Region Friuli Venezia Giulia, Regional Centre for the Training in Primary Care, Monfalcone, Italy.
BMJ Open. 2013 Feb 12;3(2). doi: 10.1136/bmjopen-2012-002304. Print 2013.
There is a strong body of evidence demonstrating the effectiveness of brief interventions by primary care professionals for risky drinkers. However, implementation levels remain low because of time constraints and other factors. Facilitated access to an alcohol reduction website offers primary care professionals a time-saving alternative to standard face-to-face intervention, but it is not known whether it is as effective.
A randomised controlled non-inferiority trial for risky drinkers comparing facilitated access to a dedicated website with standard face-to-face brief intervention to be conducted in primary care settings in the Region of Friuli Giulia Venezia, Italy. Adult patients 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. Screen positives will be requested to complete an online trial module including consent, baseline assessment and randomisation to either standard intervention by the practitioner or facilitated access to an alcohol reduction website. Follow-up assessment of risky drinking will be undertaken online at 1 month, 3 months and 1 year using the full AUDIT questionnaire. Proportions of risky drinkers in each group will be calculated and non-inferiority assessed against a specified margin of 10%. Assuming a reduction of 30% of risky drinkers receiving standard intervention, 1000 patients will be required to give 90% power to reject the null hypothesis.
The protocol was approved by the Isontina Independent Local Ethics Committee on 14 June 2012. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and public events involving the local administrations of the towns where the trial participants are resident.
Trial registration number NCT: 01638338.
有大量证据表明，初级保健专业人员对高危饮酒者进行简短干预非常有效。然而，由于时间限制和其他因素，实施水平仍然很低。通过促进高危饮酒者获得一个酒精减少网站，可以为初级保健专业人员提供一种节省时间的替代标准面对面干预的方法，但尚不清楚其是否同样有效。
这是一项在意大利弗留利-威尼斯朱利亚大区的初级保健机构中进行的随机对照非劣效试验，比较了为高危饮酒者提供专门网站的便捷访问与标准面对面简短干预。将向成年患者发放传单，邀请他们登录网站完成酒精使用障碍识别测试（AUDIT-C）酒精筛查问卷。对阳性筛查者将要求他们完成一个在线试验模块，包括同意书、基线评估和随机分配给医生的标准干预或便捷访问酒精减少网站。在 1 个月、3 个月和 1 年内，将使用完整的 AUDIT 问卷进行在线风险饮酒随访评估。将计算每组风险饮酒者的比例，并使用 10%的特定边缘进行非劣效性评估。假设接受标准干预的风险饮酒者减少 30%，则需要 1000 名患者才能达到拒绝零假设的 90%效力。
该方案于 2012 年 6 月 14 日获得伊斯托宁独立地方伦理委员会的批准。试验结果将通过同行评议期刊、国家和国际会议报告以及涉及试验参与者居住城镇的地方政府的公众活动进行传播。
试验注册号 NCT: 01638338。
