Ontario Printed Educational Materials (PEMs) for Physician Behaviour Change (OPEMS)

March 25, 2015 updated by: Merrick Zwarenstein, Institute for Clinical Evaluative Sciences

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

The purpose of this study is to determine whether printed educational materials can change physician behaviour towards more evidence based decision-making.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

There are gaps between what family practitioners do in clinical practice and the evidence-based ideal. The most commonly used strategy to narrow these gaps is the printed educational message (PEM); however, the attributes of successful printed educational messages and their overall effectiveness in changing physician practice are not clear. The current endeavor aims to determine whether such messages change prescribing quality in primary care practice, and whether these effects differ with the format of the message.

METHODS/DESIGN:

The design is a large, simple, factorial, unblinded cluster-randomized controlled trial. PEMs will be distributed with informed, a quarterly evidence-based synopsis of current clinical information produced by the Institute for Clinical Evaluative Sciences, Toronto, Canada, and will be sent to all eligible general and family practitioners in Ontario. There will be three replicates of the trial, with three different educational messages, each aimed at narrowing a specific evidence-practice gap as follows: 1) angiotensin-converting enzyme inhibitors, hypertension treatment, and cholesterol lowering agents for diabetes; 2) retinal screening for diabetes; and 3) diuretics for hypertension.For each of the three replicates there will be three intervention groups. The first group will receive informed with an attached postcard-sized, short, directive "outsert." The second intervention group will receive informed with a two-page explanatory "insert" on the same topic. The third intervention group will receive informed, with both the above-mentioned outsert and insert. The control group will receive informed only, without either an outsert or insert.Routinely collected physician billing, prescription, and hospital data found in Ontario's administrative databases will be used to monitor pre-defined prescribing changes relevant and specific to each replicate, following delivery of the educational messages. Multi-level modeling will be used to study patterns in physician-prescribing quality over four quarters, before and after each of the three interventions. Subgroup analyses will be performed to assess the association between the characteristics of the physician's place of practice and target behaviours.A further analysis of the immediate and delayed impacts of the PEMs will be performed using time-series analysis and interventional, auto-regressive, integrated moving average modeling.

Study Type

Interventional

Enrollment (Anticipated)

5000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Family physicians or general practitioners in Ontario with >100 patients over 65 years of age in fee for service practice with >$50,000 billings to Ontario Health Insurance Plan (OHIP) in 2003

Exclusion Criteria:

  • Physicians who have elected not to receive "informed". "informed" is a quarterly newsletter on evidence based practice produced by the Institute for Clinical Evaluative Sciences (ICES) and is the vehicle for delivery of the printed educational messages.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual practice; no additional information provided.
Experimental: Printed Educational Message #1
Information about Angiotensin-converting enzyme inhibitors, hypertension treatment, and cholesterol lowering agents for diabetes
Behavioral: Printed Educational Message
Three forms of printed educational materials (short or long educational messages and patient reminder notes)
Experimental: Printed Educational Message #2
Retinal screening for diabetes
Behavioral: Printed Educational Message
Three forms of printed educational materials (short or long educational messages and patient reminder notes)
Experimental: Printed Educational Message #3
Diuretics for hypertension
Behavioral: Printed Educational Message
Three forms of printed educational materials (short or long educational messages and patient reminder notes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Behavioral intention related to referring patient for retinopathy screening
Time Frame: Two months and six months post intervention
Two months and six months post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Attitude (Theory of Planned Behaviour)
Time Frame: Two months and six months post intervention
Two months and six months post intervention
Change in Subjective Norm (Theory of Planned Behaviour)
Time Frame: Two months and six months post intervention
Two months and six months post intervention
Change in Perceived Behavourial Control (Theory of Planned Behaviour)
Time Frame: Two months and six months
Two months and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical Evaluative Sciences

Investigators

  • Principal Investigator: Merrick F. Zwarenstein, MB, BCh, MSc, Institute for Clinical Evaluative Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCT-67916

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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