Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease

Heart Diseases Clinical Trial

— NAVI-HF  

Official title:

Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340364
• Other study ID #: X130515002
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: July 2019

Study information

• Verified date: July 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Behavioral:
• Education + Patient Navigation
208 patients randomized to self-care Education+ Patient Navigation-delivered self-care plan.
• Self-care Education
208 patients randomized to self-care education alone.

Locations

Country	Name	City	State
United States	UAB Medical West	Bessemer	Alabama
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission Rates	Re-hospitalization of Heart Disease patients within 30 days of being discharged home.	Within 30 days