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

ObjectiveTo 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. DesignPragmatic, 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. Setting40 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. Participants1,133 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. InterventionsClusters 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 measuresThe 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. ResultsAt 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]; Hedges g 0.21 [95% CI 0.10 to 0.33]) and 24 weeks (difference 0.20 [95% CI 0.10 to 0.30]; Hedges g 0.16 [95% CI 0.05 to 0.28]). ConclusionsThis 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 registrationUMIN000051388 What is already known on this topicO_LIBrief interventions (BIs) for hazardous drinking have been widely recommended in primary care settings, but implementation rates remain low due to various barriers. C_LIO_LIUltra-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. C_LIO_LINo randomised controlled trial has directly investigated the effectiveness of Ultra-BIs over assessment-only control in primary care settings. C_LI What this study addsO_LIThis 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. C_LIO_LIUltra-BI showed higher readiness to change drinking habits at both 12 and 24 weeks compared to SAO, despite not reducing alcohol consumption. C_LIO_LIThese findings challenge current recommendations for screening and brief interventions in primary care and suggest a need for re-evaluation of these practices. C_LI