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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
357
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.
Centro de Atención Primaria de la Salud "Dr. Favaloro"
Puerto Madryn, Chubut Province, Argentina
Centro de Atención Primaria de la Salud "Ruca Calil"
Puerto Madryn, Chubut Province, Argentina
Centro de Atención Primaria de la Salud "Malvinas Argentinas"
Rawson, Chubut Province, Argentina
Centro de Atención Primaria de la Salud "Etcheparre"
Trelew, Chubut Province, Argentina
Hospital San Luis del Palmar
San Luis del Palmar, Corrientes Province, Argentina
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
Corrientes, Argentina
Centro de Atención Primaria "Jardín Residencial"
La Rioja, Argentina
Centro de Atención Primaria de la Salud "Faldeo del Velazco"
La Rioja, Argentina
Cholesterol Level
Net change in LDL-C levels from baseline to month 12 between intervention and usual care groups among all study participants.
Time frame: 1 year
Global Cardiovascular Risk
Net change in 10-year-CVD Framingham risk score before and after the implementation of the program.
Time frame: 1 year
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.
Time frame: 1 year
Cholesterol reduction
Proportion of patients with moderate-high CVD risk who have reduced 30% and 50% of their LDL-C, respectively.
Time frame: 1 year
Treatment compliance
Level of treatment adherence evaluated through questionnaire.
Time frame: 1 year
Costs of the intervention
Cost-effectiveness of the intervention program.
Time frame: 1 year
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