Improving Heart Failure Care in Minority Communities

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Heart Failure Care in Minority Communities

Conditions
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Congestive Heart Failure (CHF), Systolic Dysfunction

Intervention / Treatment
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* Behavioral: Nurse-management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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. Exclusion Criteria: • 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse-management<br>nurse-led intervention focused on specific management problems | Behavioral: Nurse-management<br>* bilingual nurses counseled patients on diet, medication adherence, and self-management of symptoms through an initial visit and regularly scheduled follow-up telephone calls and facilitated evidence-based changes to medications in discussions with patients' clinicians.<br>* Other names: Nurse-based disease management;|
| No Intervention: Usual Care<br>Usual care as control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 12 questionnaire | self-reported physical functioning as measured by the physical component score on the Short Form 12 questionnaire | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalizations | number of hospitalizations in 12 month period | 12 months | 
| Minnesota Living with Heart Failure Questionnaire | self-reported physical functioning as measured by the physical component score on the Minnesota Living with Heart Failure Questionnaire | 12 months | 
| Number of deaths | deaths measured by the reporting of death by patient family or recording in the National Death Index | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congestive heart failure, nurse management, effectiveness trial, quality improvement, minority communities, disease management