Estrategia en equipo del Caribe y América del Sur para el control de la hipertensión (CATCH)
Implementación y ampliación de una estrategia de atención en equipo para el control de la hipertensión en Colombia y Jamaica
The CATCH cluster randomized trial will test the effectiveness and implementation outcomes of implementing and scaling up the 2017 American Heart Association and 2021 World Health Organization hypertension guidelines through a team-based care approach for blood pressure control in Colombia and Jamaica.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 to implement a single-pill combination 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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
- No prior hospitalization for heart failure
- No stage 4 or 5 chronic kidney disease (estimated glomerular filtration rate <30 ml/min/1,73m2, chronic dialysis, or transplant)
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Implementing Single-pill Combination by Team-based Care
The core component of the intervention is a single-pill combination therapy recommended by 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 single-pill combination therapy in all intervention clinics. Team-based care components will include health care team training, home BP monitoring, BP audit and feedback, and CHW-led health coaching on lifestyle modification and medication adherence. |
The core component of the intervention is single-pill combination recommended by 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 health care team training, home BP monitoring, BP audit and feedback, and CHW-led health coaching on lifestyle modification and medication adherence. |
|
Comparador activo: 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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Net difference in mean change of systolic blood pressure
Periodo de tiempo: 18 months
|
Differences in mean change of systolic BP from baseline to 18 months between intervention and control groups |
18 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Difference in blood pressure control (<130/80 mm Hg)
Periodo de tiempo: 18 months
|
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
Periodo de tiempo: 18 months
|
Differences in mean change of diastolic BP from baseline to 18 months between intervention and control groups |
18 months
|
|
Side effects
Periodo de tiempo: 18 months
|
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
Periodo de tiempo: 18 months
|
Differences in health-related quality of life (measured by EQ-SD and SF-12) between intervention and control groups |
18 months
|
|
Cost-effectiveness
Periodo de tiempo: 18 months
|
Incremental direct costs per additional percentage of hypertension control |
18 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acceptability
Periodo de tiempo: 18 months
|
Measured by validated survey |
18 months
|
|
Adoption
Periodo de tiempo: Baseline
|
Defined as % of clinics adopting intervention components |
Baseline
|
|
Appropriateness
Periodo de tiempo: 18 months
|
Measured by validated survey |
18 months
|
|
Feasibility (suitability)
Periodo de tiempo: Baseline
|
Measured by validated survey |
Baseline
|
|
Fidelity
Periodo de tiempo: 18 months
|
% of each intervention component delivered per protocol |
18 months
|
|
Implementation Costs
Periodo de tiempo: 18 months
|
Defined as all costs associated with implementation and assessed from administrative data |
18 months
|
|
Penetrance
Periodo de tiempo: 18 months
|
Defined as % of providers using the intervention approach |
18 months
|
|
Sustainability
Periodo de tiempo: 18 months
|
% of clinics maintaining intervention |
18 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Patricio López-Jaramillo, MD, PhD, Universidad de Santander
- Investigador principal: Jiang He, MD, PhD, Tulane University
- Investigador principal: Marshall Tulloch-Reid, MBBS, DSc, The University of The West Indies
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UG3HL152373 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
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.
Criterios de acceso compartido de IPD
We will offer, through our public access website, opportunities for outside investigators to collaborate with us using complete study data.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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