Clinical trial NCT05405920: Caribbean and South America Team-based Strategy to Control Hypertension
Official title: Implementing and Scaling Up a Team-based Care Strategy for Hypertension Control in Colombia and Jamaica
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Blood Pressure
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Universidad de Santander
name: University of the West Indies, Jamaica
First posted: 2022-06-06
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster-randomization of 40 primary care clinics
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Net difference in mean change of systolic blood pressure
timeFrame: 18 months
Secondary outcomes:
measure: Difference in blood pressure control (<130/80 mm Hg)
timeFrame: 18 months
measure: Net difference in mean change of diastolic blood pressure
timeFrame: 18 months
measure: Side effects
timeFrame: 18 months
measure: Health-related quality of life
timeFrame: 18 months
measure: Cost-effectiveness
timeFrame: 18 months
Other outcomes:
measure: Acceptability
timeFrame: 18 months
measure: Adoption
timeFrame: Baseline
measure: Appropriateness
timeFrame: 18 months
measure: Feasibility (suitability)
timeFrame: Baseline
measure: Fidelity
timeFrame: 18 months
measure: Implementation Costs
timeFrame: 18 months
measure: Penetrance
timeFrame: 18 months
measure: Sustainability
timeFrame: 18 months
Locations:
city: Santander
country: Colombia
facility: 20 primary care clinics in Colombia
city: Kingston
country: Jamaica
facility: 20 primary care clinics in Jamaica
Study officials:
affiliation: Tulane University
name: Jiang He, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of the West Indies, Jamaica
name: Marshall Tulloch-Reid, MBBS, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Santander
name: Patricio López-Jaramillo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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