Statins at the Primary Care Level
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

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.
    


Intervention name(s): Educational Intervention
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Dyslipidemia; Global cardiovascular risk; Statins; Educational interventions