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

Trials

Russell E. Glasgow¹  Pablo Gulayin²  Manuel Ramirez-Zea³  Kristyne Mansilla³  Meredith P. Fort³  Dina Roche³  Ana Lucia Peralta³  Diego Hernández-Galdamez³  Alejandra Paniagua-Avila⁴  Adolfo Rubinstein⁵  Eduardo Palacios⁵  Jiang He⁶  Vilma Irazola⁶ 

[1] Department of Family Medicine, and Adult and Child Center for Health Outcomes Research and Delivery Science, University of Colorado;Department of Research in Chronic Diseases, Institute for Clinical Effectiveness and Health Policy (IECS);INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama – INCAP;Mailman School of Public Health, Columbia University;Programa Nacional de Enfermedades Crónicas, Ministerio de Salud y Asistencia Social (MSPAS);Tulane University School of Public Health and Tropical Medicine and Tulane University Translational Science Institute;

关键词: Multicomponent program;    Hypertension;    Cardiovascular disease;    Primary care;    Health systems;    Implementation strategies;   

DOI  :  10.1186/s13063-020-04345-8

来源: DOAJ

【 摘 要 】

Abstract 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. Trial registration ClinicalTrials.gov: NCT03504124 . Registered on 20 April 2018.

【 授权许可】

Unknown