Psychoeducational Intervention for ICD Patients (PEACE)
Psychoeducational Intervention for ICD Patients (PEACE)
The overall purpose of this study is to test the effects of a nurse managed psychoeducational
 intervention, consisting of symptom management training (SMT) and cognitive-behavioral
 intervention (CBI), during the first year after ICD implantation using a 3 group randomized
 clinical trial.
Symptom distress and persistent physical and psychological changes characterize early and
 ongoing recovery from ventricular dysrhythmia and treatment with an implantable cardiac
 defibrillator (ICD). This study will test the effect of a psycho educational intervention on
 psychological and physical outcomes in the first 12 months after ICD implantation. Primary
 outcome measures are anxiety, depression, and functional status. The effect of the
 intervention on variables that mediate adaptation and outcomes (symptoms, illness appraisal,
 and coping behaviors) will also be examined. Secondary aims will examine subsequent
 arrhythmia events (ICD delivered therapy) and health resource utilization in relation to the
 main outcomes. The intervention and study variables are based on stress and coping theory and
 previous research with ICD patients, which documented negative outcomes of ineffective coping
 and compelling relationships between increased emotional distress and subsequent arrhythmia
 events.

 A three-group, randomized, clinical trial with a repeated-measures design will be used. ICD
 patients (n=240) will be randomized to receive either the usual standard of care, symptom
 management training plus cognitive behavioral intervention delivered in a group format, or
 symptom management training plus cognitive behavioral intervention delivered by nurse
 provided telephone counseling. The symptom management-training component will be provided in
 the acute care setting and will focus on symptoms of pain, sleep disturbances and ICD shocks.
 The four cognitive behavioral sessions by group or telephone format will begin 6-8 weeks
 after hospitalization and will focus on illness reappraisal and coping skill training. Thus
 the intervention is designed to bridge the acute and outpatient continuum of care. A booster
 intervention will be provided at 4 months after implantation. Timeframes for evaluations are
 baseline, 1, 3, 6, and 12 months after implantation. This study will test whether a
 cost-effective, accessible, theoretically based, nurse-managed, psycho educational
 intervention provides an incremental effect over usual care in improving psychological and
 physical outcomes in ICD patients. This study will provide data upon which future clinical
 practice guidelines can be based and will establish priorities for patient care according to
 which interventions are linked to improved adaptive processes and patient outcomes. Greater
 understanding of the relationships among psychological and physical outcomes, arrhythmia
 events, and health resource utilization are important for future studies and evaluation of
 clinical practice with ICD patients.
Inclusion Criteria:

 -  All subjects must have a nonthoracotomy insertion

 -  Have a primary cardiac etiology of their ventricular arrhythmia (coronary artery
 disease, cardiomyopathy, valve dysfunction, or combination)

 -  Be fluent in English

 -  Live within a 75 mile radius of the coordinating center

 -  Be accessible by telephone

 -  Only those receiving their first ICD, not replacement generators, will be entered.

 Exclusion Criteria:

 -  Being evaluated or on a waiting list for heart transplantation

 -  Congenital disease or long QT syndrome

 -  Disorientation documented in the pre-implantation hospitalization period

 -  History of psychiatric disorder or progressively debilitating comorbidity that would
 confound outcome measures