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

背景：退伍军人管理局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建立绩效衡量标准。 在全国范围内，每年约有93%的退伍军人接受筛查。然而，短暂干预的百分比 在需要的时候提供，以及这些干预措施的质量和效果都是不确定的。一位病人- 以计算机为中心的干预可通过提供量身定制的 以卓越的质量和保真度进行干预。关系代理是屏幕上的角色，他们与 耐心等待，并与他们建立“关系”。它们已经被用来改善几种健康行为 包括饮食和锻炼，并可以克服与低水平的计算机有关的沟通障碍 识字。关系代理可以放置在带有触摸屏的台式机或平板电脑上， 患者会指出他们的反应。使用激励性访谈和行为改变原则， 关系代理引导患者考虑改变。使用这样的“eHealth”工具可以减轻耗时的 来自临床医生的任务，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”诸如危险饮酒等污名化话题的工具。关系代理已经证明了 在一些研究中，在促进健康相关行为改变方面比基于网络的干预更有效。引航员 退伍军人协会波士顿分校的研究表明，退伍军人会与关系经纪人打交道，并对他们持好感。 到目前为止，还没有关于关系代理的VA试验。 研究目的：1)对退伍军人群体进行关系代理干预；2)开展 常规治疗加关系制剂与常规治疗的随机对照试验 不健康的酒精使用；以及3)深入检查退伍军人对关系代理干预的体验。 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，为退伍军人量身定做关系代理干预。一旦 关系代理是精炼的，我们将在VA波士顿医疗系统中进行双臂RCT(AIM 2)。我们 是否会将初级保健中的退伍军人随机分配到照常治疗加关系代理与按治疗 通常，使用分层随机方案来确保同等数量的退伍军人饮酒不健康 使用(危险和危险饮酒)和有酒精使用障碍的退伍军人(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是否有危险饮酒，我们 将确定筛查呈阳性的退伍军人，并要求他们参与研究。我们将招募180名退伍军人 超过15个月，目标是完成这项研究，有126到144名参与者。退伍军人分配到 关系代理干预ARM将在初级保健访问时与关系代理交互，并且 将安排一个月的后续访问，以便与关系代理进行第二次互动。这个 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 在基线和电话调查时进行3个月的随访。主要结果衡量标准将是数量和 在3个月的随访中饮酒的频率，以及短暂干预率、转诊到治疗的比率，以及 满意度是次要的结果。分组分析将允许单独检查以下因素的影响 关于不健康饮酒和有酗酒或依赖的退伍军人的关系代理。紧随其后的是 RCT，我们将进行形成性评估(目标3)，并进行深入访谈，以确定 最有效的干预，以及那些看起来无关紧要甚至适得其反的干预。 结论：通过定制一种新的电子健康干预措施并在退伍军人管理局启动其评估，本研究解决了 新关部长的T21倡议，使用最先进的技术来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.