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ACTIVE NOT RECRUITING
NCT05622929
NA

Cluster Randomized Trial of a Digital Quality Improvement Intervention on LDLCholesterol Control

Sponsor: Hospital Israelita Albert Einstein

View on ClinicalTrials.gov

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

BEHAVIORAL

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

BEHAVIORAL

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