Community-based Primary Care Program Effects on Pharmacotherapy of Type 2 Diabetes and Hypertension in Peru

• ClinicalTrials.gov Identifier: NCT05979142
• Recruitment Status: Completed
• First Posted: August 7, 2023
• Last Update Posted: August 7, 2023
• Sponsor: Asociación Siempre Salud
• Collaborator: University of Arizona
• Information provided by (Responsible Party): Asociación Siempre Salud

Study Description

Brief Summary:

The goal of this observational study is to compare usual care to a community-based primary care program (having components of treatment decisions based on clinical guidelines, self-management education, community health workers, and free health care visits and medications) in low-income Peruvians with type 2 diabetes and/or hypertension.

The main question[s] it aims to answer are:

• Compared to pre-program usual care, does the program result in greater benefits, measured as greater proportions of patients with glucose and blood pressure control or maximal quantities and doses of medications?
• Are there greater benefits when the program was provided at home compared to when the program was provided in a clinic?
• Does longer participation in the program result in greater benefits?

Participants will participate in:

• Self-management education provided by community health workers.
• Monitoring of healthy behaviors and glucose, blood pressure, and weight.
• Receipt of free medications for blood pressure, glucose, and heart disease prevention.

Condition or disease	Intervention/treatment
Type 2 Diabetes; Hypertension	Other: community-based primary care program

Detailed Description:

A pre-post study of visit-level data gathered prospectively during a community-based primary care program evaluated its effects on pharmacotherapy of type 2 diabetes and hypertension. The program was conducted by Asociación Siempre Salud, a Peruvian non-profit organization, in three neighborhoods ("the community") in Pueblo Nuevo, Chincha District, Peru. Door-to-door surveys identified all persons residing in the study community. Persons > 35 years old were eligible, without exclusions, to participate in type 2 diabetes and hypertension screening and diagnosis. Most participated in mass screenings between September and December 2011, others in later ad hoc screenings. Patients with negative screening results on medications were re-screened following medication withdrawal. Those with confirmed diagnoses were eligible to participate in the program.

Three binary exposures were evaluated for their effects on adherence to four treatment standards and one composite standard: 1) 'program exposure' (post- vs. pre-exposure); 2) 'program retention in care' (>50% of allowable time in both home and clinic care periods, compared to <50% in either care period (but not both)), and 3) 'care period', (clinic compared to home care). 'Care period treatment time' (>50% of allowable time versus less) was evaluated as an independent variable in the study of the care period exposure.

During the pre-exposure period, usual care was provided by two public hospitals, several Ministry of Health clinics, private clinics and pharmacies, and Siempre Salud. The program, to which patients were then exposed, had components of four CCM elements (delivery system design, self-management, decision support, and community resources), CHWs, and no out-of-pocket costs for visits and medications. Self-management was based on national standards and utilized educational materials from professional societies and government agencies in the USA. Decision support consisted of guidelines-based standards adapted to our low-resource setting and simplified medication treatment protocols for diabetes, hypertension, and primary prevention of CVD. The delivery system consisted of two care models employed sequentially: first home care, then clinic care (see care period exposure).

During the home care period, the physician made an initial visit, after which CHWs made weekly visits to patients' homes. CHWs monitored clinical parameters, provided self-management education and support, tracked self-care behaviors, documented visits, acted on clinical alerts, and delivered medications. They entered encounter data into a spreadsheet and filled prescriptions under physician supervision. The physician made treatment decisions reliant on home visit data and patient care conferences. During the subsequent clinic period, patients made monthly visits to the clinic physician who provided all care.

Study Design

• Study Type: Observational
• Actual Enrollment: 131 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Cohort Study of a Community-based Primary Care Program's Effects on Pharmacotherapy Quality in Low-income Peruvians With Type 2 Diabetes and Hypertension
• Actual Study Start Date: September 2011
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2014

Groups and Cohorts

Group/Cohort	Intervention/treatment
program (pre-exposure); During the pre-exposure period, usual care was provided by two public hospitals, several Ministry of Health clinics, private clinics and pharmacies, and Siempre Salud.
program (post-exposure); The program had components of four Chronic Care Model (CCM) elements (delivery system design, self-management, decision support, and community resources), community health workers (CHWs), and no out-of-pocket costs for visits and medications.	Other: community-based primary care program; See group description

Outcome Measures

Primary Outcome Measures :

1. Hypoglycemic agent standard [ Time Frame: 27 months ]
   Standard was defined as glycemic control or maximum doses of two hypoglycemic agents (metformin and glibenclamide) in eligible patients with type 2 diabetes.
2. Antihypertensive agent standard [ Time Frame: 27 months ]
   Standard was defined blood pressure control or maximum doses of three or more antihypertensive agents in eligible patients with elevated blood pressure (>130/80 mm Hg in diabetics, >140/90 mm Hg in non-diabetics)
3. Angiotensin-converting enzyme inhibitor (ACEi) standard [ Time Frame: 27 months ]
   Standard was defined as any ACEi in eligible patients with diabetes and elevated BP (>130/80 mm Hg).
4. Low-dose aspirin standard [ Time Frame: 27 months ]
   Standard was defined as any low-dose aspirin in eligible patients with 10-year cardiovascular disease (CVD) risk >10%.
5. Composite standard [ Time Frame: 27 months ]
   Coded 'yes' if all treatment standards for which eligible were achieved.

Eligibility Criteria

• Ages Eligible for Study: 35 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Three neighborhoods ("the community") in Pueblo Nuevo, Chincha District, Ica, Peru participated in the study. Peru is a middle-income country, but most people in the study community live below the poverty line. Door-to-door surveys identified all persons residing in the study community. Patients 35 years and older were eligible to participate in diabetes and hypertension screening. 83% of all eligible persons participated in mass screenings between September and December 2011. Others participated in later ad hoc screenings. Those with confirmed diagnoses of type 2 diabetes and/or hypertension were eligible to participate in the program.

Criteria

Inclusion Criteria:

35 years or older with confirmed diagnosis of type 2 diabetes and/or hypertension

Exclusion Criteria:

None

Contacts and Locations

Sponsors and Collaborators

Asociación Siempre Salud

University of Arizona

Investigators

• Principal Investigator: John E Deaver, MD; Asociación Siempre Salud

More Information

• Responsible Party: Asociación Siempre Salud
• ClinicalTrials.gov Identifier: NCT05979142
• Other Study ID Numbers: 1912252903
• First Posted: August 7, 2023
• Last Update Posted: August 7, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified study data in the following formats: Stata (*.dta) and comma-delimited text (*.csv) files and a data dictionary will be shared with Dryad data repository.
• Time Frame: during submission of manuscript for publication

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Asociación Siempre Salud:

low and middle income countries; primary care; chronic care model; community health workers; cohort study; pharmacotherapy

Additional relevant MeSH terms:

Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases