Dataset Information

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

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.

SUBMITTER: Francis JJ

PROVIDER: S-EPMC2216024 | biostudies-literature | 2007 Nov

REPOSITORIES: biostudies-literature

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Publications

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

Francis Jillian J JJ Grimshaw Jeremy M JM Zwarenstein Merrick M Eccles Martin P MP Shiller Susan S Godin Gaston G Johnston Marie M O'Rourke Keith K Presseau Justin J Tetroe Jacqueline J

Implementation science : IS 20071126

<h4>Background</h4>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 ...[more]

PMID: 18039363

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Project description:Pragmatic trials of implementation interventions focus on evaluating whether an intervention changes professional behaviour under real-world conditions rather than investigating the mechanism through which change occurs. Theory-based process evaluations conducted alongside pragmatic randomised trials address this by assessing whether the intervention changes theoretical constructs proposed to mediate change. The Ontario Printed Educational Materials (PEM) cluster trial was designed to increase family physicians' guideline-recommended prescription of thiazide diuretics. The trial found no intervention effect. Using the theory of planned behaviour (TPB), we hypothesised that changes in thiazide prescribing would be reflected in changes in intention, consistent with changes in attitude and subjective norm, with no change to their perceived behavioural control (PBC), and tested this alongside the RCT.We developed and sent TPB postal questionnaires to a random sub-sample of family physicians in each trial arm 2 months before and 6 months after dissemination of the PEMs. We used analysis of covariance to test for group differences using a 2 × 3 factorial design. We content-analysed an open-ended question about perceived barriers to thiazide prescription. Using control group data, we tested whether baseline measures of TPB constructs predicted self-reported thiazide prescribing at follow-up.Four hundred twenty-six physicians completed pre- and post-intervention questionnaires. Baseline scores on measures of TPB constructs were high: intention mean = 5.9 out of 7 (SD = 1.4), attitude mean = 5.8 (SD = 1.1), subjective norm mean = 5.8 (SD = 1.1) and PBC mean = 6.2 (SD = 1.0). The arms did not significantly differ post-intervention on any of the theory-based constructs, suggesting a possible ceiling effect. Content analysis of perceived barriers suggested post-intentional barriers to prescribing thiazides most often focused on specific patient clinical characteristics and potential side effects. Baseline intention (β = 0.63, p < 0.01) but not PBC (β = 0.04, p = 0.78) predicted 42.6 % of the variance in self-reported behaviour at follow-up in the control group.Congruent with the Ontario Printed Educational Messages trial results and aligned with the TPB, we saw no impact of the intervention on any TPB constructs. The theoretical basis of this evaluation suggests possible explanations for the failure of the PEM intervention to change professional behaviour, which can directly inform the design and content of future theory-based PEM interventions to change professional behaviour.ISRCTN, Canada ISRCTN72772651.

Project description: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.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.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.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.ISRCTN72772651.

Project description:BackgroundRecruiting participants for clinical trials poses challenges. Major barriers to participation include psychological factors (eg, fear and mistrust) and logistical constraints (eg, transportation, cost, and scheduling). The strategic design of clinical trial messaging can help overcome these barriers. While strategic communication can be done through various channels (eg, recruitment advertisements), health care providers on the internet have been found to be key sources for communicating clinical trial information to US adults in the social media era.ObjectiveThis study aims to examine how communication source (ie, medical doctors and peers) and message framing of TikTok videos (ie, psychological and logistical framing) influence clinical trial-related attitudes, perceptions, and sign-up behaviors under the guidance of the integrated behavioral model.MethodsThis study used a 2 (source: doctor vs peer) × 2 (framing: psychological vs logistical) between-participant factorial design web-based experiment targeting adults in the United States who had never participated in clinical trials (ie, newcomers). A Qualtrics panel was used to recruit and compensate the study respondents (n=561). Participants viewed short-form videos with doctors or peers, using psychological or logistical framing. The main outcome measures included perceived source credibility, self-efficacy, attitude toward clinical trial participation, behavioral intention, and sign-up behavior. Structural equation modeling was used to analyze the direct and indirect effects of message factors on the outcome variables. Source (doctor=1; peer=0) and framing (psychological=1; logistical=0) were dummy-coded.ResultsDoctor-featured messages led to greater perceived source credibility (β=.31, P<.001), leading to greater self-efficacy (95% CI 0.13-0.30), which in turn enhanced behavioral intention (95% CI 0.12-0.29) and clinical trial sign-up behavior (95% CI 0.02-0.04). Logistical barrier-framed messages led to greater self-efficacy (β=-.09, P=.02), resulting in higher intention to participate in clinical trials (95% CI -0.38 to -0.03) and improved sign-up behavior (95% CI -0.06 to -0.004). Logistical barrier-framed messages were also directly associated with an increased likelihood of signing up for a clinical trial (β=-.08, P=.03). The model accounted for 21% of the variance in clinical trial sign-up behavior. Attitude did not significantly affect behavioral intention in this study (β=.08, P=.14), and psychological and logistical barrier-framed messages did not significantly differ in attitudes toward clinical trial participation (β=-.04, P=.09).ConclusionsThese findings advance our understanding of how people process popular message characteristics in short-form videos and lend practical guidance for communicators. We encourage medical professionals to consider short-form video sites (eg, TikTok and Instagram Reels) as effective tools for discussing clinical trials and participation opportunities. Specifically, featuring doctors discussing efforts to reduce logistical barriers is recommended. Our measuring of actual behavior as an outcome is a rare and noteworthy contribution to this research.

Dataset Information

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

Background

Methods

Publications

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

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