Improving Heart Failure Care in Minority Communities
- Conditions
- Systolic DysfunctionCongestive Heart Failure (CHF)
- Interventions
- Behavioral: Nurse-management
- Registration Number
- NCT00211874
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
For congestive heart failure (CHF) patients with systolic dysfunction, a randomized controlled trial compared nurse-based disease management to address problems in patient and clinician management with usual care for effects on hospitalization and functioning among ethnically-diverse patients in ambulatory practices.
- Detailed Description
Congestive heart failure (CHF) disproportionately afflicts Black and elderly people, and is a leading cause of hospitalization \> 65 years. Although effective therapies can improve functioning and survival in patients with systolic dysfunction, many may not be receiving the full benefit of existing knowledge, including counseling on self-management and appropriate doses of medications. Patients play a critical role in managing a chronic condition such as CHF, but may not have the skills to do so. Clinicians may not provide counseling or medications consistent with evidence-based guidelines.
Systematic reviews of clinical-behavior change have suggested that interventions targeted to specific problems are more likely to be successful. Based on shortfalls identified in patient self-management and clinical care in Harlem, a predominately non-white area in northern Manhattan, we tailored a nurse-management intervention to address the problems documented, and evaluated its effectiveness in a randomized controlled trial. This trial among primarily-minority patients addresses important gaps in this literature: the study targeted problems documented among CHF patients in Harlem, enrolled patients from ambulatory practices, randomly assigned patients between nurse-management and usual care, and evaluated their subsequent health-related outcomes. Hypothesis: the nurse-management program would result in nurse patients' having fewer hospitalizations and reporting better functioning.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 406
-
• adults >18 years,
- systolic dysfunction documented on a cardiac test (echocardiography, radionuclide ventriculography, myocardial stress sestamibi/thallium testing, or left-heart catheterization),
- English- or Spanish-speaking,
- community-dwelling at enrollment, and
- current patient in a general medicine, geriatrics, or cardiology clinic or office at a participating site.
-
• medical conditions that prevented a patient's interacting with the nurse, including blindness, deafness, and cognitive impairment;
- medical conditions that required individualized management that might differ from standard protocol, namely pregnancy, renal dialysis, and terminal illness; and
- procedures that corrected systolic dysfunction, such as heart transplantation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nurse-management Nurse-management nurse-led intervention focused on specific management problems
- Primary Outcome Measures
Name Time Method Short Form 12 questionnaire 12 months self-reported physical functioning as measured by the physical component score on the Short Form 12 questionnaire
- Secondary Outcome Measures
Name Time Method Number of hospitalizations 12 months number of hospitalizations in 12 month period
Minnesota Living with Heart Failure Questionnaire 12 months self-reported physical functioning as measured by the physical component score on the Minnesota Living with Heart Failure Questionnaire
Number of deaths 12 months deaths measured by the reporting of death by patient family or recording in the National Death Index
Trial Locations
- Locations (4)
Metropolitan Hospital
🇺🇸New York, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
North General Hospital
🇺🇸New York, New York, United States
Harlem Hospital
🇺🇸New York, New York, United States