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

Abstract

IntroductionThere 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 analysisA 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 disseminationThe 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 detailsTrial registration number NCT: 01638338.

Internet Applications for Screening and Brief Interventions for Alcohol in Primary Care Settings – Implementation and Sustainability

“…The EFAR studies form part of a multi-country initiative involving a series of randomized controlled non-inferiority trials of primary care based facilitated access to an alcohol reduction website, which are at various stages of development in Italy, Spain, Australia, and the UK. The EFAR-FVG trial is being undertaken in general practices in the Friuli Venezia Giulia Region of Italy and is the first in the series ( 24 ). EFAR-FVG compares delivery by GPs of facilitated access to a dedicated website for risky drinkers with standard face-to-face brief intervention.…”

“…Research on referral of patients by health care professionals to Internet applications for screening and brief interventions for alcohol (eSBI) is still in its infancy, with early studies having been undertaken in Sweden and the UK, and a number of further studies currently underway. These include the ODHIN trial taking place in general practice settings in five European countries, and the EFAR trials, currently in progress in northern Italy and in the planning stages in Spain, Australia, and the UK ( 23 , 24 ). This paper considers the development of eSBI for delivery in health care settings and the evidence emerging from studies on implementation and uptake, and assesses the implications for the role of eSBI in the future delivery of screening and brief interventions in primary care.…”

Validation of the AUDIT-C in adults seeking help with their drinking online

“…There is also some evidence that being self-administered, online screening is likely to generate more honest reporting of risky alcohol use, in comparison with a face-to-face interview [27, 28]. The AUDIT-C has been used to screen for eligibility in two trials of web-based alcohol screening and brief intervention delivered to students in New Zealand (≥4 for men and women) [29, 30] and two trials of facilitated access to an online intervention delivered in primary care in Italy and Spain (≥5 for men and ≥4 women) [31, 32]. These trials did not validate the AUDIT-C for use online, and were not conducted in general population samples.…”

Brief interventions for alcohol misuse

“…31 Review drinking practices; and the complex social, cultural and moral context concerning what constitutes problematic drinking. 33 Time constraints may be ameliorated by the emergence of digitally mediated screening and delivery of brief interventions through the Internet or mobile devices, 34 but these are still new and do not yet have a large body of evidence supporting their effectiveness.…”