Implementing HEARTS in Guatemala

Study Overview
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Brief Summary
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The HEARTS Technical Package was developed by the World Health Organization to address the implementation gap of cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala.

Detailed Description
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A single-arm pilot trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. A planned sample of 100 adult patients diagnosed with diabetes (n=45), hypertension (n=45), or both (n=10) will be enrolled. The intervention will consist of HEARTS-aligned components: Training health workers on Healthy-lifestyle counseling and Evidence-based treatment protocols; strengthening Access to medications and diagnostics; training on Risk-based cardiovascular disease management; Team-based care and task sharing; and Systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. Co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed methods design. Secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control) and key implementation outcomes (adoption, fidelity, usability, and sustainability).

Official Title
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Implementing Integrated Diabetes and Hypertension Management in Guatemala Using the HEARTS Model

Conditions
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Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases

Intervention / Treatment
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* Other: Integrated Diabetes and Hypertension Primary Care Model
* Other: Integrated Diabetes and Hypertension Primary Care Model - Providers


Participation Criteria
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Eligibility Criteria
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Patient participants Inclusion criteria: Non-pregnant adults aged ≥18 years Diagnoses of type 2 diabetes or hypertension Present for routine care at participating MOH primary health facilities Exclusion criteria: Confirmed or suspected type 1 diabetes Pregnant Are not managed at MOH health centers or health posts Provider/other participants Inclusion criteria: • Participation in delivering HEARTS or on the Technical Advisory Committee Exclusion criteria: • None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEARTS implementation - Patients<br>A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. This arm consists of the patients whose health markers will be monitored through the study. | Other: Integrated Diabetes and Hypertension Primary Care Model<br>* The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. Training health workers on diabetes and hypertension treatment protocols Team-based care and task sharing Strengthening access to medications and diagnostics Electronic medical record system and registry Systems monitoring and feedback of key indicators<br>* Other names: HEARTS;|
| Experimental: HEARTS implementation - Providers<br>A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. This arm consists of the health care providers who will be administering care to the patient participants. | Other: Integrated Diabetes and Hypertension Primary Care Model - Providers<br>* The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. Training health workers on diabetes and hypertension treatment protocols Team-based care and task sharing Strengthening access to medications and diagnostics Electronic medical record system and registry Systems monitoring and feedback of key indicators Health care providers will administer this intervention to patient participants and will report on their experience.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Feasibility of Intervention Measure (FIM) Questionnaire | Feasibility will be assessed among Ministry of Health (MOH) participants through the four-item Feasibility of Intervention Measure (FIM) Questionnaire and semi-structured interviews. A Spanish-language version of the FIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used. | 6 months | 
| Number of target health districts that met enrollment goals | This study will be working with two different health districts, one in the west and the other in the east. This measure is the number of districts that met enrollment goals for patients for patients with diabetes (at least 25) and also for patients with hypertension (at least 25). A given patient may have both diabetes and hypertension and thus count toward each benchmark | 6 months | 
| Score on Acceptability of Intervention Measure (AIM) Questionnaire | Acceptability will be assessed among patients through the four-item Acceptability Intervention Measure (AIM) Questionnaire and semi-structured interviews. A Spanish-language version of the AIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used. | 6 months | 
| Proportion of patient participants with subsequent follow-up visit within 3 months | Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension treatment rate | Number of patients receiving hypertension medication treatment per month | 6 months | 
| Diabetes treatment rate | Number of patients receiving diabetes medication treatment per month | 6 months | 
| Proportion of participants achieving glycemic control | Proportion achieving glycemic control (fasting blood glucose <115 mg/dl or random blood glucose <160 mg/dl) among patients with diabetes | 6 months | 
| Proportion achieving control of blood pressure | Proportion achieving control of blood pressure (<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records. | 6 months | 
| Mean systolic blood pressure | Mean systolic blood pressure among patients with hypertension | 6 months | 
| Mean diastolic blood pressure | Mean diastolic blood pressure among patients with hypertension | 6 months | 
| Adoption | Number of participating health facilities who enrolled at least one patient with hypertension or diabetes | 6 months | 
| Fidelity - health worker training | Proportion of health workers in each district attending all training sessions | 6 months | 
| Fidelity - chart audit | Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits | 6 months | 
| Fidelity - team-based care and task sharing | Proportion of primary health districts conducting at least one care coordination meeting | 6 months | 
| Fidelity - access to medicines and diagnostics | Proportion of primary health facilities that had monthly availability of Ministry of Health medications and diagnostics for diabetes and hypertension. Drugs include antihypertensive medications (hydrochlorothiazide, enalapril, losartan) and oral hypoglycemic agents (metformin and glimepiride). Diagnostics including blood pressure cuffs and monitors, glucometers, lancets, and glucose strips. | 6 months | 
| Fidelity - facility-based electronic monitoring tool | Proportion of patient visits captured in DHIS2 each month compared to comprehensive records in the Ministry of Health's Health Management Information System | 6 months | 
| Fidelity - systems monitoring and feedback | Proportion of quarterly reports viewed by health district administrators | 6 months | 
| Usability | Average score on the System Usability Scale questionnaire. Scores are on a scale of 10 (worst) to 50 (best). | 6 months | 
| Sustainability | Average score on a sustainability questionnaire. Questionnaire was created by combining select questions from the System Usability Scale and the Clinical Sustainability Assessment Tool. Scores are on a scale of 10 (worst) to 70 (best). | 6 months |