Clinical trial NCT00461513: Patient-Centered Heart Failure Trial
Official title: Patient-Centered Disease Management for Heart Failure Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Keywords: Heart Failure, Congestive
Disease Management
Health Status
Quality of Life
Telemedicine
Depression
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2007-04-18
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VA Patients in Denver, Palo Alto, Richmond and Seattle who have a diagnosis of Chronic Heart Failure and have low health status.

Brief summary: The purpose of this study is to evaluate a patient-centered disease management intervention for VA patients with heart failure.

Detailed description: Background/Rationale: Chronic heart failure (CHF) is a leading cause of morbidity and mortality in the VA. Disease management is a promising strategy to improve care and outcomes, but evidence supporting CHF disease management is inconsistent and open questions remain. Prior studies have not evaluated a multi-modal intervention combining multidisciplinary collaborative care, telemonitoring, promotion of patient self-care, and an explicit intervention for comorbid depression, which is a barrier to optimal CHF care and outcomes. Moreover, the effectiveness of CHF disease management has not been evaluated in the VA.

Objective(s): We propose to evaluate a Patient-Centered Disease Management (PCDM) intervention that includes case finding, collaborative care management for both CHF and comorbid depression, and home telemonitoring. The primary aim will be to ascertain whether the PCDM intervention results in better patient health status (i.e. symptom burden, functional status, and quality of life) than usual care. Secondary aims will include assessment of whether the intervention will reduce hospitalizations or mortality, result in more guideline-concordant care, and reduce depression while increasing patient medication adherence, self-efficacy and satisfaction with treatment.

Methods: We propose a 3-year, multi-site randomized study. VA patients with CHF from 4 VA Medical Centers (Denver, Palo Alto, Richmond, and Seattle) and their affiliated clinics who have diminished CHF-specific health status (Kansas City Cardiomyopathy Questionnaire scores\<50) will be eligible. We will randomize enrolled patients to a 12-month PCDM intervention versus usual care (target 300 patients in each arm). The PCDM intervention will include collaborative care management for CHF and comorbid depression and daily telemonitoring. Patient self-care will be promoted through the telemonitoring intervention and the depression intervention. The primary analysis will be a comparison of change in health status (KCCQ scores) between enrollment and 12 months for the intervention versus usual care groups. Secondary analyses will include comparison of rates of hospitalization and death, depressive symptoms, the proportion of patients with guideline concordant CHF care, medication adherence, 6-minute walk test, self-efficacy, and patient satisfaction. In addition, cost-effectiveness analysis will be performed. All analyses will be intention to treat.

Impact: If successful, the proposed intervention will improve the quality of care and outcomes of veterans with CHF and be cost effective. The intervention has the potential to serve as model for other disease management interventions in the VA, and is designed as an 'effectiveness' trial to enhance implementation. This study will be a joint effort of the CHF and IHD QUERI groups, Patient Care Services, and Office of Care Coordination. The study directly addresses several aims of the recently published 'QUERI: A New Direction' position statement, including: a) partnership between QUERI groups; b) explicit collaborative ties between QUERI and 'operational' components of the VA (i.e. Patient Care Services and Office of Care Coordination); c) focus beyond a single disease entity (i.e. CHF and depression); and d) clinical studies of interventions that might be candidates for national VA implementation. Moreover, this study specifically engages patients in their care and emphasizes quality of life outcomes, both of central import to the VA health care mission.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Chronic Heart Failure;
* low health status.

Exclusion Criteria:

* Cognitive/psychiatric impairment (inability to complete questionnaires);
* nursing home resident;
* irreversible non-cardiac medical condition likely to affect 6-month survival or ability to execute study protocol;
* prior heart transplantation.

Primary outcomes:
measure: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months.
timeFrame: 12 months
Secondary outcomes:
measure: Mortality at 1 Year
timeFrame: 12 months
measure: Hospitalization at 1 Year
timeFrame: 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver, CO
state: Colorado
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Eastern Colorado Health Care System, Denver, CO
name: John Spalding Rumsfeld, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bekelman DB, Plomondon ME, Sullivan MD, Nelson K, Hattler B, McBryde C, Lehmann KG, Potfay J, Heidenreich P, Rumsfeld JS. Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial. BMC Cardiovasc Disord. 2013 Jul 9;13:49. doi: 10.1186/1471-2261-13-49.
citation: Lum HD, Carey EP, Fairclough D, Plomondon ME, Hutt E, Rumsfeld JS, Bekelman DB. Burdensome Physical and Depressive Symptoms Predict Heart Failure-Specific Health Status Over One Year. J Pain Symptom Manage. 2016 Jun;51(6):963-70. doi: 10.1016/j.jpainsymman.2015.12.328. Epub 2016 Feb 26.
citation: Bekelman DB, Plomondon ME, Carey EP, Sullivan MD, Nelson KM, Hattler B, McBryde CF, Lehmann KG, Gianola K, Heidenreich PA, Rumsfeld JS. Primary Results of the Patient-Centered Disease Management (PCDM) for Heart Failure Study: A Randomized Clinical Trial. JAMA Intern Med. 2015 May;175(5):725-32. doi: 10.1001/jamainternmed.2015.0315.