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 (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: To report the primary outcomes of the Patient Plus Partner randomized control trial. Methods: In a two-group (N=301) prospective RCT, we compared two social-cognitive-based intervention programs [Patient Plus Partner (P+P) and Patient Only (P only)], implementedfollowing initial ICD implant. The patient intervention, consisting of educational materials, nursedelivered 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, ICD shocks-patient); psychological adjustment (PHQ-9); relationship impact (DAS, OCBS-partner); self-efficacy and knowledge (SCA-SE, SCA-OE, KSA); and health care utilization (outpatient visits, hospitalizations), at hospital discharge, 1, 3, 6, and 12 months post-ICD.Results: For patients, P+P compared to P Only was more effective in improving symptoms (P=0.02), depression (P=0.006), self-efficacy (P=.02), outcome expectations (P=0.03), and knowledge (P=0.07). For partners, P+P was more effective in improving partner caregiver burden (P=0.002), self-efficacy (P=0.001) and ICD knowledge (P=0.04).

Social cognitive intervention following an initial implantable cardioverter defibrillator: Better treatment response for secondary versus primary prevention

“…Our research demonstrated that patients who received an initial ICD for 1 o versus 2 o prevention showed less improvement in physical health and symptoms and poorer ICD knowledge 8 . However, contributing to the heterogeneity among patients with ICDs implanted for 1 o prevention is the fact that a subset, but not all, of heart failure (HF) patients receives devices that also deliver cardiac resynchronization therapy (CRT) to improve cardiac function and reduce symptoms 14 .…”

“…This study is a secondary analysis of longitudinal patient data (n = 301) from a randomized clinical trial focused on improving physical and psychological outcomes in patients and their partners after initial ICD implant 8 . The original study used a two‐group randomized design to compare the effects of a patient only against a patient + partner (P+P) intervention from hospital discharge (baseline) to 3 months.…”

“…Multiple randomized clinical trials (RCTs) focused on improving physical or psychological health have demonstrated that educational and behavioral interventions can improve physical and psychological outcomes 7 . Most recently, Dougherty and colleagues 8 showed that a patient and partner‐focused social cognitive theory (SCT) intervention was more effective at reducing physical and depressive symptoms than a patient‐only (P‐only) intervention. The SCT intervention emphasized increasing patient self‐efficacy to manage living with an ICD 8 .…”

“…Most recently, Dougherty and colleagues 8 showed that a patient and partner‐focused social cognitive theory (SCT) intervention was more effective at reducing physical and depressive symptoms than a patient‐only (P‐only) intervention. The SCT intervention emphasized increasing patient self‐efficacy to manage living with an ICD 8 . Dunbar et al 9 demonstrated the effectiveness of an educational intervention in patients with their first ICD to improve anxiety at 3 months and reduce the likelihood of depressive symptoms at 1 year compared to usual care.…”

“…An important factor of heterogeneity in patient response to a first ICD is clinical indication for the ICD. Patients receiving an ICD for primary (1 o ) prevention tend to have more comorbidities, higher BMI, and a lower left ventricular ejection fraction (LVEF) compared to patients receiving an ICD for secondary (2 o ) prevention 8,13 . Furthermore, physical function after SCA may decrease, and patients report high levels of psychological distress with implantation of an ICD after SCA 5,6 .…”