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Journal of Pain and Symptom Management 1

Brief Quality Improvement Report

Implantable Cardioverter Defibrillator Deactivation: A Hospice Quality Improvement Initiative Sally E. Kraynik, MSN, RN, NP, ANP-BC, CHPN, David J. Casarett, MD, and Amy M. Corcoran, MD University of Pennsylvania School of Nursing (S.E.K.); and Perelman School of Medicine (D.J.C., A.M.C.), Philadelphia, Pennsylvania, USA

Abstract Background. Dying patients whose implantable cardioverter defibrillators (ICDs) continue to deliver shocks may experience significant pain, and the National Quality Forum has endorsed routine deactivation of ICDs when patients near the end of life. The overarching goal of this quality improvement project was to increase rates of ICD deactivation among hospice patients. Measures. ICD deactivation rates pre- vs. post-intervention; and clinicians’ knowledge and confidence regarding ICD management. Intervention. A multifaceted intervention included clinical tools, education, and standardized documentation templates in the electronic medical record. Outcomes. The proportion of patients whose ICD was deactivated increased after the intervention (pre- vs. post-intervention: 39/68, 57% vs. 47/56, 84%; odds ratio 3.88; 95% confidence interval 1.54e10.37; P ¼ 0.001). Clinicians’ knowledge and confidence regarding ICD management improved (pre- vs. post-intervention median questionnaire scores: 5 vs. 9 on a scale of 0 to 10; Wilcoxon signed-rank test Z ¼ 5.01; P < 0.001). Conclusions/Lessons Learned. A multifaceted intervention can increase rates of ICD deactivation among patients near the end of life. J Pain Symptom Manage 2014;-:-e-. Ó 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved. Key Words Implantable defibrillators, deactivation, palliative care, hospice care, terminal care, cardiac arrhythmias, cardiovascular disease, quality improvement, outcome assessment, patient safety

Background In the United States, 133,262 implantable cardioverter defibrillators (ICDs) were surgically Address correspondence to: Sally E. Kraynik, MSN, RN, NP, ANP-BC, CHPN. E-mail: [email protected] Accepted for publication: October 4, 2013. Ó 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

placed in 2009.1 ICDs are devices that monitor heart activity and deliver pacing and/or electrical cardioversion for arrhythmias. For patients with life-limiting illnesses who have chosen hospice care, ICD shocks may not be consistent with patient and family goals.2 Hospice care focuses on quality of life and forgoing life-prolonging therapies; painful ICD shocks may cause 0885-3924/$ - see front matter http://dx.doi.org/10.1016/j.jpainsymman.2013.09.010

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unnecessary suffering in patients and anxiety in their families.3,4 The defibrillator function of an ICD can be deactivated painlessly, without affecting the pacing function, through either reprogramming or placement of an ICDdeactivation magnet.5 Reprogramming is the preferred method of ICD deactivation, as magnet deactivation is not permanent or guaranteed under all circumstances.6 The ethical basis of ICD deactivation is widely supported in the literature.7 According to the Heart Rhythm Society, ‘‘Communication about [ICD] deactivation is an ongoing process that starts prior to implant and continues over time as patient’s health status changes.’’8 Moreover, the National Quality Forum (NQF) has endorsed ICD deactivation as a palliative care quality measure.9 The NQF’s measure focuses on hospitalized patients, and it is specified as follows: ‘‘Percentage of hospitalized patients who die an expected death from cancer or other terminal illness and who have an [ICD] in place at the time of death that was deactivated prior to death or there is documentation why it was not deactivated’’.10 There is no equivalent measure in outpatient settings, but the rationale for ICD deactivation is clear among hospice patients who have chosen comfort care.

