & Cvach, M. (2010). Monitor alarm fatigue: standardizing use of physiological monitors and decreasing nuisance alarms. American Journal of Critical Care, 19(1), 2834. Sendelbach, S., & Funk, M. (2013). Alarm fatigue: A patient safety concern. AACN Advanced Critical Care, 24(4), 378-386. Doi: 10.1097/NCI.0b013e3182a903f9 The Joint Commission, Patient Safety Advisory Group. (2013, April 8). Sentinel Event Alert. Medical device alarm safety in hospitals. 50. Retrieved from: http://www.jointcommission.org/sentinel_event.aspx Urden, L. & Stacy, K. (2011). Clinical nurse specialist orientation: ready, set, go. Clinical Nurse Specialist, 25(1), 18-27. Toolkit Contents This toolkit was developed to help the CNS on their journey to create an alarm safe environment. The following are the links to the available tools: 1. How to Get Started a. Describes a Six Sigma process to guide the CNS in a change strategy i. define, measure, analyze, design, verify 2. NACNS Crosswalk a. Extensive table of resources from the American Association of Critical Care Nurses (AACN), the Association for the Advancement of Medical Instrumentation (AAMI), ECRI, Johns Hopkins, the Joint Commission, and the Healthcare Technology Foundation. b. The table contains embedded links, enabling the CNS to have direct access to the resources. c. Literature table: an extensive literature review on alarm fatigue is included after the table, with review and grading of each article. 3. Frequently Asked Questions a. Series of frequently asked questions from the NACNS list serv and the open forum at the NACNS National Conference. NACNS Alarm Fatigue How do I Start Checklist Below is an example of a Six Sigma Process approach to change or you may utilize any other change process. Define: State the problem, specify the customer set, identify the goals, and outline the target process. Measure: Decide what parameters need to be quantified, work out the best way to measure them, collect the necessary data, and carry out the measurements by experiment. Analyze: Identify performance goals and determine how process inputs are likely to affect process outputs. Design: Work out details, optimize the methods, run simulations if necessary, and plan for design verification. Verify: Check the design to be sure it was set up according to plan, conduct trials of the processes to make sure that they work, and begin production or sales. Plan Define/Assess Define: Alarm safety is the number one technology hazard in health care. Excessive alarms in clinical environments lead to alarm fatigue: staff may ignore or disable a clinically important alarm. Assess: 1. Appropriateness of monitoring a. EB indications for cardiac monitoring 2. Clinical alarms: current state a. Unit Gap Analysis (AACN) b. Alarm data from clinical engineering / facilities i. # of alarms / defined time ii. # of crisis alarms/ defined time iii. Current defaults 3. Staff education and competency a. Current state Resources Overview Documents: NACNS Alarm Fatigue Resource Crosswalk TJC Goals/Dates R3 Report AAMI Foundation HTSI Key Points Checklist ECRI Strategies to Improve Monitor Alarm Safety Assessment Tools/Strategy Documents: VHA patient Safety Assessment Tool (PSAT) AACN Alarm Management ActionPak Device Worksheet Pre-Change Assessment Survey etc. HTF National Clinical Alarms Survey Evidence based indications for cardiac monitoring Interdisciplinary Team Member Involvement Options: Clinical Engineering CNS Nursing Director for each clinical area Physician Champion for each clinical area Quality Nurse Manager Other professionals at library for data pull etc. Nursing Informatics at library (Suggest to utilize Interdisciplinary Team to: assist in steps of project, CNS Competency Direct Care, Consultation, Systems Leadership, Collaboration, Coaching, Research, Ethical Decision-Making/Moral Agency and Advocacy NACNS Alarm Fatigue How do I Start Checklist i. Onboarding ii. Ongoing 4. Staff attitudes / perceptions 5. HTF survey 6. Patient outcomes a. Organizational data on alarm events Measure Pre-Change Data Measurement Examples: Alarm Event Data-Coordination with Facility/IT (alarm frequency etc) Rapid Response Team/Code Team Event related data HCAPS-Quiet at Night Data Pre-Change Assessment o Overall # of alarms o % nurses customizing alarms o % of high, medium, low, and technical alarms Survey staff on perceptions / attitudes Staff knowledge Analyze Identify goals: determine how process changes will affect process results. Analyze Data from Measure section Evaluate and Prioritize areas for improvement provide support, approve process steps, approve plan etc) Metrics-consider: clinical alarms safety staff education/competencies, surveys/perceptions patient outcomes Resource: See Crosswalk Consultation, Systems Leadership, Collaboration, Research, Ethical Decision-Making/Moral Agency and Advocacy Resource: See Crosswalk Consultation, Systems Leadership, Collaboration, Research, NACNS Alarm Fatigue How do I Start Checklist Design Resource: See Crosswalk Direct Care, Consultation, Systems Leadership, Collaboration, Coaching, Research, Ethical Decision-Making/Moral Agency and Advocacy Pilot Study Units to monitor change Implement changes Resource: See Crosswalk Direct Care, Consultation, Systems Leadership, Collaboration, Coaching, Research, Ethical Decision-Making/Moral Agency and Advocacy Work out details of change to be implemented Detail which alarms to change and the process to implement the change. Include nurse related educational needs for pilot. (staff education/competencies) Include dates/times to monitor data Strategies for Clinical Alarm Management: Defaults Escalation Customization Evidence based use of monitoring Clarify accountability Policy development Verify PDSA Cycle on pilot units Outcomes: o Evaluate goals for success Overall # of alarms % nurses customizing alarms % of high, medium, low, and technical alarms Survey staff on perceptions / attitudes National Association of Clinical Nurse Specialists Alarm Safety Crosswalk Table 1 Organization AACN AAMI ECRI Hopkins TJC Healthcare Technology Foundation (HTF) Website / Resource http://www.aacn. org www.aami.org https://www.e cri.org Cvach Article Graham Article http://www.jointcommission.org www.thehtf.org Spotlight on Success: Johns Hopkins improves clinical alarm safety with escalation algorithms. Free Free Free Reinforce and standardize nursing education on monitoring skills. NPSG 6: Reduce harm associated with clinical alarm systems No Create a monitor competency checklist that reinforces the practical elements regarding alarm management and ensures that nursing staff is capable of monitoring patients effectively. No No NPSG 6: Reduce harm associated with clinical alarm systems No Prepare an inventory of alarm-equipped medical devices used in clinical areas, and identify the default alarm settings and the limits appropriate for each care area. No Cost to Access to online resources Free Free Education Recommendations: Initial or ongoing No No Webinars free for members; $249 for nonmembers No Competency: No www.aami.org No Type of Technology with Alarms: Technology Assessment: Any direction on how to do a technology assessment? Recommendations for assessment of current state? 