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Using Big Data to Conduct Innovative Cardiovascular Clinical Trials

Primary Purpose

Cardiovascular Diseases, Cardiovascular Risk Factor, Dyslipidemias

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lipid management toolbox
Sponsored by
Institute for Clinical Evaluative Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Diseases focused on measuring Primary Prevention, Cardiovascular disease, Lipids, Statins, Lipid management, Lipid screening

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ICESRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Arm

Intervention Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 8, 2019
Last Updated
October 17, 2023
Sponsor
Institute for Clinical Evaluative Sciences
Collaborators
Knowledge Translation Program of St. Michael's Hospital, Heart and Stroke Foundation of Ontario, Heart & Stroke Richard Lewar Centres of Excellence in Cardiovascular Research, CorHealth Ontario, The Ontario Spor Support Unit
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1. Study Identification

Unique Protocol Identification Number
NCT04067297
Brief Title
Using Big Data to Conduct Innovative Cardiovascular Clinical Trials
Official Title
Using Big Data to Conduct Innovative Cardiovascular Clinical Trials: The Community Heart Outcomes Improvement and Cholesterol Education Study (CHOICES)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for Clinical Evaluative Sciences
Collaborators
Knowledge Translation Program of St. Michael's Hospital, Heart and Stroke Foundation of Ontario, Heart & Stroke Richard Lewar Centres of Excellence in Cardiovascular Research, CorHealth Ontario, The Ontario Spor Support Unit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Cardiovascular Risk Factor, Dyslipidemias
Keywords
Primary Prevention, Cardiovascular disease, Lipids, Statins, Lipid management, Lipid screening

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
500000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Lipid management toolbox
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of 66 -75 year old patients who filled a statin prescription
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of lipid-related visits to primary care physicians
Description
The number of lipid-related visits to primary care physicians for the primary prevention cohort of 40 to 75 year olds in each community.
Time Frame
3 years
Title
Number of 66-75 year old patients who adhered to a statin prescription
Description
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.
Time Frame
3 years
Title
Rate of 40-75 year old patients receiving lipid screening
Description
Proportion of 40 to 75 year olds in the primary prevention cohort for each community receiving lipid screening from lab data.
Time Frame
3 years
Title
Incidence of Acute Myocardial Infarction (AMI), stroke or CVD death (major CVD outcome)
Description
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.
Time Frame
3 years
Title
Incidence of revascularization procedures, AMI, stroke, or CVD death (general CVD outcome)
Description
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.
Time Frame
3 years
Title
Incidence of Diabetes Mellitus (DM)
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shalane R Basque, MSc
Phone
4165799339
Email
shalane.basque@ices.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob A Udell, MD, MPH, FRCPC
Organizational Affiliation
ICES; Women's College Hospital; Peter Munk Cardiac Centre, Toronto General Hospital; University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Farkouh, MD, FRCPC, FACC, FAHA
Organizational Affiliation
Peter Munk Cardiac Centre, Toronto General Hospital; University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICES
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shalane Basque, MSc
Phone
4165799339

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All data will be presented in aggregate, with no individual participant data sharing.
Citations:
PubMed Identifier
25781411
Citation
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.
Results Reference
background
PubMed Identifier
27712954
Citation
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.
Results Reference
background
PubMed Identifier
28385894
Citation
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.
Results Reference
background
PubMed Identifier
19923205
Citation
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.
Results Reference
background
Links:
URL
https://www.canheart.ca/choices
Description
Information on the CHOICES trial
URL
https://youtu.be/QF285N3ytO8
Description
Promotional video on the CHOICES trial

Learn more about this trial

Using Big Data to Conduct Innovative Cardiovascular Clinical Trials

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