Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial

David B Bekelman,Mark D Sullivan,John S Rumsfeld,Mary E Plomondon,Connor Mcbryde,Kenneth G Lehmann,Brack Hattler,Paul Heidenreich,Karin Nelson,Jonathan Potfay

doi:10.1186/1471-2261-13-49

Abstract

BackgroundChronic heart failure (HF) disease management programs have reported inconsistent results and have not included comorbid depression management or specifically focused on improving patient-reported outcomes. The Patient Centered Disease Management (PCDM) trial was designed to test the effectiveness of collaborative care disease management in improving health status (symptoms, functioning, and quality of life) in patients with HF who reported poor HF-specific health status.Methods/designPatients with a HF diagnosis at four VA Medical Centers were identified through population-based sampling. Patients with a Kansas City Cardiomyopathy Questionnaire (KCCQ, a measure of HF-specific health status) score of < 60 (heavy symptom burden and impaired quality of life) were invited to enroll in the PCDM trial. Enrolled patients were randomized to receive usual care or the PCDM intervention, which included: (1) collaborative care management by VA clinicians including a nurse, cardiologist, internist, and psychiatrist, who worked with patients and their primary care providers to provide guideline-concordant care management, (2) home telemonitoring and guided patient self-management support, and (3) screening and treatment for comorbid depression. The primary study outcome is change in overall KCCQ score. Secondary outcomes include depression, medication adherence, guideline-based care, hospitalizations, and mortality.DiscussionThe PCDM trial builds on previous studies of HF disease management by prioritizing patient health status, implementing a collaborative care model of health care delivery, and addressing depression, a key barrier to optimal disease management. The study has been designed as an ‘effectiveness trial’ to support broader implementation in the healthcare system if it is successful.Trial registrationUnique identifier: NCT00461513

Highlights

Chronic heart failure (HF) disease management programs have reported inconsistent results and have not included comorbid depression management or focused on improving patient-reported outcomes
The Patient Centered Disease Management (PCDM) trial builds on previous studies of HF disease management by prioritizing patient health status, implementing a collaborative care model of health care delivery, and addressing depression, a key barrier to optimal disease management
Study design overview The primary objective of the PCDM trial is to determine whether a collaborative care HF disease management intervention, including depression assessment and treatment, improves patient-reported health status between baseline and 12 months, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Summary

Discussion

The PCDM trial is unique because it uses a patientcentered measure for study entry and as the primary outcome. It employs population-based case finding methods to target HF patients with diminished selfreported health status who are at high risk and who may benefit most from disease management. The PCDM intervention uses collaborative care to address both HF and comorbid depression and leverages health information technology to provide optimal disease management. The first draft of this paper was written by DBB. All authors revised it critically for important intellectual content, and all authors read and approved the final manuscript

Background

Methods/design

Findings