Measures An ICD quality improvement (QI) project was carried out in a university-affiliated, notfor-profit hospice with a combined hospice and palliative care daily census of 300 patients. The hospice serves patients in urban and suburban settings, in various sites including: homes, nursing facilities, inpatient hospitals, and a stand-alone inpatient hospice facility. The impact of the intervention on ICD deactivation rates was examined by measuring the proportion of patients who died with a deactivated ICD pre- and post-intervention. Patients were included if they died with an ICD documented during the 30-month study period (January 1, 2011, to June 30, 2013). The 30month time frame was arbitrarily established to coincide with staff schedules. Information Services created an electronic medical record (EMR) report to obtain demographic information for all patients with a documented ICD. A supplementary manual

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EMR review also was performed. The following patient data were collected as applicable, although not all variables are fully addressed in this brief report: demographic (name, date of birth, date of death, date of admission, date of discharge, site of care, level of care, primary diagnosis), discussion surrounding patient/family ICD goals of care (supporting documentation absent or present), ICD status (unknown, active, or deactivated; deactivated via reprogramming or deactivated via ICDdeactivation magnet placement), date of ICD deactivation, and site of ICD deactivation. Clinicians were included if they completed an ICD inservice, which was presented both in person and online. Identical 10-question, multiple choice, knowledge- and confidencebased questionnaires were completed at the beginning and end of the inservice; the questionnaire is provided in Appendix I. The six confidence-based questions followed criteria previously identified as important elements of an ICD deactivation policy.6 The impact of the inservice on clinician knowledge and confidence was evaluated through analysis of responses from the two sets of questionnaires using the Wilcoxon signed-rank test. The study was approved by the University of Pennsylvania Institutional Review Board. All clinicians provided informed consent, and the Board determined that patient informed consent was not required.

Intervention The QI project focused on ICD systems issues surrounding clinical tools, documentation, and education. Systems issues are summarized in Table 1. A revised policy/procedure was adapted from a published, nonepilot-tested ICD deactivation policy.6 A free source of ICD-deactivation magnets was identified, and magnets were made available to all clinicians. In the EMR, an ICD care plan was developed in the style of existing care plans, using a standardized documentation template. Finally, for continuing education, clinicians were asked to complete an ICD inservice either in person or by watching an online video recording. Inservice content was drawn from the published ICD deactivation policy6 and from clinical case examples that clinicians had experienced.

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Table 1 Systems Issues Affecting ICD Deactivation in the Hospice Organization Domain Clinical Tools

Issue

Pre-QI Project

QI Project Intervention

ICD policy/procedure

Lacked practical details surrounding ICD deactivation; not easily accessible to clinicians

ICD manufacturer information for clinical questions or deactivation requests ICD-deactivation magnets

Not easily accessible to clinicians

Included practical details surrounding ICD deactivation; incorporated into online IDT Process Manual Compiled and incorporated into online IDT Process Manual

Documentation

ICD care plan

Not available through organization None

Education

Clinician education surrounding ICD management

Educational inservice held by outside provider

New-hire clinician education

None

Provided to all clinicians, and stocked in office Integrated into electronic medical record Educational inservice held to introduce organization’s new clinical tools and documentation system ICD management inservice recorded and posted online

ICD ¼ implantable cardioverter defibrillator; QI ¼ quality improvement; IDT ¼ interdisciplinary team.

The inservice also introduced the hospice’s new clinical tools and standardized documentation templates. Clinicians were encouraged to contribute and to ask questions so that any misunderstandings could be clarified. Examples of resources developed for this QI project are provided in Appendices I through III. Appendix I is the questionnaire used to evaluate clinician knowledge and confidence surrounding ICD management. Appendix II is the summarized ICD management policy/ procedure; the summary was adapted from ‘‘Management of Implantable Defibrillators in Hospice’’6 and distributed to clinicians along with the previously published ICD deactivation policy. Appendix III is the ICD care plan standardized documentation template. This project was conducted between January 1, 2011, and June 30, 2013. Various components of the intervention were rolled out at different times during the study period. Clinician inservices were held near the middle of the study period, so pre- and post-intervention patient participant groups were formed by dividing the study period into two 15-month intervals. Pre-intervention rates of ICD deactivation were calculated based on patients who were admitted between January 1, 2011, and March 30, 2012. There was no trend over time in the rate of ICD deactivation before the intervention started. Post-intervention rates of ICD deactivation were calculated based on patients who were admitted between April 1, 2012, and June 30, 2013.

