Improving Heart Failure Care in Minority Communities

This study has been completed.
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT00211874
First received: September 14, 2005
Last updated: October 9, 2015
Last verified: October 2015
  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-management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Improving Heart Failure Care in Minority Communities

Resource links provided by NLM:


Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Short Form 12 questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    self-reported physical functioning as measured by the physical component score on the Short Form 12 questionnaire


Secondary Outcome Measures:
  • Number of hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    number of hospitalizations in 12 month period

  • Minnesota Living with Heart Failure Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    self-reported physical functioning as measured by the physical component score on the Minnesota Living with Heart Failure Questionnaire

  • Number of deaths [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    deaths measured by the reporting of death by patient family or recording in the National Death Index


Enrollment: 406
Study Start Date: September 2000
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Nurse-based disease management
No Intervention: Usual Care
Usual care as control group

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211874

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Metropolitan Hospital
New York, New York, United States, 10029
North General Hospital
New York, New York, United States, 10035
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
  More Information

Publications:
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00211874     History of Changes
Other Study ID Numbers: GCO 99-0347  AHRQ R01 HS10402-01 
Study First Received: September 14, 2005
Last Updated: October 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Icahn School of Medicine at Mount Sinai:
Congestive heart failure
nurse management
effectiveness trial
quality improvement
minority communities
disease management

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on February 11, 2016