Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease (NAVI-HF)

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases
• Intervention / Treatment: Behavioral: Education + Patient Navigation; Behavioral: Self-care Education

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

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Bessemer, Alabama, United States, 35022
      • UAB Medical West
    • Birmingham, Alabama, United States, 35294
      • UAB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education + PN Arm; 208 patients randomized to self-care education+ Patient navigator-delivered self-care plan.	Behavioral: Education + Patient Navigation; 208 patients randomized to self-care Education+ Patient Navigation-delivered self-care plan.
Active Comparator: Educational Control Arm; - 208 patients randomized to self-care education alone.	Behavioral: Self-care Education; 208 patients randomized to self-care education alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission Rates	Re-hospitalization of Heart Disease patients within 30 days of being discharged home.	Within 30 days

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Raegan W Durant, M.D., MPH, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: January 15, 2015
• First Posted (Estimate): January 16, 2015

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Patient Navigation; Hospital Readmissions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: X130515002