ObjectiveTo determine the effectiveness of a patient decision aid (PDA) to improve decision quality and glycaemic control in people with diabetes making treatment choices using a cluster randomised controlled trial (RCT).DesignA cluster RCT.Setting49 general practices in UK randomised into intervention (n=25) and control (n=24).ParticipantsGeneral practices Inclusion criteria: >4 medical partners; list size >7000; and a diabetes register with >1% of practice population. 191 practices assessed for eligibility, and 49 practices randomised and completed the study. Patients People with type 2 diabetes mellitus (T2DM) taking at least two oral glucose-lowering drugs with maximum tolerated dose with a glycosolated haemoglobin (HbA1c) greater than 7.4% (IFCC HbA1c >57 mmol/mol) or advised in the preceeding 6 months to add or consider changing to insulin therapy. Exclusion criteria: currently using insulin therapy; difficulty reading or understanding English; difficulty in understanding the purpose of the study; visual or cognitive impairment or mentally ill. A total of 182 assessed for eligibility, 175 randomised to 95 intervention and 80 controls, and 167 completion and analysis.InterventionBrief training of clinicians and use of PDA with patients in single consultation.Primary outcomesDecision quality (Decisional Conflict Scores, knowledge, realistic expectations and autonomy) and glycaemic control (glycosolated haemoglobin, HbA1c).Secondary outcomesKnowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications.ResultsIntervention group: lower total Decisional Conflict Scores (17.4 vs 25.2, p<0.001); better knowledge (51.6% vs 28.8%, p<0.001); realistic expectations (risk of ‘hypo’, ‘weight gain’, ‘complications’; 81.0% vs 5.2%, 70.5% vs 5.3%, 26.3% vs 5.0% respectively, p<0.001); and were more autonomous in decision-making (64.1% vs 42.9%, p=0.012). No significant difference in the glycaemic control between the two groups.ConclusionsUse of the PANDAs decision aid reduces decisional conflict, improves knowledge, promotes realistic expectations and autonomy in people with diabetes making treatment choices in general practice.ISRCTN Trials Register Number14842077.

BackgroundRandomised trials provide evidence that patient decision aids improve outcomes with respect to patient knowledge, involvement and satisfaction in decision making. It is less clear how these complex interventions are implemented within patient-clinician interactions and which components are active for improving decision processes. To investigate the experiences of using a diabetes treatment decision aid and to explore how components within a complex intervention influenced the decision making process.MethodsA pragmatic mixed methods study nested within the PANDAs cluster randomised trial of a patient decision aid. Themes inductively derived from interviews and observation of consultations with further triangulation with results of decision quality and involvement measurements and case analyses.ResultsThe decision aid intervention was employed flexibly within the consultation with both the patient and clinician active in marshalling elements. The decision aid improved processing and organization of information needed for decision making within the consultation interaction. It also improved decision quality by preparing the patient for active involvement within the clinical consultation.ConclusionThe intervention was acceptable, flexible and readily implemented in primary care consultations. The decision aid was effective in facilitating cognitive processing. The intervention also facilitated rehearsal in preparation for active roles in a shared decision process.Trial registrationTrials Register Number: ISRCTN14842077. Date registered: 24.06.2010.

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BackgroundThere is a lack of practical research frameworks to guide the development of patient decision aids [PtDAs]. This paper described how a PtDA was developed using the International Patient Decision Aids (IPDAS) guideline and UK Medical Research Council (UKMRC) frameworks to support patients when making treatment decisions in type 2 diabetes mellitus.MethodsThis study used mixed methods to develop a PtDA for use in a UK general practice setting. A 10-member expert panel was convened to guide development and patients and clinicians were also interviewed individually using semi-structured interview guides to identify their decisional needs. Current literature was reviewed systematically to determine the best available evidence. The Ottawa Decision Support Framework was used to guide the presentation of the information and value clarification exercise. An iterative draft-review-revise process by the research team and review panel was conducted until the PtDA reached content and format ‘saturation’. The PtDA was then pilot-tested by users in actual consultations to assess its acceptability and feasibility. The IPDAS and UKMRC frameworks were used throughout to inform the development process.ResultsThe PANDAs PtDA was developed systematically and iteratively. Patients and clinicians highlighted the needs for information, decisional, emotional and social support, which were incorporated into the PtDA. The literature review identified gaps in high quality evidence and variations in patient outcome reporting. The PtDA comprised five components: background of the treatment options; pros and cons of each treatment option; value clarification exercise; support needs; and readiness to decide.ConclusionsThis study has demonstrated the feasibility of combining the IPDAS and the UKMRC frameworks for the development and evaluation of a PtDA. Future studies should test this model for developing PtDAs across different decisions and healthcare contexts.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-014-0503-7) contains supplementary material, which is available to authorized users.