Statins at the Primary Care Level

NCT ID: NCT02380911

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 357 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-04-30

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.

Conditions

Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Educational Intervention

Intervention Type: OTHER

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 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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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:

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute for Clinical Effectiveness and Health Policy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adolfo Rubinstein, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Clinical Effectiveness and Health Policy

Locations

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

Countries

Argentina

References

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.

Reference Type: DERIVED

PMID: 31128958 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28143840 (View on PubMed)

Other Identifiers

11526941

Identifier Type: -

Identifier Source: org_study_id