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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merrick Zwarenstein, Institute for Clinical Evaluative Sciences
ClinicalTrials.gov Identifier:
NCT00210275
First received: September 13, 2005
Last updated: March 25, 2015
Last verified: March 2015
  Purpose

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


Condition Intervention
Education, Medical, Continuing
Practice Patterns
Hypertension
Diabetes Mellitus, Type 2
Behavioral: Printed Educational Message

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Institute for Clinical Evaluative Sciences:

Primary Outcome Measures:
  • Change in Behavioral intention related to referring patient for retinopathy screening [ Time Frame: Two months and six months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Attitude (Theory of Planned Behaviour) [ Time Frame: Two months and six months post intervention ] [ Designated as safety issue: No ]
  • Change in Subjective Norm (Theory of Planned Behaviour) [ Time Frame: Two months and six months post intervention ] [ Designated as safety issue: No ]
  • Change in Perceived Behavourial Control (Theory of Planned Behaviour) [ Time Frame: Two months and six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: July 2005
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210275

Sponsors and Collaborators
Institute for Clinical Evaluative Sciences
Investigators
Principal Investigator: Merrick F. Zwarenstein, MB, BCh, MSc Institute for Clinical Evaluative Sciences
  More Information

No publications provided

Responsible Party: Merrick Zwarenstein, Senior Scientist, Institute for Clinical Evaluative Sciences
ClinicalTrials.gov Identifier: NCT00210275     History of Changes
Other Study ID Numbers: MCT-67916
Study First Received: September 13, 2005
Last Updated: March 25, 2015
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on March 26, 2015