Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210275
Status:
UNKNOWN
Last Update Posted:
2015-03-26
First Post:
2005-09-13
Brief Title:
Ontario Printed Educational Materials PEMs for Physician Behaviour Change
Sponsor:
Institute for Clinical Evaluative Sciences
Organization:
Institute for Clinical Evaluative Sciences
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2015-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPEMS
Brief Summary:
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
METHODSDESIGN
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 hypertensionFor 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 insertRoutinely collected physician billing prescription and hospital data found in Ontarios 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 physicians place of practice and target behavioursA 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
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
METHODSDESIGN
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 hypertensionFor 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 insertRoutinely collected physician billing prescription and hospital data found in Ontarios 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 physicians place of practice and target behavioursA 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None