Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/07/2005
Date assigned
21/07/2005
Last edited
19/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ices.on.ca/

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes

19/09/2016: Publication reference added. 14/09/2016: Publication reference added.