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Cluster Randomized Trial of a Digital Quality Improvement Intervention on LDLCholesterol Control
Sponsor: Hospital Israelita Albert Einstein
Summary
Elevation in low density lipoprotein (LDL) cholesterol (LDL-C) is a causal risk factor for atherosclerotic established cardiovascular disease (ASCVD). Reduction of LDL-C with statins has been clearly demonstrated as a robust and cost-effective way of reducing the burden of ASCVD in individuals at risk. ASCVD is the leading cause of death and disability in Brazil and therefore prevention guidelines recommend LDL-C reduction with the aim of reducing disease burden in individuals at risk. Studies have shown a clear hiatus on awareness and treatment of cholesterol in Brazil. Thus, it became imperative to develop knowledge translation projects aiming at bridging the gap between science and clinical practice and ultimately leading to better outcomes. Cluster randomized clinical trials are the highest quality type of clinical research to test educational and active interventions aimed at changing behaviors or clinical practices. Therefore, this study is a pragmatic cluster randomized trial to assess the effect of a digitally enabled quality improvement intervention on LDL-C control in atherosclerotic established cardiovascular disease (ASCVD) patients.
Official title: A Pragmatic Cluster Randomized Trial to Assess the Effect of a Digitally Enabled Quality Improvement Intervention on LDL Cholesterol Control in Atherosclerotic Established Cardiovascular Disease Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1465
Start Date
2023-01-10
Completion Date
2025-06-30
Last Updated
2025-01-30
Healthy Volunteers
No
Interventions
Digitally-enabled Multifaceted Quality Improvement Intervention
Digitally-enabled multifaceted strategy in addition to access to a RWE platform to provide clinical data. The digitally-enabled multifaceted strategy will include various tools that will provide support to the health professionals responsible for treating ASCVD patients in each center as well as patients, including: * Knowledge of effective lipid lowering therapies * Clinical decision support * Audit and feedback on adherence to optimal clinical management * Audit and feedback on LDL-C control
Usual care
Health professionals responsible for treating ASCVD patients in each center will continue to provide usual care to ASCVD patients in addition to provide data through a RWE platform.
Locations (28)
Hospital da Bahia
Salvador, Estado de Bahia, Brazil
Hospital Santa Lúcia
Poços de Caldas, Minas Gerais, Brazil
Hospital e Maternidade Angelina Caron
Campina Grande do Sul, Paraná, Brazil
Hospital Regional Hans Dieter Schmidt
Joinville, Santa Catarina, Brazil
Centro de Pesquisa Clínica do Coração
Aracaju, Sergipe, Brazil
Hospital Universitário São Francisco de Assis
Bragança Paulista, São Paulo, Brazil
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, Brazil
Irmandade da Santa Casa de Misericórdia de Marilia
Marília, São Paulo, Brazil
Hospital Carlos Fernando Malzoni
Matão, São Paulo, Brazil
Hospital Universitário João de Barros Barreto
Belém, Brazil
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu
Botucatu, Brazil
Santa Casa de Curitiba
Curitiba, Brazil
Centro de Pesquisas em Diabetes e Doenças Endócrino-metabólicas
Fortaleza, Brazil
Hospital Municipal de Aparecida de Goiânia
Goiânia, Brazil
Hospital Ruy Azeredo
Goiânia, Brazil
Centro de Pesquisas Clínicas Dr Marco Mota
Maceió, Brazil
Instituto Atena de Pesquisa Clínica
Natal, Brazil
Unidade Hospital Municipal Antônio Giglio
Osasco, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Santa Casa de Porto Alegre
Porto Alegre, Brazil
Hospital Regional Presidente Prudente
Presidente Prudente, Brazil
Clínica Silvestre Santé
Rio Branco, Brazil
Instituto Nacional de Cardiologia
Rio de Janeiro, Brazil
Instituto de Cardiologia de Santa Catarina
São José, Brazil
Hospital São Paulo (UNIFESP)
São Paulo, Brazil
Hospital São Paulo Universidade Federal de São Paulo
São Paulo, Brazil
Instituto de Cardiologia Dante Pazzanese
São Paulo, Brazil
Hospital Evangélico de Vila Velha
Vila Velha, Brazil