Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease

Not Applicable

Completed

• Conditions: Heart Diseases
• Interventions: Behavioral: Self-care Education; Behavioral: Education + Patient Navigation

• Registration Number: NCT02340364
• Lead Sponsor: University of Alabama at Birmingham

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-16
• Study Start: 2015-03
• Status Verified: 2019-07
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 301

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Educational Control Arm	Self-care Education	- 208 patients randomized to self-care education alone.
Education + PN Arm	Education + Patient Navigation	208 patients randomized to self-care education+ Patient navigator-delivered self-care plan.

Primary Outcome Measures

Name	Time	Method
Readmission Rates	Within 30 days	Re-hospitalization of Heart Disease patients within 30 days of being discharged home.

Trial Locations

Locations (2)

UAB Medical West; 🇺🇸 Bessemer, Alabama, United States

UAB; 🇺🇸 Birmingham, Alabama, United States