1. Cardiac monitors 2. Pulse oximetry 3. Ventilator s 4. Bed Exit Alarms No Gap Analysis Webinar: How to Identify the Most Important Alarm Signals to Manage No 1. Alarm Parameter Inventory 2. Alarm Inventory Grid Sample 3. How to Identify the Most Important Alarm Signals to Manage: No No No Spotlight on Success: Johns Hopkins improves clinical alarm safety with escalation algorithms. Use smart alarms or alarm technology that incorporates delays Spotlight on Success: Johns Hopkins improves clinical alarm safety with escalation algorithms. Change ECG electrodes daily or when ECG tracings are poor Spotlight on Success: Johns Hopkins improves clinical alarm safety with escalation algorithms. NPSG 6: Reduce harm associated with clinical alarm systems Recognize the Contributing Conditions: 1. Alarm parameters were not set to actionable levels 2. Alarm thresholds were set too tight resulting in too many false positives 3. Staff working in large clinical units did not have clear accountability to respond to alarm conditions 4. Patient rooms with closed doors made it difficult for staff to hear alarm signals 5. Too many duplicate alarm conditions desensitized staff to alarm signals 6. Lengthy time-lags between installation of devices and staff training on those devices did not allow for staff to Identify the most important alarm signals to manage based on the following: National Clinical Alarms Survey 1. Input from the medical staff and clinical departments; 2. Risk to patients if the alarm signal is not attended to or if it malfunctions; 3. Whether specific alarm signals are needed or unnecessarily contribute to alarm noise and alarm fatigue; 4. Potential for patient harm based on internal incident history; 1 National Association of Clinical Nurse Specialists Alarm Safety Crosswalk Table 1 Organization AACN AAMI ECRI Hopkins TJC become accustomed to the auditory alarm signals of new equipment Recommendations for Defaults Recommendations for best practice No www.aami.org www.aacn.org Christiana Hospital No Using data to drive alarm systems improvements. Graham Article Interventions to Improve Alarm Safety: Evidence Based Practice Recommendations to decrease alarm fatigue covering: 1. Technology 2. Hospital 3. Caregiver Cvach Article Address Special Populations (e.g., peds) No Children's National Hospital No Template for reports; dashboards AACN Alarm Fatigue Materials Children's National Hospital No Spotlight on Success: Johns Hopkins improves clinical alarm safety with escalation algorithms. No Develop an alarm management policy or address alarm management in an existing cardiac monitor policy. Healthcare Technology Foundation (HTF) 5. Published best practices and guidelines. No No 1. To help reduce nuisance alarm signals, change single-use sensors (i.e. ECG leads) according to manufacturer's recommendations. 2. Assess whether the acoustics in patient care areas allow critical alarm signals to be audible. No No No No Spotlight on Success: Johns Hopkins improves clinical alarm safety with escalation algorithms. The Joint Commission (TJC): NPSG No No No No NPSG 6: Reduce harm associated with clinical alarm systems 1. R3 Report ı Requirement, Rationale, Reference 2.VHA Patient Safety Assessment Tool 3. Work plan for the NPSG (Hyman): http://thehtf.org/clinical.asp CUSP (Comprehensive Unit based Safety Program) No No No Utilized CUSP on participating units: A five-step program designed to change a unit’s workplace culture—and in so doing bring about significant safety improvements—by empowering staff to assume responsibility for safety in their environment. This goal is achieved by providing employees education, awareness, access to organizational resources, and a toolkit of interventions. Its five steps include: 1. Train staff in the science of safety 2. Engage staff to identify defects 3. Senior executive partnership/ safety rounds 4. Continue to learn from deficits 5. Implement tools for improvement. No No Using Data to Drive Alarm System Improvements 2 National Association of Clinical Nurse Specialists Alarm Safety Crosswalk Table 1 Organization AACN AAMI ECRI Hopkins TJC Healthcare Technology Foundation (HTF) Change Strategies Gap Analysis No No No No No Order Sets No www.aami.org No No No No Resources AACN Alarm Fatigue Materials www.aami.org www.aami.org The Joint Commission Sentinel Event Alert, Number 50, April, 2013 TJC Sentinel Event Alert. Alarms Clinical Alarms Management and Integration Forms, templates, data formats AACN Alarm Fatigue Materials www.aami.org www.aami.org Using Data to Drive Alarm Systems Improvements Resource Guide: Risky Business Conducting Proactive Risk Assessments: Joint Commission Resources Quality & Safety Network Strategies on how to obtain monitor data No No No Recommended data to obtain: 1. # Of high / medium / low priority and technical alarms over a defined period 2. Average duration of alarms 3. Average daily census and average daily census on telemetry Spotlight on Success: Johns Hopkins improves clinical alarm safety with escalation algorithms.. No No Media Available Webinars, voice over PPT, videos Webinars Webinars Resources No No Joint Commission webinar on Alarm Safety (May 1, 2013) TJC Alarm Webinar Transcript No 1. NTI Action Pack: 2. Fault Tree Analysis of clinical alarms (Hyman) http://thehtf.org/clinical.asp 3 National Association of Clinical Nurse Specialists Alarm Safety Crosswalk Table 2: Alarm Fatigue Literature Article Association for the Advancement of Medical Instrumentation. (2011). A siren call to action. Design/Purpose White paper of recommendations from AAMI Alarm Safety Summit in 2011. Sample/Setting Measurements/Instruments Summit participants included AAMI; FDA; TJC; ACCE; and ECRI Strengths and Weaknesses Relevance to Problem Established 7 clarion themes, a call to action to eliminate harm related to alarms. Strengths: 1. Clarion themes are inclusive; include the challenge, the priority action, and accountability. 2. Short term / long term solutions Weaknesses: 1. Lack of dissemination 2. Document is complex Addresses broad spectrum of alarm safety issues. More than 30% of all telemetry days did not meet accepted indications for monitoring The incidence of significant arrhythmia on a day where the patient was not-indicated for monitoring was extremely small 3.1 out of 100 telemetry monitored days Telemetry monitoring can be expensive. It is estimated to cost $53.00 per patient per day for telemetry; conservative estimates assume for 400 bed hospital patients with no indication for monitoring can cost hospital up to $250,000 per year. Several studies have demonstrated that the majority of alarms created by patient monitoring systems have no clinical relevance Strengths: large study of four different hospitals; findings of the study reveal similar trends in monitoring utilization among organizations Weaknesses: economic analysis was limited; it only included cost of staff monitoring. Indirect costs were not included for maintenance of equipment or potential outflow of patients needing telemetry beds Time attending to alarms of non-indicated monitoring patients takes time and attention away from patients in need of monitoring. Reducing over-monitoring reduces costs and improves safety Level III Grade B Strengths: Table of literature included with clear description of each article Weaknesses: Search strategy, inclusion/exclusion criteria not included Level V Grade C Skin preparation done by using One Step Skin Prep or the ECG Prep Pads used once significantly decreased skin potentials by 2.3 mV and 3.3 mV respectively. There was no significant difference in the control group and the group in which ECG Prep Pads were used five times. Strengths: Large study sample of 120 individuals Weaknesses: skin preparation on arms, and in laboratory not The purpose of this article was to present the current issues and significance of alarm fatigue within the ICU environment This article was included (despite a large focus on smart alarms), because it discussed how human factors are just as important as engineering factors to minimize alarms ***Landmark study used in AACN ECG monitoring recommendations and AHA guidelines on ECG monitoring (Drew et al., 2004). Clarion themes, challenges, and priority actions established by experts. Benjamin et al., (2013), Impact of cardiac telemetry monitoring on patient safety and cost. Quality Improvement Analysis of 1095 adult patients with cardiac telemetry on medical surgical and progressive units (non-ICU), at 4 teaching hospitals Retrospective analysis of 1095 monitored telemetry patients Researchers reviewed total days of telemetry monitoring, incidents of arrhythmias, adherence to guidelines for ECG monitoring and adherence to appropriate discontinuation of telemetry Total days of telemetry measured Borowski et al., (2011). Reducing False Alarms of Intensive Care OnlineMonitoring Systems: An Evaluation of Two Signal Extraction Algorithms. Review of medical device alarms The purpose of the article was to present the current situation regarding clinical alarms and their problems in intensive care such as lack of clinical relevance, and alarm fatigue Review of 10 key articles based on the workshop titled “Too many alarms? Too few alarms? Organized by the section patient Monitors and the Workgroup Alarms of the German Association of Biomedical Engineering th Workshop held November 25 , 2009 Research themes: Ergonomics and human factors engineering could improve clinical effectiveness and usability of alarms Alarm algorithms can be used to optimize alarm modalities, and combine existing data into smart monitors Intelligent alarm systems are needed for a higher level of abstraction and suppression using alarm validation