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

Primary Purpose

Education, Medical, Continuing, Practice Patterns, Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Printed Educational Message
Sponsored by
Institute for Clinical Evaluative Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Education, Medical, Continuing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Control

    Printed Educational Message #1

    Printed Educational Message #2

    Printed Educational Message #3

    Arm Description

    Usual practice; no additional information provided.

    Information about Angiotensin-converting enzyme inhibitors, hypertension treatment, and cholesterol lowering agents for diabetes

    Retinal screening for diabetes

    Diuretics for hypertension

    Outcomes

    Primary Outcome Measures

    Change in Behavioral intention related to referring patient for retinopathy screening

    Secondary Outcome Measures

    Change in Attitude (Theory of Planned Behaviour)
    Change in Subjective Norm (Theory of Planned Behaviour)
    Change in Perceived Behavourial Control (Theory of Planned Behaviour)

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    March 25, 2015
    Sponsor
    Institute for Clinical Evaluative Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00210275
    Brief Title
    Ontario Printed Educational Materials (PEMs) for Physician Behaviour Change
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2005 (undefined)
    Primary Completion Date
    July 2015 (Anticipated)
    Study Completion Date
    July 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Institute for Clinical Evaluative Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Education, Medical, Continuing, Practice Patterns, Hypertension, Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    5000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Usual practice; no additional information provided.
    Arm Title
    Printed Educational Message #1
    Arm Type
    Experimental
    Arm Description
    Information about Angiotensin-converting enzyme inhibitors, hypertension treatment, and cholesterol lowering agents for diabetes
    Arm Title
    Printed Educational Message #2
    Arm Type
    Experimental
    Arm Description
    Retinal screening for diabetes
    Arm Title
    Printed Educational Message #3
    Arm Type
    Experimental
    Arm Description
    Diuretics for hypertension
    Intervention Type
    Behavioral
    Intervention Name(s)
    Printed Educational Message
    Intervention Description
    Three forms of printed educational materials (short or long educational messages and patient reminder notes)
    Primary Outcome Measure Information:
    Title
    Change in Behavioral intention related to referring patient for retinopathy screening
    Time Frame
    Two months and six months post intervention
    Secondary Outcome Measure Information:
    Title
    Change in Attitude (Theory of Planned Behaviour)
    Time Frame
    Two months and six months post intervention
    Title
    Change in Subjective Norm (Theory of Planned Behaviour)
    Time Frame
    Two months and six months post intervention
    Title
    Change in Perceived Behavourial Control (Theory of Planned Behaviour)
    Time Frame
    Two months and six months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Merrick F. Zwarenstein, MB, BCh, MSc
    Organizational Affiliation
    Institute for Clinical Evaluative Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Ontario Printed Educational Materials (PEMs) for Physician Behaviour Change

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