What is the clinical evidence from this study?

Study design: Observational. Population: Hypertension and type 2 diabetes. Intervention: HEARTS model implementation strategies vs. Standard Ministry of Health primary care. Primary outcome: Hypertension and diabetes treatment rates (monthly count of patients treated at the district level).

What question did this study set out to answer?

The study aims to evaluate the implementation of the HEARTS model in Guatemala's primary care system to improve management of hypertension and diabetes.

June 12, 2026Open Access

Evaluating implementation of the HEARTS model for management of hypertension and diabetes in Guatemala: protocol for a prospective observational hybrid type 3 study

DFDavid FloodUniversity of Michigan ICIrmgardt Alicia María Wellmann CastellanosInstitute of Nutrition of Central America and Panama LALuis Fernando AyalaInstitute of Nutrition of Central America and Panama

Key Result

The HEARTS model implementation for hypertension and diabetes management in Guatemala is being evaluated in this prospective observational study protocol, with results pending.

Key Points

The study aims to evaluate the implementation of the HEARTS model in Guatemala's primary care system to improve management of hypertension and diabetes.
Prospective observational evaluation using a hybrid type 3 effectiveness-implementation design.
Implementation strategies include training, standardized protocols, task sharing, and patient engagement.
Evaluation guided by the RE-AIM framework with co-primary outcomes from administrative data.
Co-primary outcomes will include treatment rates for hypertension and diabetes based on administrative data.
Additional outcomes will assess disease control, strategy fidelity, and sustainability after external support.
Semi-structured interviews will explain variations in outcomes using mixed methods.

Study Design

Type

Observational

Multicenter

Yes

Structured PICO

Does HEARTS model implementation improve hypertension and diabetes treatment rates in adults in the primary care system in Guatemala?

Population

Adults with hypertension or type 2 diabetes in 107 primary health facilities across 40 health districts in Guatemala, evaluated over a 22-33 month implementation period and 24-month maintenance period.

Intervention

HEARTS model implementation (6 strategies: training and supportive supervision for health workers, standardized treatment protocols, strengthening availability of medications and diagnostics, task sharing with non-physician health workers, quality monitoring systems, and patient engagement and community outreach).

Comparator

Standard Ministry of Health primary care in non-HEARTS comparator districts.

Outcome

Co-primary outcomes: hypertension and diabetes treatment rates (monthly count of patients treated at the district level adjusted for eligible population size).surrogate

This study protocol describes a prospective observational evaluation of the HEARTS model implementation for hypertension and diabetes management in Guatemala's primary care system.

Limitations

Potential misclassification of diagnoses or treatments in administrative data
Variation in data entry practices across districts
Validity of the difference-in-differences approach relies on the parallel trends assumption

Abstract

The HEARTS model (Healthy-lifestyle counseling, Evidence-based treatment protocols, Access to essential medicines and technologies, Risk-based management, Team-based care, and Systems for monitoring) is recommended by the World Health Organization and the Pan American Health Organization to improve primary care management of hypertension, diabetes, and other cardiovascular disease risk factors in national health systems. The objective of this study is to evaluate HEARTS implementation in the Ministry of Health primary care system in Guatemala, where a scale-up project covering approximately 10% of the country began in 2024. This is a prospective, observational evaluation using a hybrid type 3 effectiveness-implementation design with three sequential periods: pre-implementation, implementation, and maintenance. The six HEARTS-aligned multilevel implementation strategies are: (1) training and supportive supervision for health workers, (2) standardized treatment protocols, (3) strengthening availability of medications and diagnostics, (4) task sharing with non-physician health workers, (5) quality monitoring systems, and (6) patient engagement and community outreach. The evaluation is guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. Co-primary outcomes are hypertension and diabetes treatment rates (Reach), estimated from MOH administrative data using a difference-in-differences approach comparing intervention districts with non-HEARTS comparator districts. Additional quantitative outcomes include treatment intensity and retention (Reach), disease control (Effectiveness), district-level uptake (Adoption), strategy-specific fidelity (Implementation), and sustainment of outcomes after external support concludes (Maintenance). To explain variation in quantitative outcomes, semi-structured interviews will be conducted with MOH staff, government officials, international advisors, and civil society stakeholders using an explanatory sequential mixed methods design. The study will include a cost-effectiveness analysis and budget impact analysis to inform policy decisions on scale-up and sustainability. This study will provide evidence on HEARTS implementation in Guatemala. Findings will inform decisions about national scale-up and contribute to the global evidence base on implementation of hypertension and diabetes management in primary care health systems. This study is registered on the Open Science Framework ( https://osf.io/easm9 ).

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