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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,465
- 试验地点
- 30
- 主要终点
- Phase 1: LDL-C levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Eligibility Criteria:
- •Inclusion Criteria:
- •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)
- •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
排除标准
- •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.
研究组 & 干预措施
Intervention group
Real-world evidence (RWE) platform to provide data on their clinical practice + usual care + Digitally-enabled Multifaceted Quality Improvement Intervention
干预措施: Digitally-enabled Multifaceted Quality Improvement Intervention (Behavioral)
Control group
RWE platform to provide data on their clinical practice + usual care
干预措施: Usual care (Behavioral)
结局指标
主要结局
Phase 1: LDL-C levels
时间窗: Baseline
LDL-C levels measured at a single visit
Phase 2: LDL-C
时间窗: 6 months
LDL-C levels measured at the end of follow up of Phase 2
次要结局
- Phase 2: Adherence to prescribed lipid-lowering therapy(6 months)
- Phase 1: Prescribed lipid-lowering therapy(Baseline)
- Phase 1: Prescribed combination lipid-lowering therapy(Baseline)
- Phase 1: Prescribed intensive lipid-lowering therapy(Baseline)
- Phase 1: Prescription of any statins(Baseline)
- Phase 1: Prescription of high intensity statins(Baseline)
- Phase 1: Prescription of ezetimibe(Baseline)
- Phase 1: Prescription of PCSK9 monoclonal antibody or siRNA PCSK9 inhibitors(Baseline)
- Phase 1: LDL-C < 50 mg/dL(Baseline)
- Phase 2: Prescribed lipid-lowering therapy(6 months)
- Phase 2: Prescribed combination lipid-lowering therapy(6 months)
- Phase 2: Prescribed intensive lipid-lowering therapy(6 months)
- Phase 2: Prescription of any statins(6 months)
- Phase 2: Prescription of high intensity statins(6 months)
- Phase 2: Prescription of moderate intensity statins(6 months)
- Phase 2: Prescription of low intensity statins(6 months)
- Phase 2: Prescription of ezetimibe(6 months)
- Phase 2: Prescription of PCSK9 monoclonal antibody or siRNA PCSK9 inhibitors(6 months)
- Phase 2: LDL-C < 50 mg/dL(6 months)
- Phase 2: Barriers for drug adherence(6 months)
- Phase 2: LDL-C relative change(6 months)
- Phase 2: LDL-C reduction of ≥50%(6 months)
- Phase 2: non-HDL-C relative change(6 months)
- Phase 2: Barriers for drug prescription(6 months)
- Phase 2: Intolerance to Statins(6 months)