Clochesy, Cifani, & Howe, (1991). Electrode site preparation techniques: a follow-up study. Comparison of electrode site preparation techniques A posttest-only control group design was used to study the effect of electrode site preparation techniques on reducing electrical potential across ECG skin electrodes One hundred twenty healthy volunteers were randomly assigned into one control and three treatment groups of 30 subjects each. The three treatments were One Step Skin Prep used once, ECG Prep Pad used five times, and ECG Prep Pad used once. To control for handedness, the skin preparation site was randomly assigned to either the left or right forearm Retrospective analysis of patient with cardiac monitoring within 4 teaching hospitals to quantify telemetry over-monitoring Level of Evidence and Grade Results Level III Grade B 4 National Association of Clinical Nurse Specialists Alarm Safety Crosswalk Table 2: Alarm Fatigue Literature Cvach, (2012). Monitor alarm fatigue: An integrative review. Integrative clinical review investigating the clinical problem of alarm fatigue Review included 72 articles related to alarm management and alarm fatigue Cvach, Biggs, Rothwell, & Charles-Hudson (2013). Daily electrode change and effect on cardiac monitor alarms: an evidence-based practice approach. Quality improvement study Purpose of the study was to determine if daily electrode changes reduced number of cardiac monitor alarms in acute care unit 2 different adult acute care units at John Hopkins: 15 bed medical progressive care unit (MPC). 25 bed cardiology care unit (CCU) (combined step-down and ICU beds) Drew et al., (2004). Practice standards for electrocardiographic monitoring in hospital settings. Clinical guideline Standards specifically for hospitalized patients; both children and adults Purpose of the guideline is to provide standards for ECG monitoring within the hospital setting Major themes: Excessive alarms have detrimental effects on staff; distrust in monitoring that leads staff to disable alarms Nurse response to alarms is matched by the perceived accuracy of the alarm Alarm audibility; humans can only distinguish a small number of audible noises at one time. Technology can be used to improve rate of alarms; delays, adjusting default settings, and customization of alarm limits can be used to reduce false alarms Average number of alarms per day measured pre and post intervention Total number of alarms were measured continuously for 8 days preintervention and 8 days after intervention Data (total number of alarms) retrieved by clinical engineering There are a variety of quality improvement studies that have been successful in reducing the alarm burden with nursing based strategies: skin prep, education, customization of alarms, and review of default settings Strengths: there is a large amount of literature documenting the significant number of false alarms within the clinical setting Reduction of total number of alarms per day by 46% Randomized clinical trials relative to standard ECG monitoring are nonexistent. Guidelines offer recommendations for ECG lead placement, skin preparation, and what patient Strengths: Clear description methodology. Skin preparation included clipping hair, abrading skin prep site, washing with soap/water, and completely drying before electrode change. Daily electrode change between 8anoon. All ST/QT alarms set for all patients and used all default monitoring parameters Weaknesses: Lack of monitored compliance of unlicensed staff. In future have specific plan to hold staff accountable to ensure daily changes are occurring Strengths: Guideline offers first and only ECG standards based on retrospective adverse outcomes for monitored patients. Includes RCTs Weaknesses: there are very few RCTs related to monitoring standards or appropriate parameters, leads, or what patients to monitor and for how long. Much of the guideline is expert consensus. Little information given on disclosure of authors or plans/tools/guides for implementing the standards within healthcare organizations. Majority of the consensus is based on expert opinions and research in the field of electrocardiography. A knowledge gap exists regarding how to suppress false alarms Level III Grade A Daily change of electrodes with skin preparation resulted in fewer cardiac monitor alarms (reduced number of alarms by 46%) Noted that increases in ‘lead off’ alarms during electrode change time due to techs not pausing alarms during daily electrode change. Alarms are silenced when taking patients off monitors for any reason. Level III Grade B Only published standards of ECG monitoring Level II Grade B An overall score of 4/7 was based on AGREE Research Trust (2009) tool for appraising guidelines Weaknesses: Most evidence related to reducing alarms is from observational studies. Very few RCTs 5 National Association of Clinical Nurse Specialists Alarm Safety Crosswalk Table 2: Alarm Fatigue Literature Edworthy, (2013). Medical audible alarms. Review of the available research related to design of auditory alarms in healthcare Aim of the article it to demonstrate that false alarms for medical devices are unacceptable and alarm design principles must be addressed Literature searched specifically for audibility and visual medical alarms Review examined 50 journal articles, three books, and 100 conference papers Feder & Funk, (2013). Overmonitoring and alarm fatigue: For whom do the bells toll? Expert Opinion/ Descriptive review Overview of literature related to over-monitoring Hospitalized patients both adults and pediatrics Funk et al., (2010). Unnecessary arrhythmia monitoring and underutilization of ischemia and QT interval monitoring in current clinical practice: Baseline results of the Practical Use of the Latest Standards for Electrocardiography Trials. Multi-site prospective observational study examining ECG monitoring based on American Heart Association’s standards for ECG monitoring Purpose is to determine if patients are appropriately monitored as ongoing efforts to reduce clinically insignificant alarms. 17 cardiac units in 17 hospitals 15 in the United States, one in Canada and one hospital in Hong Kong. Hospitals were either academic medical centers or community hospitals, all received IRB approval, and all organization treat medical and cardiac surgical patient populations Funk et al. (2013). An alarming rate of unnecessary monitoring in the Practical Use of the Latest Standards of Electrocardiography (PULSE) trial. Poster Analysis of data from PULSE trial: multisite RCT addressing ECG monitoring practices Evaluation of appropriate use of ECG monitoring Main themes: There are a high number of false alarms There is a lack of standardized alarm philosophy and mapping of alarms to provide end users and understanding of alarm priorities Audible alarm design can be improved; users cannot interpret and understand the vast number of melodic tones of alarms IEC-60601-1-8 is an international standard aimed at harmonizing medical device alarms. This provides a philosophy of alarms to prevent proliferation of alarms that determines the success of alarms Presents articles that suggest monitoring does not contribute to early detection of clinically relevant arrhythmias, decrease long term mortality or alter treatment of patients; instead it is distracting and contributes to the high number of false and irrelevant alarms. No literature to support telemetry monitoring as a method to prevent, detect, or improve survival for cardiac arrest Medical records were reviewed by 3 experienced ICU nurse researchers to determine if the patient had either a Class I or Class II indication for monitoring. Furthermore, the researchers reviewed monitoring for QTc/ST segment monitoring 5 day visit to each unit Prospective medical records review for class I and class II indications for ECG monitoring. 