Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website: cost-effectiveness analysis

To evaluate the 12-month costs and quality-adjusted life years (QALYs) gained to the Italian National Health Service of facilitated access to a website for hazardous drinkers compared with a standard face-to-face brief intervention (BI)

Randomised controlled non-inferiority trial of primary care based facilitated access to an alcohol reduction website (EFAR-FVG)

Introduction There is a strong body of evidence demonstrating effectiveness of brief interventions by primary care professionals for risky drinkers but implementation levels remain low. Facilitated access to an alcohol reduction website constitutes an innovative approach to brief intervention, offering a time-saving alternative to face to face intervention, but it is not known whether it is as effective. Objective To determine whether facilitated access to an alcohol reduction website is equivalent to face to face intervention. Methods Randomised controlled non-inferiority trial for risky drinkers comparing facilitated access to a dedicated website with face to face brief intervention conducted in primary care settings in the Region of Friuli Venezia-Giulia, Italy. Adult patients are given a leaflet inviting them to log on to a website to complete the AUDIT-C alcohol screening questionnaire. Screen positives are requested to complete an online trial module including consent, baseline assessment and randomisation to either standard intervention by the practitioner or facilitated access to an alcohol reduction website. Follow up assessment of risky drinking is undertaken online at 1 month, 3 months and 1 year using the full AUDIT questionnaire. Proportions of risky drinkers in each group will be calculated and non-inferiority assessed against a specified margin of 10%. The trial is being undertaken as an initial pilot and a subsequent main trial. Results 12 practices have participated in the pilot, and more than 1300 leaflets have been distributed. 89 patients have been recruited to the trial with a one month follow-up rate of 79%. Discussion The findings of the pilot study suggest that the trial design is feasible, though modifications will be made to optimize performance in the main trial which will commence in January 2014. Plans are concurrently underway to replicate the trial in Australia, and potentially in the UK and Spain

A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR-FVG): the study protocol.

INTRODUCTION: There is a strong body of evidence demonstrating the effectiveness of brief interventions by primary care professionals for risky drinkers. However, implementation levels remain low because of time constraints and other factors. Facilitated access to an alcohol reduction website offers primary care professionals a time-saving alternative to standard face-to-face intervention, but it is not known whether it is as effective. METHODS AND ANALYSIS: A randomised controlled non-inferiority trial for risky drinkers comparing facilitated access to a dedicated website with standard face-to-face brief intervention to be conducted in primary care settings in the Region of Friuli Giulia Venezia, Italy. Adult patients will be given a leaflet inviting them to log on to a website to complete the Alcohol Use Disorders Identification Test (AUDIT-C) alcohol screening questionnaire. Screen positives will be requested to complete an online trial module including consent, baseline assessment and randomisation to either standard intervention by the practitioner or facilitated access to an alcohol reduction website. Follow-up assessment of risky drinking will be undertaken online at 1 month, 3 months and 1 year using the full AUDIT questionnaire. Proportions of risky drinkers in each group will be calculated and non-inferiority assessed against a specified margin of 10%. Assuming a reduction of 30% of risky drinkers receiving standard intervention, 1000 patients will be required to give 90% power to reject the null hypothesis. ETHICS AND DISSEMINATION: The protocol was approved by the Isontina Independent Local Ethics Committee on 14 June 2012. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and public events involving the local administrations of the towns where the trial participants are resident. REGISTRATION DETAILS: Trial registration number NCT: 01638338