Cluster‐randomized trial to improve the quality of diabetes management: The study for the efficacy assessment of the standard diabetes manual (SEAS‐DM)

Aims/Introduction ‘The Standard Diabetes Manual’ has been developed by clinical researchers from multiple major institutions in Japan, such as the National Center for Global Health and Medicine, as a comprehensive disease management program, including collaboration between primary care physicians ( PCP s) and specialist services. The present study evaluated the efficacy of the manual as a quality improvement strategy in diabetes care by PCP s. Materials and Methods A total of 42 PCP s in eight domestic districts of the Japan Medical Association were allocated to either the intervention group or the control group in a cluster‐randomized design. The PCP s in both groups were provided with a copy of the Diabetes Treatment Guide published by the Japan Diabetes Society, and the PCP s in the intervention group additionally received a copy of the manual and a 30‐min relevant seminar at the inception of the intervention. The primary end‐point was the adherence to the following performances as quality indicators: evaluation of retinopathy, and urinary albumin excretion measurements and serum creatinine measurements, as recommended by the Japan Medical Association. Results A total of 416 patients were enrolled by 36 PCP s. During the 1‐year follow‐up period, the proportion of PCP s who adhered to recommendation‐concordant measurements of urinary albumin excretion was significantly higher in the intervention group than in the control group (adherence: 17.9% vs 5.3%, P = 0.016). The other parameters were not statistically different between the two groups. Conclusions Implementation of ‘The Standard Diabetes Manual’ potentially leads to an improved quality of diabetes management by PCP s.