PMID- 23129571 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20121107 LR - 20220321 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 2 IP - 6 DP - 2012 TI - Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice. LID - 10.1136/bmjopen-2012-001469 [doi] LID - e001469 AB - OBJECTIVE: To 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). DESIGN: A cluster RCT. SETTING: 49 general practices in UK randomised into intervention (n=25) and control (n=24). PARTICIPANTS: General 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 anlaysis. INTERVENTION: Brief training of clinicians and use of PDA with patients in single consultation. PRIMARY OUTCOMES: Decision quality (Decisional Conflict Scores, knowledge, realistic expectations and autonomy) and glycaemic control (glycosolated haemoglobin, HbA1c). SECONDARY OUTCOMES: Knowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications. RESULTS: Intervention 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. CONCLUSIONS: Use 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 NUMBER: 14842077. FAU - Mathers, Nigel AU - Mathers N AD - Academic Unit of Primary Medical Care, Northern General Hospital, University of Sheffield, Sheffield, UK. FAU - Ng, Chirk Jenn AU - Ng CJ FAU - Campbell, Michael Joseph AU - Campbell MJ FAU - Colwell, Brigitte AU - Colwell B FAU - Brown, Ian AU - Brown I FAU - Bradley, Alastair AU - Bradley A LA - eng GR - IAT/I-PF/010/003/DH_/Department of Health/United Kingdom PT - Journal Article DEP - 20121105 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 PMC - PMC3532975 EDAT- 2012/11/07 06:00 MHDA- 2012/11/07 06:01 PMCR- 2012/11/10 CRDT- 2012/11/07 06:00 PHST- 2012/11/07 06:00 [entrez] PHST- 2012/11/07 06:00 [pubmed] PHST- 2012/11/07 06:01 [medline] PHST- 2012/11/10 00:00 [pmc-release] AID - bmjopen-2012-001469 [pii] AID - 10.1136/bmjopen-2012-001469 [doi] PST - epublish SO - BMJ Open. 2012 Nov 5;2(6):e001469. doi: 10.1136/bmjopen-2012-001469. Print 2012.