Relational Agent to Improve Alcohol Screening and Treatment in Primary Care: RCT

背景：VA通过实施电子临床提醒和 为不健康饮酒的筛查和短暂干预制定绩效措施。 在全国范围内，每年约有93%的退伍军人接受筛查。然而，简短发言的百分比 这些干预措施的质量和有效性尚不确定。一个病人- 以计算机为中心的干预可以通过提供量身定制的 以优质和忠实的方式进行干预。关系代理是屏幕上的角色， 与他们建立“关系”。它们已被用于改善几种健康行为 包括饮食和锻炼，并能克服与计算机水平低有关的沟通障碍。 素养关系代理可以放置在带有触摸屏的台式机或平板电脑上， 患者给出了他们的回答。使用动机性面试和行为改变原则， 关系代理引导患者考虑改变。使用这种“电子保健”工具， 任务，同时为可能具有有限计算机技能的患者提供无威胁的 “讨论”一个被污名化的话题，如危险的酒精使用。关系代理已经证明了更多 在一些研究中，在促进与健康有关的行为改变方面，试点 波士顿退伍军人管理局的研究表明，退伍军人会与关系型代理人交往，并对他们持有利态度。 到目前为止，还没有关系代理人的VA试验。 目的：本研究的目的是：1）为退伍军人群体量身定制关系代理干预; 2）进行一次 随机对照试验，治疗作为药物加相关药物与治疗作为药物， 不健康的酒精使用;和3）深入研究退伍军人的经验与关系代理干预。 方法：为了实现目标1，我们将使用标准的软件开发技术，包括认知 访谈和可用性测试，为退伍军人群体量身定制关系代理干预。一旦 关系型代理人是完善的，我们将进行一项双臂随机对照试验（目标2）在弗吉尼亚州波士顿医疗保健系统。我们 将初级保健中的退伍军人随机分为治疗组和治疗组， 使用分层随机化方案，以确保相同数量的退伍军人与不健康的酒精 使用（风险和危险饮酒）和退伍军人与酒精使用障碍（更严重的分类）， 每组与初级保健人员密切合作，他们经常筛查退伍军人的危险酒精使用，我们 将确定筛查呈阳性的退伍军人，并要求他们参与研究。招募180名退伍军人 在15个月内，目标是完成126至144名参与者的研究。退伍军人分配到 关系代理干预组将在初级保健访视时与关系代理互动， 将安排一个月的随访访问，与关系代理进行第二次互动。的 关系代理将为退伍军人和临床医生提供个人反馈，并将标记退伍军人， 符合转诊治疗的标准。酒精使用和相关行为将通过面对面调查进行评估 在基线时和3个月随访时通过电话调查。主要结果指标将是数量和 3个月随访时的饮酒频率，以及短暂干预率、转诊治疗率，以及 满意度作为次要结果。亚组分析将允许单独检查 关系代理对不健康的酒精使用和退伍军人与酒精滥用或依赖。后 RCT，我们将进行形成性评估（目标3），并进行深入访谈，以描述 这些干预是最有效干预，而那些干预似乎是无关的，甚至是适得其反的。 结论：通过定制一种新的电子健康干预措施，并在VA中进行评估，本研究解决了 部长Shinseki的T21倡议，采用最先进的技术，以改善退伍军人的医疗保健。

Background: VA has demonstrated national leadership by implementing electronic clinical reminders and establishing performance measures for both screening and brief intervention for unhealthy alcohol use. Nationally, about 93% of Veterans are screened annually. However, the percentage of brief interventions delivered when needed, and the quality and effectiveness of those interventions, are uncertain. A patient- centered computer-based intervention can help to close the performance gap by delivering a tailored intervention with excellent quality and fidelity. Relational Agents are on-screen characters that speak to the patient and establish a "relationship" with them. They have been used to improve several health behaviors including diet and exercise, and can overcome communication barriers related to low levels of computer literacy. The Relational Agent can be placed on a desktop or tablet computer with a touch screen, on which patients indicate their responses. Using Motivational Interviewing and behavior change principles, the Relational Agent guides patients to consider change. Use of such an "eHealth" tool offloads a time-intensive task from the clinician while providing the patient, who may have limited computer skills, a non-threatening vehicle for "discussing" a stigmatized topic such as risky alcohol use. Relational Agents have proven more effective than web-based interventions in promoting health-related behavior changes in some studies. Pilot studies at VA Boston demonstrate that Veterans will engage with Relational Agents and view them favorably. To date, there have been no VA trials of Relational Agents. Aims: The study aims are to 1) Tailor the Relational Agent Intervention to the Veteran population; 2) Conduct a randomized controlled trial of Treatment as Usual plus the Relational Agent versus Treatment as Usual for unhealthy alcohol use; and 3) Examine in-depth Veterans' experience with the Relational Agent Intervention. Methods: To achieve Aim 1, we will use standard software development techniques, including cognitive interviewing and usability testing, to tailor the Relational Agent Intervention to the Veteran population. Once the Relational Agent is refined, we will conduct a two-arm RCT (Aim 2) in the VA Boston Healthcare System. We will randomize Veterans in primary care to Treatment as Usual plus the Relational Agent versus Treatment as Usual, using a stratified randomization scheme to ensure equal numbers of Veterans with unhealthy alcohol use (risky and hazardous drinking) and Veterans with alcohol use disorders (a more severe classification) in each group. Working closely with primary care staff, who routinely screen Veterans for risky alcohol use, we will identify Veterans who screen positive and ask them to participate in the study. We will recruit 180 Veterans over 15 months, with a goal of completing the study with 126 to 144 participants. Veterans allocated to the Relational Agent Intervention arm will interact with the Relational Agent at the time of the primary care visit and will be scheduled for a one-month follow-up visit for a second interaction with the Relational Agent. The Relational Agent will provide personal feedback for the Veteran and the clinician, and will flag Veterans who meet criteria for referral to treatment. Alcohol use and related behaviors will be assessed by in-person survey at baseline and by telephone survey at a 3-month follow-up. Primary outcome measures will be quantity and frequency of alcohol use at the 3-month follow-up, with rates of brief intervention, referral to treatment, and satisfaction as secondary outcomes. Subgroup analyses will allow for examining separately the effects of the Relational Agent on unhealthy alcohol use and on Veterans with alcohol abuse or dependence. Following the RCT, we will conduct a formative evaluation (Aim 3), with in-depth interviews, to characterize the elements of the Intervention that emerge as most effective and those that seem extraneous or even counter-productive. Conclusion: By tailoring a novel eHealth intervention and initiating its evaluation in VA, this study addresses Secretary Shinseki's T21 initiative to employ state-of-the-art technology to improve Veterans' health care.