Effectiveness of screening and ultra-brief alcohol intervention in primary care: a pragmatic cluster randomised controlled trial

Objective To evaluate the effectiveness of screening and ultra-brief intervention (Ultra-BI) delivered by primary care physicians in less than 1 minute compared to simplified assessment only (SAO) for reducing alcohol consumption among patients with hazardous drinking. Design Pragmatic, cluster randomised, parallel-group, superiority trial. We used a computer-generated random sequence to allocate clusters. Only participants and personnel who collected participant-reported outcomes remained blinded. Setting 40 primary care clinics in Japan, which did not provide routine screening and brief intervention for hazardous drinking, treatment, or self-help groups for alcohol dependence. Participants 1,133 outpatients aged 20-74 years with hazardous drinking (scores of Alcohol Use Disorders Identification Test-Consumption [AUDIT-C] ≥5 for men and ≥4 for women). Patients who were pregnant or suspected of having COVID-19-like symptoms were excluded. Interventions Clusters were randomised to Ultra-BI (21 clusters, n=531) or SAO (19 clusters, n=602) groups. Ultra-BI comprised screening with AUDIT, brief oral advice, and an alcohol information leaflet. SAO involved only simplified assessment with AUDIT-C. Main outcome measures The primary outcome was total alcohol consumption in the preceding 4 weeks (TAC) at 24 weeks post-randomisation. Secondary outcomes included TAC at 12 weeks and readiness to change drinking habits at 12 and 24 weeks. Results At 24 weeks, the difference in TAC between Ultra-BI (1046.9g/4 weeks, 95% confidence interval [CI] 918.3-1175.4) and SAO (1019.0g/4 weeks, 95% CI 893.5-1144.6) groups was 27.8g/4 weeks (95% CI -149.7 to 205.4). Bayes factor analysis (0.08±0.25) strongly supported the null hypothesis for TAC at 24 weeks. Ultra-BI group showed higher readiness to change drinking habits at both 12 (difference 0.30 [95% CI 0.10 to 0.40]; Hedge’s g 0.21 [95% CI 0.10 to 0.33]) and 24 weeks (difference 0.20 [95% CI 0.10 to 0.30]; Hedge’s g 0.16 [95% CI 0.05 to 0.28]). Conclusions This trial did not support the effectiveness of Ultra-BI for alcohol consumption compared to SAO, but did improve readiness to change compared to SAO. These findings call for developing effective, low-cost interventions in primary care settings. Trial registration UMIN000051388 What is already known on this topic Brief interventions (BIs) for hazardous drinking have been widely recommended in primary care settings, but implementation rates remain low due to various barriers. Ultra-brief interventions (Ultra-BIs) have shown mixed results in different settings, with some studies suggesting they can be as effective as longer advice or counselling. No randomised controlled trial has directly investigated the effectiveness of Ultra-BIs over assessment-only control in primary care settings. What this study adds This large-scale pragmatic cluster randomised controlled trial did not support the effectiveness of Ultra-BI on alcohol consumption at 12 and 24 weeks compared to simplified assessment only (SAO) in Japanese primary care settings. Ultra-BI showed higher readiness to change drinking habits at both 12 and 24 weeks compared to SAO, despite not reducing alcohol consumption. These findings challenge current recommendations for screening and brief interventions in primary care and suggest a need for re-evaluation of these practices.