Cardiovascular Diseases, Diabetes Mellitus, Type 2, Hypertension
Conditions
Brief summary
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
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).
Interventions
OTHERIntegrated Diabetes and Hypertension Primary Care Model
The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. 1. Training health workers on diabetes and hypertension treatment protocols 2. Team-based care and task sharing 3. Strengthening access to medications and diagnostics 4. Electronic medical record system and registry 5. Systems monitoring and feedback of key indicators
OTHERIntegrated Diabetes and Hypertension Primary Care Model - Providers
The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. 1. Training health workers on diabetes and hypertension treatment protocols 2. Team-based care and task sharing 3. Strengthening access to medications and diagnostics 4. Electronic medical record system and registry 5. Systems monitoring and feedback of key indicators Health care providers will administer this intervention to patient participants and will report on their experience.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Institute of Nutrition of Central America and Panama
Ministry of Health, Guatemala
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on Feasibility of Intervention Measure (FIM) Questionnaire | 6 months | 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. |
| Number of Target Health Districts That Met Enrollment Goals | 6 months | 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 |
| Score on Acceptability of Intervention Measure (AIM) Questionnaire | 6 months | Acceptability will be assessed among providers 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. |
| Proportion of Patient Participants With Subsequent Follow-up Visit Within 3 Months | 3 months | Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adoption | 6 months | Count and percentage of participating health facilities who enrolled at least one patient with hypertension or diabetes. |
| Fidelity - Health Worker Training | 6 months | Number of health workers in each district attending all training sessions |
| Fidelity - Team-based Care and Task Sharing | 6 months | Proportion of primary health facilities conducting at least one care coordination meeting |
| Fidelity - Access to Medicines and Diagnostics | 6 months | Months in which primary health facilities 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. Data is reported in clinic-months, which is the sum number of months that each clinic reported monthly availability of medications and diagnostics (n=60 total clinic months(10 clinics x 6 months)). |
| Fidelity - Facility-based Electronic Monitoring Tool | 6 months | Proportion of patient visits captured in DHIS2 during the study compared to comprehensive records in the Ministry of Health's Health Management Information System. Data was collected at the end of the 6th month study. Data is presented as percent of visits that were captured. |
| Hypertension Treatment Rate | 6 months | Number of patients receiving hypertension medication treatment in the 6th month of the study. |
| Sustainability | 6 months | Mean score on a sustainability questionnaire. Questionnaire was created by combining 6 questions from the Program Sustainability Assessment Tool (PSAT) and Clinical Sustainability Assessment Tools (CSAT). Scores range from 1 (worst) to 7 (best). The data reported is the median of the mean scores for each of the health providers. |
| Mean Systolic Blood Pressure | 6 months | Mean systolic blood pressure among patients with hypertension |
| Mean Diastolic Blood Pressure | 6 Months | Mean diastolic blood pressure among patients with hypertension |
| Fidelity - Chart Audit | 6 months | Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits |
| Fidelity - Systems Monitoring and Feedback | 6 months | Proportion of quarterly reports viewed by health district administrators |
| Usability | 6 months | Average score on the System Usability Scale questionnaire. Scores have a range of 0 (worst) to 100 (best). Questionnaire was given to the provider arm only. |
| Diabetes Treatment Rate | 6 months | Number of patients receiving diabetes medication treatment in the 6th month of the trial.. |
| Proportion of Patient Participants Achieving Glycemic Control | 6 months | Proportion achieving glycemic control (fasting blood glucose \<115 mg/dl or random blood glucose \<160 mg/dl) among patients with diabetes |
| Proportion Achieving Control of Blood Pressure | 6 months | Proportion achieving control of blood pressure (\<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records. |
Countries
Guatemala
Participant flow
Pre-assignment details
Providers not considered Enrolled
Participants by arm
| Arm | Count |
|---|---|
| HEARTS Implementation - Patients A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.
Integrated Diabetes and Hypertension Primary Care Model: The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.
1. Training health workers on diabetes and hypertension treatment protocols
2. Team-based care and task sharing
3. Strengthening access to medications and diagnostics
4. Electronic medical record system and registry
5. Systems monitoring and feedback of key indicators | 964 |
| HEARTS Implementation - Providers A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.
Integrated Diabetes and Hypertension Primary Care Model - Providers: The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care.
1. Training health workers on diabetes and hypertension treatment protocols
2. Team-based care and task sharing
3. Strengthening access to medications and diagnostics
4. Electronic medical record system and registry
5. Systems monitoring and feedback of key indicators
Health care providers will administer this intervention to patient participants and will report on their experience. | 20 |
| Total | 984 |
Baseline characteristics
| Characteristic | HEARTS Implementation - Patients | Total | HEARTS Implementation - Providers |
|---|---|---|---|
| Age, Continuous | 55.2 years | 55.2 years | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 474 Participants | 474 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 486 Participants | 486 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | — |
| Region of Enrollment Guatemala | 964 participants | 984 participants | 20 participants |
| Sex: Female, Male Female | 760 Participants | 760 Participants | — |
| Sex: Female, Male Male | 204 Participants | 204 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 964 | 0 / 0 |
| other Total, other adverse events | 0 / 964 | 0 / 0 |
| serious Total, serious adverse events | 0 / 964 | 0 / 0 |
Outcome results
Primary
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
Time frame: 6 months
Population: This outcome measure only applies to the Patients group. No data was collected for the Providers group.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| HEARTS Implementation - Providers | Number of Target Health Districts That Met Enrollment Goals | 2 Districts |
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HEARTS Implementation - Providers | Proportion of Patient Participants With Subsequent Follow-up Visit Within 3 Months | 36 percentage of patients |
Primary
Score on Acceptability of Intervention Measure (AIM) Questionnaire
Acceptability will be assessed among providers 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.
