Statins at the Primary Care Level

Dyslipidemia Clinical Trial

— EPRINA  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380911
• Other study ID #: 11526941
• Status: Completed
• Phase: N/A
• First received: January 26, 2015
• Last updated: August 14, 2017
• Start date: April 2015
• Est. completion date: April 2017

Study information

• Verified date: August 2017
• Source: Institute for Clinical Effectiveness and Health Policy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Other:
• Educational Intervention
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: 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. 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical Effectiveness and Health Policy

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cholesterol Level stratified by history of diabetes	Net change in LDL-C levels from baseline to month 12 between intervention and usual care groups stratified by history of diabetes.	1 year
Other	Global Cardiovascular Risk stratified by history of diabetes	Net change in 10-year-CVD Framingham risk score before and after the implementation of the program stratified by history of diabetes.	1 year
Other	Clinical practice guidelines compliance stratified by history of diabetes		1 year
Other	Cholesterol reduction stratified by history of diabetes		1 year
Other	Treatment compliance stratified by history of diabetes		1 year
Other	Cholesterol level stratified by 10-year-CVD Framingham risk score level.		1 year
Other	Clinical practice guidelines compliance stratified by 10-year-CVD Framingham risk score level.		1 year
Other	Cholesterol reduction stratified by 10-year-CVD Framingham risk score level.		1 year
Other	Treatment compliance stratified by stratified by 10-year-CVD Framingham risk score level.		1 year
Primary	Cholesterol Level	Net change in LDL-C levels from baseline to month 12 between intervention and usual care groups among all study participants.	1 year
Secondary	Global Cardiovascular Risk	Net change in 10-year-CVD Framingham risk score before and after the implementation of the program.	1 year
Secondary	Clinical practice guidelines compliance	Proportion of patients with high CVD risk who are on statins, and are receiving an appropriate dose according to the CPG.	1 year
Secondary	Cholesterol reduction	Proportion of patients with moderate-high CVD risk who have reduced 30% and 50% of their LDL-C, respectively.	1 year
Secondary	Treatment compliance	Level of treatment adherence evaluated through questionnaire.	1 year
Secondary	Costs of the intervention	Cost-effectiveness of the intervention program.	1 year