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