1 research outputs found
A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain): The study protocol
ABSTRACT
Introduction: 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 webbased
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.
Method and analysis: A randomised controlled noninferiority
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.
Ethics and dissemination: 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 presentation