Outcomes Patient outcomes are displayed in Table 2. A total of 124 patients died with an ICD documented during the study period (68 [55%] preintervention and 56 [45%] post-intervention). Overall (pre- and post-intervention), ICD deactivations were generally in inpatient settings. The proportion of patients who died with a deactivated ICD increased after the intervention (pre- vs. post-intervention: 39/68 [57%] vs. 47/ 56 [84%]; odds ratio [OR] 3.88; 95% CI 1.54e10.37; P ¼ 0.001). Documentation of ICD status also improved; there was a decrease in the proportion of patients for whom ICD status was not documented (pre- vs. post-intervention: 26/68 [38%] vs. 7/56 [13%]; OR 4.33; 95% CI 1.60e12.91; P ¼ 0.001). Of particular importance, documentation of patient/family ICD goals of care improved; there was a decrease in the proportion of patients for whom ICD goals were not documented (pre- vs. postintervention: 21/68 [31%] vs. 2/56 [4%]; OR 12.06; 95% CI 2.67e109.7; P < 0.001). Of 120 hospice clinicians, 49 (41%) volunteered to complete the ICD inservice. Of the 37 clinician-participants who indicated their disciplines (37/49, 76%), most were nurses (26, 70%), and the remaining clinicians were physicians/nurse practitioners (1, 3%), certified nurse assistants (2, 5%), social workers (3, 8%), chaplains (4, 11%), and bereavement staff (1, 3%). Pre- and post-ICD inservice questionnaires were obtained from 34 clinicians.

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Table 2 Patient Participant Results Variable No. of patients (n) Age, y (median, SD, range) Primary diagnosis (n, %) Heart Cancer Kidney Lung Liver Dementia Other Site of care (n, %) Home Inpatient hospice Inpatient hospital Nursing facility Inpatient and other (moved during admission) Site of ICD deactivation (n, %) Inpatient hospice Inpatient hospital Home Nursing facility Unknown site of ICD Deactivation or ICD active ICD status (n, %) Deactivated Active Not documented Patient/family ICD goals of care (n, %) Documented Not documented

Pre-intervention 68 74

14.6

34 22 3 2 0 1 6

Post-intervention 56 74

10.9

50 32 4 3 0 1 9

23 15 5 2 2 2 7

41 27 9 4 4 4 13

20 19 6 2 21

29 28 9 3 31

16 16 7 2 15

29 29 13 4 27

7 7 6 0 48

10 10 9 0 71

14 10 4 2 26

25 18 7 4 46

39 3 26

57 4 38

47 2 7

84 4 13

47 21

69 31

54 2

96 4

25e105

47e93

SD ¼ standard deviation.

Clinicians’ knowledge and confidence regarding ICD management increased pre- vs. postintervention (pre- vs. post-ICD inservice median questionnaire scores: 5 vs. 9; Wilcoxon signedrank test Z ¼ 5.01; P < 0.001); scores were based on a scale of 0 to 10.

Conclusions/Lessons Learned In this study, a multifaceted intervention based on a previously published ICD deactivation policy6 was effective in increasing deactivation rates. ICD deactivation rates were consistent with those previously reported (in this study, pre- vs. post-intervention: 57% vs. 84%). In a nationwide survey of hospices, those with an ICD deactivation policy had a mean ICD deactivation rate of 73%.6 It is possible that the increase in ICD deactivation rates reported here is the result of secular trends. However, we did not observe any trends over time in deactivation rates either before or after the intervention. Therefore, this steplike

increase in rates seems unlikely to be the result of secular trends. Throughout the QI project, it was important to ensure congruence between ICD education, documentation templates, and clinical tools. For example, the ICD policy/procedure included making ICD-deactivation magnets accessible. The EMR care plan specified the need to obtain a verbal order for ICD-deactivation magnet placement as needed to emergently prevent ICD shock, and to leave the magnet in the patient’s home. To make this procedure feasible, supply services ensured that free ICD-deactivation magnets were accessible to all clinicians. The online ICD inservice was a novel innovation for this hospice, and it proved to be a significant challenge. However, it was essential to this project because it enabled clinician participants to complete the educational component at their convenience. The recording also made consistent ICD education available for new clinicians. During the study period, 49 of 120 clinicians (41%) attended an ICD inservice. A relatively high proportion of

