title: Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Chronic 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
  Patients 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  Unique identifier: NCT00461513.
authors.affiliation: Department of Veterans Affairs, Eastern Colorado Health Care System, Research (151), 1055 Clermont Street, Denver, CO 80220, USA. david.bekelman@va.gov
authors.forename: David B
authors.initials: DB
authors.lastname: Bekelman
authors.forename: Mary E
authors.initials: ME
authors.lastname: Plomondon
authors.forename: Mark D
authors.initials: MD
authors.lastname: Sullivan
authors.forename: Karin
authors.initials: K
authors.lastname: Nelson
authors.forename: Brack
authors.initials: B
authors.lastname: Hattler
authors.forename: Connor
authors.initials: C
authors.lastname: McBryde
authors.forename: Kenneth G
authors.initials: KG
authors.lastname: Lehmann
authors.forename: Jonathan
authors.initials: J
authors.lastname: Potfay
authors.forename: Paul
authors.initials: P
authors.lastname: Heidenreich
authors.forename: John S
authors.initials: JS
authors.lastname: Rumsfeld
mesh_terms: D019468:Disease Management; D005500:Follow-Up Studies; D006333:Heart Failure / Q000175:diagnosis* / Q000453:epidemiology* / Q000628:therapy; D006801:Humans; D018802:Patient-Centered Care / Q000379:methods*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014493:United States Department of Veterans Affairs