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Randomized Controlled Trial
. 2021 Mar-Apr;36(2):143-150.
doi: 10.1097/JCN.0000000000000694.

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

Krystina B Lewis, David Birnie, Sandra L Carroll, Carolynne Brousseau-Whaley, Lorraine Clark, Martin Green, Girish M Nair, Pablo B Nery, Calum Redpath, Dawn Stacey
Randomized Controlled Trial

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

Krystina B Lewis et al. J Cardiovasc Nurs. 2021 Mar-Apr.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT02668900.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

References

    1. 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.
    1. Lewis KB, Nery PB, Birnie DH. Decision making at the time of ICD generator change: patients' perspectives. JAMA Intern Med. 2014;174:1508–1511.
    1. 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.
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