Implementing and Scaling Up a Team-based Care Strategy for Hypertension Control in Colombia and Jamaica
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,280
- 试验地点
- 2
- 主要终点
- Net difference in mean change of systolic blood pressure
研究概览
简要总结
The CATCH cluster randomized trial will test the implementation and effectiveness outcomes of implementing and scaling up a team-based care strategy for blood pressure control in Colombia and Jamaica.
详细描述
The CATCH Study includes a two-year UG3 Planning Phase and a four-year UH3 Implementation Phase. In the UH3 Implementation Phase, we will first conduct a cluster randomized implementation trial to test the effectiveness and implementation of a team-based care strategy for hypertension control among patients with hypertension in 40 clinics from Colombia and Jamaica (20 in each country). Twenty clinics will be randomized to the team-based care intervention and 20 to provider training intervention. A total of 1,680 patients (42 per clinic) with uncontrolled hypertension will be recruited into the study and followed for 18 months for effectiveness and implementation outcomes. A post-intervention study visit will take place 6 months after the end of the 18-month intervention to evaluate the sustainability of the implementation strategies. We will subsequently conduct a pre- and post- scale-up comparison study to implement the team-based care strategy in all remaining public primary care clinics that provide chronic disease management in Jamaica and primary care clinics in the seven participating departments in Colombia. A pre- and post- scale-up comparison design will be used to assess barriers and implementation outcomes before and 12 months after the scale-up intervention at the clinic, primary care physician, nurse/pharmacist, and community health worker (CHW) levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the cluster design and intervention program, the study participants, primary care physicians, nurses, community health workers, and research staff who collected clinical outcome data will not be blinded. The outcome adjudication committee members, however, will be blinded to randomization assignment for adverse event evaluation.
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
- •for clinics:
- •Serving >300 hypertensive patients during the previous year
- •Clinic visits and BP medications are free of charge to patients
- •Not sharing physicians, nurses, pharmacists, or community health workers (CHWs) with other clinics
- •Inclusion criteria for participants:
- •Men or women aged ≥ 21 years who receive primary care from participating clinics
- •Average untreated BP ≥140/90 mm Hg among individuals without a history of clinical cardiovascular disease (CVD), chronic kidney disease (CKD), or diabetes; average untreated BP ≥130/80 mm Hg among individuals aged ≥65 years or those with clinical CVD, CKD, or diabetes; or average treated BP ≥130/80 mm Hg from six BP readings at two screening visits
- •Not pregnant or planning to become pregnant in the next 18 months
- •Able and willing to give informed consent
- •No plans to change primary care clinic in the next 18 months
- •Not an immediate family member of staff at the primary care clinic
排除标准
- 未提供
研究组 & 干预措施
Team-based Care Strategy for Hypertension Control
The core component of the intervention is a stepped-care protocol, based on the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) Clinical Practice Guideline for High Blood Pressure and the 2021 World Health Organization (WHO) Hypertension Guideline. Using a team-based care model, a physician-nurse-CHW team will work with patients to implement clinical guideline-based treatment in all intervention clinics. Team-based care components will include task sharing and shifting, health care team training, home BP monitoring, BP audit and feedback, and CHW-led health coaching on lifestyle modification and medication adherence.
干预措施: Team-based Care Strategy for Hypertension Control (Behavioral)
Enhanced Usual Care
We will train the primary care physicians, nurses, and other clinic staff in performing standardized BP measurements. We will offer physician education on clinical guidelines for hypertension management and issue continuing medical education credits. Patient educational materials will be distributed. We will not conduct any other interventions in the enhanced usual care clinics.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Net difference in mean change of systolic blood pressure
时间窗: 18 months
Differences in mean change of systolic BP from baseline to 18 months between intervention and control groups
次要结局
- Difference in blood pressure control (<130/80 mm Hg)(18 months)
- Side effects(18 months)
- Health-related quality of life(18 months)
- Net difference in mean change of diastolic blood pressure(18 months)
- Cost-effectiveness(18 months)
研究者
Jiang He, MD, PhD
Professor and Chair
Tulane University