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      Looking inside the black box: results of a theory-based process evaluation exploring the results of a randomized controlled trial of printed educational messages to increase primary care physicians’ diabetic retinopathy referrals [Trial registration number ISRCTN72772651]

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          Abstract

          Background

          Theory-based process evaluations conducted alongside randomized controlled trials provide the opportunity to investigate hypothesized mechanisms of action of interventions, helping to build a cumulative knowledge base and to inform the interpretation of individual trial outcomes. Our objective was to identify the underlying causal mechanisms in a cluster randomized trial of the effectiveness of printed educational materials (PEMs) to increase referral for diabetic retinopathy screening. We hypothesized that the PEMs would increase physicians’ intention to refer patients for retinal screening by strengthening their attitude and subjective norm, but not their perceived behavioral control.

          Methods

          Design: A theory based process evaluation alongside the Ontario Printed Educational Material (OPEM) cluster randomized trial. Postal surveys based on the Theory of Planned Behavior were sent to a random sample of trial participants two months before and six months after they received the intervention. Setting: Family physicians in Ontario, Canada. Participants: 1,512 family physicians (252 per intervention group) from the OPEM trial were invited to participate, and 31.3% (473/1512) responded at time one and time two. The final sample comprised 437 family physicians fully completing questionnaires at both time points. Main outcome measures: Primary: behavioral intention related to referring patient for retinopathy screening; secondary: attitude, subjective norm, perceived behavioral control.

          Results

          At baseline, family physicians reported positive intention, attitude, subjective norm, and perceived behavioral control to advise patients about retinopathy screening suggesting limited opportunities for improvement in these constructs. There were no significant differences on intention, attitude, subjective norm, and perceived behavioral control following the intervention. Respondents also reported additional physician- and patient-related factors perceived to influence whether patients received retinopathy screening.

          Conclusions

          Lack of change in the primary and secondary theory-based outcomes provides an explanation for the lack of observed effect of the main OPEM trial. High baseline levels of intention to advise patients to attend retinopathy screening suggest that post-intentional and other factors may explain gaps in care. Process evaluations based on behavioral theory can provide replicable and generalizable insights to aid interpretation of randomized controlled trials of complex interventions to change health professional behavior.

          Trial registration

          ISRCTN72772651.

          Electronic supplementary material

          The online version of this article (doi:10.1186/1748-5908-9-86) contains supplementary material, which is available to authorized users.

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          Most cited references8

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          The Design and Administration of Mail Surveys

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            The theory of planned behavior: a review of its applications to health-related behaviors.

            To review applications of Ajzen's theory of planned behavior in the domain of health and to verify the efficiency of the theory to explain and predict health-related behaviors. Most material has been drawn from Current Contents (Social and Behavioral Sciences and Clinical Medicine) from 1985 to date, together with all peer-reviewed articles cited in the publications thus identified. The results indicated that the theory performs very well for the explanation of intention; an averaged R2 of .41 was observed. Attitude toward the action and perceived behavioral control were most often the significant variables responsible for this explained variation in intention. The prediction of behavior yielded an averaged R2 of .34. Intention remained the most important predictor, but in half of the studies reviewed perceived behavioral control significantly added to the prediction. The efficiency of the model seems to be quite good for explaining intention, perceived behavioral control being as important as attitude across health-related behavior categories. The efficiency of the theory, however, varies between health-related behavior categories.
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              Printed educational materials: effects on professional practice and healthcare outcomes.

