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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

April 17, 2007
April 18, 2007
November 19, 2014
December 8, 2014
July 12, 2018
May 2009
June 2012   (Final data collection date for primary outcome measure)
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.
Change in Chronic Heart Failure Health Status Between Baseline and 12 Months.
Complete list of historical versions of study NCT00461513 on ClinicalTrials.gov Archive Site
  • Mortality at 1 Year [ Time Frame: 12 months ]
    Mortality at 1 year
  • Hospitalization at 1 Year [ Time Frame: 12 months ]
    Hospitalization at 1 year
Hospitalization and Mortality, Depressive Symptoms, Patients' Self-efficacy in Management of CHF, Adherence to Prescribed Medications, Patient Satisfaction, Proportion of Patients With Guideline-concordant Care, Cost-effectiveness of the Intervention.
Not Provided
Not Provided
 
Patient-Centered Heart Failure Trial
Patient-Centered Disease Management for Heart Failure Trial
The purpose of this study is to evaluate a patient-centered disease management intervention for VA patients with heart failure.

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.

Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
VA Patients in Denver, Palo Alto, Richmond and Seattle who have a diagnosis of Chronic Heart Failure and have low health status.
Heart Failure, Congestive
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.
  • Intervention
    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.
    Intervention: Behavioral: Intervention
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
384
600
June 2012
June 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00461513
IIR 06-068
Yes
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: John Spalding Rumsfeld, MD PhD VA Eastern Colorado Health Care System, Denver, CO
VA Office of Research and Development
June 2018