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

Sponsor

Hospital Israelita Albert Einstein (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05622929

Collaborator

epHealth primary care solutions (Other), Novartis (Industry)

2,800

Enrollment

Arms

22.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Atherosclerosis Dyslipidemias	Behavioral: Digitally-enabled Multifaceted Quality Improvement Intervention Behavioral: Usual care	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster randomized clinical trialCluster randomized clinical trial

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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

Anticipated Study Start Date :

Nov 25, 2022

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Real-world evidence (RWE) platform to provide data on their clinical practice + usual care + Digitally-enabled Multifaceted Quality Improvement Intervention	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
Active Comparator: Control group RWE platform to provide data on their clinical practice + usual care	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.

Arm

Intervention/Treatment

Experimental: Intervention group

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

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

Active Comparator: Control group

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

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.

Outcome Measures

Primary Outcome Measures

Phase 1: LDL-C levels [Baseline]
LDL-C levels measured at a single visit
Phase 2: LDL-C [12 months]
LDL-C levels measured at the end of follow up of Phase 2

Secondary Outcome Measures

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 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 inhibitors [Baseline]
Percentage of prescription of 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 [12 months]
Percentage of patients on prescribed lipid-lowering therapy
Phase 2: Prescribed combination lipid-lowering therapy [12 months]
Percentage of patients on prescribed combination lipid-lowering therapy
Phase 2: Prescribed intensive lipid-lowering therapy [12 months]
Percentage of patients on prescribed intensive lipid-lowering therapy
Phase 2: Prescription of high intensity statins [12 months]
Percentage of prescription of high intensity statins
Phase 2: Prescription of moderate intensity statins [12 months]
Percentage of prescription of moderate intensity statins
Phase 2: Prescription of low intensity statins [12 months]
Percentage of prescription of low intensity statins
Phase 2: Prescription of ezetimibe [12 months]
Percentage of prescription of ezetimibe
Phase 2: Prescription of PCSK9 inhibitors [12 months]
Percentage of prescription of PCSK9 inhibitors
Phase 2: LDL-C < 50 mg/dL [12 months]
Percentage of patients with LDL-C < 50 mg/dL
Phase 2: LDL-C relative change [12 months]
Change in LDL-C relative to baseline
Phase 2: LDL-C reduction of ≥50% [12 months]
Percentage of patients with LDL-C reduction of ≥50% relative to baseline
Phase 2: Barriers for drug prescription [12 months]
Barriers for drug prescription at the system (cluster) and physician level
Phase 2: Adherence to prescribed lipid-lowering therapy [12 months]
Patient´s adherence to prescribed lipid-lowering therapy
Phase 2: Barriers for drug adherence [12 months]
Patient´s barriers for drug adherence
Phase 2: Intolerance to Statins [12 months]
Percentage of patients with intolerance to Statins
Phase 2: 5P-MACE (Major Cardiovascular Events) [12 months]
Composite endpoint of time to first occurrence of a major cardiovascular event 5P-MACE including cardiovascular deaths. non-fatal stroke or transient ischemic attack (TIA), non-fatal myocardial infarction, hospitalization for unstable angina, or coronary revascularization, whichever occurs first
Phase 2: 3P-MACE (Major Cardiovascular Events) [12 months]
Composite endpoint of time to first occurrence of a major cardiovascular event 3P-MACE including cardiovascular deaths, non-fatal stroke or TIA, or non-fatal myocardial infarction, whichever occurs first
Phase 2: Cardiovascular death [12 months]
Time to cardiovascular death
Phase 2: Death from any cause [12 months]
Time to death from any cause
Phase 2: Myocardial infarction [12 months]
Time to first myocardial infarction
Phase 2: Stroke [12 months]
Time to first stroke
Phase 2: Coronary revascularization [12 months]
Time to first coronary revascularization
Phase 2: Total deaths [12 months]
Total deaths within 12 months from inclusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

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

Exclusion Criteria:

Patients with a recent cardiovascular event, less than 3 months prior to study inclusion
Patients with LDL-C ≤ 70 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