Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 30 - 90 |
| Updated: | 11/30/2018 |
| Start Date: | March 2015 |
| End Date: | December 2019 |
| Contact: | Billy L Alexander, MSN |
| Email: | blalexander@uabmc.edu |
| Phone: | 205-934-8767 |
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.
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.
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
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
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.
We found this trial at
2
sites
Birmingham, Alabama 35233
Principal Investigator: Raegan W Durant, M.D., MPH
Phone: 205-934-8767
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Bessemer, Alabama 35022
Principal Investigator: Raegan Durant, MD, MPH
Phone: 205-934-8767
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