Collaboration to Improve Blood Pressure in the US Black Belt-addressing the Triple Threat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,592
- 试验地点
- 6
- 主要终点
- Number of Participants With Blood Pressure Control (Systolic Pressure Less Than 140 mm Hg and Diastolic Pressure Less Than 90 mm Hg) at 12 Months
研究概览
简要总结
The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt".
In year 1, we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. In years 2-5, the investigators will test the interventions.
Year 2-5, Aim 3: Enroll 80 practices and 25 African American patients with uncontrolled HTN at each practice (total n=2000) in a cluster-randomized, controlled, 4-arm pragmatic implementation trial to evaluate the three multi- component, multi-level functional interventions finalized in the UH2 phase compared with enhanced usual care.
The study's 4 arms are:
- Enhanced Usual Care: Practices are provided with educational materials and tools to enhance patient care
- Peer Coaching: Patients enrolled in these practices will be matched with a peer coach. The peer coach helps the patient to set goals around self-management, including medications, home monitoring, and diet and exercise, and she helps the patient to strategize how to accomplish the goals, using motivational interviewing techniques
- Practice Facilitation: Practices randomized to this arm will work with a practice facilitator. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction
- Peer coaching and practice facilitation: Practices randomized to this arm will receive both the peer coach intervention and the practice facilitation intervention. Practice facilitators and peer coaches will receive the same training for this hybrid intervention, but the practice facilitator change packet will add examples of activities that integrate peer coaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African American adults aged 19-85 years
- •Uncontrolled HTN, defined as BP >140/90 mm Hg at the time of study enrollment
- •Black Belt resident
- •English speaking
- •Willing to work with a peer coach
- •Willing to sign informed consent
排除标准
- •Plans to move out of the area within the next two years
- •Advanced illness with limited life expectancy
- •Pregnant or plans to get pregnant in the next year
- •Advanced chronic kidney disease (estimated glomerular filtration rate <45 ml/min/1.73 m2)
- •Unwillingness to work with a peer coach or to sign informed consent
结局指标
主要结局
Number of Participants With Blood Pressure Control (Systolic Pressure Less Than 140 mm Hg and Diastolic Pressure Less Than 90 mm Hg) at 12 Months
时间窗: 12 months
Blood pressure (BP) control is defined as systolic pressure less than 140 mm Hg and diastolic pressure less than 90 mm Hg. Difference in BP control at 12 month follow-up between trial arms. BP was assessed in the practice by a research assistant using a standardized protocol at baseline, 6, and 12 months.
次要结局
- Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12)(12 months)
- Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months(between baseline and 6 months)
- Change in Systolic Blood Pressure Between Baseline and 12 Months(12 months)
- Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12)(12 months)
- Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months(between baseline to 6 months)
- Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month(between 6 month to 12 month)
- Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months(12 months)
- Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months(between 6 months to 12 month)
- Change in Perceived Stress(12 months)
研究者
Andrea Cherrington, MD
Principal Investigator
University of Alabama at Birmingham