Psychoeducational Intervention for ICD Patients (PEACE)
Condition: Heart Failure; Ventricular Arrhythmias
MeSH terms: Heart Failure; Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Psychoeducational Telephone counseling (TC); Psychoeducational Intervention by Group (SG); Usual Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided through telephone sessions; Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided in 4 group sessions; Usual Care provided by providers
Other intervention name(s): TC; SG; UC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Heart failure; Ventricular arrhythmias; ICD; Psychoeducational intervention