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Using Big Data to Conduct Innovative Cardiovascular Clinical Trials

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ClinicalTrials.gov Identifier: NCT04067297
Recruitment Status : Not yet recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborators:
Knowledge Translation Program at St. Michael's Hospital
The Heart and Stroke Foundation
Heart and Stroke Richard Lewar Centres of Excellence in Cardiovascular Research
CorHealth Ontario
The Ontario Spor Support Unit
Information provided by (Responsible Party):
Dr. Jacob Udell, Institute for Clinical Evaluative Sciences

Brief Summary:
Traditional randomized clinical trials (RCTs) have provided extremely valuable information on medical therapies and procedures that have changed the way heart diseases are treated. However, despite these contributions, traditional RCTs are costly, the findings may not be applicable to patients unlike those in the study, and the use of trial findings may be infrequent. These limitations may be addressed by incorporating 'big data' in RCTs, which is the emerging field using electronic information that is routinely collected in various large administrative health databases. The Community Heart Outcomes Improvement and Cholesterol Education Study (CHOICES) will test the potential of using 'big data' in a 'real-world' clinical trial to measure outcomes using routinely collected health information. CHOICES aims to increase the use of cholesterol-lowering statin drugs to prevent heart attack and stroke in high-risk health regions across Ontario using a 'toolbox' of interventions. The 'toolbox' of interventions are informational strategies targeted for both patients and family physicians to help improve cholesterol management and contribute to shared decision making for heart healthy goals.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Cardiovascular Risk Factor Dyslipidemias Other: Lipid management toolbox Not Applicable

Detailed Description:

An estimated 19,500 cardiac events could be prevented each year in Canada by use of statin therapy as recommended in the Canadian Cardiovascular Society's Lipid Guidelines. Despite substantial evidence supporting statin use, several studies suggest dyslipidemia management in Canada remains suboptimal. In Ontario, prior work using the 2008 Cardiovascular Health in Ambulatory Care Research Team (CANHEART) 'big data' registry of almost the entire Ontario population of 9.8 million adults created through linkage of 17+ population health databases at ICES, has documented an approximate 2-fold variation across the province in cardiovascular events that is associated with performance of key cardiovascular preventive measures, particularly lipid screening and statin prescribing. This work noted that the variation did not have a clear association with traditional clinical risk factors or socioeconomic conditions. This observation suggests that heterogeneity in this care process may be modifiable with an intervention geared to improving adherence to national guidelines.

In this pragmatic, cluster randomized registry trial, 'big data' is used to test the 'real world' effectiveness of a tailored, multicomponent intervention strategy aimed at improving lipid management (screening, risk assessment, statin initiation, statin adherence) amongst a primary prevention cohort of 40 to 75 year olds individuals living in 14 (of 28) communities in Ontario with higher than average rates of cardiovascular events. A multicomponent intervention strategy will include a 'toolbox' of lipid management resources for both patient and physicians in the intervention (high-risk) communities of the province. The intervention strategy will include tools to enable patients and physicians to make informed and shared decisions about statin therapy and will be implemented in the intervention communities using targeted local and social media strategies. Patient characteristics for those aged 40 to 75 and clinical outcomes in this study will be measured without primary data collection using the 2016 CANHEART 'big data' registry, with the exception of stain use and adherence data available only in adults 66 to 75 years old.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a two-arm parallel assignment trial, cluster randomized at a community level. The 14 communities in each arm of the study will receive either the usual standard of care or the intervention in parallel.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The participants and care providers will be masked to what communities are enrolled in the trial, but due to the large scale study promotion that is required for dissemination, they may be aware that the resources they are receiving are part of an ongoing clinical trial. The principal investigator and a statistician will be blinded from which communities are assigned to which arm.
Primary Purpose: Health Services Research
Official Title: Using Big Data to Conduct Innovative Cardiovascular Clinical Trials: The Community Heart Outcomes Improvement and Cholesterol Education Study (CHOICES)
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Arm
The 14 communities that are in the control arm of the trial will receive usual standard of care. The usual standard of care will follow clinical daily practice patterns provided by family physicians in Ontario for CVD prevention. This follows the periodic standard of care provided by Canadian cholesterol, hypertension, and diabetes best practice guideline recommendations utilized based on each physician's clinical judgement, physical assessment, and discretion. Patients also typically have access to existing cardiovascular prevention materials offered online through publicly available websites.
Experimental: Intervention Arm
The 14 communities that are in the intervention arm of the trial will receive a multicomponent intervention that provides both physicians and patients with access to a 'toolbox' of lipid management resources. The components planned for the 'toolbox' are all evidence-based interventions and chosen after consultations with Canadian family physicians and implementation science experts based on their potential for scalability to the entire population, cost and practicality. Online tools will be used and the trial will leverage pre-existing implementation initiatives (e.g., newsletters, listservs) wherever possible to minimize study costs and increase accessibility.
Other: Lipid management toolbox
The intervention toolbox will include: 1) community-level report cards on lipid management (developed using an updated version of the 2016 CANHEART 'big data' registry of ~10.9 million adults created through linkage of 19+ population health databases) to distribute to family physicians, 2) printed and electronic patient education materials on cholesterol screening and management, 3) a new online clinical decision aid to facilitate shared decision-making between patients and their family physicians regarding statin utilization, 3) patient educational videos, and 4) physician educational videos and material.




Primary Outcome Measures :
  1. Number of 66 -75 year old patients who filled a statin prescription [ Time Frame: 3 years ]
    Proportion of FRS determined intermediate- and high-risk residents (aged 66 to 75) in each community who filled a statin prescription within 100 days, as measured by the CANHEART registry at the completion of the 3 year intervention period.


Secondary Outcome Measures :
  1. Number of lipid-related visits to primary care physicians [ Time Frame: 3 years ]
    The number of lipid-related visits to primary care physicians for the primary prevention cohort of 40 to 75 year olds in each community.

  2. Number of 66-75 year old patients who adhered to a statin prescription [ Time Frame: 3 years ]
    Adherence rates to statins in FRS determined intermediate- and high-risk statin users 66 to 75 year olds in each community. Adherence will be measured at 1.2 times the prescription length.

  3. Rate of 40-75 year old patients receiving lipid screening [ Time Frame: 3 years ]
    Proportion of 40 to 75 year olds in the primary prevention cohort for each community receiving lipid screening from lab data.

  4. Incidence of Acute Myocardial Infarction (AMI), stroke or CVD death (major CVD outcome) [ Time Frame: 3 years ]
    The proportion of AMI, stroke or CVD death in the primary prevention cohort of 40 to 75 year olds in each community, along with the individual components of these incident composite outcomes.

  5. Incidence of revascularization procedures, AMI, stroke, or CVD death (general CVD outcome) [ Time Frame: 3 years ]
    The proportion of AMI, stroke, or CVD death in addition to revascularization procedures in the primary prevention cohort of 40 to 75 year olds in each community, along with the individual components of these incident composite outcomes.

  6. Incidence of Diabetes Mellitus (DM) [ Time Frame: 3 years ]
    The incident rates of DM in 40 to 75 year olds in the primary prevention cohort of 40 to 75 year olds in each community.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Community with CVD incidence rates higher than the Ontario provincial average
  • Community with a population size greater than 5,000 40 to 75 year olds
  • Community with at least 1,000 66 to 75 year olds
  • Community with 20 to 130 active and practicing family physicians

Exclusion Criteria:

  • Patients with established CVD within each community

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067297


Contacts
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Contact: Laura E Ferreira-Legere, MScN 416-480-4055 laura.ferreira-legere@ices.on.ca

Locations
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Canada, Ontario
ICES Not yet recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Laura Ferreira-Legere, MScN    416 480 4055      
Sponsors and Collaborators
Institute for Clinical Evaluative Sciences
Knowledge Translation Program at St. Michael's Hospital
The Heart and Stroke Foundation
Heart and Stroke Richard Lewar Centres of Excellence in Cardiovascular Research
CorHealth Ontario
The Ontario Spor Support Unit
Investigators
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Principal Investigator: Jacob A Udell, MD, MPH, FRCPC ICES; Women's College Hospital; Peter Munk Cardiac Centre, Toronto General Hospital; University of Toronto
Principal Investigator: Michael Farkouh, MD, FRCPC, FACC, FAHA Peter Munk Cardiac Centre, Toronto General Hospital; University of Toronto

Additional Information:
Publications:
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Responsible Party: Dr. Jacob Udell, Co-Principal Investigator, Institute for Clinical Evaluative Sciences
ClinicalTrials.gov Identifier: NCT04067297     History of Changes
Other Study ID Numbers: 2019-008-E
151211 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be presented in aggregate, with no individual participant data sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Jacob Udell, Institute for Clinical Evaluative Sciences:
Primary Prevention
Cardiovascular disease
Lipids
Statins
Lipid management
Lipid screening
Additional relevant MeSH terms:
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Dyslipidemias
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases