Using Big Data to Conduct Innovative Cardiovascular Clinical Trials

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

Interventions

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.

Sponsors & Collaborators

• Knowledge Translation Program of St. Michael's Hospital

  collaborator UNKNOWN

• Heart and Stroke Foundation of Ontario

  collaborator OTHER

• Heart & Stroke Richard Lewar Centres of Excellence in Cardiovascular Research

  collaborator UNKNOWN

• CorHealth Ontario

  collaborator OTHER

• The Ontario Spor Support Unit

  collaborator OTHER

• Institute for Clinical Evaluative Sciences

  lead OTHER

Principal Investigators

• Jacob A Udell, MD, MPH, FRCPC · ICES; Women's College Hospital; Peter Munk Cardiac Centre, Toronto General Hospital; University of Toronto

• Michael Farkouh, MD, FRCPC, FACC, FAHA · Peter Munk Cardiac Centre, Toronto General Hospital; University of Toronto

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-01

Primary Completion

2024-12-31

Completion

2025-03-31

Countries

• Canada

Study Locations