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Patient-Centered Heart Failure Trial (PCDM)

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ClinicalTrials.gov Identifier: NCT00461513
Recruitment Status : Completed
First Posted : April 18, 2007
Results First Posted : December 8, 2014
Last Update Posted : July 12, 2018
Information provided by (Responsible Party):
VA Office of Research and Development

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

Condition or disease Intervention/treatment
Heart Failure, Congestive Behavioral: Intervention

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.

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Study Type : Observational
Actual Enrollment : 384 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Patient-Centered Disease Management for Heart Failure Trial
Study Start Date : May 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
The PCDM intervention will include evaluation of CHF care by the collaborative care team, with diagnostic and therapeutic treatment recommendations based on current ACC/AHA national clinical practice guidelines, daily telemonitoring and patient self-care support utilizing the VA telemonitoring system, and screening and treatment for comorbid depression. The Collaborative Care (CC) team at each site will consist of a primary care provider, cardiologist, and psychiatrist, who are local opinion leaders, as well as a nurse site coordinator and pharmacist. For a given intervention patient, there will be an initial assessment of care by the CC team following the enrollment visit. Each intervention patient will be re-reviewed by the CC team a minimum of 2 additional times (at 6-weeks and 6 months). In addition, patients will have daily telemonitoring, and their care will be reviewed by the CC team if the telemonitoring data suggests clinical deterioration.
Behavioral: Intervention
Disease management has emerged as a promising strategy to improve the outcomes of patients with CHF. Disease management in this study will use a multidisciplinary collaborative care, leveraging health information technology, and focusing on patient self-care.Collaborative care is the use of multidisciplinary teams to deliver evidence-based treatment to a defined population of patients with chronic illness.

Usual Care
Patients randomized to the usual care arm will continue to receive care at the discretion of their regular VA providers (for a given patient, this could include cardiology specialty care in addition to PCP care, participation in site-specific CHF programs such as CHF patient education classes, etc.), in direct continuity with the care they were receiving prior to enrollment. Patients in the usual care group will also be given information sheets that outline self-care for CHF, and will be provided with a scale, if needed, at the enrollment visit. Patients in the usual care group will have the same amount of interaction with the study team as the intervention patients (i.e. complete questionnaires at the same frequency; have the same study visits). PCPs of usual care patients will be notified of the results of all screening studies (patient survey results, lab tests) as we have done in previous studies.

Primary Outcome Measures :
  1. Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. [ Time Frame: 12 months ]
    The primary outcome was average change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score. This is reported for each group (Intervention and Usual Care). The average for each group and standard deviation are reported. A positive score change represents an improvement in overall patient health status for the group of patients with congestive heart failure. A negative score change represents a worsening in overall patient health status for the group of patients with congestive heart failure.

Secondary Outcome Measures :
  1. Mortality at 1 Year [ Time Frame: 12 months ]
    Mortality at 1 year

  2. Hospitalization at 1 Year [ Time Frame: 12 months ]
    Hospitalization at 1 year

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461513

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United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
United States, Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: John Spalding Rumsfeld, MD PhD VA Eastern Colorado Health Care System, Denver, CO
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00461513    
Other Study ID Numbers: IIR 06-068
First Posted: April 18, 2007    Key Record Dates
Results First Posted: December 8, 2014
Last Update Posted: July 12, 2018
Last Verified: June 2018
Keywords provided by VA Office of Research and Development:
Heart Failure, Congestive
Disease Management
Health Status
Quality of Life
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases