Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Using Big Data to Conduct Innovative Cardiovascular Clinical Trials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067297
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : February 12, 2020
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

Tracking Information
First Submitted Date  ICMJE August 8, 2019
First Posted Date  ICMJE August 26, 2019
Last Update Posted Date February 12, 2020
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Big Data to Conduct Innovative Cardiovascular Clinical Trials
Official Title  ICMJE Using Big Data to Conduct Innovative Cardiovascular Clinical Trials: The Community Heart Outcomes Improvement and Cholesterol Education Study (CHOICES)
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Cardiovascular Diseases
  • Cardiovascular Risk Factor
  • Dyslipidemias
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Lipid management toolbox
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2019)
500000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Laura E Ferreira-Legere, MScN 416-480-4055 laura.ferreira-legere@ices.on.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04067297
Other Study ID Numbers  ICMJE 2019-008-E
151211 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: All data will be presented in aggregate, with no individual participant data sharing.
Responsible Party Dr. Jacob Udell, Institute for Clinical Evaluative Sciences
Study Sponsor  ICMJE Institute for Clinical Evaluative Sciences
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account Institute for Clinical Evaluative Sciences
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP