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
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
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.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.