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Informed shared decision-making programme for patients with type 2 diabetes in primary care: cluster randomised controlled trial
  1. Susanne Buhse1,
  2. Nadine Kuniss2,3,
  3. Kathrin Liethmann1,4,
  4. Ulrich Alfons Müller2,3,
  5. Thomas Lehmann5,
  6. Ingrid Mühlhauser1
  1. 1 Health Sciences and Education, University of Hamburg, Hamburg, Germany
  2. 2 Department of Internal Medicine III, Endocrinology and Metabolic Diseases, Jena University Hospital, Jena, Germany
  3. 3 Diabetes Centre Thuringia, Jena, Germany
  4. 4 Institute of Medical Psychology and Sociology, University Medical Center Schleswig Holstein, Kiel, Germany
  5. 5 Centre for Clinical Studies, Jena University Hospital, Jena, Germany
  1. Correspondence to Susanne Buhse; Susanne.Buhse{at}


Objective To 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.

Design Patient-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.

Setting 22 general practices providing care according to the German Disease Management Programme (DMP) for type 2 diabetes.

Participants 279 of 363 eligible patients without myocardial infarction or stroke.

Interventions The 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 measures Primary 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.

Results ISDM-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%.

Conclusions The ISDM-P was successfully implemented in general practices. Adherence to medication was very high making improvements hardly detectable.

Trial registration number ISRCTN77300204; Results.

  • primary care
  • diabetes mellitus, Type 2
  • decision support techniques
  • patient education as topic
  • health educators
  • health knowledge, attitudes, practice

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  • Contributors The study was carried out in collaboration between all authors. SB and IM designed the study. SB and KL designed and tested the provider training. SB, NK and UAM were involved in the planning, coordination and management of data acquisition at the study sites (primary care practices). TL did the statistical planning and analyses of the study. SB and IM wrote the first draft of the manuscript. NK, KL and UAM contributed to the draft of the manuscript. All authors critically revised the manuscript and approved the final version. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

  • Funding This study was funded by the European Foundation for the Study of Diabetes (EFSD) on behalf of the European Association for the Study of Diabetes (EASD). NK’s salary has been partly financed by the non-profit association “Diabeteszentrum Thüringen e.V.” (Diabetes Centre Thuringia).

  • Disclaimer The EFSD and the Diabetes Centre Thuringia had no role in the design of the study, collection, analysis and interpretation of data, and preparation and approval of the manuscript.

  • Competing interests NK reports grant from the Diabetes Centre Thuringia during the conduct of the study.

  • Patient consent Obtained.

  • Ethics approval The study protocol was approved by the ethics committee of the Medical Association of Thuringia in April 2014 (ref: 29739/2014/31).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The corresponding author can be contacted to forward request for data sharing.

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