Article Text

Download PDFPDF

Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website
  1. Paul Wallace1,
  2. Pierliugi Struzzo2,3,4,
  3. Roberto Della Vedova3,
  4. Francesca Scafuri2,
  5. Costanza Tersar4,
  6. Charilaos Lygidakis5,
  7. Richard McGregor6,
  8. Emanuele Scafato7,
  9. Rachael Hunter2,
  10. Nick Freemantle2
  1. 1 Department of Primary Care and Population Health, University College London, London, UK
  2. 2 Regional Centre for Training in Primary Care, Monfalcone, Italy
  3. 3 Centro Studi e Ricerca Medicina Generale, Udine, Italy
  4. 4 Department of Life Sciences, University of Trieste, Trieste, Italy
  5. 5 Research Unit INSIDE, Institute for Health and Behaviour, University of Luxembourg, Luxembourg City, Luxembourg
  6. 6 Codeface Ltd, Hove, UK
  7. 7 WHO Collaborating Centre for Research and Health Promotion on Alcohol and Alcohol-Related Health Problems, Istituto Superiore di Sanita, Roma, Lazio, Italy
  1. Correspondence to Dr Nick Freemantle; nicholas.freemantle{at}ucl.ac.uk

Abstract

Background Brief interventions (BIs) delivered in primary care have been shown to be effective in reducing risky drinking, but implementation is limited. Facilitated access to a digital application offers a novel alternative to face-to-face intervention, but its relative effectiveness is unknown.

Methods Primary care-based, non-inferiority, randomised controlled trial comparing general practitioner (GP) facilitated access to an interactive alcohol reduction website (FA) with face-to-face BI for risky drinking. Patients screening positive on the short Alcohol Use Disorders Identification Test (AUDIT-C) were invited to participate in the trial. Assessment at baseline, 3 months and 12 months was carried out using AUDIT and EQ-5D-5L questionnaires.

Findings 58 participating GPs approached 9080 patients of whom 4529 (49.9%) logged on, 3841 (84.8%) undertook screening, 822 (21.4%) screened positive and 763 (19·9%) were recruited. 347 (45.5%) were allocated to FA and 416 (54.5%) to BI. At 3 months, subjects in FA group with an AUDIT score of ≥8 reduced from 95 (27.5%) to 85 (26.8%) while those in BI group increased from 123 (20.6%) to 141 (37%). Differences between groups were principally due to responses to AUDIT question 10. Analysis of primary outcome indicated non-inferiority of FA compared with BI, and prespecified subgroup analysis indicated benefits for older patients and those with higher levels of computer literacy and lower baseline severity. Additional analyses undertaken to take account of bias in response to AUDIT question 10 failed to support non-inferiority within the prespecified 10% boundary.

Interpretation Prespecified protocol-driven analyses of the trial indicate that FA is non-inferior to BI; however, identified bias in the outcome measure and further supportive analyses question the robustness of this finding. It is therefore not possible to draw firm conclusions from this trial, and further research is needed to determine whether the findings can be replicated using more robust outcome measures.

Trial registration number NCT01638338; Results.

  • Mental health
  • Health informatics
  • Public health

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

View Full Text

Statistics from Altmetric.com

Footnotes

  • Contributors PW, PS and RDV conceived the study and together with NF developed the design. PS, PW, RDV, CT, CL and RMG were responsible for the development of the website, and PW, PS, FS, RDV, CT were responsible for the management of the study and follow-up of patients. NF was responsible for statistical analyses and RH for the health economic analyses. PW, PS and NF wrote the first draft and RH, PW, PS and NF contributed to its revision. ES participated in the management of the study and contributed to the review of the manuscript and its final approval, together with all the other authors.

  • Funding This study was jointly supported by the Italian Ministry of Health and by the regional school for the training in Primary Care of the Region Friuli-Venezia Giulia, Italy (grant number: D25E12002900003). The funders had no direct influence over the design or conduct of the study.

  • 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 co-founder and chief executive officer at Lumos Medica Srl, which provides software solutions for clinical trials. The other authors declare no competing interests.

  • Patient consent No personal medical information about an identifiable living individual is included in this paper.

  • Ethics approval Isontina Independent Local Ethics Committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Anonymised trial data is held on secure servers at University College London. To access the data, please contact the corresponding author, supplying study protocol and approval.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.