Effects of a patient oriented decision aid for prioritising treatment goals in diabetes: pragmatic randomised controlled trialBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5651 (Published 25 September 2014) Cite this as: BMJ 2014;349:g5651
- Petra Denig, professor of drug utilisation quality12,
- Jan Schuling, general practitioner trainer2,
- Flora Haaijer-Ruskamp, professor in drug utilisation studies12,
- Jaco Voorham, assistant professor clinical pharmacology12
- 1Clinical Pharmacy and Pharmacology, University Medical Center Groningen, PO Box 30.001, Groningen, Netherlands
- 2University of Groningen, University Medical Center Groningen, Groningen, Netherlands
- Correspondence to: P Denig
- Accepted 28 August 2014
Objective To assess the effects of a patient oriented decision aid for prioritising treatment goals in diabetes compared with usual care on patient empowerment and treatment decisions.
Design Pragmatic randomised controlled trial.
Setting 18 general practices in the north of the Netherlands.
Participants 344 patients with type 2 diabetes aged ≤65 years at the time of diagnosis and managed in primary care between April 2011 and August 2012: 225 were allocated to the intervention group and 119 to the usual care group.
Intervention The intervention comprised a decision aid for people with diabetes, with individually tailored risk information and treatment options for multiple risk factors. The aid was intended to empower patients to prioritise between clinical domains and to support treatment decisions. It was offered to participants before a regular diabetes check-up and to their healthcare provider during the consultation. Four different formats of the decision aid were included for additional explorative analyses.
Main outcome measures The primary outcome was the effects on patient empowerment for setting and achieving goals. The secondary outcomes were changes in the prescribing of drugs to regulate glucose, blood pressure, lipids, and albuminuria. Data were collected through structured questionnaires and automated data extraction from electronic health records during six months before and after the intervention.
Results Of all intervention participants, 103 (46%) reported to have received the basic elements of the intervention. For the primary outcome analysis, 199 intervention and 107 control patients with sufficient baseline and follow-up data could be included. The mean empowerment score increased 0.1 on a 5 point scale in the overall intervention group, which was not significantly different from that of the control group (mean difference after adjusting for baseline 0.039, 95% confidence interval −0.056 to 0.134). Lipid regulating drug treatment was intensified in 25% of intervention and 12% of control participants with increased cholesterol levels, which did not reach significance when the intervention was compared with the usual care group (odds ratio 2.54, 95% confidence interval 0.89 to 7.23). Prespecified explorative analyses showed that this effect was significant for the printed version of the decision aid in comparison to usual care (3.90, 1.29 to 11.80). No relevant or significant changes were seen for other treatments.
Conclusion We found no evidence that the patient oriented treatment decision aid improves patient empowerment by an important amount. The aid was not used to its full extent in a substantial number of participants.
Trial registration Dutch trial register NTR1942.
Contributors: PD, FH-R, and JV designed the study and formulated the research questions. PD, JS, and JV developed and tested the decision aid. All authors researched and interpreted the data. PD drafted the manuscript. FH-R, JS, and JV critically revised and edited the manuscript: All authors read and approved the final manuscript. The funders had no role in the study design, the data collection, analysis and interpretation, the writing of the report, nor the decision to submit the article for publication. All authors had full access to all of the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. PD is the guarantor of this study.
Funding: This study has been funded by ZonMW—the Netherlands Organisation for Health Research and Development.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by the medical ethics committee of the University Medical Center Groningen (ABR No NL 29042.042.09).
Data sharing: Patient level data are stored within the GIANTT database at the University Medical Centre Groningen. Research team members have been granted access to the required data by the GIANTT steering committee. Presented data are anonymised and risk of identification is low. No consent for data sharing with other parties was obtained but the corresponding author may be contacted to forward requests for data sharing.
Transparency: The lead author (PD) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported. No important aspects of the study have been omitted.
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