Effect of a Community-Based Program to Accelerate Referral to Physicians for Individuals at High-Risk of Lifestyle-Related Diseases: A Cluster Randomized Trial

Aim: A cluster randomized trial was conducted within 41 Japanese municipalities (21 intervention and 22 usual care) to examine whether the standardized health counseling for individuals at high cardiovascular risk screened at community sites accelerates clinic visits to strengthen the primary health care system. Methods: Among high-risk individuals aged 40–74 years screened by health checkups, 8,977 and 6,733 were allocated to the intervention and usual care groups, respectively, who were not under medical treatment but had high levels of blood pressure (systolic/diastolic ≥ 160/100 mmHg), hemoglobin A1c or glucose (≥ 7.0% or corresponding glucose levels), LDL-cholesterol (≥ 180 mg/dL for men), and/or proteinuria of ≥ 2+. The intervention was performed from May 2014 to March 2016 under a standardized health counseling program based on the health belief model primarily by public health nurses. The usual care group was provided with local counseling protocols. Results: The cumulative proportions of clinic visits for 12 months after health checkups were 58.1% (95% confidence interval, 57.0%, 59.3%) versus 44.5% (43.2%, 45.8%), with the probability ratio of clinic visits between the groups being 1.46 (1.24, 1.72). The between-group differences between the baseline and 1-year surveys were −1.50 (−2.59, −0.41) mmHg for diastolic blood pressure in the hypertension category, −0.30% (−0.53%, −0.07%) for HbA1c in the diabetes category, −0.37 (−0.48, −0.27) mmol/L for LDL-cholesterol in the dyslipidemia category, and none for proteinuria. Conclusion: Standardized health counseling for high-risk individuals accelerated clinic visits, with larger reductions in blood pressure, HbA1c, and LDL-cholesterol levels. The nationwide use of counseling after health checkups for high-risk individuals could help in controlling risk factors and in preventing lifestyle-related diseases.