Time frame: 6 months
Population: Only 20 providers responded to this survey. This measure only applies to the provider arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HEARTS Implementation - Providers | Score on Acceptability of Intervention Measure (AIM) Questionnaire | 5.0 score on a scale |
Primary
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.
Time frame: 6 months
Population: This outcome measure only applies to the Providers group. No data was collected for the Patients group. Only 20 providers responded to this survey.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HEARTS Implementation - Providers | Score on Feasibility of Intervention Measure (FIM) Questionnaire | 5.0 score on a scale |
Secondary
Adoption
Count and percentage of participating health facilities who enrolled at least one patient with hypertension or diabetes.
Time frame: 6 months
Population: One of the eleven initially planned health facilities declined to participate in the study.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| HEARTS Implementation - Providers | Adoption | 10 Clinics |
Secondary
Diabetes Treatment Rate
Number of patients receiving diabetes medication treatment in the 6th month of the trial..
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEARTS Implementation - Providers | Diabetes Treatment Rate | 108 Participants |
Secondary
Fidelity - Access to Medicines and Diagnostics
Months in which primary health facilities 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. Data is reported in clinic-months, which is the sum number of months that each clinic reported monthly availability of medications and diagnostics (n=60 total clinic months(10 clinics x 6 months)).
Time frame: 6 months
Population: One of the eleven initially planned facilities declined to participate in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HEARTS Implementation - Providers | Fidelity - Access to Medicines and Diagnostics | 49 clinic-months |
Secondary
Fidelity - Chart Audit
Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits
Time frame: 6 months
Population: While this outcome measure was part of the original plan for the study, implementation of monitoring this outcome failed and no data was collected due to physicians' declination to use the software. This measure only applied to the patients arm.
Secondary
Fidelity - Facility-based Electronic Monitoring Tool
Proportion of patient visits captured in DHIS2 during the study compared to comprehensive records in the Ministry of Health's Health Management Information System. Data was collected at the end of the 6th month study. Data is presented as percent of visits that were captured.
Time frame: 6 months
Population: Number of patient visits
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HEARTS Implementation - Providers | Fidelity - Facility-based Electronic Monitoring Tool | 7.6 percentage of visits |
Secondary
Fidelity - Health Worker Training
Number of health workers in each district attending all training sessions
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HEARTS Implementation - Providers | Fidelity - Health Worker Training | District 1 | 20 Participants |
| HEARTS Implementation - Providers | Fidelity - Health Worker Training | District 2 | 20 Participants |
Secondary
Fidelity - Systems Monitoring and Feedback
Proportion of quarterly reports viewed by health district administrators
Time frame: 6 months
Population: While this outcome measure was part of the original plan for the study, implementation of monitoring this outcome failed and no data was collected due to physicians' declination to use the software.
Secondary
Fidelity - Team-based Care and Task Sharing
Proportion of primary health facilities conducting at least one care coordination meeting
Time frame: 6 months
Population: This group is of Clinics, not of participants. One of the eleven initially planned facilities declined to participate in this study.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| HEARTS Implementation - Providers | Fidelity - Team-based Care and Task Sharing | 10 Clinics |
Secondary
Hypertension Treatment Rate
Number of patients receiving hypertension medication treatment in the 6th month of the study.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEARTS Implementation - Providers | Hypertension Treatment Rate | 197 Participants |
Secondary
Mean Diastolic Blood Pressure
Mean diastolic blood pressure among patients with hypertension
Time frame: 6 Months
Population: While this outcome measure was part of the original plan for the study, implementation of monitoring this outcome failed and data was only collected for 71 patients. This outcome measure did not apply to the provider's arm. While Systolic pressure was recorded for 72 participants, diastolic pressure was not recorded from one of these participants due to an unknown error at the clinic.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEARTS Implementation - Providers | Mean Diastolic Blood Pressure | 81.5 mmHg | Standard Deviation 11.2 |
Secondary
Mean Systolic Blood Pressure
Mean systolic blood pressure among patients with hypertension
Time frame: 6 months
Population: While this outcome measure was part of the original plan for the study, implementation of monitoring this outcome failed and data was only collected for 72 patients. This outcome measure did not apply to the provider's arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEARTS Implementation - Providers | Mean Systolic Blood Pressure | 141.7 mmHg | Standard Deviation 18.5 |
Secondary
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.
Time frame: 6 months
Population: The monitoring system was incompletely utilized and only captured this data for 83 participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HEARTS Implementation - Providers | Proportion Achieving Control of Blood Pressure | 50.6 percent |
Secondary
Proportion of Patient 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
Time frame: 6 months
Population: Monitoring system only captured data from 39 participants and failed to capture data for other participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HEARTS Implementation - Providers | Proportion of Patient Participants Achieving Glycemic Control | 41 percent |
Secondary
Sustainability
Mean score on a sustainability questionnaire. Questionnaire was created by combining 6 questions from the Program Sustainability Assessment Tool (PSAT) and Clinical Sustainability Assessment Tools (CSAT). Scores range from 1 (worst) to 7 (best). The data reported is the median of the mean scores for each of the health providers.
Time frame: 6 months
Population: 20 of the 40 provider participants responded to this survey.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HEARTS Implementation - Providers | Sustainability | 5.3 units on a scale |
Secondary
Usability
Average score on the System Usability Scale questionnaire. Scores have a range of 0 (worst) to 100 (best). Questionnaire was given to the provider arm only.
Time frame: 6 months
Population: Questionnaire was given to the provider arm only. 20 of the 40 providers responded to this survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEARTS Implementation - Providers | Usability | 67.7 units on a scale | Standard Deviation 23.5 |