Monitoring Study Participants and Implementation with Phone Calls to Support Hypertension Control During the COVID-19 Pandemic: The Case of a Multicomponent Intervention Trial in Guatemala.

Background: The COVID-19 pandemic presents a challenge to health care for patients with chronic diseases, especially hypertension, because of the important association and increased risk of these patients with a severe presentation of COVID-19 disease. The Guatemalan Ministry of Health has been implementing a multi-component program aimed at improving hypertension control in rural communities since 2019 as a part of an intervention research cluster randomized trial. When the first cases of COVID-19 were reported (March 13, 2020) in Guatemala, our study paused all study field activities, and began monitoring participants through phone calls. The objective of this paper is to describe the approach used to monitor study participants during the COVID-19 pandemic and compare data obtained during phone calls for intervention and control group participants. Methods: We developed a cross-sectional study within the HyTREC (Hypertension Outcomes for T4 Research within Lower Middle-Income Countries) project 'Multicomponent Intervention to Improve Hypertension Control in Central America: Guatemala' in which phone calls were made to participants from both intervention and control groups to monitor measures important to the study: delivery of antihypertensive medications in both groups, receipt of coaching sessions and use of a home blood pressure monitor by intervention group participants, as well as reasons that they were not implemented. Results: Regarding the delivery of antihypertensive drugs by the MoH to participants, those in the intervention group had a higher level of medication delivery (73%) than the control group (51%), p<0.001. Of the total participants in the intervention group, 62% had received at least one health coaching session in the previous three months and 81% used a digital home blood pressure monitor at least twice a week. Intervention activities were lower than expected due to restricted public transportation on top of decreased availability of health providers. Conclusion: In Guatemala, specifically in rural settings, access to antihypertensive medications and health services during pandemic times was impaired and less than expected, even after accounting for the program's implementation activities and actions.

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

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.