Study protocol

Testing a TheoRY-inspired MEssage ('TRY-ME'): a sub-trial within the Ontario Printed Educational Message (OPEM) trial

Jillian J Francis¹ , Jeremy M Grimshaw^2,3 , Merrick Zwarenstein^4,5 , Martin P Eccles⁶ , Susan Shiller⁴ , Gaston Godin⁷ , Marie Johnston⁸ , Keith O'Rourke⁹ , Justin Presseau¹⁰ and Jacqueline Tetroe¹¹

¹  Health Services Research Unit, University of Aberdeen, Aberdeen, UK

²  Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa, Canada

³  Institute of Population Health, University of Ottawa, Ottawa, Canada

⁴  Institute of Clinical Evaluative Sciences, Toronto, Ontario, Canada

⁵  Department of Health Policy Management and Evaluation, University of Toronto, Toronto, Canada; Clinical Epidemiology Unit, Center for Health Services Sciences, Sunnybrook Hospital, Toronto, Ontario; Keenan Research Center, Li Ka Shing Knowledge Institute, St Michaels Hospital, Toronto, Ontario

⁶  Institute of Health and Society, University of Newcastle upon Tyne, Newcastle upon Tyne, UK

⁷  School of Nursing, University of Laval, Quebec City, Canada

⁸  Department of Psychology, University of Aberdeen, Aberdeen, UK

⁹  Department of Epidemiology and Community Medicine, University of Ottawa, Canada

¹⁰  School of Psychology, University of Ottawa, Ottawa, Canada

¹¹  Knowledge Translation Branch, Canadian Institutes of Health Research, 160 Elgin Street, Ottawa, Canada

author email corresponding author email

Implementation Science 2007, 2:39doi:10.1186/1748-5908-2-39

Published:	26 November 2007

Abstract

Background

A challenge for implementation researchers is to develop principles that could generate testable hypotheses that apply across a range of clinical contexts, thus leading to generalisability of findings. Such principles may be provided by systematically developed theories. The opportunity has arisen to test some of these theoretical principles in the Ontario Printed Educational Materials (OPEM) trial by conducting a sub-trial within the existing trial structure. OPEM is a large factorial cluster-randomised trial evaluating the effects of short directive and long discursive educational messages embedded into informed, an evidence-based newsletter produced in Canada by the Institute for Clinical Evaluative Sciences (ICES) and mailed to all primary care physicians in Ontario. The content of educational messages in the sub-trial will be constructed using both standard methods and methods inspired by psychological theory. The aim of this study is to test the effectiveness of the TheoRY-inspired MEssage ('TRY-ME') compared with the 'standard' message in changing prescribing behaviour.

Methods

The OPEM trial participants randomised to receive the short directive message attached to the outside of informed (an 'outsert') will be sub-randomised to receive either a standard message or a message informed by the theory of planned behaviour (TPB) using a two (long insert or no insert) by three (theory-based outsert or standard outsert or no outsert) design. The messages will relate to prescription of thiazide diuretics as first line drug treatment for hypertension (described in the accompanying protocol, "The Ontario Printed Educational Materials trial"). The short messages will be developed independently by two research teams.

The primary outcome is prescription of thiazide diuretics, measured by routinely collected data available within ICES. The study is designed to answer the question, is there any difference in guideline adherence (i.e., thiazide prescription rates) between physicians in the six groups? A process evaluation survey instrument based on the TPB will be administered pre- and post-intervention (described in the accompanying protocol, "Looking inside the black box"). The second research question concerns processes that may underlie observed differences in prescribing behaviour. We expect that effects of the messages on prescribing behaviour will be mediated through changes in physicians' cognitions.

Trial registration number

Current controlled trial ISRCTN72772651