Hypertension and diabetes frequently co-occur and together are a leading cause of death and disability. Despite the availability of effective treatments, many patients remain untreated or uncontrolled. HEARTS is a package of implementation strategies recommended by the World Health Organization and Pan American Health Organization to improve cardiovascular disease management in primary care. To date, most HEARTS projects have focused on hypertension alone, and rigorous evaluations of HEARTS for integrated hypertension and diabetes care are lacking.
This cluster-randomized trial will be conducted in 36 Ministry of Health primary care facilities (Health Centers) in Guatemala. Health Centers will be randomized 1:1 to HEARTS or enhanced usual care. The HEARTS intervention consists of five implementation strategies adapted to Guatemala: (1) training and supportive supervision for health workers; (2) simplifying treatment protocols; (3) strengthening supply chains of medications and supplies; (4) task sharing with non-physician health workers; and (5) implementing quality monitoring systems. The comparator arm receives enhanced usual care, which includes standard Ministry of Health clinical care plus supply chain strengthening to ensure between-arm differences are not attributable to medication availability.
Approximately 1,440 patients with hypertension-diabetes multimorbidity (40 per facility) will be enrolled and assessed at baseline and 12 months. Co-primary outcomes are change in systolic blood pressure and hemoglobin A1c. Secondary outcomes include diastolic blood pressure, and proportions achieving blood pressure control (<130/<80 mmHg), hemoglobin A1c control (<7.0%), and combined control. A cost-effectiveness and budget impact analysis will be conducted from the health care sector perspective. The implementation period is 30 months, followed by a 12-month maintenance period.
