Clinical trial NCT00211874: Improving Heart Failure Care in Minority Communities
Official title: Improving Heart Failure Care in Minority Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure (CHF)
Systolic Dysfunction
Keywords: Congestive heart failure
nurse management
effectiveness trial
quality improvement
minority communities
disease management
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2005-09-21
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Primary outcomes:
measure: Short Form 12 questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Number of hospitalizations
timeFrame: 12 months
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: 12 months
measure: Number of deaths
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Metropolitan Hospital
state: New York
city: New York
country: United States
facility: North General Hospital
state: New York
city: New York
country: United States
facility: Harlem Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jane Sisk, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Paul Hebert, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.7326/0003-4819-145-4-200608150-00007.
citation: 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.
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. doi: 10.7326/0003-4819-146-4-200702200-00014. No abstract available.