Effectiveness of screening and ultra-brief intervention for hazardous drinking in primary care: pragmatic cluster randomised controlled trial

To evaluate the effectiveness of a doctor delivered screening and ultra-brief intervention (<1 minute) compared with simplified assessment only for reducing alcohol intake among patients with hazardous drinking in primary care. Pragmatic cluster randomised controlled trial. 40 primary care clinics in Japan that did not provide routine screening and brief intervention for hazardous drinking or treatment or self-help groups for alcohol dependency. 1133 outpatients aged 20-74 years with hazardous drinking (AUDIT-C (alcohol use disorders identification test-consumption) scores ≥5 for men and ≥4 for women). Clinic clusters were allocated to a study arm using a computer generated random sequence. Participants and staff who collected participant reported outcomes remained blinded to assignment. Primary care clinics were randomised to ultra-brief intervention (21 clinics, 531 patients) or simplified assessment only (19 clinics, 602 patients) groups. The intervention group comprised screening with AUDIT-C followed by brief oral advice and an alcohol information leaflet delivered in <1 minute. The control group comprised simplified assessment with AUDIT-C only. The primary outcome was total alcohol consumption in the four weeks preceding the 24 week follow-up. Secondary outcomes included total alcohol consumption in the four weeks preceding the 12 week follow-up, and readiness to change drinking behaviour, measured at 12 and 24 weeks. At 24 weeks, the difference in total alcohol consumption between the ultra-brief intervention group (1046.9 g/4 weeks (g/4wk), 95% confidence interval (CI) 918.3 to 1175.4) and control group (1019.0 g/4wk, 893.5 to 1144.6) was 27.8 g/4wk (-149.7 to 205.4, P=0.75), with a Hedges' g of 0.02 (95% CI -0.10 to 0.14). At 12 weeks, the difference in total alcohol consumption between the intervention group (1034.1 g/4wk, 919.6 to 1148.7) and control group (979.3 g/4wk, 866.1 to 1092.4) was 54.9 g/4wk (-104.1 to 213.9, P=0.49), with a Hedges' g of 0.04 (-0.08 to 0.16). This trial found no evidence to support the effectiveness of a doctor delivered ultra-brief intervention for hazardous drinking compared with simplified assessment only in primary care in Japan. UMIN Clinical Trials Registry UMIN000051388.