Clinical trial NCT05622929: Cluster Randomized Trial of a Digital Quality Improvement Intervention on LDLCholesterol Control
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Atherosclerosis
Dyslipidemias
Keywords: Cardiovascular diseases
Atherosclerosis
Dyslipidemias
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: epHealth primary care solutions
name: Novartis
First posted: 2022-11-21
Enrollment: 1465
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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 ≤ 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.

Primary outcomes:
measure: Phase 1: LDL-C levels
timeFrame: Baseline
measure: Phase 2: LDL-C
timeFrame: 6 months
Secondary outcomes:
measure: Phase 1: Prescribed lipid-lowering therapy
timeFrame: Baseline
measure: Phase 1: Prescribed combination lipid-lowering therapy
timeFrame: Baseline
measure: Phase 1: Prescribed intensive lipid-lowering therapy
timeFrame: Baseline
measure: Phase 1: Prescription of any statins
timeFrame: Baseline
measure: Phase 1: Prescription of high intensity statins
timeFrame: Baseline
measure: Phase 1: Prescription of ezetimibe
timeFrame: Baseline
measure: Phase 1: Prescription of PCSK9 monoclonal antibody or siRNA PCSK9 inhibitors
timeFrame: Baseline
measure: Phase 1: LDL-C < 50 mg/dL
timeFrame: Baseline
measure: Phase 2: Prescribed lipid-lowering therapy
timeFrame: 6 months
measure: Phase 2: Prescribed combination lipid-lowering therapy
timeFrame: 6 months
measure: Phase 2: Prescribed intensive lipid-lowering therapy
timeFrame: 6 months
measure: Phase 2: Prescription of any statins
timeFrame: 6 months
measure: Phase 2: Prescription of high intensity statins
timeFrame: 6 months
measure: Phase 2: Prescription of moderate intensity statins
timeFrame: 6 months
measure: Phase 2: Prescription of low intensity statins
timeFrame: 6 months
measure: Phase 2: Prescription of ezetimibe
timeFrame: 6 months
measure: Phase 2: Prescription of PCSK9 monoclonal antibody or siRNA PCSK9 inhibitors
timeFrame: 6 months
measure: Phase 2: LDL-C < 50 mg/dL
timeFrame: 6 months
measure: Phase 2: LDL-C relative change
timeFrame: 6 months
measure: Phase 2: LDL-C reduction of ≥50%
timeFrame: 6 months
measure: Phase 2: non-HDL-C relative change
timeFrame: 6 months
measure: Phase 2: Barriers for drug prescription
timeFrame: 6 months
measure: Phase 2: Adherence to prescribed lipid-lowering therapy
timeFrame: 6 months
measure: Phase 2: Barriers for drug adherence
timeFrame: 6 months
measure: Phase 2: Intolerance to Statins
timeFrame: 6 months
Other outcomes:
measure: Phase 2: 5P-MACE (Major Cardiovascular Events)
timeFrame: 6 months
measure: Phase 2: 3P-MACE (Major Cardiovascular Events)
timeFrame: 6 months
measure: Phase 2: Cardiovascular death
timeFrame: 6 months
measure: Phase 2: Death from any cause
timeFrame: 6 months
measure: Phase 2: Myocardial infarction
timeFrame: 6 months
measure: Phase 2: Stroke
timeFrame: 6 months
measure: Phase 2: Coronary revascularization
timeFrame: 6 months
measure: Phase 2: Total deaths
timeFrame: 6 months
Locations:
city: Salvador
country: Brazil
facility: Hospital da Bahia
state: BA
city: Poços De Caldas
country: Brazil
facility: Hospital Santa Lúcia
state: MG
city: Campina Grande Do Sul
country: Brazil
facility: Hospital e Maternidade Angelina Caron
state: PR
city: Joinville
country: Brazil
facility: Hospital Regional Hans Dieter Schmidt
state: SC
city: Aracaju
country: Brazil
facility: Centro de Pesquisa Clínica do Coração
state: SE
city: Bragança Paulista
country: Brazil
facility: Hospital Universitário São Francisco de Assis
state: SP
city: Campinas
country: Brazil
facility: Instituto de Pesquisa Clínica de Campinas
state: SP
city: Marília
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Marilia
state: SP
city: Matão
country: Brazil
facility: Hospital Carlos Fernando Malzoni
state: SP
city: Belém
country: Brazil
facility: Hospital Universitário João de Barros Barreto
city: Botucatu
country: Brazil
facility: UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu
city: Curitiba
country: Brazil
facility: Santa Casa de Curitiba
city: Fortaleza
country: Brazil
facility: Centro de Pesquisas em Diabetes e Doenças Endócrino-metabólicas
city: Goiânia
country: Brazil
facility: Hospital Municipal de Aparecida de Goiânia
city: Goiânia
country: Brazil
facility: Hospital Ruy Azeredo
city: Maceió
country: Brazil
facility: Centro de Pesquisas Clínicas Dr Marco Mota
city: Natal
country: Brazil
facility: Instituto Atena de Pesquisa Clínica
city: Osasco
country: Brazil
facility: Unidade Hospital Municipal Antônio Giglio
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Santa Casa de Porto Alegre
city: Presidente Prudente
country: Brazil
facility: Hospital Regional Presidente Prudente
city: Rio Branco
country: Brazil
facility: Clínica Silvestre Santé
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Cardiologia
city: São José
country: Brazil
facility: Instituto de Cardiologia de Santa Catarina
city: São Paulo
country: Brazil
facility: Hospital São Paulo (UNIFESP)
city: São Paulo
country: Brazil
facility: Hospital São Paulo Universidade Federal de São Paulo
city: São Paulo
country: Brazil
facility: Instituto de Cardiologia Dante Pazzanese
city: Vila Velha
country: Brazil
facility: Hospital Evangélico de Vila Velha
Study officials:
affiliation: epHealth
name: M. Julia Machline-Carrion, PhD
role: PRINCIPAL_INVESTIGATOR
References: