Using Big Data to Conduct Innovative Cardiovascular Clinical Trials

Using Big Data to Conduct Innovative Cardiovascular Clinical Trials: The Community Heart Outcomes Improvement and Cholesterol Education Study (CHOICES)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Dyslipidemias; Cardiovascular Risk Factor
• Intervention / Treatment: Other: Lipid management toolbox

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.

• Study Type: Interventional
• Enrollment (Estimated): 500000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • ICES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of 66 -75 year old patients who filled a statin prescription	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of lipid-related visits to primary care physicians	The number of lipid-related visits to primary care physicians for the primary prevention cohort of 40 to 75 year olds in each community.	3 years
Number of 66-75 year old patients who adhered to a statin prescription	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 years
Rate of 40-75 year old patients receiving lipid screening	Proportion of 40 to 75 year olds in the primary prevention cohort for each community receiving lipid screening from lab data.	3 years
Incidence of Acute Myocardial Infarction (AMI), stroke or CVD death (major CVD outcome)	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.	3 years
Incidence of revascularization procedures, AMI, stroke, or CVD death (general CVD outcome)	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.	3 years
Incidence of Diabetes Mellitus (DM)	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.	3 years

Collaborators and Investigators

• Sponsor: Institute for Clinical Evaluative Sciences
• Collaborators: Unity Health Toronto; Heart and Stroke Foundation of Ontario; The Ontario Spor Support Unit; CorHealth Ontario; Heart & Stroke Richard Lewar Centres of Excellence in Cardiovascular Research
• Investigators: 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

Publications and helpful links

General Publications

• Tu JV, Donovan LR, Lee DS, Wang JT, Austin PC, Alter DA, Ko DT. Effectiveness of public report cards for improving the quality of cardiac care: the EFFECT study: a randomized trial. JAMA. 2009 Dec 2;302(21):2330-7. doi: 10.1001/jama.2009.1731. Epub 2009 Nov 18.
• Anderson TJ, Gregoire J, Pearson GJ, Barry AR, Couture P, Dawes M, Francis GA, Genest J Jr, Grover S, Gupta M, Hegele RA, Lau DC, Leiter LA, Lonn E, Mancini GB, McPherson R, Ngui D, Poirier P, Sievenpiper JL, Stone JA, Thanassoulis G, Ward R. 2016 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult. Can J Cardiol. 2016 Nov;32(11):1263-1282. doi: 10.1016/j.cjca.2016.07.510. Epub 2016 Jul 25.
• James S, Rao SV, Granger CB. Registry-based randomized clinical trials--a new clinical trial paradigm. Nat Rev Cardiol. 2015 May;12(5):312-6. doi: 10.1038/nrcardio.2015.33. Epub 2015 Mar 17.
• Tu JV, Chu A, Maclagan L, Austin PC, Johnston S, Ko DT, Cheung I, Atzema CL, Booth GL, Bhatia RS, Lee DS, Jackevicius CA, Kapral MK, Tu K, Wijeysundera HC, Alter DA, Udell JA, Manuel DG, Mondal P, Hogg W; Cardiovascular Health in Ambulatory Care Research Team (CANHEART). Regional variations in ambulatory care and incidence of cardiovascular events. CMAJ. 2017 Apr 3;189(13):E494-E501. doi: 10.1503/cmaj.160823.

Helpful Links

• Information on the CHOICES trial
• Promotional video on the CHOICES trial

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Lipids; Statins; Primary Prevention; Lipid management; Lipid screening
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Cardiovascular Diseases; Dyslipidemias
• Other Study ID Numbers: 2019-008-E; 151211 (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be presented in aggregate, with no individual participant data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No