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.
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
- Conditions the study is for
- Education, Medical, Continuing, Practice Patterns, Hypertension
- What is being tested?
- Printed Educational Message
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Education, Medical, Continuing, Practice Patterns, Hypertension, Diabetes Mellitus, Type 2
- 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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual practice; no additional information provided. |
| Printed Educational Message #1 | Experimental | Information about Angiotensin-converting enzyme inhibitors, hypertension treatment, and cholesterol lowering agents for diabetes Receives: Behavioral: Printed Educational Message |
| Printed Educational Message #2 | Experimental | Retinal screening for diabetes Receives: Behavioral: Printed Educational Message |
| Printed Educational Message #3 | Experimental | Diuretics for hypertension Receives: Behavioral: Printed Educational Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Behavioral intention related to referring patient for retinopathy screening
Measured: Two months and six months post intervention
Secondary outcomes (3)
Change in Attitude (Theory of Planned Behaviour)
Measured: Two months and six months post intervention
Change in Subjective Norm (Theory of Planned Behaviour)
Measured: Two months and six months post intervention
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.
- First posted21 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionJul 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education, Medical, ContinuingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Evaluative Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merrick Zwarenstein, Institute for Clinical Evaluative Sciences
- Investigators
- Merrick F. Zwarenstein, MB, BCh, MSc, Principal investigator, Institute for Clinical Evaluative Sciences
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00210275
- Acronym / sponsor ID
- OPEMS / MCT-67916
- Conditions
- Education, Medical, Continuing, Practice Patterns, Hypertension, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Institute for Clinical Evaluative SciencesUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether printed educational materials can change physician behaviour towards more evidence based decision-making.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual practice; no additional information provided. |
| Printed Educational Message #1 | Experimental | Behavioral: Printed Educational MessageInformation about Angiotensin-converting enzyme inhibitors, hypertension treatment, and cholesterol lowering agents for diabetes |
| Printed Educational Message #2 | Experimental | Behavioral: Printed Educational MessageRetinal screening for diabetes |
| Printed Educational Message #3 | Experimental | Behavioral: Printed Educational MessageDiuretics for hypertension |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Printed Educational MessageThree forms of printed educational materials (short or long educational messages and patient reminder notes) | Behavioural | Printed Educational Message #1, Printed Educational Message #2, Printed Educational Message #3 |
Primary outcome
Change in Behavioral intention related to referring patient for retinopathy screening
Time frame: Two months and six months post intervention
3 secondary outcomes
Change in Attitude (Theory of Planned Behaviour)
Time frame: Two months and six months post intervention
Change in Subjective Norm (Theory of Planned Behaviour)
Time frame: Two months and six months post intervention
Change in Perceived Behavourial Control (Theory of Planned Behaviour)
Time frame: Two months and six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merrick F. Zwarenstein, MB, BCh, MSc principal investigator
Institute for Clinical Evaluative Sciences
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.