Statins at the Primary Care Level (EPRINA)

An Educational Intervention to Improve Effectiveness in the Detection, Treatment and Control of Patients With High Cardiovascular Risk in Low-resource Settings in Argentina: Rationale and Study Design of a Cluster Randomized Controlled Trial.

Hypercholesterolemia, a major cause of disease burden in both the developed and developing world, is estimated to cause 2.6 million deaths annually (4.5% of all deaths) and one third of ischemic heart diseases., and result in 29.7 million DALY lost. In Argentina, the prevalence of hypercholesterolemia increased between 2005 and 2013 from 27.9% to 29.8%, whereas the rate of non-optimal LDL-C, was 28.0%. The rate of high cholesterol awareness was 37.3 % and the proportion of those who are under pharmacological treatment was dismally low: only 11.1%. Furthermore, only one out of four subjects with a self-reported diagnosis of coronary heart disease (CHD) is taking statins. and most individuals with CHD who are on statins have sub-optimal LDL-C levels. Although other antihypertensive, antidiabetic and low-dose aspirin were available free-of-charge at the primary care clinics of the public sector, statins had not been included until recently. As of 2014, statins (simvastatin 20mg) were incorporated into the package of drugs provided free-of-charge for patients with high cholesterol, according to CVD risk stratification. The goal of this study is to test whether a multifaceted educational intervention targeting physicians and pharmacist assistants, improves detection, treatment and control of hypercholesterolemia among uninsured patients with moderate to high cardiovascular risk in Argentina. Specifically, the intervention will test whether a multifaceted educational intervention program lowers LDL-cholesterol levels and CVD risk in moderate to high cardiovascular risk patients, improves physician compliance with clinical practice guidelines, and improves patient care management and adherence to medication. A cost-effectiveness study will be conducted to compare the intervention to the usual standard of care. This randomized cluster trial will enroll 350 patients from 10 public primary care clinics who will be assigned to receive either the intervention or the usual care. This study is timely and will generate urgently needed data on effective and, practical and sustainable intervention programs aimed at the prevention and control of CVD risk that can be directly used in other primary care settings and health care systems in LMICs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Corrientes, Argentina, 1034
        • Centro de Atención Primaria de la Salud N°11
      • Corrientes, Argentina
        • Centro de Atención Primaria de la Salud Dr. Balbastro
      • Corrientes, Argentina
        • Centro de Atención Primaria de la Salud N°13
      • La Rioja, Argentina
        • Centro de Atención Primaria "Jardín Residencial"
      • La Rioja, Argentina
        • Centro de Atención Primaria de la Salud "Faldeo del Velazco"
    • Chubut
      • Puerto Madryn, Chubut, Argentina
        • Centro de Atención Primaria de la Salud "Dr. Favaloro"
      • Puerto Madryn, Chubut, Argentina
        • Centro de Atención Primaria de la Salud "Ruca Calil"
      • Rawson, Chubut, Argentina
        • Centro de Atención Primaria de la Salud "Malvinas Argentinas"
      • Trelew, Chubut, Argentina
        • Centro de Atención Primaria de la Salud "Etcheparre"
    • Corrientes
      • San Luis del Palmar, Corrientes, Argentina
        • Hospital San Luis del Palmar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Arteriosclerotic cardiovascular disease: defined as acute coronary syndrome; history of myocardial infarction, stable or unstable angina, coronary revascularization, stroke, or transient ischemic attack presumed to be of atherosclerotic origin and revascularization.
  • Moderate-High CVD risk according to the WHO charts adapted by the National MoH (estimated 10-year CVD risk ≥ 20%)
  • LDL-C level ≥ 190 mg/dL
  • Type 2 diabetes in patients between 40 and 75 years of age

Exclusion Criteria:

  • Patients that are already receiving statins, pregnant women, bed-bound, and patients who cannot give informed consent.
  • End stage chronics kidney disease receiving dialysis ,HIV/AIDS, tuberculosis, alcohol or drugs abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The intervention group will receive a multifaceted educational intervention targeting physicians and pharmacist assistants to improve detection, treatment and control of hypercholesterolemia among uninsured patients with moderate-high cardiovascular risk in Argentina.

Physicians belonging to the PCC randomized to the intervention group receive a 3-component intervention: education workshop, Educational Outreach Visits and a mHealth application uploaded to their smartphones.

In addition, 2 intervention support tools are used at the intervention clinics:

  1. A web-based platform that is tailored to send SMS messages for lifestyle modification, and prompts and reminders for clinic appointments are used to improve medication adherence for patients.
  2. On-site training to pharmacist assistants at the first EOV is given by physician trainers focused on counseling to improve medication adherence among patients initiating statin therapy and at each patient visit to the clinic to refill drug prescriptions.
No Intervention: No Intervention Group
This group will continue with the usual care. Irrespective of the assignment of the clinic to the intervention or control group, all physicians from participating PCCs have received previous training on global cardiovascular risk management, given by the Ministry of Health

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholesterol Level
Time Frame: 1 year
Net change in LDL-C levels from baseline to month 12 between intervention and usual care groups among all study participants.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Cardiovascular Risk
Time Frame: 1 year
Net change in 10-year-CVD Framingham risk score before and after the implementation of the program.
1 year
Clinical practice guidelines compliance
Time Frame: 1 year
Proportion of patients with high CVD risk who are on statins, and are receiving an appropriate dose according to the CPG.
1 year
Cholesterol reduction
Time Frame: 1 year
Proportion of patients with moderate-high CVD risk who have reduced 30% and 50% of their LDL-C, respectively.
1 year
Treatment compliance
Time Frame: 1 year
Level of treatment adherence evaluated through questionnaire.
1 year
Costs of the intervention
Time Frame: 1 year
Cost-effectiveness of the intervention program.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholesterol Level stratified by history of diabetes
Time Frame: 1 year
Net change in LDL-C levels from baseline to month 12 between intervention and usual care groups stratified by history of diabetes.
1 year
Global Cardiovascular Risk stratified by history of diabetes
Time Frame: 1 year
Net change in 10-year-CVD Framingham risk score before and after the implementation of the program stratified by history of diabetes.
1 year
Clinical practice guidelines compliance stratified by history of diabetes
Time Frame: 1 year
1 year
Cholesterol reduction stratified by history of diabetes
Time Frame: 1 year
1 year
Treatment compliance stratified by history of diabetes
Time Frame: 1 year
1 year
Cholesterol level stratified by 10-year-CVD Framingham risk score level.
Time Frame: 1 year
1 year
Clinical practice guidelines compliance stratified by 10-year-CVD Framingham risk score level.
Time Frame: 1 year
1 year
Cholesterol reduction stratified by 10-year-CVD Framingham risk score level.
Time Frame: 1 year
1 year
Treatment compliance stratified by stratified by 10-year-CVD Framingham risk score level.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Adolfo Rubinstein, MD, MSc, PhD, Institute for Clinical Effectiveness and Health Policy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

March 1, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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