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

NCT ID: NCT05622929

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1465 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2025-06-30

Brief 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.

Detailed Description

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.To our knowledge, data from this study will be crucial to leverage LDL-C treatment in Brazil, considering efforts to improve population health. The present study represents one of the first trials testing a quality improvement (QI) intervention targeted to LDL-C reduction in ASCVD patients conducted in a middle-income country. These results will address whether the proposed QI intervention is feasible and effective in these settings. Therefore, this study is a pragmatic cluster randomized trial to assess the effect of a digitally enabled QI intervention on LDL-C control in ASCVD patients. This study will have 2 phases. Phase 1 will be an observational phase prior to randomization of clusters with the objective to assess the baseline LDL-C levels achieved for target patients. Phase 2 will be an interventional phase, in which clusters will be randomized to the digitally enabled quality improvement intervention or usual care, with the objective to assess the effect of a digitally enabled QI intervention on control of LDL-C levels in ASCVD patients.

Conditions

Cardiovascular Diseases; Atherosclerosis; Dyslipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention group

Real-world evidence (RWE) platform to provide data on their clinical practice + usual care + Digitally-enabled Multifaceted Quality Improvement Intervention

Group Type: EXPERIMENTAL

Digitally-enabled Multifaceted Quality Improvement Intervention

Intervention Type: BEHAVIORAL

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

Control group

RWE platform to provide data on their clinical practice + usual care

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Capable of using a smartphone with iOS or Android System AND
• Established ASCVD, including:

1. Coronary Artery Disease (CAD):

• Prior myocardial infarction
• Prior coronary revascularization - percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
• Angiographic or computerized tomography (CT)-imaging evidence of coronary atherosclerosis (≥ 50% stenosis in at least one major epicardial coronary artery)

2. Stroke:

• Prior ischemic stroke thought not to be caused by an embolic cause (e.g., atrial fibrillation, valvular heart disease or mural thrombus)

3. Peripheral Artery Disease (PAD):

• Prior documentation of a resting ankle-brachial index ≤ 0.9
• History of prior percutaneous or surgical revascularization of an iliac, femoral, or popliteal artery
• Prior non-traumatic amputation of a lower extremity due to peripheral artery disease
• History of prior percutaneous or surgical carotid artery revascularization
• Carotid Stenosis > 50% on prior angiography or ultrasound AND
• Provision of informed consent

• Outpatient Clinics from public or private hospitals OR, Private Practices, which assist patients with previous ASCVD on secondary prevention that provide a unit/institution authorization form for participation in the trial AND
• Minimum monthly volume of 20 ASCVD patients

Exclusion Criteria

• Patients with a recent cardiovascular event, less than 3 months prior to study inclusion
• Patients with LDL-C ≤ 50 mg/dL
• Current participation in other clinical trials involving lipid lowering treatments
• Patients that do not consent to trial participation

Cluster Eligibility Criteria:

• Clusters that do not provide the unit/institution authorization form.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

epHealth primary care solutions

UNKNOWN

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. Julia Machline-Carrion, PhD

Role: PRINCIPAL_INVESTIGATOR

epHealth

Locations

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

Countries

Brazil

References

Machline-Carrion MJ, Girotto AN, Raupp P, Marton Pereira P, Monfardini F, Santos RD, Santo K, Ray K, Cannon CP, Berwanger O. Rationale, design and prerandomization data for a cluster randomized trial to assess the effect of a digitally enabled quality improvement intervention on LDL-C control in established atherosclerotic cardiovascular disease patients: The SAPPHIRE-LDL trial. Am Heart J. 2025 Jun;284:1-10. doi: 10.1016/j.ahj.2025.01.019. Epub 2025 Feb 3.

Reference Type: DERIVED

PMID: 39909341 (View on PubMed)

Other Identifiers

63520022.6.1001.0071

Identifier Type: OTHER

Identifier Source: secondary_id

CKJX839A1BR05R

Identifier Type: -

Identifier Source: org_study_id