Improving Heart Failure Care in Minority Communities

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT00211874

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

406

Enrollment

Locations

Arms

Duration (Months)

101.5

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure (CHF) Systolic Dysfunction	Behavioral: Nurse-management	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

406 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Improving Heart Failure Care in Minority Communities

Study Start Date :

Sep 1, 2000

Actual Primary Completion Date :

Sep 1, 2002

Actual Study Completion Date :

Sep 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nurse-management nurse-led intervention focused on specific management problems	Behavioral: Nurse-management 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. Other Names: Nurse-based disease management
No Intervention: Usual Care Usual care as control group

Arm

Intervention/Treatment

Experimental: Nurse-management

nurse-led intervention focused on specific management problems

Behavioral: Nurse-management

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.

Other Names:

Nurse-based disease management

No Intervention: Usual Care

Usual care as control group

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai School of Medicine	New York	New York	United States	10029-6574
2	Metropolitan Hospital	New York	New York	United States	10029
3	North General Hospital	New York	New York	United States	10035
4	Harlem Hospital	New York	New York	United States	10037

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai
Agency for Healthcare Research and Quality (AHRQ)

Investigators

Principal Investigator: Jane Sisk, Ph.D., Icahn School of Medicine at Mount Sinai
Principal Investigator: Paul Hebert, MD, Icahn School of Medicine at Mount Sinai