[Effects of government supervision on quality of integrated diabetes care: a cluster randomized controlled trial].

Objectives: The quality of integrated diabetes care is important for reducing the burden of diabetes. Therefore, we have evaluated the effect of a supervision program on the quality of integrated diabetes care in the Netherlands in the 2011-2012 period.

Methods: In this cluster RCT, the supervision program was assigned to randomly selected care groups providing care to diabetes patients. The supervision program included announcements of inspections, site visits, and sending individualized reports. Indicators of effectiveness were derived from the structures, processes, and outcomes of care. These indicators were collected from patients' files, before and after the supervision program. Hierarchical linear and logistic regression models were used to analyze data from 356 patients of 10 intervention and 8 control care groups.

Results: Structures and processes of care did not improve more in the intervention groups than in the control care groups. Moreover, health outcomes did not improve more in the intervention groups than in the control care groups. Although structures of care improved over time in the total population of intervention and control care groups, there were no changes in process of care or health outcomes.

Conclusions: In this cluster RCT, we could not demonstrate improvements in quality of integrated diabetes care resulting from the supervision program. Although structures of care did improve over time, other quality-improvement initiatives are necessary to substantially strengthen integrated care for diabetes patients.