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A theory-based process evaluation alongside a randomised controlled trial of printed educational messages to increase primary care physicians' prescription of thiazide diuretics for hypertension [ISRCTN72772651].

ABSTRACT: 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.

SUBMITTER: Presseau J

PROVIDER: S-EPMC5020459 | biostudies-other | 2016 Sep

REPOSITORIES: biostudies-other

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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:Evidence of the effectiveness of printed educational messages in narrowing the gap between guideline recommendations and practice is contradictory. Failure to screen for retinopathy exposes primary care patients with diabetes to risk of eye complications. Screening is initiated by referral from family practitioners but adherence to guidelines is suboptimal. We aimed to evaluate the ability of printed educational messages aimed at family doctors to increase retinal screening of primary care patients with diabetes.Design: Pragmatic 2×3 factorial cluster trial randomized by physician practice, involving 5,048 general practitioners (with 179,833 patients with diabetes). Setting: Ontario family practitioners. Interventions: Reminders (that retinal screening helps prevent diabetes-related vision loss and is covered by provincial health insurance for patients with diabetes) with prompts to encourage screening were mailed to each physician in conjunction with a widely-read professional newsletter. Alternative printed materials formats were an 'outsert' (short, directive message stapled to the outside of the newsletter), and/or a two-page, evidence-based article ('insert') and a pre-printed sticky note reminder for patients. Main Outcome Measure: A successful outcome was an eye examination (which includes retinal screening) provided to a patient with diabetes, not screened in the previous 12 months, within 90 days after visiting a family practitioner. Analysis accounted for clustering of doctors within practice groups.No intervention effect was detected (eye exam rates were 31.6% for patients of control physicians, 31.3% for the insert, 32.8% for the outsert, 32.3% for those who received both, and 31.2% for those who received both plus the patient reminder with the largest 95% confidence interval around any effect extending from -1.3% to 1.1%).This large trial conclusively failed to demonstrate any impact of printed educational messages on screening uptake. Despite their low cost, printed educational messages should not be routinely used in attempting to close evidence-practice gaps relating to diabetic retinopathy screening.ISRCTN72772651.

Project description:Evidence on the effectiveness of printed educational messages in contributing to increasing evidence-based clinical practice is contradictory. Nonetheless, these messages flood physician offices, in an attempt to promote treatments that can reduce costs while improving patient outcomes. This study evaluated the ability of printed educational messages to promote the choice of thiazides as the first-line treatment for individuals newly diagnosed with hypertension, a practice supported by good evidence and included in guidelines, and one which could reduce costs to the health care system.The study uses a pragmatic, cluster randomized controlled trial (randomized by physician practice group).The setting involves all Ontario general/family practice physicians. Messages advising the use of thiazides as the first-line treatment of hypertension were mailed to each physician in conjunction with a widely read professional newsletter. Physicians were randomized to receive differing versions of printed educational messages: an "insert" (two-page evidence-based article) and/or one of two different versions of an "outsert" (short, directive message stapled to the outside of the newsletter). One outsert was developed without an explicit theory and one with messages developed targeting factors from the theory of planned behaviour or neither (newsletter only, with no mention of thiazides). The percentage of patients aged over 65 and newly diagnosed with hypertension who were prescribed a thiazide as the sole initial prescription medication. The effect of the intervention was estimated using a logistic regression model estimated using generalized estimating equation methods to account for the clustering of patients within physician practices.Four thousand five hundred four physicians (with 23,508 patients) were randomized, providing 97 % power to detect a 5 % absolute increase in prescription of thiazides. No intervention effect was detected. Thiazides were prescribed to 27.6 % of the patients who saw control physicians, 27.4 % for the insert, 26.8 % for the outsert and 28.3 % of the patients who saw insert + outsert physicians, p = 0.54.The study conclusively failed to demonstrate any impact of the printed educational messages on increasing prescribing of thiazide diuretics for first-line management of hypertension.ISRCTN72772651.

Project description:BackgroundA 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.MethodsThe 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.

Project description:ObjectivesWe compared the effectiveness of diabetes-focused messaging strategies at increasing enrolment in a healthy food programme among adults with diabetes.MethodsVitality is a multifaceted wellness benefit available to members of Discovery Health, a South Africa-based health insurer. One of the largest Vitality programmes is HealthyFood (HF), an incentive-based programme designed to encourage healthier diets by providing up to 25% cashback on healthy food purchases. We randomised adults with type 2 diabetes to 1 of 5 arms: (1) control, (2) a diabetes-specific message, (3) a message with a recommendation of HF written from the perspective of a HF member with diabetes, (4) a message containing a physician's recommendation of HF, or (5) the diabetes-specific message from arm 2 paired with an 'enhanced active choice'(EAC). In an EAC, readers are asked to make an immediate choice (in this case, to enrol or not enrol); the pros and cons associated with the preferred and non-preferred options are highlighted. HF enrolment was assessed 1 month following the first emailed message.ResultsWe randomised 3906 members. After excluding those who enrolled in HF or departed from the Vitality programme before the first intervention email, 3665 (94%) were included in a modified intent-to-treat analysis. All 4 experimental arms had significantly higher HF enrolment rates compared with control (p<0.0001 for all comparisons). When comparing experimental arms, the diabetes-specific message with the EAC had a significantly higher enrolment rate (12.6%) than the diabetes-specific message alone (7.6%, p=0.0016).ConclusionsMessages focused on diabetes were effective at increasing enrolment in a healthy food programme. The addition of a framed active choice to a message significantly raised enrolment rates in this population. These findings suggest that simple, low-cost interventions can enhance enrolment in health promoting programmes and also be pragmatically tested within those programmes.Trial registration numberNCT02462057.

Project description:IntroductionKnowledge of different factors that influence physician decision-making in general practice for prescribing antibiotics is vital for successfully implementing antimicrobial stewardship interventions. The Theory of planned behaviour (TPB) is an established model that describes how cognitions drive human behaviour.ObjectivesThe present study was performed to identify the socio-cultural and behavioural determinants that affect antibiotics prescription behaviour among primary care physicians and estimate the awareness about antibiotic resistance of public health importance.MethodologyThe questionnaire was divided into three sections: Section-I, which contained demographic content. Section-II contained 21 question items measuring attitudes, subjective norms, perceived behavioural control, and behavioural intentions of the prescribers. Section III had 12 questions related to knowledge about antibiotic resistance. As determined by Cronbach's α for each set of measured constructs of questionnaire scale, the internal consistency was good (α ≥ 0.7). The participants' socio-cultural and behavioural determinants were graded in 3 categories depending upon the mean score, while frequencies were used to estimate antibiotic resistance awareness. The data was analyzed by calculating the one-way ANOVA and by post-hoc Tukey-Kramer HSD multiple comparison test.ResultsFour hundred thirty-four primary health care physicians responded to the questionnaire, and data was statistically investigated. Participants' knowledge of antibiotic-resistant bacteria was poor with greater behavioural intentions to prescribe antibiotics, but a positive attitude and acceptable perceived social pressure towards antibiotics.ConclusionOur study showed that awareness towards antibiotic-resistant bacteria among primary care physicians of Saudi Arabia stands insufficient but favourable attitude and satisfactory social pressure towards antibiotics with greater behavioural intentions to prescribe antibiotics. The continued medical education (CME) and frequent training interventions can increase these parameters of rational prescribing practice for antibiotics.

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A theory-based process evaluation alongside a randomised controlled trial of printed educational messages to increase primary care physicians' prescription of thiazide diuretics for hypertension [ISRCTN72772651].

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