Clinical Research Directory
Browse clinical research sites, groups, and studies.
Using Big Data to Conduct Innovative Cardiovascular Clinical Trials
Sponsor: Institute for Clinical Evaluative Sciences
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.
Official title: Using Big Data to Conduct Innovative Cardiovascular Clinical Trials: The Community Heart Outcomes Improvement and Cholesterol Education Study (CHOICES)
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
500000
Start Date
2019-10-01
Completion Date
2027-12-31
Last Updated
2026-03-27
Healthy Volunteers
Yes
Interventions
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.
Locations (1)
ICES
Toronto, Ontario, Canada