Decision Support for Implantable Cardioverter-Defibrillator Replacement: A Pilot Feasibility Randomized Controlled Trial.


Journal

The Journal of cardiovascular nursing
ISSN: 1550-5049
Titre abrégé: J Cardiovasc Nurs
Pays: United States
ID NLM: 8703516

Informations de publication

Date de publication:
Historique:
pubmed: 27 5 2020
medline: 29 10 2021
entrez: 27 5 2020
Statut: ppublish

Résumé

Decision support can help patients facing implantable cardioverter-defibrillator (ICD) replacement understand their options and reach an informed decision reflective of their preferences. The aim of this study was to evaluate the feasibility of a decision support intervention for patients faced with the decision to replace their ICD. A pilot feasibility randomized trial was conducted. Patients approaching ICD battery depletion were randomized to decision support intervention or usual care. Feasibility outcomes included recruitment rates, intervention use, and completeness of data; secondary outcomes were knowledge, values-choice concordance, decisional conflict, involvement in decision making, and choice. A total of 30 patients were randomized to intervention (n = 15) or usual care (n = 15). The intervention was used as intended, with 2% missing data. Patients in the intervention arm had better knowledge (77.4% vs 51.1%; P = .002). By 12 months, 8 of 13 (61.5%) in the intervention arm and 10 of 14 (71.4%) in the usual care arm accepted ICD replacement; 1 per arm declined (7.7% vs 7.1%, respectively). It was feasible to deliver the intervention, collect data, despite slow recruitment. The decision support intervention has the potential to improve ICD replacement decision quality.

Sections du résumé

BACKGROUND
Decision support can help patients facing implantable cardioverter-defibrillator (ICD) replacement understand their options and reach an informed decision reflective of their preferences.
OBJECTIVE
The aim of this study was to evaluate the feasibility of a decision support intervention for patients faced with the decision to replace their ICD.
METHODS
A pilot feasibility randomized trial was conducted. Patients approaching ICD battery depletion were randomized to decision support intervention or usual care. Feasibility outcomes included recruitment rates, intervention use, and completeness of data; secondary outcomes were knowledge, values-choice concordance, decisional conflict, involvement in decision making, and choice.
RESULTS
A total of 30 patients were randomized to intervention (n = 15) or usual care (n = 15). The intervention was used as intended, with 2% missing data. Patients in the intervention arm had better knowledge (77.4% vs 51.1%; P = .002). By 12 months, 8 of 13 (61.5%) in the intervention arm and 10 of 14 (71.4%) in the usual care arm accepted ICD replacement; 1 per arm declined (7.7% vs 7.1%, respectively).
CONCLUSION
It was feasible to deliver the intervention, collect data, despite slow recruitment. The decision support intervention has the potential to improve ICD replacement decision quality.

Identifiants

pubmed: 32453274
pii: 00005082-202103000-00011
doi: 10.1097/JCN.0000000000000694
doi:

Banques de données

ClinicalTrials.gov
['NCT02668900']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

143-150

Subventions

Organisme : CIHR
Pays : Canada

Informations de copyright

Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

Déclaration de conflit d'intérêts

The authors have no conflicts of interest to disclose.

