Trials / Active Not Recruiting
Active Not RecruitingNCT05405920
Caribbean and South America Team-based Strategy to Control Hypertension
Implementing and Scaling Up a Team-based Care Strategy for Hypertension Control in Colombia and Jamaica
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,280 (estimated)
- Sponsor
- Tulane University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
| 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. |
Timeline
- Start date
- 2023-02-01
- Primary completion
- 2026-08-31
- Completion
- 2026-08-31
- First posted
- 2022-06-06
- Last updated
- 2024-11-26
Locations
2 sites across 2 countries: Colombia, Jamaica
Source: ClinicalTrials.gov record NCT05405920. Inclusion in this directory is not an endorsement.