Ontario Printed Educational Materials (PEMs) for Physician Behaviour Change

Hypertension Clinical Trial

— OPEMS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00210275
• Other study ID #: MCT-67916
• Status: Active, not recruiting
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 25, 2015
• Start date: July 2005
• Est. completion date: July 2016

Study information

• Verified date: March 2015
• Source: Institute for Clinical Evaluative Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: July 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Education, Medical, Continuing
• Hypertension
• Practice Patterns

Intervention

Behavioral:
• Printed Educational Message
Three forms of printed educational materials (short or long educational messages and patient reminder notes)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical Evaluative Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Behavioral intention related to referring patient for retinopathy screening		Two months and six months post intervention	No
Secondary	Change in Attitude (Theory of Planned Behaviour)		Two months and six months post intervention	No
Secondary	Change in Subjective Norm (Theory of Planned Behaviour)		Two months and six months post intervention	No
Secondary	Change in Perceived Behavourial Control (Theory of Planned Behaviour)		Two months and six months	No