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clinicians who indicated their disciplines were nurses (26/37, 70%), and various factors may have contributed to this finding. Nurses comprise the largest proportion of clinicians within the hospice (57/120, 48%). Also, in this hospice, nurses are responsible for documenting and implementing plans of care surrounding ICD management. Relatively few physicians/ nurse practitioners attended an ICD inservice (1/37, 3%); within this particular hospice, it seems likely that this group previously felt confident with the ICD deactivation process. Data collection was another challenging component of this project. A manual EMR review was performed because, before the QI project, clinical ICD information could be documented only as free text. This increased the possibility of error in data collection. The ICD care plan documentation template was designed to make useful clinical information easily accessible. QI staff members will continue to monitor ICD deactivation data, and they will present feedback to clinicians in the same manner QI measures are currently shared (internal QI reports, clinician meetings). To move this QI project to a wider audience, the authors have presented at a national poster session and a state podium session. The authors also want to share resources developed through this project for potential adaptation and use by other hospices (see Appendices I through III). This study supports current literature recommendations and provides a methodology for improving success rates for ICD deactivation in individuals facing the end of life from terminal conditions. The QI project relied on a practical and integrated approach. Interdisciplinary staff members volunteered to lead the project, and no funding was required. Several components of the project will remain in place including the following: a revised ICD policy/procedure, clinician access to ICD-deactivation magnets, an ICD inservice recording, and an electronic ICD care plan. The significantly improved outcomes and anticipated sustainability of the ICD deactivation QI project support the adaptation of similar projects in other hospice organizations.

Geriatric Academic Career Award K01HP 20493. The information or content and conclusions are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by the Department of Health and Human Services, HRSA, Bureau of Health Professions or the U.S. Government. The authors thank the staff at Penn Wissahickon Hospice, especially Jennifer Savon and Aliya Rogers, for their support and involvement.

Disclosures and Acknowledgments

10. RAND Corporation. Hospitalized patients who die an expected death with an ICD that has been deactivated. 2013. Available from http://www. qualityforum.org. Accessed July 27, 2013.

Dr. A. M. C. is supported by a Health Resources and Services Administration (HRSA)

References 1. Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverterdefibrillators: calendar year 2009da World Society of Arrhythmia’s project. Pacing Clin Electrophysiol 2011;34:1013e1027. 2. Dodson JA, Fried TR, Van Ness PH, Goldstein NE, Lampert R. Patient preferences for deactivation of implantable cardioverter-defibrillators. JAMA Intern Med 2013;173:377e379. 3. Russo JE. Original research: deactivation of ICDs at the end of life: a systematic review of clinical practices and provider and patient attitudes. Am J Nurs 2011;111:26e35. 4. Thanavaro JL. ICD deactivation: review of literature and clinical recommendations. Clin Nurs Res 2013;22:36e50. 5. Braunschweig F, Boriani G, Bauer A, et al. Management of patients receiving implantable cardiac defibrillator shocks: recommendations for acute and long-term patient management. Europace 2010;12:1673e1690. 6. Goldstein N, Carlson M, Livote E, Kutner JS. Brief communication: management of implantable cardioverter-defibrillators in hospice: a nationwide survey. Ann Intern Med 2010;152:296e299. 7. Padeletti L, Arnar DO, Boncinelli L, et al. EHRA expert consensus statement on the management of cardiovascular implantable electronic devices in patients nearing end of life or requesting withdrawal of therapy. Europace 2010;12:1480e1489. 8. Lampert R, Hayes DL, Annas GJ, et al. HRS expert consensus statement on the management of cardiovascular implantable electronic devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Heart Rhythm 2010;7:1008e1026. 9. Centura Health. Palliative care endorsed measures. 2012. Available from http://www.quality forum.org. Accessed July 27, 2013.

