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

改善初级保健中酒精筛查和治疗的相关代​​理：RCT

• 批准号: 10176244
• 负责人: STEVEN R. SIMON
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10176244
• 关键词: Acute; Address; Age; Alcohol abuse; Alcohol consumption; Alcohol dependence; Alcohols; Behavior; Behavioral; Boston; Caring; Chronic; Classification; Clinical; Communication Barriers; Complex; Computer Literacy; Computers; Counseling; Coupled; Development; Disease; Drug abuse; Education; Effectiveness; Elements; Ensure; Evaluation; Feedback; Foundations; Frequencies; Future; Goals; Health; Health Promotion; Health Status; Health behavior; Healthcare; Healthcare Systems; Human; Information Technology; Intervention; Interview; Leadership; Measures; Mental Health; Methods; Online Systems; Outcome Measure; Participant; Patients; Performance; Persons; Pilot Projects; Population; Prevalence; Primary Health Care; Provider; Randomized; Randomized Controlled Trials; Reporting; Research; Risk; Schedule; Scheme; Stigmatization; Subgroup; Surveys; System; Tablet Computer; Technology; Telephone; Testing; Text; Time; Touch sensation; Training; Uncertainty; Veterans; Visit; Work; alcohol abuse therapy; alcohol misuse; alcohol screening; alcohol use disorder; arm; base; behavior change; brief alcohol intervention; brief intervention; cognitive interview; computer center; computerized; design; diet and exercise; drinking; eHealth; effective intervention; effective therapy; experience; follow-up; formative assessment; hazardous drinking; health literacy; high risk drinking; improved; innovation; medical specialties; member; motivational enhancement therapy; novel; patient oriented; preference; primary care setting; primary outcome; recruit; response; routine screening; satisfaction; screening and brief intervention; secondary outcome; skills; software development; technique development; technological innovation; tool; touchscreen; treatment arm; treatment as usual; trial comparing; usability

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）： 背景资料：VA通过实施电子临床提醒和建立不健康酒精使用筛查和短暂干预的绩效指标，展示了国家领导力。在全国范围内，每年约有93%的退伍军人接受筛查。然而，在需要时提供的简短干预措施的百分比以及这些干预措施的质量和有效性尚不确定。以患者为中心的基于计算机的干预可以通过提供具有优异质量和保真度的定制干预来帮助缩小性能差距。关系代理是与患者说话并与他们建立“关系”的屏幕角色。它们已被用于改善包括饮食和运动在内的几种健康行为，并可以克服与计算机素养水平低有关的沟通障碍。关系代理可以放置在带有触摸屏的台式机或平板电脑上，患者在触摸屏上指示他们的反应。使用动机访谈和行为改变原则，关系代理人引导患者考虑改变。使用这种“电子健康”工具可以减轻临床医生的时间密集型任务，同时为可能具有有限计算机技能的患者提供一种无威胁的工具，用于“讨论”诸如危险酒精使用之类的污名化话题。在一些研究中，关系代理人已经被证明比基于网络的干预措施更有效地促进健康相关的行为改变。弗吉尼亚州波士顿的试点研究表明，退伍军人将与关系代理人接触，并对他们有利。到目前为止，还没有关系代理人的VA试验。目的：该研究的目的是：1）为退伍军人群体量身定制关系代理干预; 2）进行一项随机对照试验，将治疗作为不健康的酒精使用的治疗加关系代理与治疗作为不健康的酒精使用; 3）深入研究退伍军人对关系代理干预的经验。研究方法：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。一旦关系代理被完善，我们将在VA波士顿医疗保健系统中进行双臂RCT（目标2）。我们将在初级保健中随机分配退伍军人治疗作为治疗加关系代理与治疗作为治疗，使用分层随机化方案，以确保每组中不健康饮酒（危险和危险饮酒）的退伍军人和酒精使用障碍（更严重的分类）的退伍军人数量相等。与初级保健工作人员密切合作，他们经常筛查退伍军人的危险酒精使用，我们将确定筛查阳性的退伍军人，并要求他们参加这项研究。我们将在15个月内招募180名退伍军人，目标是完成126至144名参与者的研究。分配到关系型代理干预组的退伍军人将在初级保健访视时与关系型代理互动，并将安排一个月的随访访视，以便与关系型代理进行第二次互动。关系代理将为退伍军人和临床医生提供个人反馈，并将标记符合转诊治疗标准的退伍军人。将在基线时通过面对面调查和3个月随访时通过电话调查评估酒精使用和相关行为。主要结局指标是3个月随访时饮酒的数量和频率，次要结局是短暂干预率、转诊率和满意度。亚组分析将允许分别检查关系代理对不健康的酒精使用和对酒精滥用或依赖的退伍军人的影响。在随机对照试验之后，我们将进行一次形成性评估（目标3），并进行深入访谈，以确定干预中最有效的要素和那些看似无关甚至适得其反的要素。结论：通过定制一种新的电子健康干预措施，并在弗吉尼亚州开始其评估，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。