Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 4
- 主要终点
- Readmission Rates
研究概览
简要总结
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.
详细描述
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:
- 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
- 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
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •African American
- •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.
排除标准
- •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.
研究组 & 干预措施
Education + PN Arm
208 patients randomized to self-care education+ Patient navigator-delivered self-care plan.
干预措施: Education + Patient Navigation (Behavioral)
Educational Control Arm
- 208 patients randomized to self-care education alone.
干预措施: Self-care Education (Behavioral)
结局指标
主要结局
Readmission Rates
时间窗: Within 30 days
Re-hospitalization of Heart Disease patients within 30 days of being discharged home.
次要结局
未报告次要终点
研究者
Reagan W. Durant, MD
Principal investigator
University of Alabama at Birmingham