Objectives 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).
Design Randomised 1:1 non-inferiority trial.
Setting Practices of 58 general practitioners (GPs) in Italy.
Participants Of 9080 patients (>18 years old) approached to take part in the trial, 4529 (49·9%) logged on to the website and 3841 (84.8%) undertook online screening for hazardous drinking. 822 (21.4%) screened positive and 763 (19.9%) were recruited to the trial.
Interventions Patients were randomised to receive either a face-to-face BI or access via a brochure from their GP to an alcohol reduction website (facilitated access).
Primary and secondary outcome measures The primary outcome is the cost per QALY gained of facilitated access compared with face-to-face. A secondary analysis includes total costs and benefits per 100 patients, including number of hazardous drinkers prevented at 12 months.
Results The average time required for the face-to-face BI was 8 min (95% CI 7.5 min to 8.6 min). Given the maximum time taken for facilitated access of 5 min, face-to-face is an additional 3 min: equivalent to having time for another GP appointment for every three patients referred to the website. Complete case analysis adjusting for baseline the difference in QALYs for facilitated access is 0.002 QALYs per patient (95% CI −0.007 to 0.011).
Conclusions Facilitated access to a website to reduce hazardous drinking costs less than a face-to-face BI given by a GP with no worse outcomes. The lower cost of facilitated access, particularly in regards to investment of time, may facilitate the increase in provision of BIs for hazardous drinking.
Trial registration number NCT01638338; Post-results.
- health economics
- substance misuse
- information technology
- world wide web technology
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Contributors PW, PS and RDV: conceived the study and together with NF developed the design. PS, PW, RDV, CT, CL and RMcG: were responsible for the development of the website. PS, FS, RDV and CT: were responsible for follow-up of patients. RH: was responsible for the analysis and wrote the first draft. All authors: contributed to its revision and final approval.
Funding The study was jointly supported by the Italian Ministry of Health and by the Region Friuli-Venezia Giulia, Italy (grant number: D25E12002900003). The funders had no role in the conception, preparation, review, approval, or submission of this manuscript. We thank Dr Alaman Allamani for chairing of the Trial Steering Committee.
Competing interests PW has intellectual property rights for www.downyourdrink.org.uk, is Chief Medical Advisor to the UK charity Drinkaware and has provided private consultancy on the topic of screening and brief interventions to several agencies. CL is the cofounder and Chief Executive Officer at Lumos Medica Srl, which provides software solutions for clinical trials. The other authors declare no competing interests.
Ethics approval Ethical Committee of the Azienda Sanitaria 4 Medio Friuli, Udine, IT. The protocol was approved on 14 June 2012 by the Independent Local Ethics Committee for Clinical Research of the Health Services Agency No 2 Isontina, Italy.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Anonymised trial data are held on secure servers at University College London. For access to the data please contact the corresponding author. Access will be granted subject to approval by the steering committee.
Collaborators The EFAR Study Team include Giosué Acampora, Maria Angela Bravo, Chiara Bregant, Gianna Bunello, Leonardo Butà, Lucia Casatta, Castellarin, Egidio Chamouni, Moshé Benyamin, Maria Pia Cisilin, Clemente Condello, Nelly Drigani, Tiziano Ermacora, Alessandro Falcidia, Adriana Fasiolo, Angelo Florio, Mauro Gubiani, Gianni Iacuzzo, Edi Ietri, Giuseppe Latella, Guglielmo Lucca, Ciro Mamolo, Carmelo Matera, Lucia Mei, Francesca Melon, Emilio Mezzasalma, Isabella Milan, Carlo Miotti, Gian Franco Panizzo, Francesca Pighin, Raffaela Principato, Pierina Revignas, Antonella Rolff, Ivana Rupalti, Rosanna Sellibara, Michela Sereni, Gianfranco Silverii, Giuseppe Taglialatela, Chiara Toffoletti, Massimo Toffolo, Laura Ivana Tonelli, Simone Trevisani, Roberto Troisi, Gianni Tubaro, Roberto Vallini, Elisabetta Zappalà and Antonio Zappi.