Contact information
Type
Scientific
Primary contact
Dr Merrick Flynn Zwarenstein
ORCID ID
Contact details
Institute for Clinical Evaluative Sciences
2075 Bayview Ave
G106
Toronto
Ontario
M4N 3M5
Canada
+1 (0)416 480 4055 ext. 7439
merrick.zwarenstein@ices.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-67916
Study information
Scientific title
Printed Educational Materials (PEMs) and their impact on physician decision making towards more evidence based choices: a single centre randomised tria
Acronym
OPEM
Study hypothesis
Printed Educational Materials (PEMs) will change physician decision making towards more evidence based choices.
Study Objective:
To measure the impact of PEMs on physician behaviour.
This description covers three replicates, independantly randomised. Each of the three sequential studies, aimed to asses the effects of printed educational materials on practice change by physicians. Each of the three replicates was aimed at a different condition and group of patients, and used different messages, but the same message formats.
These three seperate trials, essentially identical in design, tested the impact of printed educational messages aimed at:
1. Increasing coverage of retinal screening among all adult patients with diabetes
2. Intensification of cardiovascular treatment for patients over 65 years of age, with diabetes, and
3. At encouraging physicians to choose thiazides for initiation of hypertension therapy in their patients over 65 years, with newly diagnosed uncomplicated hypertension.
Ethics approval
Research Ethics Board of Sunnybrook & Women's College Health Science Centre, Toronto, Ontario (Canada), 29/04/2004, ref: #135-2004
Study design
Single-centre randomised cluster and factorial trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Diabetes, hypertension
Intervention
Posted printed educational materials (PEM) as follows:
Intervention arm 1 will receive 'informed' with an attached short outsert
Intervention arm 2 will receive 'informed' with an attached short outsert and longer insert
Intervention arm 3 will receive 'informed' with an attached long insert
Control arm will receive 'informed' only with no attachments
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Three trials:
1. Proportion of new hypertensives on diuretics
2. Proportion of diabetics who receive retinal screening
3. Proportion of diabetics who receive lipid lowering and antihypertensive medication and an ACE inhibitor
All measured from routinely collected health insurance and administrative information: OHRI, ODB, CIHI
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/01/2005
Overall trial end date
01/07/2006
Reason abandoned
Eligibility
Participant inclusion criteria
5547 actively practicing family (FP) and general practitioners (GP) in Ontario (~25 years and above, either sex) that have more than 100 patients over 65 years of age in fee for service practice with greater $50,000 billings to OHIP in 2003, randomised each time for three mail-outs of PEMs - the Printed Educational Materials
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5547
Participant exclusion criteria
Physicians who have elected not to receive 'informed', a newsletter on evidence based practice out of the Institute for Clinical Evaluative Sciences (ICES)
Recruitment start date
01/01/2005
Recruitment end date
01/07/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Institute for Clinical Evaluative Sciences
Toronto, Ontario
M4N 3M5
Canada
Sponsor information
Organisation
Institute for Clinical Evaluative Sciences - Toronto (Canada)
Sponsor details
Room G1 06
2075 Bayview Avenue
Toronto
M4N 3M5
Canada
-
info@ices.on.ca
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada), ref: MCT-67916
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18039361
2007 process evaluation protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18039362
2007 sub-trial protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18039363
2014 diabetic retinopathy results in: http://www.ncbi.nlm.nih.gov/pubmed/25098587
2014 diabetic retinopathy results in: http://www.ncbi.nlm.nih.gov/pubmed/25098442
2016 hypertension results in: http://www.ncbi.nlm.nih.gov/pubmed/27619339
2016 hypertension results in: http://www.ncbi.nlm.nih.gov/pubmed/27640126
Publication citations
-
Protocol
Zwarenstein M, Hux JE, Kelsall D, Paterson M, Grimshaw J, Davis D, Laupacis A, Evans M, Austin PC, Slaughter PM, Shiller SK, Croxford R, Tu K, The Ontario printed educational message (OPEM) trial to narrow the evidence-practice gap with respect to prescribing practices of general and family physicians: a cluster randomized controlled trial, targeting the care of individuals with diabetes and hypertension in Ontario, Canada., Implement Sci, 2007, 2, 37, doi: 10.1186/1748-5908-2-37.
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Protocol
Grimshaw JM, Zwarenstein M, Tetroe JM, Godin G, Graham ID, Lemyre L, Eccles MP, Johnston M, Francis JJ, Hux J, O'Rourke K, Légaré F, Presseau J, Looking inside the black box: a theory-based process evaluation alongside a randomised controlled trial of printed educational materials (the Ontario printed educational message, OPEM) to improve referral and prescribing practices in primary care in Ontario, Canada., Implement Sci, 2007, 2, 38, doi: 10.1186/1748-5908-2-38.
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Protocol
Francis JJ, Grimshaw JM, Zwarenstein M, Eccles MP, Shiller S, Godin G, Johnston M, O'Rourke K, Presseau J, Tetroe J, Testing a TheoRY-inspired MEssage ('TRY-ME'): a sub-trial within the Ontario Printed Educational Message (OPEM) trial., Implement Sci, 2007, 2, 39, doi: 10.1186/1748-5908-2-39.
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Results
Zwarenstein M, Shiller SK, Croxford R, Grimshaw JM, Kelsall D, Paterson JM, Laupacis A, Austin PC, Tu K, Yun L, Hux JE, Printed educational messages aimed at family practitioners fail to increase retinal screening among their patients with diabetes: a pragmatic cluster randomized controlled trial [ISRCTN72772651]., Implement Sci, 2014, 9, 1, 87, doi: 10.1186/1748-5908-9-87.
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Results
Grimshaw JM, Presseau J, Tetroe J, Eccles MP, Francis JJ, Godin G, Graham ID, Hux JE, Johnston M, Légaré F, Lemyre L, Robinson N, Zwarenstein M, Looking inside the black box: results of a theory-based process evaluation exploring the results of a randomized controlled trial of printed educational messages to increase primary care physicians' diabetic retinopathy referrals [Trial registration number ISRCTN72772651]., Implement Sci, 2014, 9, 86, doi: 10.1186/1748-5908-9-86.