4,678 observations on 3,250 patients in 17 hospitals in cardiac care units There are a high number of false alarms and reduction in false alarm rates means that the design of audible alarms must be improved. Standardization of audible alarms is best practice. Strengths: Provides unique perspective of alarm management from biomedical sciences perspective and the ability of humans to detect audible alarms Weaknesses: Narrative review; search strategy, inclusion criteria not included Practical alarm management strategies such as delays are likely to reduce the rate of false alarms There is a need for standardization of alarm principles, audibility, and alarm ergonomics Level V Grade C Rationale that more monitoring leads to more alarms without a significant improvement in outcomes for many patients. Based on information from literature, 35% of all monitored patients have no indication for monitoring Strengths: Rationale for not supporting widespread monitoring supported by retrospective studies examining survival and outcomes with/without telemetry monitoring Weaknesses: No RCTs comparing outcomes of monitored and unmonitored patients. Recognition that practice standards are now outdated; need updated standards based on new monitoring technology Strengths: Large multisite study. Uses clear definitions for indications for monitoring from AHA standards. Patients randomly selected. Also tracked use of ST segment and QTc monitoring that are known to detect serious clinical events. Weaknesses: Authors suggest that the staff of the study and may have changed their behaviors because they knew the study was in progress (Hawthorne Effect) Over-monitoring is a contributing factor to alarm fatigue and the high number of false alarms Level V Grade B Monitoring is inappropriate and can result in unnecessary alarms: There is over-monitoring for patients with no indication for monitoring Patients with indication for ST segment or QTc monitoring are under monitored Level III Grade B Over monitoring leads to unnecessary alarms. Eliminating unnecessary monitoring will decrease the alarm burden and decrease sentinel events related to alarm fatigue. Level II Total of 1816 patients 89.9% patients with indication for monitoring were monitored 84.9% of patients with no indication for monitoring were monitored Of patients with indication for ST segment monitoring, 34.5% were monitored with ST segment monitoring Of patients with indication for QTc monitoring, only 21.4% had a documented QTc interval within the past 24 hours 26% of patients had no indication for monitoring Grade B 6 National Association of Clinical Nurse Specialists Alarm Safety Crosswalk Table 2: Alarm Fatigue Literature Gorges, Markesitz, & Westenskow, (2009). Improving alarm performance in the medical intensive care unit using delays and clinical context. Graham & Cvach, (2010). Monitor alarm fatigue: Standardizing use of physiological monitors and decreasing nuisance alarms. Observational study Observing monitor alarms in ICU; study of how many alarms are observed to be ignored by staff and how many are actionable. After observation, determine how many alarms could have been avoided by an alarm delay. The purpose of the study was to observe alarms in the Medical ICU to identify methods for reducing the number of false alarms by using delays and finding correlations between alarms and clinical context 200 hours of direct staff observation in a Utah 12 bed Medical ICU Quality improvement project Purpose of the study was to determine if RN adjustment of alarm limits on monitors, changes to default alarm settings, and involvement of interdisciplinary monitor task force team reduced number of monitor alarms and improved noise level of the unit. 15 bed Medical ICU John Hopkins Hospital Data from January 2006 to June 2007 Number of alarms were recorded as well as the number of tasks performed in response to alarms 1214 alarms occurred 2344 tasks were performed in response to the alarms -On average 6.07 alarms occurred each hour -41% of alarms were ignored -Alarms were active for an average duration of 17 seconds before acted on -36% of the alarms were ineffective A 14 second delay would have eliminated 50% of the ignored alarms A 19 second alarm would have eliminated 67% of all alarms. Suctioning, washing, repositioning, and oral care caused 152 ignored or ineffective ventilator alarms Clinical engineers counted all cardiac alarms for an 18 day period both pre and post intervention. 4 types of alarm categories: Crisis: Asystole VT, VF, bradycardia Warning: tachycardia, bradycardia Advisory: pulse oximetry and PVCs Message: irregular System warning: lead failure or arrhythmia Study also measured pretest/posttest RN questionnaire on monitor knowledge and perception of unit noise level Critical monitor alarms were reduced by 43% from baseline data due to adjustment of alarm limits, and implementation of an interdisciplinary monitor policy. Pretest: 83% of nurses changed alarm parameters when a patient condition changed, Post intervention 94% of RNs reported to change alarm parameters to individual patient needs Pretest: 78% of nurses changed alarm parameters at the beginning of their shift. Post: 94% Noise level: Rated 1-5 (1= low, 5=high noise level) Pre: 4.0/5 unit overall noise Pre: 3.1/5 noise from monitors Post intervention: 3.5/5 unit overall noise Post 2.97/5 noise from monitors Strengths: Demonstrates that introduction of an alarm delay improves alarm reliability at the expense of lengthening response time. Appeared that staff respond selectively to alarms or wait before responding. Unique perspective for classifying alarm based on response rather than event triggering the alarm Weaknesses: observation based; subjective of context awareness of alarms that is difficult to define Strengths: breakdown of all alarms before and post intervention in table. -No interpretation of alarms as false/true -Study included cardiac telemetry alarms and pulse ox alarms. Weaknesses: Surveys on alarm limit adjustment compliance and unit noise level may not be accurate as survey not required and was on volunteer basis for RNs. Single unit study Many alarms are false or provider induced. Introducing alarm delays and purposefully silencing alarms during routine care (such as suctioning) can make alarms more reliable and elicit a more timely response, reduce workload, reduce the noise pollution, and potentially improve patient safety. Level III Grade B RN adjustment of alarm limits is starting point in reducing number of physiologic monitor alarms Nurses must be trained to adjust alarm limits. RNs were advised to widen alarm limits for blood pressure and heart rate by +/- 20 points of the patient’s normal values. Level III Grade B 7 National Association of Clinical Nurse Specialists Alarm Safety Crosswalk Table 2: Alarm Fatigue Literature Gross, Dahl, & Neilsen, (2011). Physiologic monitoring alarm load on medical/surgical floors of a community hospital. Quality Improvement Study Purpose of the study was to determine if it was possible to significantly reduce the number of physiologic monitor alarms for med/surg patients by adjusting alarm limits (HR high alarm from 120 to 130 and pulse oximetry low alarm from 90 to 85) A 79 med/surg beds of community hospital located in urban Arizona Data collected over 1 year time period Retrospective evaluation of alarm frequency from April 2009 to January 2010 Before alarm limit adjustment, the average rate of alarms was 95.6 alarms per patient per day. For all patients, the average hours of monitoring were 16.5 hours/patient. Reduction of alarm frequency by 50% by adjusting high HR alarm from 120 to 130 Reduction of pulse ox alarm by 36% reducing the Sp02 alarms from 90% to 85%. Harris, Manavizadeh, McPherson, & Smith, (2011). Do you hear bells: The increasing problem of alarm fatigue. Quality Improvement Descriptive study outlining one organization’s strategies for heightening awareness of alarm fatigue to reduce alarm burden 988 bed academic community hospital with Magnet designation Three hospital entities sites The organization developed a multidisciplinary team of staff, biomedical engineers, and educators to strategize ways to reduce the alarm burden The team provided education to the bedside staff regarding alarm fatigue. Staff also received education on the monitor capabilities. Education on monitoring capabilities was in a CD format for staff to review The Joint Commission, Patient Safety Advisory Group. (2013, April 8). Sentinel Event Alert. Medical device alarm safety in hospitals. Regulatory Safety Alert Sentinel event (SE) database; FDA Maude database. Identified risks associated with clinical alarms based on reports in sentinel event database. Information from sentinel event database. The team analyzed baseline alarm data, reviewed hospital protocols for alarm management. Discovered in this process that staff did not know how to use monitors to their full potential; no training was offered on monitoring. Preceptors taught new staff what they knew about monitors. No formal education After education for staff (6 months) the alarms were reevaluated: the ICU had a 30% improvement in alarm burden and a 12% reduction in alarms was noted on progressive units Recommendations / potential strategies for improvement The Joint Commission (2013). Spotlight on Success: Johns Hopkins improves clinical alarm safety with escalation algorithms. Interview w/ clinical expert about QI project on escalation strategies for alarm safety Discussion of QI project from Johns Hopkins; introduced alarm escalation New wireless device to create escalation process for clinical alarms Outside of the escalation QI project: 1. Identified 7 strategies to improve alarm safety 2. 