Clinical trial NCT02340364: Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease
Official title: Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Keywords: Hospital Readmissions
Patient Navigation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 301
Sex: MALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The investigators are asking subjects to take part in the Patient NAVIgation to Reduce Readmissions among Black Men with Heart Disease (NAVI-HF) research study. This research study will test how well trained laypeople working as patient navigators will help patients recently hospitalized for heart failure avoid future hospitalizations. NAVI-HF is a new program sponsored by funding from the National Institute of Minority Health and Health Disparities. People who enter into the study will work with a patient navigator to undergo the full program or work with a trained layperson to receive general education on heart disease treatment and prevention. The purpose of the study is to determine whether a patient navigation program will be effective in reducing the number of hospitalizations in the future for program participants. This study will enroll 416 participants from UAB.

Detailed description: Therefore, in the Patient NAVIgation to Reduce Readmissions among Black Men with Heart Disease (NAVI-HF) study, the investigators propose to recruit 416 AA men with Heart Disease receiving inpatient care at UAB Hospital and randomize them either to Heart Disease self-care education plus a patient navigator-delivered self-care plan (Education + PN arm) or to Heart Disease self-care education alone (Educational Control arm). The investigators will compare participant outcomes such as all-cause and Heart Disease readmission rates, Heart Disease self-care adherence as well as cost effectiveness across the two intervention arms. Our Specific Aims are:

1. To assess the 30-day all-cause readmission rates among male African American Heart Disease patients receiving Heart Disease self-care education plus a patient navigator-delivered self-care plan versus Heart Disease self-care education alone
2. To assess the Heart Disease self-efficacy and heart failure self-care adherence among male African American Heart Disease patients receiving Heart Disease self-care education plus a patient navigator-delivered self-care plan versus Heart Disease self-care education alone
3. To evaluate the cost-effectiveness of Heart Disease self-care education plus a patient navigator-delivered self-care plan versus Heart Disease self-care education alone

Eligibility criteria: Inclusion Criteria:

* African American
* Male
* Age = 30 or older
* Inpatient admission at UAB Hospital or UAB Medical West with a diagnosis of heart disease as a principle or one of the first 3 diagnosis.
* Residence in Jefferson or Shelby Counties, Alabama within 45 miles of UAB Hospital.
* English Speaking
* Physically and cognitively able to listen to 30-minute video undergo a home visit and telephone contacts over several weeks.

Exclusion Criteria:

* Heart transplant or awaiting heart transplant (admitted to UAB Advanced HF/Transplant Service).
* Currently participating in another clinical research study with an overlapping intervention.
* Current or anticipated long term (\>2 weeks) residence in a skilled nursing facility.
* Patients who indicated that they were unwilling to make lifestyle changes now or in the near future.
* Patients whose symptoms may be eliminated by surgery (e.g., severe aortic stenosis) or who had undergone surgery (e.g., coronary artery bypass grafting valvular replacement/repair) in the last month.

Primary outcomes:
measure: Readmission Rates
timeFrame: Within 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bessemer
country: United States
facility: UAB Medical West
state: Alabama
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Raegan W Durant, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: