Effects of a patient oriented decision aid for prioritising treatment goals in diabetes: pragmatic randomised controlled trial.

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.