              Printed educational materials are widely used passive dissemination strategies to improve the quality of clinical practice and patient outcomes. Traditionally they are presented in paper formats such as monographs, publication in peer-reviewed journals and clinical guidelines. To assess the effect of printed educational materials on the practice of healthcare professionals and patient health outcomes.To explore the influence of some of the characteristics of the printed educational materials (e.g. source, content, format) on their effect on professional practice and patient outcomes. For this update, search strategies were rewritten and substantially changed from those published in the original review in order to refocus the search from published material to printed material and to expand terminology describing printed materials. Given the significant changes, all databases were searched from start date to June 2011. We searched: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), HealthStar, CINAHL, ERIC, CAB Abstracts, Global Health, and the EPOC Register. We included randomised controlled trials (RCTs), quasi-randomised trials, controlled before and after studies (CBAs) and interrupted time series (ITS) analyses that evaluated the impact of printed educational materials (PEMs) on healthcare professionals' practice or patient outcomes, or both. We included three types of comparisons: (1) PEM versus no intervention, (2) PEM versus single intervention, (3) multifaceted intervention where PEM is included versus multifaceted intervention without PEM. There was no language restriction. Any objective measure of professional practice (e.g. number of tests ordered, prescriptions for a particular drug), or patient health outcomes (e.g. blood pressure) were included. Two review authors undertook data extraction independently, and any disagreement was resolved by discussion among the review authors. For analyses, the included studies were grouped according to study design, type of outcome (professional practice or patient outcome, continuous or dichotomous) and type of comparison. For controlled trials, we reported the median effect size for each outcome within each study, the median effect size across outcomes for each study and the median of these effect sizes across studies. Where the data were available, we re-analysed the ITS studies and reported median differences in slope and in level for each outcome, across outcomes for each study, and then across studies. We categorised each PEM according to potential effects modifiers related to the source of the PEMs, the channel used for their delivery, their content, and their format. The review includes 45 studies: 14 RCTs and 31 ITS studies. Almost all the included studies (44/45) compared the effectiveness of PEM to no intervention. One single study compared paper-based PEM to the same document delivered on CD-ROM. Based on seven RCTs and 54 outcomes, the median absolute risk difference in categorical practice outcomes was 0.02 when PEMs were compared to no intervention (range from 0 to +0.11). Based on three RCTs and eight outcomes, the median improvement in standardised mean difference for continuous profession practice outcomes was 0.13 when PEMs were compared to no intervention (range from -0.16 to +0.36). Only two RCTs and two ITS studies reported patient outcomes. In addition, we re-analysed 54 outcomes from 25 ITS studies, using time series regression and observed statistically significant improvement in level or in slope in 27 outcomes. From the ITS studies, we calculated improvements in professional practice outcomes across studies after PEM dissemination (standardised median change in level = 1.69). From the data gathered, we could not comment on which PEM characteristic influenced their effectiveness. The results of this review suggest that when used alone and compared to no intervention, PEMs may have a small beneficial effect on professional practice outcomes. There is insufficient information to reliably estimate the effect of PEMs on patient outcomes, and clinical significance of the observed effect sizes is not known. The effectiveness of PEMs compared to other interventions, or of PEMs as part of a multifaceted intervention, is uncertain.
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                Author and article information

                Contributors
                jgrimshaw@ohri.ca
                justin.presseau@ncl.ac.uk
                jacqueline.tetroe@cihr-irsc.gc.ca
                martin.eccles@ncl.ac.uk
                Jill.Francis.1@city.ac.uk
                Gaston.Godin@fsi.ulaval.ca
                igraham@ohri.ca
                Jan.Hux@diabetes.ca
                m.johnston@abdn.ac.uk
                france.legare@mfa.ulaval.ca
                Louise.Lemyre@uOttawa.ca
                njt.robinson@gmail.com
                merrick.zwarenstein@ices.on.ca
                Journal
                Implement Sci
                Implement Sci
                Implementation Science : IS
                BioMed Central (London )
                1748-5908
                6 August 2014
                6 August 2014
                2014
                : 9
                : 1
                : 86
                Affiliations
                [ ]Ottawa Hospital Research Institute, The Ottawa Hospital - General Campus, 501 Smyth Road, Box 711, Ottawa, Ontario K1H 8 L6 Canada
                [ ]Department of Medicine, University of Ottawa, 451 Smyth Rd, Ottawa, Ontario K1H 8 M5 Canada
                [ ]Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle Upon Tyne, NE2 4AX England
                [ ]Canadian Institutes of Health Research, 160 Elgin St, Ottawa, Ontario K1A 0 W9 Canada
                [ ]School of Health Sciences, City University London, Northampton Square, London, EC1V 0HB UK
                [ ]Faculty of Nursing, Laval University, Pavillon Ferdinand-Vandry, 1050 Avenue de la Medicine, Room 1445, Quebec City, Quebec G1V 0A6 Canada
                [ ]School of Nursing, Faculty of Health Sciences, University of Ottawa, 451 Smyth Rd, Ottawa, Ontario K1H 8 M5 Canada
                [ ]Canadian Diabetes Association, 522 University Ave, Toronto, ON M5G 2A2 Canada
                [ ]Institute of Applied Health Sciences, College of Life Sciences and Medicine, 2nd floor, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD UK
                [ ]Department of Family Medicine and Emergency Medicine, Université Laval, Québec City, Québec G1K 7P4 Canada
                [ ]School of Psychology, 120 University, Social Sciences Building, Ottawa, Ontario K1N 6N5 Canada
                [ ]Institute for Clinical Evaluative Sciences, University of Toronto, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5 Canada
                Article
                796
                10.1186/1748-5908-9-86
                4261878
                25098442
                42a56ee1-6e0e-48a8-8c46-bb8639c0b63b
                © Grimshaw et al.; licensee BioMed Central Ltd. 2014

                This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 14 September 2013
                : 21 April 2014
                Categories
                Research
                Custom metadata
                © The Author(s) 2014

                Medicine
                process evaluation,theory of planned behavior,printed educational material,healthcare professional behavior,behavior change

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