Patient-centered communication and shared decision making to reduce HbA1c levels of patients with poorly controlled type 2 diabetes mellitus - results of the cluster-randomized controlled DEBATE trial

Abstract

Background Does an intervention designed to foster patient-centered communication and shared decision making among GPs and their patients with poorly controlled type 2 diabetes mellitus reduce the level of HbA1c. Methods The DEBATE trial is a cluster-randomized controlled trial conducted in German primary care and including patients with type 2 diabetes mellitus having an HbA1c level of 8.0% (64 mmol/mol) or above at the time of recruitment. Data was measured before intervention (baseline, T0), 6–8 months (T1), 12–14 months (T2), 18–20 months (T3), and 24–26 months (T4) after baseline. Main outcome measure is the level of HbA1c. Results In both, the intervention and the control group the decline of the HbA1c level from T0 to T4 was statistically significant (− 0.67% (95% CI: − 0.80,-0.54%; p < 0.0001) and − 0.64% (95% CI: − 0.78, − 0.51%; p < 0.0001), respectively). However, there was no statistically significant difference between both groups. Conclusions Although the DEBATE trial was not able to confirm effectiveness of the intervention tested compared to care as usual, the results suggest that patients with poorly controlled type 2 diabetes are able to improve their blood glucose levels. This finding may encourage physicians to stay on task to regularly approach this cohort of patients. Trial registration The trial was registered at ISRCTN registry under the reference ISRCTN70713571 . Electronic supplementary material The online version of this article (10.1186/s12875-019-0977-9) contains supplementary material, which is available to authorized users.

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

“…The effect, however, was not significantly different between both groups. Results are published elsewhere [ 26 ].…”

“…Primary outcome was the change of HbA1c level from T0 to T4, which was statistically significant within each group, but not between groups. Results have been published elsewhere [ 26 ].…”

“…Members of the study team collected data by phone at the different points of measurements. Detailed information on data collection procedures was published elsewhere [ 26 , 27 ].…”

Reduction of potentially inappropriate medication in the elderly: design of a cluster-randomised controlled trial in German primary care practices (RIME)

“…Practitioners and practice staff not able to attend the training event at any of the alternative dates suggested, will be offered training in their practice by qualified and experienced GPs of the study team, that is ‘training by peers’. 28,29…”

“…Practitioners and practice staff not able to attend the training event at any of the alternative dates suggested, will be offered training in their practice by qualified and experienced GPs of the study team, that is 'training by peers'. 28,29 Physicians from the subgroup of the experimental intervention, in which both physicians and their practice staff are involved, also attend the above mentioned professional training event. Yet the training of the practice teams will always be in their respective practices.…”