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At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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BMC Primary Care
Published in: BMC Primary Care 1/2021

Open Access 01-12-2021 | Care | Research article

Shared decision making and patient-centeredness for patients with poorly controlled type 2 diabetes mellitus in primary care—results of the cluster-randomised controlled DEBATE trial

Authors: Anja Wollny, Christin Löffler, Eva Drewelow, Attila Altiner, Christian Helbig, Anne Daubmann, Karl Wegscheider, Susanne Löscher, Michael Pentzek, Stefan Wilm, Gregor Feldmeier, Sara Santos

Published in: BMC Primary Care | Issue 1/2021

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Abstract

Background

We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus?

Methods

We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline.

Results

Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups.

Conclusions

The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness.

Trial registration

The trial was registered on March 10th, 2011 at ISRCTN registry under the reference ISRCTN70713571.
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Metadata
Title
Shared decision making and patient-centeredness for patients with poorly controlled type 2 diabetes mellitus in primary care—results of the cluster-randomised controlled DEBATE trial
Authors
Anja Wollny
Christin Löffler
Eva Drewelow
Attila Altiner
Christian Helbig
Anne Daubmann
Karl Wegscheider
Susanne Löscher
Michael Pentzek
Stefan Wilm
Gregor Feldmeier
Sara Santos
Publication date
01-12-2021
Publisher
BioMed Central
Published in
BMC Primary Care / Issue 1/2021
Electronic ISSN: 2731-4553
DOI
https://doi.org/10.1186/s12875-021-01436-6

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