title: A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain): the study protocol.
abstract: BACKGROUND
  Early identification (EI) and brief interventions (BIs) for risky drinkers are effective tools in primary care. Lack of time in daily practice has been identified as one of the main barriers to implementation of BI. There is growing evidence that facilitated access by primary healthcare professionals (PHCPs) to a web-based BI can be a time-saving alternative to standard face-to-face BIs, but there is as yet no evidence about the effectiveness of this approach relative to conventional BI. The main aim of this study is to test non-inferiority of facilitation to a web-based BI for risky drinkers delivered by PHCP against face-to-face BI.
  
  
  METHODS
  A randomised controlled non-inferiority trial comparing both interventions will be performed in primary care health centres in Catalonia, Spain. Unselected adult patients attending participating centres 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. Participants with positive results will be requested online to complete a trial module including consent, baseline assessment and randomisation to either face-to-face BI by the practitioner or BI via the alcohol reduction website. Follow-up assessment of risky drinking will be undertaken online at 3 months and 1 year using the full AUDIT and D5-EQD5 scale. Proportions of risky drinkers in each group will be calculated and non-inferiority assessed against a specified margin of 10%. Assuming reduction of 30% of risky drinkers receiving standard intervention, 1000 patients will be required to give 90% power to reject the null hypothesis.
  
  
  BACKGROUND
  The protocol was approved by the Ethics Commmittee of IDIAP Jordi Gol i Gurina P14/028. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02082990.
authors.affiliation: GRAC, Addictions Unit, Department of Psychiatry, Clinical Institute of Neuroscience, Hospital Clínic, Fundació Clínic Recerca Biomèdica (FCRB), RETICS, University of Barcelona, Barcelona, Spain.
authors.forename: Hugo
authors.initials: H
authors.lastname: López-Pelayo
authors.affiliation: Department of Primary Care and Population Health, University College London, London, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Wallace
authors.affiliation: Program on Substance Abuse, Public Health Agency, Government of Catalonia, Barcelona, Spain.
authors.forename: Lidia
authors.initials: L
authors.lastname: Segura
authors.affiliation: GRAC, Addictions Unit, Department of Psychiatry, Clinical Institute of Neuroscience, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), RETICS, University of Barcelona, Barcelona, Spain.
authors.forename: Laia
authors.initials: L
authors.lastname: Miquel
authors.affiliation: Program on Substance Abuse, Public Health Agency, Government of Catalonia, Barcelona, Spain.
authors.forename: Estela
authors.initials: E
authors.lastname: Díaz
authors.affiliation: GRAC, Addictions Unit, Department of Psychiatry, Clinical Institute of Neuroscience, Hospital Clínic, Fundació Clínic Recerca Biomèdica (FCRB), RETICS, University of Barcelona, Barcelona, Spain.
authors.forename: Lidia
authors.initials: L
authors.lastname: Teixidó
authors.affiliation: Program on Substance Abuse, Public Health Agency, Government of Catalonia, Barcelona, Spain.
authors.forename: Begoña
authors.initials: B
authors.lastname: Baena
authors.affiliation: Region Friuli Venezia Giulia, Regional Centre for the Training in Primary Care, Monfalcone, Italy.
authors.forename: Pierliugio
authors.initials: P
authors.lastname: Struzzo
authors.affiliation: Program on Substance Abuse, Public Health Agency, Government of Catalonia, Barcelona, Spain.
authors.forename: Jorge
authors.initials: J
authors.lastname: Palacio-Vieira
authors.affiliation: GRAC, Addictions Unit, Department of Psychiatry, Clinical Institute of Neuroscience, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), RETICS, University of Barcelona, Barcelona, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Casajuana
authors.affiliation: Program on Substance Abuse, Public Health Agency, Government of Catalonia, Barcelona, Spain.
authors.forename: Joan
authors.initials: J
authors.lastname: Colom
authors.affiliation: GRAC, Addictions Unit, Department of Psychiatry, Clinical Institute of Neuroscience, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), RETICS, University of Barcelona, Barcelona, Spain.
authors.forename: Antoni
authors.initials: A
authors.lastname: Gual
mesh_terms: D000328:Adult; D000428:Alcohol Drinking / Q000517:prevention & control*; D000437:Alcoholism / Q000175:diagnosis*; D002985:Clinical Protocols; D005260:Female; D006297:Health Services Accessibility; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care / Q000458:organization & administration*; D013030:Spain; D055815:Young Adult