Enhancing Systems of Care to Improve Hypertension Guideline Implementation to Communities With Health Disparities
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in systolic blood pressure
研究概览
简要总结
This study is a prospective cluster randomized trial testing a systems-level strategy to implement current American Heart Association hypertension guidelines in African American communities at risk for cardiovascular related health disparities. The trial will take place within an integrated health system serving Detroit and will assess blood pressure control over one year's time.
详细描述
The trial will randomize 12 clinics within the Henry Ford Health System to two arms. The first arm will be comparison clinics that continue to use existing team-based strategies for hypertension management. The second arm will be intervention clinics. These clinics will have enhancements to existing team-based hypertension management. The first enhancement is clinical decision support based in the electronic health record. The second enhancement is improved protocols to implement telehealth prescribing that is nurse-led.
The trial will enroll participants through an urban emergency department. Participants will be assigned to one of these 12 clinics and continue study activities for 1 year. Clinicians at the clinics will manage blood pressure. Study specific visits will occur at 3, 6, 9, and 12 months. Primary outcome assessment is 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>18 years) African Americans
- •Lacks established primary care for BP management
- •History of HTN
- •SBP ≥ 140 mmHg
排除标准
- •Pregnancy
- •Need for hospitalization from ED
- •Serious comorbid conditions
- •Alcohol or drug dependence
- •Suspected resistant HTN
- •Anticipated poor-adherence to study designated primary care clinic
研究组 & 干预措施
Active Comparator
Team-based care
干预措施: Active Comparator (Other)
Intervention
Enhanced team-based care
干预措施: Intervention (Other)
结局指标
主要结局
Change in systolic blood pressure
时间窗: 12 months
mean change
次要结局
- Change in systolic blood pressure(6 months)
- Change in diastolic blood pressure(12 months)
- Therapeutic Intensity(12 months)
- Treatment Congruence(12 months)
研究者
Joseph Miller, MD
Senior Staff
Henry Ford Health System