53% decrease in high priority alarms 3. 23% decrease in duration of high priority alarms Strengths: True and false alarm criteria specifically defined -Raw data provided for true alarms, false alarms, and uncertain alarms. -Alarms reviewed by two independent clinical researchers for validity, in case of disagreement a third clinical ‘judge’ was used -Included both telemetry and pulse oximetry Weaknesses: Only 34% of HR alarms and 63% of pulse ox alarms considered true alarms continue to work on sensitivity/specificity of clinical alarms. Strengths: Article provides discussion of the challenges to implementing a change at a large hospital with multiple entities. Weaknesses: The study did not provide methodology for collecting baseline alarm data or how or when the follow-up data collection was completed. No raw data is provided only two percentages indicating there was a reduction in the alarms. Sample size is not provided. Current alarm limits from Philips monitors appear to be too tight for non-ICU patient and contribute to an unnecessarily high alarm load. -Small adjustments in clinical alarms limits significantly reduce alarm load Studied only critical or high priority alarms for telemetry Level III Grade B A reduction in alarm burden was achieved though educating nurses about alarm fatigue, customization of alarm parameters, and the capabilities of the monitors. Level VI Grade C Strengths: clear data & recommendations. Raised awareness across healthcare about the risks associated with the overwhelming number / volume of alarms. Weaknesses: Industry experts believe reports underrepresent actual number of events. Strengths: 7 strategies recommended are within the scope of most organizations to integrate immediately. Weaknesses: Nomenclature is vendor specific for the alarms. Escalation strategy requires purchase of wireless devices Seven strategies are clear and can make a significant impact without structural changes / significant resources. Introduction of wireless devices would be more challenging. Level VI Grade C 8 National Association of Clinical Nurse Specialists Alarm Safety Crosswalk Table 2: Alarm Fatigue Literature Jonasson, (2007). A prospective study on the relevance of skin preparation for noise, impedance and ECG intervals among healthy males. Prospective study Study designed to determine relevance of ECG skin preparation to reduce noise and impedance (artifact) among healthy males 22 healthy male test subjects June 2006 Halmsted, Sweden Korniewics, Clark, & David, (2008). A national online survey on the effectiveness of clinical alarms. Descriptive Analysis based on a national survey to identify the problems associated with alarms in hospitals Medina, Clochesy, & Omery, (1989). Comparison of electrode site preparation techniques. Comparison of electrode site preparation techniques A posttest-only control group design Melendez & Pino, (2012). Electrocardiogram Interference: A Thing of the Past? Quasi-Experimental design ECG interface was controlled and studied in a laboratory environment and then tested in the clinical environment Purpose of the study is to find the best method to reduce interference of physiologic waveforms from electrodes to improve alarm reliability Researchers received survey results from t 1327 healthcare workers’= 94% worked in acute care hospitals 51% were RNs 31% worked in ICU Survey was developed by a 16 member task force of nurses and clinical engineers 60 health volunteers were randomly divided into one control and two treatment groups of 20 subjects each Within each group, the skin preparation for the ECG electrodes (treatment) was further assigned randomly to either the right or left forearm. In the laboratory: a controlled electrode impedance mismatch was simulated on one patient with various skin preparations on the left leg. In the clinical setting ECG interference was tested in the cardiac stress test laboratory and the electroencephalography (EEG) laboratory Male subjects wearing ECG monitors were recorded over 5 minute time periods at 5 time points at 3 separate 24 hour visits with different types of ECG skin prep 1. No skin prep 2. Abrasion only 3. Abrasion and alcohol skin prep At the end of each visit, i.e. 24 hours after electrode application, each subject was questioned regarding itching from the electrodes on a fivestep scale of no itching, mild, moderate, severe, and very severe itching. Artifact measured in ECG impedance and ECG amplitude. -Sandpaper, grain 400, was used for skin abrasion - Skin impedance was to be measured prior to each ECG recording period in leads V2 and V3 using a Prep-Check Electrode Impedance Meter 81% reported alarms disrupt care 78% distrust alarms and disable them >90% agreed that that there is a need for prioritized and easily differentiated audible and visual alarms Skin preparation with One Step Skin Prep, ECG prep pads, or no skin preparation Interference from electrodes on monitoring was measure using impedance monitors. Interference was measured in the laboratory setting on test patients with test equipment and then further tested in real clinical settings Skin preparation by abrasion showed statistically significant reduction in skin impedance and noise for all ECG leads (compared to no skin preparation) Skin cleansing with alcohol is not warranted. Strengths: All statistical data included in article -Controlled study environment -Documentation of body size, weight, BMI -Impedance measured in individuals leads Weaknesses: Lack of randomization -Small sample size -Skin itching and irritation did not differ between three skin preps -Hair was trimmed on all patients, no study findings on clipping vs. shaving hair for optimal electrode adhesion Level III Grade B The survey results suggest that there is a need for Equipment redesign Clinicians who take an active learning in how to use physiologic monitoring correctly Hospitals must recognize the complexities of managing clinical alarms Skin preparation by using One Step Skin Prep significantly decreased skin potentials (1.90 mV) whereas the group in which ECG Prep Pads were used and the control group had no significant change Strengths: one of very few studies describing the perspective of the bedside staff in dealing with the alarm burden Weaknesses: convenience sample of respondents Surveys may not provide the most accurate data related to a subject area It is necessary to provide staff with education and policies related to alarm responsiveness and awareness of alarm fatigue Level VI Grade C Strengths: randomized trial Weaknesses: testing only in laboratory setting on patient forearms. Small sample size ***Landmark study used in AHA guidelines on ECG monitoring (Drew et al., 2004) Level II Grade B Skin preparation with pumice was more effective that skin adhesive or alcohol Dry electrodes that are not kept in manufacturer packaging causes the electrodes to dry and lose effectiveness Train clinical and technical staff on what causes electrode interference Strengths: Interference was measured using with impedance meters to create objective measurement of interference Weaknesses: Sample size unknown. All skin preparations tested are not included in the study methodology. Article describes a ‘trial and error’ technique to slowly changing out products, skin preparations, and electrodes until interference was reduced With consistent skin preparation and testing of electrodes with impedance meters, interference can be eliminated in some clinical settings including the operating room Simple changes such as fresh electrodes and skin preparation make potentially dramatic changes in performance of ECG monitors Level III Grade C 9 National Association of Clinical Nurse Specialists Alarm Safety Crosswalk Table 2: Alarm Fatigue Literature Phillips, (2006). Clinical alarms: Complexity and common sense. Expert Opinion/ Descriptive analysis The article provides a guide from the acute care team in evaluating alarm systems in the clinical environment Review of components of alarm safety programs Includes strategies for review of alarms and evaluation of alarm burden in all acute care settings Article provides assessment tools for use in evaluation of organizational alarm systems Steps in evaluation include: An environmental assessment Assessment of alarm response; who is responsible for responding to and assessing alarms Assessment of alarm system problems from environmental, user, technical, and other categories. Assessment of alarm system will guide clinical policies related to Initiation and prioritization of alarms Policies related to silencing and disabling alarms Bed to bed notifications Bedside device integration How to deal with ‘lead off’ Volume of alarms Strengths: article provides an evidence based tool kit for assessing alarms within an organization and strategies for reducing alarm burden Weaknesses: No guides for appropriate default settings or methods for customizing individual patient alarms Sendelbach, (2012). Alarm fatigue. Literature Review Overview of phenomenon of alarm fatigue and alarm management literature Includes review of total number of alarms measured in a variety of clinical settings: emergency departments, critical care, operating rooms, and medical/surgical units. Based on the current literature, there is a range of only about 0.6%- 8% of alarms that are clinically significant Strengths: comprehensive analysis of the issue of alarm fatigue and task forces working on reducing false alarms Weaknesses: only offers overview of literature and no recommendations for individual organizational alarm improvement strategies Sendelbach, S., & Funk, M. (2013). Alarm Fatigue: A Patient Safety Concern. Clinical review Information from TJC, ECRI, HTF, AAMI, AACN related to alarm safety Major themes: 1. Described alarm fatigue: how, why, impact 2. Discussed recommendations by each organization to combat alarm fatigue Based on the high rate of false alarms there are a variety of practice alerts to address alarm fatigue: Biomedical engineering to consider smart alarms and alarm mapping to reduce alarms Nursing policy and procedure for skin preparation, ongoing education, and alarm customization are recommended Hospitals must educate staff and pay attention to the default settings and monitoring capabilities of organizational software Recommendations: Alarms need to be sensitive and specific. Interventions to decrease alarm fatigue have not been rigorously tested. Strengths: Proposed future research in false alarms; nonactionable alarms; appropriate use of monitoring; processes of care Identified alarm systems that are supposed to help, but actually increase risk because of alarm fatigue Siebig et al., (2010). Intensive care unit alarms: How many do we need? Observational study to validate the number of a cardiac alarms among critically ill patients to determine the relevance of alarms Medical intensive care unit at a University Hospital from Jan 2006 to May 2007 Recording of 982 hours of alarm data 982 hours recorded by video and observed by a physician Video recordings were annotated for alarm relevance and technical validity Physiologic data from monitors was recorded at 1 second intervals that were extracted from the monitoring network software Within the 982 hours there were a total of 5934 alarms 40% of alarms did not describe the patient condition correctly 68% of alarms were caused by staff manipulation Only 15% were true alarms Most (70%) of alarms were simple threshold alarms 45% were related to arterial blood pressure monitoring from arterial lines Strengths: Comprehensive analysis of each type of alarm and validation by observing physician related to the relevance and clinical ‘trueness’ of each alarm Weaknesses: Possible bias introduced by individual interpretation of clinical relevance of alarms. Other studies had 2-3 clinical observers to arrive at group consensus of alarm relevance Suggestion that because most alarms are due to simple thresholds customization of alarm limits may significantly reduce the number of false alarms It is suggested that customization for alarm parameters could be targeted around +/- 20% of ‘normal’ Identify strategies to decrease alarm fatigue Clinical alarms are important in the healthcare environment but it is essential for organization to make efforts to improve the reliability of alarms. Standardization of alarm management techniques is critical to creating alarm systems that are safe ** Reviewing the previous shifts alarm customization is essential to creating a cultural norm to customize alarms Provides an overview of the clinical problem of alarm fatigue and safety concerns related to the high number of false alarms in the current healthcare environment Level VI Grade B Level V Grade B Level III Grade B 10 National Association of Clinical Nurse Specialists Alarm Safety Crosswalk Table 2: Alarm Fatigue Literature Urden, L. D., & Stacy, K. M. (2011). Clinical nurse specialist orientation: ready, set, go! Qualitative study Welch (2011). An evidencebased approach to reduce nuisance alarms and alarm fatigue. Quality Improvement Study Study to determine if adjustment of alarm thresholds reduces number of alarms for pulse oximetry monitors in post-surgical patients. Retrospective analysis of alarm load pre/post intervention. Quality Improvement Study Study to determine variables that would safely reduce noncritical telemetry monitor alarms by altering manufactures default alarm settings Whalen et al., (2013). Novel Approach to the Management of Clinical Alarm Fatigue. CNS team at Magnet community hospital Design the CNS orientation process using the 3 spheres of influence 1. Review of the literature 2. Initial competency validation checklist for CNS Development of evidence based tool for orientation of the new CNS or CNS new to the hospital Strengths: Evidence based tool for orientation of CNS Outlines the spheres of influence of the CNS Level VI Grade C Weaknesses: External validity is questionable, only done in one setting. Post-surgical patients on 36 bed floor over 11 month time period Baseline data: most common alarm is SpO2 less than 90% that alarmed 4.4% of the entire monitoring time equating to 63 minutes per patient per day Intervention (reducing alarm threshold to 89, 88, 87, 86 or 85) and delaying the alarms at times ranging from 5-15 seconds Decreasing alarm thresholds from 90% to 88% decreases alarms by 45% Reducing the low alarm threshold from 90% to 85% decreases alarm rate by 75% Increasing alarm delays from 5 seconds to 15 seconds reduces alarm rate by 70% Strengths: Large sample size, measurements over extended period of time. Weaknesses: Only measured alarms of pulse oximetry. No discussion of alarms due to disconnections of cable, loss of connection due to application of sensors to pulse ox alarms. Altering alarm limits or slightly delaying alarms is a cost effective approach to reducing burden of alarm fatigue Not all institutions ok with lowering alarm limits by large amounts in critically ill or acutely ill patients. Level III Grade B General medical-surgical unit at Boston Medical Center 24 bed pilot unit 2 week time period Alarm data, nurses response to alarms, unit noise in dB, and patient satisfaction, and nursing perception of noise were measured Baseline data: 87,823 audible alarms per week on the unit. After intervention: 9967 alarms in one week on the pilot unit. Default alarm settings altered and education for RNs to customize alarms Nursing staff perception of noise via anonymous survey Overall an 89% reduction in audible alarms was achieved on the pilot unit (t = 8.84; P < .001) The incidence of Code Blue events decreased by 50% Noise levels evaluated in decibels from 54-90 dB preimplementation Post-implementation noise ranged from 60-72 dB. Patient satisfaction scores based on Press-Ganey. Nurse domain rank increased by 15 percentile ranks, noise in room increased by 12, promptness to call lights increased by 39. Overall rank increased by 31 Nursing perception of noise increased from noise is acceptable 0% of the time to post-study of noise acceptable 64% of the time Strengths: complete report of changes to alarms, alarm distribution and statistical significance of alarm burden pre/post study Weaknesses: nursing satisfaction post-implementation measured by ‘comments’ rather than established tool A significant reduction in alarm burden can be achieved without costly resources or new technology. Incidence of safety events was successfully decreased and patient satisfaction improved Level III Grade B Articles Not Included in Literature Review that Provide Background Information 11 National Association of Clinical Nurse Specialists Alarm Safety Crosswalk Table 2: Alarm Fatigue Literature Article Association for the Advancement of Medical Instrumentation, (2011). Design/Purpose 2011 Summit; a call to action for addressing healthcare alarms Key stakeholders are identified and seven themes related to alarm management are addressed Descriptive analysis of technological communication strategies to alert providers of critical alerts Rationale for not including in Literature Review Provides background and overview of medical device safety issues related to alarms. Summit publication provides background information regarding the history of alarm fatigue, medical device alarms, and significance of the problem. Focus is primary on technology/smart alarm integration of monitoring equipment with pagers and alerts to communicate alarms with bedside staff. Focus is on smart monitoring Bush-Vishniac et al., (2005). Noise levels in Johns Hopkins Hospital Descriptive analysis of noise levels in John Hopkins Hospital; particular at night Provides background evidence related to the problem of noise in hospitals and the noise that is attributed to alarms and physiologic monitors Emergency Care Research Institute (2011). An organizational publication that regularly reviews healthcare technology Descriptive analysis/Expert Opinion related to the history of alarm fatigue An introduction into the top ten health safety concerns Descriptive analysis of alarm fatigue Newspaper article describing a highly publicized patient death attributed to alarm fatigue Expert opinion Background information on tracking and evaluating medical device safety and safety issues related to alarm fatigue Provides background information and definition of alarm fatigue Descriptive analysis examining the effects of nursing burnout on patient outcomes Literature review describing sources of noise in ICU environment Background information related to the patient safety risks associated with nursing burnout Descriptive analysis/ Expert opinion of risks associated with hospital noise Observational study quantifying the noise levels in hospitals Background information related to alarms contributing to noise in hospitals Bonzheim et al., (2011). Communication Strategies and Timeliness of Response to Life Critical Telemetry Alarms Hannibal (2011). ECG Challenges: Monitor Alarms and Alarm Fatigue Keller (2012). Making clinical alarm management a patient safety priority. Kerr & Hayes (1983). An “alarming situation in the intensive therapy unit. Kowalczyk (2011). ‘Alarm fatigue’ linked to patient’s death. Mazer (2012). Creating a Culture of Safety Reducing Hospital Noise Poghosyan, Clarke, Finlayson, & Aiken, (2010). Nurse Burnout and Ratings of Quality of Care: A Six-Country Study Pugh, Jones, & Griffith, (2007). The impact of noise in the intensive care unit. Wallis (2012). Alarm fatigue linked to patient death. Yoder et al., (2012). Noise and Sleep Among Adult Medical Inpatients: Far From a Quiet Night Level I Level II Level III Level IV Level V Level VI Level VII Grade A High Grade B Moderate Grade C Weak Background information related to safety of medical devices Older article; provides background and history of alarm sensitivity and alarm fatigue Background information related to alarm fatigue and patient safety Background information. Description of noise in hospitals; what devices contribute to noise burden Background information; alarms contributing to noise Background information related to alarms and noise Level of Evidence (Melnyk & Fineout-Overholt, 2011) Systematic review & meta-analysis of randomized controlled trials; clinical guidelines based on systematic reviews or meta-analyses One or more randomized controlled trials Controlled trial (no randomization) Case-control or cohort study Systematic review of descriptive & qualitative studies Single descriptive or qualitative study Expert opinion Grade Rating: Strength of Evidence (Melynk & Fineout-Overholt, 2005) Reflects a high degree of clinical certainty and is based on availability of high quality level I, II, or III evidence. Reflects moderate clinical certainty and is based on availability of level III and/or level IV evidence. There are some minor flaws or inconsistencies Level V, VI, or V evidence. There is limited or low quality evidence; has limited or unknown effectiveness 12 FAQs on Alarm Management Question Nursing Practice What are the best strategies to reduce the number of clinical alarms? For monitored units, how often do you review alarms? What does your review include (i.e. arrhythmias, yellow alarms, trends, alarm limits, etc.)? Where do nurses document alarm review? How can I support the appropriate use of telemetry? (or June, 2014 Answer Multifactorial: Establish an inter-professional team to address alarm fatigue across all environments of care Conduct an inventory of alarm-equipped medical devices Develop guidelines for alarm settings & tailoring of alarms Provide proper skin preparation for EKG electrodes Customize alarm parameters & levels on EKG monitors Customize delay & threshold settings on O2 sat monitors Provide initial & ongoing education about devices with alarms Monitor only those patients with clinical indications for monitoring http://www.aacn.org/wd/practice/docs/practicealerts/alarm-management-practice-alert.pdf Managing Alarm Fatigue: New Approaches and Best Practices Live Q&A: Alarm Management Implementation Revisited Sendelbach,S. & Funk, M.(2013). Alarm fatigue: A patient safety concern. AACN Advanced Critical Care, 24(4), 378-388. Documentation is organization specific. Consider patient acuity level Determine priority of alarms (high, medium, low) and risk of death/unintended consequences if unattended Identify actionable alarms (requires clinical intervention or some type of action) Identify non-actionable alarm signal (true alarms that do not require a clinical intervention or action) http://www.aami.org/meetings/webinars/HTSI/resources/10302013_Slides.pdf http://www.aami.org/meetings/webinars/htsi/resources/12032013_Checklist.pdf Sendelbach, S., & Funk, M. (2013). Alarm fatigue: a patient safety concern. AACN advanced critical care, 24(4), 378. Documentation is organization specific. Policies should guide: Standardized location of information What is included in the documentation (e.g., lead, rhythm interpretation, intervals, alarm review, alarm limits) Frequency of documentation How often the strip must be run, interpreted and posted How often documentation of the rhythm needs to be in the medical record Evidence Based Practice: FAQs on Alarm Management make sure telemetry is not over-prescribed or implement a ” telemetry use reduction project”) How can I encourage physician buy-in? June, 2014 Expert opinion and research recommend monitoring only those patients with clinical indications for monitoring Developing an alarm safety program helps identify the appropriate patients and helps standardize the practice across clinical environments. http://www.aacn.org/wd/practice/docs/practicealerts/alarm-management-practice-alert.pdf http://www.aami.org/meetings/webinars/HTSI/resources/10302013_Slides.pdf http://www.aami.org/meetings/webinars/htsi/resources/12032013_Checklist.pdf Drew, B. J., Califf, R. M., Funk, M., Kaufman, E. S., Krucoff, M. W., Laks, M. M., & Van Hare, G. F. (2004). Practice Standards for Electrocardiographic Monitoring in Hospital Settings An American Heart Association Scientific Statement From the Councils on Cardiovascular Nursing, Clinical Cardiology, and Cardiovascular Disease in the Young: Endorsed by the International Society of Computerized Electrocardiology and the American Association of Critical-Care Nurses. Circulation, 110(17), 2721-2746. http://circ.ahajournals.org/content/110/17/2721.full.pdf+html Feder, S., & Funk, M. (2013). Over-monitoring and alarm fatigue: For whom do the bells toll? Heart & Lung: The Journal of Acute and Critical Care, 42(6), 395-396. Funk, M., Stephens, K., May, J., Fennie, K., Feder, S., & Drew, B. (2013). An alarming rate of unnecessary monitoring in the Practical Use of the Latest Standards of Electrocardiography (PULSE) trial. Journal