Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease

NCT ID: NCT02340364

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-07-31

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

Conditions

Heart Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Education + PN Arm

208 patients randomized to self-care education+ Patient navigator-delivered self-care plan.

Group Type: EXPERIMENTAL

Education + Patient Navigation

Intervention Type: BEHAVIORAL

208 patients randomized to self-care Education+ Patient Navigation-delivered self-care plan.

Educational Control Arm

\- 208 patients randomized to self-care education alone.

Group Type: ACTIVE_COMPARATOR

Self-care Education

Intervention Type: BEHAVIORAL

208 patients randomized to self-care education alone.

Interventions

Education + Patient Navigation

208 patients randomized to self-care Education+ Patient Navigation-delivered self-care plan.

Intervention Type: BEHAVIORAL

Self-care Education

208 patients randomized to self-care education alone.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Reagan W. Durant, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raegan W Durant, M.D., MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Medical West

Bessemer, Alabama, United States

UAB

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

X130515002

Identifier Type: -

Identifier Source: org_study_id