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Education, Medical, ContinuingOPEMSNCT00210275

Ontario Printed Educational Materials (PEMs) for Physician Behaviour Change

A study testing Printed Educational Message in people with Education, Medical, Continuing and Practice Patterns, run by Institute for Clinical Evaluative Sciences.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Any age
What is being tested?
Printed Educational Message
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,000 participants
Where
No sites listed yet
Study dates
Jul 2005to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

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

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

Read the 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.

Being tested
Printed Educational Message
Medical subject headings
Hypertension, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Printed Educational MessageBehavioural

    Three forms of printed educational materials (short or long educational messages and patient reminder notes)

Study groups in NCT00210275
Study groupRoleWhat they receive
ControlNo interventionUsual practice; no additional information provided.
Printed Educational Message #1ExperimentalInformation about Angiotensin-converting enzyme inhibitors, hypertension treatment, and cholesterol lowering agents for diabetes
Receives: Behavioral: Printed Educational Message
Printed Educational Message #2ExperimentalRetinal screening for diabetes
Receives: Behavioral: Printed Educational Message
Printed Educational Message #3ExperimentalDiuretics for hypertension
Receives: Behavioral: Printed Educational Message

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Behavioral intention related to referring patient for retinopathy screening

    Measured: Two months and six months post intervention

Secondary outcomes (3)
  1. Change in Attitude (Theory of Planned Behaviour)

    Measured: Two months and six months post intervention

  2. Change in Subjective Norm (Theory of Planned Behaviour)

    Measured: Two months and six months post intervention

  3. Change in Perceived Behavourial Control (Theory of Planned Behaviour)

    Measured: Two months and six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionJul 2015 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00210275
Sponsor's protocol ID
MCT-67916
Acronym
OPEMS
Status last verified
Mar 2015
First submitted
13 Sep 2005
Last updated
26 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Printed Educational Message in people with Education, Medical, Continuing and Practice Patterns, run by Institute for Clinical Evaluative Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Behavioral intention related to referring patient for retinopathy screening (time frame: Two months and six months post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.

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