Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial

Autores
Paniagua Avila, Alejandra; Fort, Meredith P.; Glasgow, Russell E.; Gulayin, Pablo Elías; Hernández Galdamez, Diego; Mansilla, Kristyne; Palacios, Eduardo; Peralta, Ana Lucia; Roche, Dina; Rubinstein, Adolfo Luis; He, Jiang; Ramirez Zea, Manuel; Irazola, Vilma
Año de publicación
2020
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Background: Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback.Methods: Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness.Discussion: We will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs.
Fil: Paniagua Avila, Alejandra. Columbia University; Estados Unidos
Fil: Fort, Meredith P.. Institute Of Nutrition Of Central America And Panamá; Guatemala
Fil: Glasgow, Russell E.. University of Colorado; Estados Unidos
Fil: Gulayin, Pablo Elías. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Hernández Galdamez, Diego. institute of Nutrition of Central America and Panamá; Guatemala
Fil: Mansilla, Kristyne. institute of Nutrition of Central America and Panamá; Guatemala
Fil: Palacios, Eduardo. Ministerio de Salud y Asistencia Social; Guatemala
Fil: Peralta, Ana Lucia. Institute of Nutrition of Central America and Panamá ; Guatemala
Fil: Roche, Dina. Institute of Nutrition of Central America and Panamá ; Guatemala
Fil: Rubinstein, Adolfo Luis. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: He, Jiang. University Translational Science Institute; Estados Unidos
Fil: Ramirez Zea, Manuel. Institute of Nutrition of Central America and Panamá ; Guatemala
Fil: Irazola, Vilma. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Materia
CARDIOVASCULAR DISEASE
GUATEMALA
HEALTH SYSTEMS
HYPERTENSION
IMPLEMENTATION SCIENCE
IMPLEMENTATION STRATEGIES
LOW-INCOME AND MIDDLE-INCOME COUNTRIES
MULTICOMPONENT PROGRAM
NON-COMMUNICABLE DISEASES
PRIMARY CARE
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/142202
Acceder
id CONICETDig_1203370d02b6f70ac0a9c1f24bc8c598
oai_identifier_str oai:ri.conicet.gov.ar:11336/142202
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trialPaniagua Avila, AlejandraFort, Meredith P.Glasgow, Russell E.Gulayin, Pablo ElíasHernández Galdamez, DiegoMansilla, KristynePalacios, EduardoPeralta, Ana LuciaRoche, DinaRubinstein, Adolfo LuisHe, JiangRamirez Zea, ManuelIrazola, VilmaCARDIOVASCULAR DISEASEGUATEMALAHEALTH SYSTEMSHYPERTENSIONIMPLEMENTATION SCIENCEIMPLEMENTATION STRATEGIESLOW-INCOME AND MIDDLE-INCOME COUNTRIESMULTICOMPONENT PROGRAMNON-COMMUNICABLE DISEASESPRIMARY CAREhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Background: Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback.Methods: Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness.Discussion: We will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs.Fil: Paniagua Avila, Alejandra. Columbia University; Estados UnidosFil: Fort, Meredith P.. Institute Of Nutrition Of Central America And Panamá; GuatemalaFil: Glasgow, Russell E.. University of Colorado; Estados UnidosFil: Gulayin, Pablo Elías. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Hernández Galdamez, Diego. institute of Nutrition of Central America and Panamá; GuatemalaFil: Mansilla, Kristyne. institute of Nutrition of Central America and Panamá; GuatemalaFil: Palacios, Eduardo. Ministerio de Salud y Asistencia Social; GuatemalaFil: Peralta, Ana Lucia. Institute of Nutrition of Central America and Panamá ; GuatemalaFil: Roche, Dina. Institute of Nutrition of Central America and Panamá ; GuatemalaFil: Rubinstein, Adolfo Luis. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: He, Jiang. University Translational Science Institute; Estados UnidosFil: Ramirez Zea, Manuel. Institute of Nutrition of Central America and Panamá ; GuatemalaFil: Irazola, Vilma. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaBioMed Central2020-06info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/142202Paniagua Avila, Alejandra; Fort, Meredith P.; Glasgow, Russell E.; Gulayin, Pablo Elías; Hernández Galdamez, Diego; et al.; Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial; BioMed Central; Trials; 21; 1; 6-2020; 1-111745-6215CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04345-8info:eu-repo/semantics/altIdentifier/doi/10.1186/s13063-020-04345-8info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:39:55Zoai:ri.conicet.gov.ar:11336/142202instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:39:55.679CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial
title Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial
spellingShingle Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial
Paniagua Avila, Alejandra
CARDIOVASCULAR DISEASE
GUATEMALA
HEALTH SYSTEMS
HYPERTENSION
IMPLEMENTATION SCIENCE
IMPLEMENTATION STRATEGIES
LOW-INCOME AND MIDDLE-INCOME COUNTRIES
MULTICOMPONENT PROGRAM
NON-COMMUNICABLE DISEASES
PRIMARY CARE
title_short Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial
title_full Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial
title_fullStr Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial
title_full_unstemmed Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial
title_sort Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial
dc.creator.none.fl_str_mv Paniagua Avila, Alejandra
Fort, Meredith P.
