Improving Heart Failure Care in Minority Communities
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Congestive Heart Failure (CHF) Systolic Dysfunction |
Behavioral: Nurse-based disease management |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training |
| Official Title: | Improving Heart Failure Care in Minority Communities |
- All-cause hospitalizations and self-reported physical functioning as measured by the physical component score on the Short Form 12 questionnaire and Minnesota Living with Heart Failure Questionnaire.
- Costs and cost-effectiveness
| Estimated Enrollment: | 406 |
| Study Start Date: | September 2000 |
| Estimated Study Completion Date: | October 2003 |
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. We hypothesized that the nurse-management program would result in nurse patients’ having fewer hospitalizations and reporting better functioning.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• adults >18 years,
- systolic dysfunction documented on a cardiac test (echocardiography, radionuclide ventriculography, myocardial stress sestamibi/thallium testing, or left-heart catherization),
- 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.
Contacts and Locations| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029-6574 | |
| Harlem Hospital | |
| New York, New York, United States, 10037 | |
| Metropolitan Hospital | |
| New York, New York, United States, 10029 | |
| North General Hospital | |
| New York, New York, United States, 10035 | |
| Principal Investigator: | Jane Sisk, Ph.D. | Mount Sinai School of Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00211874 History of Changes |
| Other Study ID Numbers: | AHRQ R01 HS10402-01, 99-0347 |
| Study First Received: | September 14, 2005 |
| Last Updated: | September 14, 2005 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mount Sinai School of Medicine:
|
Congestive heart failure nurse management effectiveness trial |
quality improvement minority communities disease management |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013