of the American College of Cardiology, 61(10_S). Is there a standard or recommendation for how often to change ECG electrodes? Evidence suggests that changing EKG electrodes daily decreases the number of false alarms. http://www.aacn.org/wd/practice/docs/practicealerts/alarm-management-practice-alert.pdf Should nurses be allowed to adjust default alarm settings? Are there guidelines available? Default settings are programmed into the monitors by clinical / biomedical engineers. Settings should be revised to eliminate duplicate alarms and so that alarms are clinically significant and actionable- nurses should be educated to prospectively individualize alarm parameters so that alarms are meaningful & actionable (Graham & Cvach, 2010) Graham, K.C. & Cvach, M. (2010). Monitor alarm fatigue: Standardizing use of physiological monitors and decreasing nuisance alarms. American Journal of Critical Care, 19(1), 28-34. FAQs on Alarm Management June, 2014 Advancing Safety in Medical Technology. (2011). A siren call to action: Priority issues from the Medical Device Alarm Summit. Retrieved from http://www.aami.org/htsi/alarms/pdfs/2011_Alarms_Summit_publication.pdf Gross, B., Dahl, D., & Nieson, L. (2011). Physiologic monitoring alarm load on medical/surgical floors of a community hospital. Biomedical Instrumentation & Technology, 45(1), 29-36. doi:http://dx.doi.org/10.2345/0899-8205-45.s1.29 Sendelbach,S. & Funk, M.(2013). Alarm fatigue: A patient safety concern. AACN Advanced Critical Care, 24(4), 378-388. Are educational resources/competencies available for staff regarding clinical alarm management? Which interventions will result in the greatest alarm reduction? Welch, J. (2011). An evidence-based approach to reduce nuisance alarms and alarm fatigue. Biomedical Instrumentation & Technology, 45(1), 46-52. doi:http://dx.doi.org/10.2345/08998205-45.s1.46 Link to Staff Education/Competency and/or section on NACNS Alarm Safety Crosswalk EBP utilization for telemetry monitoring. An analysis of 1095 adult patients with cardiac telemetry on medical surgical and progressive units (non-ICU), at 4 teaching hospitals. More than 30% of all telemetry days did not meet accepted indications for monitoring. Benjamin, E.M., Klugman, R.A., Luckmann, R., Fairchild, D.G., & Abookire, S.A. (2013). Impact of cardiac telemetry monitoring on patient safety and cost. American Journal of Managed Care, 19(6), 225-232. Drew, B. J., Califf, R. M., Funk, M., Kaufman, E. S., Krucoff, M. W., Laks, M. M., & Van Hare, G. F. (2004). Practice Standards for Electrocardiographic Monitoring in Hospital Settings An American Heart Association Scientific Statement From the Councils on Cardiovascular Nursing, Clinical Cardiology, and Cardiovascular Disease in the Young: Endorsed by the International Society of Computerized Electrocardiology and the American Association of Critical-Care Nurses. Circulation, 110(17), 2721-2746. http://circ.ahajournals.org/content/110/17/2721.full.pdf+html Defaults / Parameters How can I ensure/demonstrate appropriate staff decision making regarding alarm parameters? One strategy is to use case studies. Select cases for patients that are most often seen in your practice area and create key questions. For example, for heart failure patients, how many PVCs would the provider treat? If the patient’s normal pulse ox is 85%, what would be an appropriate setting? 82%? 80%? Ask providers what do they want to be notified about – ask FAQs on Alarm Management Are there established default settings for physiologic monitoring? Are they evidence-based? Are they variable based on the level of acuity? How can I sort out multi-parameter monitors and eliminate or reduce duplicate alarms? How do I determine the current default settings? Fatigue How can I measure alarm fatigue? June, 2014 if that is how the parameters can be set. Link to Best Practices section on NACNS Alarm Safety Crosswalk There is no evidence that recommends particular default settings. There is evidence that will guide you to how changes in defaults can decrease the number of alarms. Defaults are a starting point, if specific default values are not appropriate for individual patients, customization is essential. Korneiwicz, D.M., Clark, T., & David, Y. (2008). A national online survey on the effectiveness of clinical alarms. American Journal of Critical Care, 17(1), 37-41. Each brand of monitor is set up differently. Consult with the clinical liaison from your monitoring company, ask very specific questions. If an alarm assessment has not been completed, that may be helpful. Evaluate the need for each parameter to be on as a default, i.e., do all patients need continuous respiratory rate monitoring? Some organizations have the same defaults for all monitors; others have specific defaults for specific units. One strategy to decide on defaults is to analyze data for particular values (eg, HR, RR, BP) over a period of time (possibly a week) and use that information to decide what values specific defaults should be. Link to Defaults section on NACNS Alarm Safety Crosswalk Healthcare Technology Foundation Clinical Alarms Survey http://www.thehtf.org/clinical.asp Korneiwicz, D.M., Clark, T., & David, Y. (2008). A national online survey on the effectiveness of clinical alarms. American Journal of Critical Care, 17(1), 37-41. Data What types of reports are available from my equipment? How can I partner with the equipment vendors? How can I obtain data from my monitor system? Technology Each vendor has different reports available. It is important to organize the information you need and meet with the vendor and the clinical / biomedical engineers. Be specific about the data you need, the frequency you need the report and a plan for dissemination (e.g., monthly or weekly reports). Collaborate with clinical / biomedical engineers and the monitor vendor. Establish concrete data points that are available from the monitor, work to set up ongoing reports, supplied by either clinical / biomedical engineers or the monitor vendor. Be very clear about the data request: what data; from which units; how often. Establish a plan for data analysis and dissemination. FAQs on Alarm Management How can I test clinical alarms for audibility? What is the best process for monitoring telemetry? How many patients should a monitor tech be in charge of? What is best process for notifying nurse of an alarm? When should an alarm be escalated? Miscellaneous Does the hospital receive additional reimbursement for a patient on telemetry? How do I obtain information (or who do I contact) regarding serious safety event data? Who are the key stakeholders? Who should I include on my multidisciplinary team to address clinical alarms? Should I try to address all clinical alarms, or just cardiac monitoring? What about specialized alarms, like fetal monitoring? June, 2014 Descriptive analysis of noise levels in John Hopkins Hospital; particular at night. Busch-Vishniac, I. J., West, J. E., Barnhill, C., Hunter, T., Orellana, D., & Chivukula, R. (2005). Noise levels in Johns Hopkins hospital. The Journal of the Acoustical Society of America, 118(6), 3629-3645. There are no outcome data to support one type of telemetry model (eg, local telemetry techs, “war room” model of telemetry techs, nurse accountability without tele techs). There is no evidence to specify how many monitors one technician can observe. If a tele tech needs to notify a nurse, the best strategy is through direct communication via an individual phone or communication device. Whenever there is an intermediary, there is a risk for delayed or dropped communication. An alarm should be escalated when the risk of the alarm going unanswered could possibly result in patient harm. Most hospitals are paid based on negotiated contracts. On admission, the hospital is reimbursed per DRG by most payers, including Medicare. Rarely, commercial contracts may pay more for patients on telemetry, but it would need to be on a pre-negotiated contract. Data on serious safety events is aggregated by different people in different organizations. Some examples of resources for the data include risk management; the office of patient safety; and the office of regulatory compliance. Link to the AACN and AAMI websites on NACNS Alarm Safety Crosswalk This is an organizational decision. The NPSG requires that you identify alarms that could result in harm if not attended to in a timely way, the focus of the work needs to prioritize those alarms.