Internet delivery of a multi-centre randomised controlled trial in general practice.
Conducting trials in general practice is time consuming and costly, and achieving the required numbers of recruits frequently challenging. The internet offers a potential solution to this, but while it is increasingly used to collect information from patients recruited to trials, there has only been limited experience of its use to deliver the complete trial process from screening to randomisation to intervention and follow-up.
We have designed and conducted an online non-inferiority randomised controlled trial of facilitated access by GPs to an internet based package to deliver screening and brief intervention for alcohol problems in general practice. Other than the initial brief discussion to encourage the patient to access the online package, the entire conduct of the trial was conducted via the internet, including screening, consent, baseline assessment, randomisation and follow-up. The experimental intervention was also delivered via the internet while the control intervention was face to face.
A total of 47 general practitioners in the Northern Italian region of Friuli-Venezia Giulia recruited 674 patients to the trial in a period of 7 months. More than 50% (n= 3974) of the patients who received facilitated access went on to log on to the website and undertake screening using the AUDIT-C questionnaire. Just under 20% (n = 718) screened positive and 94% (n= 674) of these completed the baseline questionnaires and were randomised (n= 674). Of the 310 patients randomised to the experimental internet intervention, 90% (n = 278) logged on to the site. Of the 364 patients randomised to face to face intervention, 263 (72%) were seen by their GP. A follow-up rate of 94% was achieved at 3 months.
To our knowledge, this is one of the first general practice trials to be reported where the internet has been used to enable all aspects of delivery from recruitment to intervention and follow up. This trial design resulted in high levels of performance at all stages and while further research is needed, these findings suggest that this approach to research delivery in general practice could be more widely implemented.
- Paul Wallace, Regional Centre for Primary Care Training, Udine, Italy
- Piero Struzzo, Regional Centre for Primary Care Training, Udine, Italy
- Nicholas Freemantle, Regional Centre for Primary Care Training, Udine, Italy
- Roberto Della Vedova, University of Trieste, Trieste, Italy
- Costanza Tersar, University of Trieste, Trieste, Italy
- Harris Lygidakis, University of Trieste, Trieste, Italy
- Francesca Tarfuri, CSeRMEG Centro studi e Ricerche in Medicina Generale, Monza, Italy
- Donatella Ferrante
- Francesco Marcatto