Background

Brief interventions (BI) for risky drinkers in primary healthcare have been demonstrated to be cost-effective but they are still poorly implemented. Digital BI seems to be a complementary strategy to overcome some barriers to implementation but there is a scarcity of studies in clinical environments. We present the results of a randomized controlled non-inferiority trial which tests the non-inferiority of facilitated access to a digital intervention (experimental condition) for risky drinkers against a face-to-face BI (control condition) provided by primary healthcare professionals.

Method

In a non-inferiority randomized controlled trial, unselected primary healthcare patients (≥ 18 years old) were given a brief introduction and asked to log on to the study website to fill in the 3-item version of the Alcohol Use Disorders Identification Test. Positively screened patients (4+ for women and 5+ for men) received further online assessment (AUDIT, socio-demographic characteristics and EQ-5D-5L) and were automatically randomized to either face-to-face or digital BI (1:1). The primary outcome was the proportion of patients classified as risky drinkers by the digitally administered AUDIT at month 3. A multiple imputation approach for the missing data was performed.

Results

Of the 4499 patients approached by 115 healthcare professionals, 1521 completed the AUDIT-C. Of the 368 positively screened patients, 320 agreed to participate and were randomized to either intervention. At month 3, there were more risky drinkers in the experimental group (59.8%) than in the control group (52%), which was similar to the distribution at baseline and less than the pre-specified margin of 10%. The difference was not significant when accounting for possible confounders.

Conclusion

Digital BI was not inferior to face-to-face BI, in line with previous findings and the a priori hypothesis. However, the low power of the final sample, due to the low recruitment and loss to follow-up, limits the interpretation of the findings. New approaches in this field are required to ensure the effective implementation of digital interventions in actual practice.

中文翻译：

---

基于初级保健的随机对照非劣效性试验促进了对酒精减少网站的访问（西班牙 EFAR）

背景

初级保健中针对危险饮酒者的简短干预 (BI) 已被证明具有成本效益，但实施起来仍然很差。数字 BI 似乎是克服一些实施障碍的补充策略，但临床环境中的研究很少。我们介绍了一项随机对照非劣效性试验的结果，该试验测试了针对危险饮酒者的数字干预（实验条件）的便利访问与初级医疗保健专业人员提供的面对面 BI（控制条件）的非劣效性。

方法

在一项非劣效性随机对照试验中，对未选择的初级保健患者（≥ 18 岁）进行了简要介绍，并要求他们登录研究网站填写酒精使用障碍识别测试的 3 项版本。阳性筛查患者（女性 4+，男性 5+）接受进一步的在线评估（AUDIT、社会人口特征和 EQ-5D-5L），并自动随机分配到面对面或数字 BI (1:1) ). 主要结果是第 3 个月时被数字管理的 AUDIT 归类为危险饮酒者的患者比例。对缺失数据进行了多重插补法。

结果

在 115 名医疗保健专业人员接洽的 4499 名患者中，1521 名完成了 AUDIT-C。在 368 名筛查阳性的患者中，有 320 名同意参加并被随机分配到任一干预组。第 3 个月时，实验组中的危险饮酒者 (59.8%) 多于对照组 (52%)，这与基线时的分布相似，但低于预先指定的 10% 差值。在考虑可能的混杂因素时，差异并不显着。

结论

数字 BI 并不逊色于面对面 BI，这与之前的发现和先验假设一致。然而，由于招募率低和失访，最终样本的低功效限制了对结果的解释。需要该领域的新方法以确保在实际实践中有效实施数字干预。