Improving Heart Failure Care in Minority Communities

NCT ID: NCT00211874

Last Updated: 2015-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2002-09-30

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.

Conditions

Congestive Heart Failure (CHF); Systolic Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Nurse-management

nurse-led intervention focused on specific management problems

Group Type: EXPERIMENTAL

Nurse-management

Intervention Type: BEHAVIORAL

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.

Usual Care

Usual care as control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Nurse-based disease management

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jane Sisk, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Paul Hebert, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai School of Medicine

New York, New York, United States

Metropolitan Hospital

New York, New York, United States

North General Hospital

New York, New York, United States

Harlem Hospital

New York, New York, United States

Countries

United States

References

Sisk JE, Hebert PL, Horowitz CR, McLaughlin MA, Wang JJ, Chassin MR. Effects of nurse management on the quality of heart failure care in minority communities: a randomized trial. Ann Intern Med. 2006 Aug 15;145(4):273-83. doi: 10.7326/0003-4819-145-4-200608150-00007.

Reference Type: RESULT

PMID: 16908918 (View on PubMed)

Horowitz CR, Rein SB, Leventhal H. A story of maladies, misconceptions and mishaps: effective management of heart failure. Soc Sci Med. 2004 Feb;58(3):631-43. doi: 10.1016/s0277-9536(03)00232-6.

Reference Type: RESULT

PMID: 14652059 (View on PubMed)

Pignone MP, DeWalt DA. Health literacy and heart failure care in minority communities. Ann Intern Med. 2007 Feb 20;146(4):312; author reply 312. doi: 10.7326/0003-4819-146-4-200702200-00014. No abstract available.

Reference Type: RESULT

PMID: 17310058 (View on PubMed)

Other Identifiers

AHRQ R01 HS10402-01

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 99-0347

Identifier Type: -

Identifier Source: org_study_id