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Appendix I Questionnaire: ICD Managementa 1. I can promptly identify a patient with an ICD. a. No b. Unsure c. Yes 2. I can discuss the ethics surrounding ICD deactivation. a. No b. Unsure c. Yes 3. I can discuss the benefits and burdens of an ICD as related to a patient’s illness. a. No b. Unsure c. Yes 4. I can coordinate ICD reprogramming for a patient. a. No b. Unsure c. Yes 5. I can coordinate ICD reprogramming for a patient who cannot travel. a. No b. Unsure c. Yes 6. I can use an ICD-deactivation magnet in a setting that is emergent. a. No b. Unsure c. Yes 7. An ICD may deliver a shock after a patient has died. a. True b. False 8. To determine the model of a specific patient’s ICD, a clinician could contact the ICD manufacturer. a. True b. False 9. ICD-deactivation magnet placement is the best intervention for shock prevention over a period of months. a. True b. False 10. ICD-deactivation magnet placement may affect the pacemaker portion of a patient’s ICD. a. True b. False a

Adapted from ‘‘Management of Implantable Defibrillators in Hospice’’.6

Appendix II Policy and Procedure Summary: ICD Managementa  Identification of Device B Identify ICD: - Ask patient/family if ICD is present - Physically examine chest wall B Determine nature of ICD: - Manufacturer and model - Would emergent deactivation be possible via ICD-deactivation magnet? B Possible sources of patient-specific ICD information:

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Patient/family with card provided when ICD implanted Attending physician/nurse practitioner and/or cardiologist who implanted ICD - ICD manufacturing company (will not know if magnet deactivation is possible) B Make ICD magnet accessible: - Obtain physician/nurse practitioner verbal order for ICD-deactivation magnet placement PRN ICD shock prevention - Leave ICD-deactivation magnet in patient’s home B Document physician/nurse practitioner communication surrounding ICD B Select relevant ICD Care Plan goals and interventions Informed Consent Discussion About Device Deactivation B Potential benefits/burdens of ICD B ICD deactivation Process for Reprogramming the ICD B Note: Reprogramming ICD will permanently stop shock delivery B Inform attending physician/nurse practitioner and cardiologist who implanted ICD of patient/family decision to reprogram ICD B If patient is ambulatory, contact cardiologist/electrophysiologist to coordinate office visit for ICD reprogramming B If patient is homebound, develop plan with physician/nurse practitioner for in-home or hospice inpatient unit ICD reprogramming by either of the following (hospice nurse should be present during home reprogramming to provide support): - Cardiologist/electrophysiologist - Representative from ICD manufacturing company Process for ICD Deactivation in an Urgent Scenario B Note: Placing magnet over ICD will stop shock delivery, but typically only while magnet is physically present over ICD. Rarely, an ICD has been programed NOT to deactivate with a magnet B Review ICD Care Plan for ICD-deactivation magnet-related documentation B Tape ICD-deactivation magnet over ICD Post-mortem Patient Care B After patient death, ICD shocks will not be delivered B Remove ICD-deactivation magnet if present B If cremation is planned, notify funeral director of ICD, because battery can explode if incinerated -

 





a

Adapted from ‘‘Management of Implantable Defibrillators in Hospice’’.6

Appendix III Care Plan: ICD Management  Note: During each visit, clinician is to select applicable goals and interventions  Goal Description B ICD management will align with patient and caregiver goals of care B Patient and caregiver will verbalize understanding of ICD shock benefits vs. burdens at current point in patient’s illness  Intervention Description B Instruct patient and caregiver on ICD shock benefits vs. burdens B ICD manufacturer: _________ - For ICD manufactured by Boston Scientific or Medtronic, tape magnet over center of ICD to deactivate - For ICD manufactured by St Jude, tape magnet over top or bottom of ICD to deactivate. B ICD active B ICD deactivated temporarily with ICD-deactivation magnet B ICD deactivated permanently with reprogramming B Place ICD-deactivation magnet in home B Place ICD-deactivation magnet over ICD and adhere with cloth tape as needed for shock prevention

Implantable cardioverter defibrillator deactivation: a hospice quality improvement initiative.

Dying patients whose implantable cardioverter defibrillators (ICDs) continue to deliver shocks may experience significant pain, and the National Quali...
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