Using Big Data to Conduct Innovative Cardiovascular Clinical Trials

NCT04067297 | Active Not Recruiting DMC

• 2 other identifiers: 2019-008-E151211
• Study Type: interventional
• Target: 500,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factor; Dyslipidemias

Keywords

Primary Prevention; Cardiovascular disease; Lipids; Statins; Lipid management; Lipid screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of lipid-related visits to primary care physicians

  3 years

• Number of 66-75 year old patients who adhered to a statin prescription

  3 years

• Rate of 40-75 year old patients receiving lipid screening

  3 years

• Incidence of Acute Myocardial Infarction (AMI), stroke or CVD death (major CVD outcome)

  3 years

• Incidence of revascularization procedures, AMI, stroke, or CVD death (general CVD outcome)

  3 years

Study Arms (2)

Control Arm

NO INTERVENTION

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.

Intervention Arm

EXPERIMENTAL

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

Interventions

Lipid management toolbox OTHER

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.

Intervention Arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with established CVD within each community

Sponsors & Collaborators

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

Study Sites (1)

ICES

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (4)

• 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.

  PMID: 25781411 BACKGROUND

• 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.

  PMID: 27712954 BACKGROUND

• 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.

  PMID: 28385894 BACKGROUND

• 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.

  PMID: 19923205 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Cardiovascular Diseases; Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 26, 2019
• Study Start: October 1, 2019
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)