Caribbean and South America Team-based Strategy to Control Hypertension (CATCH)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Blood Pressure
• Intervention / Treatment: Behavioral: Team-based Care Strategy for Hypertension Control; Behavioral: Enhanced Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 1280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Santander, Colombia
    • 20 primary care clinics in Colombia
• Jamaica
  • Kingston, Jamaica
    • 20 primary care clinics in Jamaica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Cost-effectiveness	Incremental direct costs per additional percentage of hypertension control	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Measured by validated survey	18 months
Adoption	Defined as % of clinics adopting intervention components	Baseline
Appropriateness	Measured by validated survey	18 months
Feasibility (suitability)	Measured by validated survey	Baseline
Fidelity	% of each intervention component delivered per protocol	18 months
Implementation Costs	Defined as all costs associated with implementation and assessed from administrative data	18 months
Penetrance	Defined as % of providers using the intervention approach	18 months
Sustainability	% of clinics maintaining intervention	18 months

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: National Institutes of Health (NIH); Universidad de Santander, Colombia; University of the West Indies, Jamaica
• Investigators: Principal Investigator: Marshall Tulloch-Reid, MBBS, DSc, University of the West Indies, Jamaica; Principal Investigator: Patricio López-Jaramillo, MD, PhD, Universidad de Santander, Colombia; Principal Investigator: Jiang He, MD, PhD, Tulane University

Publications and helpful links

Helpful Links

• CATCH Study Website

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: UG3HL152373 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Our study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository and will be implemented in a timely manner. Study data, including data from baseline and follow-up visits, will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). Data will be prepared by the study data manager/biostatistician and sent to the Program Official for review prior to release. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." We are very open to sharing data enthusiastically with the general scientific community, since we also believe in the added value of other investigators working on these data.
• IPD Sharing Time Frame: Data sets will be submitted to the study's NHLBI Program Official no later than 3 years after the end of the final patient follow-up visit or 2 years after the main paper of the trial has been published, whichever comes first.
• IPD Sharing Access Criteria: We will offer, through our public access website, opportunities for outside investigators to collaborate with us using complete study data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No