Glasgow, Russell E.
Gulayin, Pablo Elías
Hernández Galdamez, Diego
Mansilla, Kristyne
Palacios, Eduardo
Peralta, Ana Lucia
Roche, Dina
Rubinstein, Adolfo Luis
He, Jiang
Ramirez Zea, Manuel
Irazola, Vilma
author Paniagua Avila, Alejandra
author_facet Paniagua Avila, Alejandra
Fort, Meredith P.
Glasgow, Russell E.
Gulayin, Pablo Elías
Hernández Galdamez, Diego
Mansilla, Kristyne
Palacios, Eduardo
Peralta, Ana Lucia
Roche, Dina
Rubinstein, Adolfo Luis
He, Jiang
Ramirez Zea, Manuel
Irazola, Vilma
author_role author
author2 Fort, Meredith P.
Glasgow, Russell E.
Gulayin, Pablo Elías
Hernández Galdamez, Diego
Mansilla, Kristyne
Palacios, Eduardo
Peralta, Ana Lucia
Roche, Dina
Rubinstein, Adolfo Luis
He, Jiang
Ramirez Zea, Manuel
Irazola, Vilma
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv CARDIOVASCULAR DISEASE
GUATEMALA
HEALTH SYSTEMS
HYPERTENSION
IMPLEMENTATION SCIENCE
IMPLEMENTATION STRATEGIES
LOW-INCOME AND MIDDLE-INCOME COUNTRIES
MULTICOMPONENT PROGRAM
NON-COMMUNICABLE DISEASES
PRIMARY CARE
topic CARDIOVASCULAR DISEASE
GUATEMALA
HEALTH SYSTEMS
HYPERTENSION
IMPLEMENTATION SCIENCE
IMPLEMENTATION STRATEGIES
LOW-INCOME AND MIDDLE-INCOME COUNTRIES
MULTICOMPONENT PROGRAM
NON-COMMUNICABLE DISEASES
PRIMARY CARE
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Background: Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback.Methods: Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness.Discussion: We will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs.
Fil: Paniagua Avila, Alejandra. Columbia University; Estados Unidos
Fil: Fort, Meredith P.. Institute Of Nutrition Of Central America And Panamá; Guatemala
Fil: Glasgow, Russell E.. University of Colorado; Estados Unidos
Fil: Gulayin, Pablo Elías. Instituto de Efectividad Clínica y Sanitaria; Argentina
Fil: Hernández Galdamez, Diego. institute of Nutrition of Central America and Panamá; Guatemala
Fil: Mansilla, Kristyne. institute of Nutrition of Central America and Panamá; Guatemala
Fil: Palacios, Eduardo. Ministerio de Salud y Asistencia Social; Guatemala
Fil: Peralta, Ana Lucia. Institute of Nutrition of Central America and Panamá ; Guatemala
Fil: Roche, Dina. Institute of Nutrition of Central America and Panamá ; Guatemala
Fil: Rubinstein, Adolfo Luis. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: He, Jiang. University Translational Science Institute; Estados Unidos
Fil: Ramirez Zea, Manuel. Institute of Nutrition of Central America and Panamá ; Guatemala
Fil: Irazola, Vilma. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
description Background: Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback.Methods: Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness.Discussion: We will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs.
publishDate 2020
dc.date.none.fl_str_mv 2020-06
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/142202
Paniagua Avila, Alejandra; Fort, Meredith P.; Glasgow, Russell E.; Gulayin, Pablo Elías; Hernández Galdamez, Diego; et al.; Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial; BioMed Central; Trials; 21; 1; 6-2020; 1-11
1745-6215
CONICET Digital
CONICET
url http://hdl.handle.net/11336/142202
identifier_str_mv Paniagua Avila, Alejandra; Fort, Meredith P.; Glasgow, Russell E.; Gulayin, Pablo Elías; Hernández Galdamez, Diego; et al.; Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial; BioMed Central; Trials; 21; 1; 6-2020; 1-11
1745-6215
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04345-8
info:eu-repo/semantics/altIdentifier/doi/10.1186/s13063-020-04345-8
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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