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

Cardiovascular Diseases Clinical Trial

— SAPPHIRE-LDL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05622929
• Other study ID #: CKJX839A1BR05R
• Secondary ID: 63520022.6.1001.
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Hospital Israelita Albert Einstein
• Contact: Karla E Santo, PhD
• Phone: +55 11 2151-5915
• Email: karla.santo[@]einstein.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient 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

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Dyslipidemias

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
• 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

Country	Name	City	State
Brazil	Centro de Pesquisa Clínica do Coração	Aracaju	SE
Brazil	Hospital Universitário São Francisco de Assis	Bragança Paulista	SP
Brazil	Hospital e Maternidade Angelina Caron	Campina Grande Do Sul	PR
Brazil	Instituto de Pesquisa Clínica de Campinas	Campinas	SP
Brazil	Hospital Regional Hans Dieter Schmidt	Joinville	SC
Brazil	Irmandade da Santa Casa de Misericórdia de Marilia	Marília	SP
Brazil	Hospital Carlos Fernando Malzoni	Matão	SP
Brazil	Hospital Santa Lúcia	Poços De Caldas	MG
Brazil	Hospital da Bahia	Salvador	BA

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	epHealth primary care solutions, Novartis

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: LDL-C levels	LDL-C levels measured at a single visit	Baseline
Primary	Phase 2: LDL-C	LDL-C levels measured at the end of follow up of Phase 2	12 months
Secondary	Phase 1: Prescribed lipid-lowering therapy	Percentage of patients on prescribed lipid-lowering therapy	Baseline
Secondary	Phase 1: Prescribed combination lipid-lowering therapy	Percentage of patients on prescribed combination lipid-lowering therapy	Baseline
Secondary	Phase 1: Prescribed intensive lipid-lowering therapy	Percentage of patients on prescribed intensive lipid-lowering therapy	Baseline
Secondary	Phase 1: Prescription of high intensity statins	Percentage of prescription of high intensity statins	Baseline
Secondary	Phase 1: Prescription of ezetimibe	Percentage of prescription of ezetimibe	Baseline
Secondary	Phase 1: Prescription of PCSK9 inhibitors	Percentage of prescription of PCSK9 inhibitors	Baseline
Secondary	Phase 1: LDL-C < 50 mg/dL	Percentage of patients with LDL-C < 50 mg/dL	Baseline
Secondary	Phase 2: Prescribed lipid-lowering therapy	Percentage of patients on prescribed lipid-lowering therapy	12 months
Secondary	Phase 2: Prescribed combination lipid-lowering therapy	Percentage of patients on prescribed combination lipid-lowering therapy	12 months
Secondary	Phase 2: Prescribed intensive lipid-lowering therapy	Percentage of patients on prescribed intensive lipid-lowering therapy	12 months
Secondary	Phase 2: Prescription of high intensity statins	Percentage of prescription of high intensity statins	12 months
Secondary	Phase 2: Prescription of moderate intensity statins	Percentage of prescription of moderate intensity statins	12 months
Secondary	Phase 2: Prescription of low intensity statins	Percentage of prescription of low intensity statins	12 months
Secondary	Phase 2: Prescription of ezetimibe	Percentage of prescription of ezetimibe	12 months
Secondary	Phase 2: Prescription of PCSK9 inhibitors	Percentage of prescription of PCSK9 inhibitors	12 months
Secondary	Phase 2: LDL-C < 50 mg/dL	Percentage of patients with LDL-C < 50 mg/dL	12 months
Secondary	Phase 2: LDL-C relative change	Change in LDL-C relative to baseline	12 months
Secondary	Phase 2: LDL-C reduction of =50%	Percentage of patients with LDL-C reduction of =50% relative to baseline	12 months
Secondary	Phase 2: Barriers for drug prescription	Barriers for drug prescription at the system (cluster) and physician level	12 months
Secondary	Phase 2: Adherence to prescribed lipid-lowering therapy	Patient´s adherence to prescribed lipid-lowering therapy	12 months
Secondary	Phase 2: Barriers for drug adherence	Patient´s barriers for drug adherence	12 months
Secondary	Phase 2: Intolerance to Statins	Percentage of patients with intolerance to Statins	12 months
Secondary	Phase 2: 5P-MACE (Major Cardiovascular Events)	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	12 months
Secondary	Phase 2: 3P-MACE (Major Cardiovascular Events)	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	12 months
Secondary	Phase 2: Cardiovascular death	Time to cardiovascular death	12 months
Secondary	Phase 2: Death from any cause	Time to death from any cause	12 months
Secondary	Phase 2: Myocardial infarction	Time to first myocardial infarction	12 months
Secondary	Phase 2: Stroke	Time to first stroke	12 months
Secondary	Phase 2: Coronary revascularization	Time to first coronary revascularization	12 months
Secondary	Phase 2: Total deaths	Total deaths within 12 months from inclusion	12 months