Abstract
BackgroundThe results of randomised controlled trials can be usefully illuminated by studies of the processes by which they achieve their effects. The Theory of Planned Behaviour (TPB) offers a framework for conducting such studies. This study used TPB to explore the observed effects in a pragmatic cluster randomised controlled trial of a structured recall and prompting intervention to increase evidence-based diabetes care that was conducted in three Primary Care Trusts in England.MethodsAll general practitioners and nurses in practices involved in the trial were sent a postal questionnaire at the end of the intervention period, based on the TPB (predictor variables: attitude; subjective norm; perceived behavioural control, or PBC). It focussed on three clinical behaviours recommended in diabetes care: measuring blood pressure; inspecting feet; and prescribing statins. Multivariate analyses of variance and multiple regression analyses were used to explore changes in cognitions and thereby better understand trial effects.ResultsFifty-nine general medical practitioners and 53 practice nurses (intervention: n = 55, 41.98% of trial participants; control: n = 57, 38.26% of trial participants) completed the questionnaire. There were no differences between groups in mean scores for attitudes, subjective norms, PBC or intentions. Control group clinicians had 'normatively-driven' intentions (i.e., related to subjective norm scores), whereas intervention group clinicians had 'attitudinally-driven' intentions (i.e., related to attitude scores) for foot inspection and statin prescription. After controlling for effects of the three predictor variables, this group difference was significant for foot inspection behaviour (trial group × attitude interaction, beta = 0.72, p < 0.05; trial group × subjective norm interaction, beta = -0.65, p < 0.05).ConclusionAttitudinally-driven intentions are proposed to be more consistently translated into action than normatively-driven intentions. This proposition was supported by the findings, thus offering an interpretation of the trial effects. This analytic approach demonstrates the potential of the TPB to explain trial effects in terms of different relationships between variables rather than differences in mean scores. This study illustrates the use of theory-based process evaluation to uncover processes underlying change in implementation trials.
Highlights
The results of randomised controlled trials can be usefully illuminated by studies of the processes by which they achieve their effects
It may have been that the automated prompts to patients and clinicians regarding the need for a review consultation resulted in increased concordance in interactions between patients and clinicians and that this increased patients' involvement in the management of their condition. This theory-based process evaluation of the Diabetes Recall and Management System (DREAM) trial explored cognitions about three clinical behaviours relating to the management of diabetes to identify possible effects of the trial intervention on cognitions, including intentions
Of whether participants were in the intervention group or control group, professional role and practice size influenced attitudes, PBC, and intentions
Summary
The results of randomised controlled trials can be usefully illuminated by studies of the processes by which they achieve their effects. This study used TPB to explore the observed effects in a pragmatic cluster randomised controlled trial of a structured recall and prompting intervention to increase evidence-based diabetes care that was conducted in three Primary Care Trusts in England. A recent systematic review [4] of quality improvement interventions to improve the quality of care in patients with diabetes showed that a range of different interventions resulted in small to modest improvements in glycaemic control and in provider adherence to optimal care. It identified important methodological concerns, including evidence of publication bias. Because of difficulties operating this element of the software, it was not possible to run the final feature during the lifetime of the trial
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