Clinical trial NCT04067297: 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
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
Dyslipidemias
Keywords: Primary Prevention
Cardiovascular disease
Lipids
Statins
Lipid management
Lipid screening
Lead sponsor: Institute for Clinical Evaluative Sciences
Sponsor class: OTHER
Collaborators: name: Knowledge Translation Program of St. Michael's Hospital
name: Heart and Stroke Foundation of Ontario
name: Heart & Stroke Richard Lewar Centres of Excellence in Cardiovascular Research
name: CorHealth Ontario
name: The Ontario Spor Support Unit
First posted: 2019-08-26
Enrollment: 500000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of 66 -75 year old patients who filled a statin prescription
timeFrame: 3 years
Secondary outcomes:
measure: Number of lipid-related visits to primary care physicians
timeFrame: 3 years
measure: Number of 66-75 year old patients who adhered to a statin prescription
timeFrame: 3 years
measure: Rate of 40-75 year old patients receiving lipid screening
timeFrame: 3 years
measure: Incidence of Acute Myocardial Infarction (AMI), stroke or CVD death (major CVD outcome)
timeFrame: 3 years
measure: Incidence of revascularization procedures, AMI, stroke, or CVD death (general CVD outcome)
timeFrame: 3 years
measure: Incidence of Diabetes Mellitus (DM)
timeFrame: 3 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: ICES
state: Ontario
Study officials:
affiliation: ICES; Women's College Hospital; Peter Munk Cardiac Centre, Toronto General Hospital; University of Toronto
name: Jacob A Udell, MD, MPH, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Peter Munk Cardiac Centre, Toronto General Hospital; University of Toronto
name: Michael Farkouh, MD, FRCPC, FACC, FAHA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.