Caribbean and South America Team-based Strategy to Control Hypertension

Hypertension Clinical Trial

— CATCH  

Official title:

Implementing and Scaling Up a Team-based Care Strategy for Hypertension Control in Colombia and Jamaica

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05405920
• Other study ID #: UG3HL152373
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: August 2023
• Source: Tulane University
• Contact: Meryl Hahne, MPH
• Phone: 504-988-3099
• Email: mhahne[@]tulane.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1280
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria 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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	20 primary care clinics in Colombia	Santander
Jamaica	20 primary care clinics in Jamaica	Kingston

Sponsors (4)

Lead Sponsor	Collaborator
Tulane University	National Institutes of Health (NIH), Universidad de Santander, Colombia, University of the West Indies, Jamaica

Countries where clinical trial is conducted

Colombia,  Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability	Measured by validated survey	18 months
Other	Adoption	Defined as % of clinics adopting intervention components	Baseline
Other	Appropriateness	Measured by validated survey	18 months
Other	Feasibility (suitability)	Measured by validated survey	Baseline
Other	Fidelity	% of each intervention component delivered per protocol	18 months
Other	Implementation Costs	Defined as all costs associated with implementation and assessed from administrative data	18 months
Other	Penetrance	Defined as % of providers using the intervention approach	18 months
Other	Sustainability	% of clinics maintaining intervention	18 months
Primary	Net difference in mean change of systolic blood pressure	Differences in mean change of systolic BP from baseline to 18 months between intervention and control groups	18 months
Secondary	Difference in blood pressure control (<130/80 mm Hg)	Difference in the proportion of patients with systolic BP <130 mm Hg and diastolic BP <80 mm Hg between intervention and control groups at 18 months	18 months
Secondary	Net difference in mean change of diastolic blood pressure	Differences in mean change of diastolic BP from baseline to 18 months between intervention and control groups	18 months
Secondary	Side effects	Differences in medication side effects between intervention and control groups will be assessed by survey. A list of common side effects associated with high blood pressure will be asked of participants to collect presence and frequency of side effects.	18 months
Secondary	Health-related quality of life	Differences in health-related quality of life (measured by EQ-SD and SF-12) between intervention and control groups	18 months
Secondary	Cost-effectiveness	Incremental direct costs per additional percentage of hypertension control	18 months

External Links

•   CATCH Study Website