Improving Heart Failure Care in Minority Communities

Systolic Dysfunction Clinical Trial

Official title:

Improving Heart Failure Care in Minority Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211874
• Other study ID #: GCO 99-0347
• Secondary ID: AHRQ R01 HS10402
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: October 9, 2015
• Start date: September 2000
• Est. completion date: September 2002

Study information

• Verified date: October 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: September 2002
• Est. primary completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Congestive Heart Failure (CHF)
• Heart Failure
• Systolic Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	Harlem Hospital	New York	New York
United States	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

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Form 12 questionnaire	self-reported physical functioning as measured by the physical component score on the Short Form 12 questionnaire	12 months	No
Secondary	Number of hospitalizations	number of hospitalizations in 12 month period	12 months	No
Secondary	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	No
Secondary	Number of deaths	deaths measured by the reporting of death by patient family or recording in the National Death Index	12 months	No