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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
|
| No Intervention Group | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Cardiovascular Risk | Net change in 10-year-CVD Framingham risk score before and after the implementation of the program. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Global Cardiovascular Risk stratified by history of diabetes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adolfo Rubinstein, MD, MSc, PhD | Institute for Clinical Effectiveness and Health Policy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Atención Primaria de la Salud "Dr. Favaloro" | Puerto Madryn | Chubut Province | Argentina | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31128958 | Derived | 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. | |
| 28143840 | Derived |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
| 1 year |
| Cholesterol reduction | Proportion of patients with moderate-high CVD risk who have reduced 30% and 50% of their LDL-C, respectively. | 1 year |
| Treatment compliance | Level of treatment adherence evaluated through questionnaire. | 1 year |
| Costs of the intervention | Cost-effectiveness of the intervention program. | 1 year |
Net change in 10-year-CVD Framingham risk score before and after the implementation of the program stratified by history of diabetes.
| 1 year |
| Clinical practice guidelines compliance stratified by history of diabetes | 1 year |
| Cholesterol reduction stratified by history of diabetes | 1 year |
| Treatment compliance stratified by history of diabetes | 1 year |
| Cholesterol level stratified by 10-year-CVD Framingham risk score level. | 1 year |
| Clinical practice guidelines compliance stratified by 10-year-CVD Framingham risk score level. | 1 year |
| Cholesterol reduction stratified by 10-year-CVD Framingham risk score level. | 1 year |
| Treatment compliance stratified by stratified by 10-year-CVD Framingham risk score level. | 1 year |
| 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 | 1034 | 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 |
| 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. |
| D011314 | Preventive Health Services |