Clinical trial NCT02380911: Statins at the Primary Care Level
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Keywords: Dyslipidemia
Global cardiovascular risk
Statins
Educational interventions
Lead sponsor: Institute for Clinical Effectiveness and Health Policy
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 357
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cholesterol Level
timeFrame: 1 year
Secondary outcomes:
measure: Global Cardiovascular Risk
timeFrame: 1 year
measure: Clinical practice guidelines compliance
timeFrame: 1 year
measure: Cholesterol reduction
timeFrame: 1 year
measure: Treatment compliance
timeFrame: 1 year
measure: Costs of the intervention
timeFrame: 1 year
Other outcomes:
measure: Cholesterol Level stratified by history of diabetes
timeFrame: 1 year
measure: Global Cardiovascular Risk stratified by history of diabetes
timeFrame: 1 year
measure: Clinical practice guidelines compliance stratified by history of diabetes
timeFrame: 1 year
measure: Cholesterol reduction stratified by history of diabetes
timeFrame: 1 year
measure: Treatment compliance stratified by history of diabetes
timeFrame: 1 year
measure: Cholesterol level stratified by 10-year-CVD Framingham risk score level.
timeFrame: 1 year
measure: Clinical practice guidelines compliance stratified by 10-year-CVD Framingham risk score level.
timeFrame: 1 year
measure: Cholesterol reduction stratified by 10-year-CVD Framingham risk score level.
timeFrame: 1 year
measure: Treatment compliance stratified by stratified by 10-year-CVD Framingham risk score level.
timeFrame: 1 year
Locations:
city: Puerto Madryn
country: Argentina
facility: Centro de Atención Primaria de la Salud "Dr. Favaloro"
state: Chubut
city: Puerto Madryn
country: Argentina
facility: Centro de Atención Primaria de la Salud "Ruca Calil"
state: Chubut
city: Rawson
country: Argentina
facility: Centro de Atención Primaria de la Salud "Malvinas Argentinas"
state: Chubut
city: Trelew
country: Argentina
facility: Centro de Atención Primaria de la Salud "Etcheparre"
state: Chubut
city: San Luis del Palmar
country: Argentina
facility: Hospital San Luis del Palmar
state: Corrientes
city: Corrientes
country: Argentina
facility: Centro de Atención Primaria de la Salud N°11
city: Corrientes
country: Argentina
facility: Centro de Atención Primaria de la Salud Dr. Balbastro
city: Corrientes
country: Argentina
facility: Centro de Atención Primaria de la Salud N°13
city: La Rioja
country: Argentina
facility: Centro de Atención Primaria "Jardín Residencial"
city: La Rioja
country: Argentina
facility: Centro de Atención Primaria de la Salud "Faldeo del Velazco"
Study officials:
affiliation: Institute for Clinical Effectiveness and Health Policy
name: Adolfo Rubinstein, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gulayin PE, Lozada A, Beratarrechea A, Gutierrez L, Poggio R, Chaparro RM, Santero M, Masson W, Rubinstein A, Irazola V. An Educational Intervention to Improve Statin Use: Cluster RCT at the Primary Care Level in Argentina. Am J Prev Med. 2019 Jul;57(1):95-105. doi: 10.1016/j.amepre.2019.02.018. Epub 2019 May 23.
citation: Gulayin P, Irazola V, Lozada A, Chaparro M, Santero M, Gutierrez L, Poggio R, Beratarrechea A, Rubinstein A. Educational intervention to improve effectiveness in treatment and control of patients with high cardiovascular risk in low-resource settings in Argentina: study protocol of a cluster randomised controlled trial. BMJ Open. 2017 Jan 31;7(1):e014420. doi: 10.1136/bmjopen-2016-014420.