Références

Bennett M, Parkash R, Nery P, et al. Canadian Cardiovascular Society/Canadian Heart Rhythm Society 2016 implantable cardioverter-defibrillator guidelines. Can J Cardiol. 2017;33:174–188.
Lewis KB, Nery PB, Birnie DH. Decision making at the time of ICD generator change: patients' perspectives. JAMA Intern Med. 2014;174:1508–1511.
Lewis KB, Birnie D, Carroll SL, et al. User-centered development of a decision aid for patients facing implantable cardioverter-defibrillator replacement: a mixed-methods study. J Cardiovasc Nurs. 2018;33:481–491.
Thylén I, Moser DK, Chung ML, Miller J, Fluur C, Stromberg A. Are ICD recipients able to foresee if they want to withdraw therapy or deactivate defibrillator shocks?Int J Cardiol Heart Vessel. 2013;1:22–31.
Makoul G, Clayman ML. An integrative model of shared decision making in medical encounters. Patient Educ Couns. 2006;60:301–312.
Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS guideline for Management of Patients with Ventricular Arrhythmias and the prevention of sudden cardiac death: executive summary: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines and the Heart Rhythm Society. Circulation. 2018;138(13):e210–e271.
Legare F, Adekpedjou R, Stacey D, et al. Interventions for increasing the use of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2018;7:CD006732.
Elwyn G, O'Connor A, Stacey D, et al. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006;333(7565):417–410.
Eldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239.
Sepucha KR, Abhyankar P, Hoffman AS, et al. Standards for Universal reporting of patient decision aid evaluation studies: the development of SUNDAE checklist. BMJ Qual Saf. 2018;27(5):380–388.
O'Connor AM, Tugwell P, Wells GA, et al. A decision aid for women considering hormone therapy after menopause: decision support framework and evaluation. Patient Educ Couns. 1998;33:267–279.
Lewis KB, Stacey D, Matlock DD. Making decisions about implantable cardioverter-defibrillators from implantation to end of life: an integrative review of patients' perspectives. Patient. 2014;7:243–260.
Lewis KB, Stacey D, Carroll SL, Boland L, Sikora L, Birnie D. Estimating the risks and benefits of implantable cardioverter defibrillator generator replacement: a systematic review. Pacing Clin Electrophysiol. 2016;39:709–722.
Hess PL, Al-Khatib SM, Han JY, et al. Survival benefit of the primary prevention implantable cardioverter-defibrillator among older patients: does age matter? An analysis of pooled data from 5 clinical trials. Circ Cardiovasc Qual Outcomes. 2015;8:179–186.
Healey JS, Hallstrom AP, Kuck KH, et al. Role of the implantable defibrillator among elderly patients with a history of life-threatening ventricular arrhythmias. Eur Heart J. 2007;28:1746–1749.
Yung D, Birnie D, Dorian P, et al. Survival after implantable cardioverter-defibrillator implantation in the elderly. Circulation. 2013;127:2383–2392.
McHorney CA, Ware JE Jr., Raczek AE. The MOS 36-item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993;31(3):247–263.
Burns JL, Serber ER, Keim S, Sears SF. Measuring patient acceptance of implantable cardiac device therapy: initial psychometric investigation of the Florida patient acceptance survey. J Cardiovasc Electrophysiol. 2005;16(4):384–390.
O'Connor AM, Tugwell P, Wells GA, et al. Randomized trial of a portable, self-administered decision aid for postmenopausal women considering long-term preventive hormone therapy. Med Decis Making. 1998;18:295–303.
O'Connor A. User Manual—Decisional Conflict Scale. 2010. https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf. Accessed April 22, 2020.
Strull WM, Lo B, Charles G. Do patients want to participate in medical decision making?JAMA. 1984;252:2990–2994.
Carroll SL, Stacey D, McGillion M, et al. Evaluating the feasibility of conducting a trial using a patient decision aid in implantable cardioverter defibrillator candidates: a randomized controlled feasibility trial. Pilot Feasibility Stud. 2017;3:49.
O'Connor AM, Cranney A. User Manual - Acceptability. 2002. https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Acceptability.pdf. Accessed April 22, 202.
Tercyak KP, Johnson SB, Roberts SF, Cruz AC. Psychological response to prenatal genetic counseling and amniocentesis. Patient Educ Couns. 2001;43:73–84.
Stacey D, Kryworuchko J, Bennett C, Murray MA, Mullan S, Legare F. Decision coaching to prepare patients for making health decisions: a systematic review of decision coaching in trials of patient decision AIDS. Med Decis Making. 2012;32:E22–E33.
Stacey D, Legare F, Lewis K, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017;4:CD001431.

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