Cluster Randomized Trial of a Digital Quality Improvement Intervention on LDLCholesterol Control
- Conditions
- AtherosclerosisCardiovascular DiseasesDyslipidemias
- Interventions
- Behavioral: Usual careBehavioral: Digitally-enabled Multifaceted Quality Improvement Intervention
- Registration Number
- NCT05622929
- Lead Sponsor
- Hospital Israelita Albert Einstein
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1465
-
Capable of using a smartphone with iOS or Android System AND
-
Established ASCVD, including:
-
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)
-
Stroke:
• Prior ischemic stroke thought not to be caused by an embolic cause (e.g., atrial fibrillation, valvular heart disease or mural thrombus)
-
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
- 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:
Inclusion Criteria:
- 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:
- Clusters that do not provide the unit/institution authorization form.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Usual care RWE platform to provide data on their clinical practice + usual care Intervention group Digitally-enabled Multifaceted Quality Improvement Intervention Real-world evidence (RWE) platform to provide data on their clinical practice + usual care + Digitally-enabled Multifaceted Quality Improvement Intervention
- Primary Outcome Measures
Name Time Method Phase 1: LDL-C levels Baseline LDL-C levels measured at a single visit
Phase 2: LDL-C 6 months LDL-C levels measured at the end of follow up of Phase 2
- Secondary Outcome Measures
Name Time Method Phase 1: Prescribed lipid-lowering therapy Baseline Percentage of patients on prescribed lipid-lowering therapy
Phase 1: Prescribed combination lipid-lowering therapy Baseline Percentage of patients on prescribed combination lipid-lowering therapy
Phase 1: Prescribed intensive lipid-lowering therapy Baseline Percentage of patients on prescribed intensive lipid-lowering therapy
Phase 1: Prescription of any statins Baseline Percentage of prescription of any statins
Phase 1: Prescription of high intensity statins Baseline Percentage of prescription of high intensity statins
Phase 1: Prescription of ezetimibe Baseline Percentage of prescription of ezetimibe
Phase 1: Prescription of PCSK9 monoclonal antibody or siRNA PCSK9 inhibitors Baseline Percentage of prescription of PCSK9 monoclonal antibody or siRNA PCSK9 inhibitors
Phase 1: LDL-C < 50 mg/dL Baseline Percentage of patients with LDL-C \< 50 mg/dL
Phase 2: Prescribed lipid-lowering therapy 6 months Percentage of patients on prescribed lipid-lowering therapy
Phase 2: Prescribed combination lipid-lowering therapy 6 months Percentage of patients on prescribed combination lipid-lowering therapy
Phase 2: Prescribed intensive lipid-lowering therapy 6 months Percentage of patients on prescribed intensive lipid-lowering therapy
Phase 2: Prescription of any statins 6 months Percentage of prescription of any statins
Phase 2: Prescription of high intensity statins 6 months Percentage of prescription of high intensity statins
Phase 2: Prescription of moderate intensity statins 6 months Percentage of prescription of moderate intensity statins
Phase 2: Prescription of low intensity statins 6 months Percentage of prescription of low intensity statins
Phase 2: Prescription of ezetimibe 6 months Percentage of prescription of ezetimibe
Phase 2: Prescription of PCSK9 monoclonal antibody or siRNA PCSK9 inhibitors 6 months Percentage of prescription of PCSK9 monoclonal antibody or siRNA PCSK9 inhibitors
Phase 2: LDL-C < 50 mg/dL 6 months Percentage of patients with LDL-C \< 50 mg/dL
Phase 2: LDL-C relative change 6 months Change in LDL-C relative to baseline
Phase 2: LDL-C reduction of ≥50% 6 months Percentage of patients with LDL-C reduction of ≥50% relative to baseline
Phase 2: non-HDL-C relative change 6 months Change in non-HDL-C relative to baseline
Phase 2: Barriers for drug prescription 6 months Barriers for drug prescription at the system (cluster) and physician level
Phase 2: Adherence to prescribed lipid-lowering therapy 6 months Patient´s adherence to prescribed lipid-lowering therapy
Phase 2: Barriers for drug adherence 6 months Patient´s barriers for drug adherence
Phase 2: Intolerance to Statins 6 months Percentage of patients with intolerance to Statins
Trial Locations
- Locations (28)
Santa Casa de Porto Alegre
🇧🇷Porto Alegre, Brazil
Hospital da Bahia
🇧🇷Salvador, BA, Brazil
Hospital Santa Lúcia
🇧🇷Poços De Caldas, MG, Brazil
Hospital e Maternidade Angelina Caron
🇧🇷Campina Grande Do Sul, PR, Brazil
Hospital Regional Hans Dieter Schmidt
🇧🇷Joinville, SC, Brazil
Centro de Pesquisa Clínica do Coração
🇧🇷Aracaju, SE, Brazil
Hospital Universitário São Francisco de Assis
🇧🇷Bragança Paulista, SP, Brazil
Instituto de Pesquisa Clínica de Campinas
🇧🇷Campinas, SP, Brazil
Irmandade da Santa Casa de Misericórdia de Marilia
🇧🇷Marília, SP, Brazil
Hospital Carlos Fernando Malzoni
🇧🇷Matão, SP, 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
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