ObjectiveTo evaluate an informed shared decision-making programme (ISDM-P) for people with type 2 diabetes under high fidelity conditions.DesignRandomised, single-blinded trial with sham control intervention and follow-up of 6 months.SettingSingle-centre diabetes clinic providing care according to the national disease management programme in Germany.Participants154 people with type 2 diabetes without diagnosis of ischaemic heart disease or stroke.InterventionsThe ISDM-P is executed by diabetes educators. Core component is a patient decision aid on the prevention of myocardial infarction supplemented by a 90 min group teaching session. The structurally equivalent control intervention addresses stress issues.Main outcome measuresPrimary outcome was risk comprehension, including realistic expectations about benefits and harms of interventions. It was assessed by a 12-item questionnaire after the teaching session when patients set and prioritise their treatment goals. Key secondary outcome was adherence to treatment goals, operationalised as achievement of individual goals and medication uptake. ISDM-P teaching sessions were video-taped to monitor intervention fidelity.Results72 of 77 ISDM-P and 71 of 77 control patients completed the questionnaire (score 0–12). ISDM-P patients achieved higher levels of risk comprehension, mean score 8.25 vs 2.62, difference 5.63 (95% CI 4.82 to 6.44), and realistic expectations (score 0–6), 4.51 vs 0.85, 3.67 (3.23 to 4.11). More ISDM-P patients wished to take statins, 59.2% vs 30.4%, 28.7% (12.9% to 44.5%); more prioritised blood pressure control, 51.4% vs 25.7%, and fewer intensive glucose control, 33.3% vs 60%, p=0.002. More ISDM-P patients achieved their glycated haemoglobin goals, 95.8% vs 85.7%, 10.1% (0.6% to 19.5%). Achievement of prioritised goals and medication uptake were comparable between groups.ConclusionsThe ISDM-P on preventive measures in type 2 diabetes was effective under high fidelity conditions. Involvement of diabetes educators may facilitate implementation of the informed shared decision-making.Trial registration numberISRCTN84636255.

ObjectiveTo translate an informed shared decision-making programme (ISDM-P) for patients with type 2 diabetes from a specialised diabetes centre to the primary care setting.DesignPatient-blinded, two-arm multicentre, cluster randomised controlled trial of 6 months follow-up; concealed randomisation of practices after patient recruitment and acquisition of baseline data.Setting22 general practices providing care according to the German Disease Management Programme (DMP) for type 2 diabetes.Participants279 of 363 eligible patients without myocardial infarction or stroke.InterventionsThe ISDM-P comprises a patient decision aid, a corresponding group teaching session provided by medical assistants and a structured patient–physician encounter.Control group received standard DMP care.Primary and secondary outcome measuresPrimary endpoint was patient adherence to antihypertensive or statin drug therapy by comparing prescriptions and patient-reported uptake after 6 months. Secondary endpoints included informed choice, risk knowledge (score 0–11 from 11 questions) and prioritised treatment goals of patients and doctors.ResultsISDM-P: 11 practices with 151 patients; standard care: 11 practices with 128 patients; attrition rate: 3.9%. There was no difference between groups regarding the primary endpoint. Mean drug adherence rates were high for both groups (80% for antihypertensive and 91% for statin treatment). More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8). ISDM-P patients achieved higher levels of risk knowledge, with a mean score of 6.96 vs 2.86, difference 4.06 (95% CI 2.96 to 5.17). In the ISDM-P group, agreement on prioritised treatment goals between patients and doctors was higher, with 88.5% vs 57%.ConclusionsThe ISDM-P was successfully implemented in general practices. Adherence to medication was very high making improvements hardly detectable.Trial registration number ISRCTN77300204; Results.

Only 1.2% of our outpatients with diabetes on primary care level showed high diabetes-related distress. Higher rates in the current literature are probably due to not investigating on primary care level. Guidelines should consider this.

Prevalence of diabetes-related long-term complications was overestimated in people with diabetes type 2. Approximately one third of the participants showed even great fear. Patient expectation and fear about diabetes-associated complications did not correspondent with data on clinical reality.