Patient plus partner trial: A randomized controlled trial of 2 interventions to improve outcomes after an initial implantable cardioverter-defibrillator

Abstract

Background: Interventions to improve physical and psychological outcomes in recipients with an initial implantable cardioverter-defibrillator (ICD) and their intimate partners are largely unstudied, though likely to have a major impact on adjustment to the ICD and general well-being.

Objective: The purpose of this study was to report the primary outcomes of the patient plus partner randomized controlled trial.

Methods: In a 2-group (N = 301) prospective randomized controlled trial, we compared 2 social-cognitive-based intervention programs-patient plus partner (P+P) and patient only (P only)-implemented after initial ICD implantation. The patient intervention, consisting of educational materials, nurse-delivered telephone coaching, videotape demonstrations, and access to a nurse via a 24/7 pager, was implemented in both groups. P+P also incorporated partner participation. The primary patient outcomes were symptoms and anxiety at 3 months. Other outcomes were physical function (SF-36 [Short Form 36] and ICD shocks-patient), psychological adjustment (PHQ-9 [Patient Health Questionaire-9]), relationship impact (Dyadic Adjustment Scale and Oberst Caregiving Burden Scale (DAS and OCBS) partner), self-efficacy and knowledge (Sudden Cardiac Arrest-Self Efficacy [SCA-SE], Sudden Cardiac Arrest-Outcomes Expectation [SCA-OE], and Knowledge Self-Assessment [KSA]), and health care utilization (outpatient visits and hospitalizations) at hospital discharge and 1, 3, 6, and 12 months post-ICD implantation.

Results: For patients, P+P compared with P only was more effective in improving symptoms (P = .02), depression (P = .006), self-efficacy (P = .02), outcome expectations (P = .03), and knowledge (P = .07). For partners, P+P was more effective in improving partner caregiver burden (P = .002), self-efficacy (P = .001), and ICD knowledge (P = .04).

Conclusion: An intervention that integrated the partner into the patient's recovery after an ICD improved outcomes for both. Beyond survival benefits of the ICD, intervention programs designed to address both the patient and their partner living successfully with an ICD are needed and promising.

Trial registration: ClinicalTrials.gov NCT01252615.

Keywords: Anxiety; Clinical trial; Depression; Health care use; ICD; Partner; Self-efficacy; Sudden cardiac arrest; Telephone intervention.

Figure 1:

Consort Diagram

Figure 2.

Significant changes by study group for patients (Panel A & B) and partners (Panel C & D) across 12 months post-ICD implant.