Kusajili – Centralise les essais cliniques mondiaux

Primary Care-based Facilitated Access to a Web Based Brief Intervention to Reduce Alcohol Consumption Brief Interventions (BIs) for risky drinkers are an effective tool in primary care. Lack of time in daily practice has been identified as a barrier for the wide implementation of BI. There is growing evidence that e-health tools such as web based BIs can be an efficient alternative to standard face-to-face BIs and save time to general practitioners (GP). The main aim of this study is to test non-inferiority of a web based BI for risky drinkers against a traditional face to face BI delivered by a general practitioner. We have designed a randomised controlled non-inferiority trial comparing both interventions, to be performed in primary care health centres in Catalonia, Spain. Adults attending in primary care centres and willing to participate, will be invited to fill the short Alcohol Use Disorders Identification Test (AUDIT-C) in a specific website. Those screening positive and who accept to share the baseline data with their GP will be invited to an online assessment of their drinking and randomized to a standard BI with their GP or to the online BI. Follow-up assessment will be conducted online at months 3 and 12, using the full Alcohol Use Disorder Identification Test (AUDIT) and the quality of life questionnaire (D5-EQD5). The main outcome will be the proportion of risky drinkers according to the AUDIT. Assuming a 30% reduction in the proportion of risky drinkers in the control group (classroom), allowing for an overall attrition of 10% of patients in the trial and non-inferiority assessed against a specified margin of 10%, it is estimated that 500 patients would be required in each group to give the test a 90% power (1-β) to reject the null hypothesis.

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