Improving Heart Failure Care in Minority Communities

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.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure (CHF); Systolic Dysfunction
• Intervention / Treatment: Behavioral: Nurse-management

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 Type: Interventional
• Enrollment (Actual): 406
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029-6574
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10029
      • Metropolitan Hospital
    • New York, New York, United States, 10037
      • Harlem Hospital
    • New York, New York, United States, 10035
      • North General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form 12 questionnaire	self-reported physical functioning as measured by the physical component score on the Short Form 12 questionnaire	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hospitalizations	number of hospitalizations in 12 month period	12 months
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
Number of deaths	deaths measured by the reporting of death by patient family or recording in the National Death Index	12 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (Actual): September 1, 2002
• Study Completion (Actual): September 1, 2002

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): October 12, 2015
• Last Update Submitted That Met QC Criteria: October 9, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: effectiveness trial; quality improvement; disease management; Congestive heart failure; nurse management; minority communities
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: GCO 99-0347; AHRQ R01 HS10402-01 (Other Identifier: AHRQ)