Virtual MOUD Treatment: Virtual Point-of-Care Toxicology Testing to Accompany Virtual Medication Assisted Treatment for Opioid Use Disorder

虚拟 MOUD 治疗：虚拟护理点毒理学测试伴随阿片类药物使用障碍的虚拟药物辅助治疗

• 批准号: 10316571
• 负责人: ERIC HERMES
• 金额: --
• 依托单位: VA CONNECTICUT HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10316571
• 关键词: Abstinence; Address; American; Behavior Therapy; Buprenorphine; Caring; Characteristics; Clinical; Computerized Medical Record; Connecticut; Consolidated Framework for Implementation Research; Data; Data Analyses; Data Collection; Diagnostic Reagent Kits; Documentation; Drug Prescriptions; Drug usage; Education; Feedback; Future; Goals; Healthcare Systems; Hybrids; Institution; Intervention; Interview; Laboratories; Leadership; Liquid substance; Massachusetts; Medical Records; Medicine; Methodology; Methods; Modality; Opioid; Oral; Outcome; Outpatients; Patient Schedules; Patient-Centered Care; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Phase; Policies; Privacy; Procedures; Process; Provider; Publishing; Randomized; Randomized Clinical Trials; Reading; Regulation; Research; Resources; Saliva; Sampling; Secure; Self Administration; Services; Site; Societies; Specific qualifier value; Stigmatization; Structure; Substance Use Disorder; Telephone; Test Result; Testing; Time; Toxicology; Travel; United States Department of Veterans Affairs; Urine; Veterans; Visit; Visualization; addiction; arm; base; contingency management; design; drug of abuse; drug testing; effectiveness evaluation; health service use; improved; innovation; medication-assisted treatment; meetings; multi-site trial; novel; opioid use disorder; pandemic disease; pilot trial; point of care; point of care testing; randomized effectiveness trial; randomized trial; scale up; self testing; social stigma; substance use; testing uptake; trend; uptake; usability; user centered design; virtual; virtual delivery; virtual healthcare

Background. Medication treatment of Opioid Use Disorder (MOUD) saves lives and is increasingly delivered virtually. Currently, 60% of VA outpatient addiction treatment occurs over video. The pandemic accelerated this trend, but it will be sustained through multiple VA policies. However, toxicology testing, a major component of MOUD care, currently requires in-person visits. A process for virtual point-of-care toxicology testing is needed. Significance. In current virtual MOUD care, toxicology testing is either not completed or requires in-person urine testing, which is inconvenient and stigmatizing. A process for virtual point-of-care testing, which mitigates these barriers, will be developed through this research. Such as process will be more acceptable, facilitate patient-centered care, and decrease stigma, improving MOUD utilization and patient outcomes. This research will directly address VA stated goals to “Improve MOUD implementation” and “Understand how to address stigma.” Innovation. MOUD care, which incorporates (1) virtual toxicology testing, (2) patient self-testing at the point-of- care, and (3) oral-fluid test kits, is entirely novel. There has been no research on virtual point-of-care toxicology testing among Veterans. In addition, virtual toxicology testing will advance other innovative addiction treatments such as virtual contingency management. Specific Aims. This research will develop a Virtual Point-of-Care Toxicology Testing Process for VA. AIM 1 (Pre-Pilot) will design and iteratively modify a Virtual Toxicology Testing Process, which uses oral fluid test kits. AIM 2 (Pilot Trial) will evaluate the feasibility, acceptability, and proximal effects of the process by evaluating provider and patient testing uptake, qualitative feedback, and health service use. AIM 3 (Scale-up) will (1) prepare a Virtual Point-of-Care Toxicology Testing Toolkit and (2) operationalize testing for a future multi-site randomized trial. Methodology. Mixed-methods will be used to develop and evaluate the testing process, which will use an oral- fluid test for common drugs of abuse. Patients will self-administer the test during virtual MOUD visits and assess results with providers. In the pre-pilot phase, stakeholder groups of VA-wide clinical/laboratory leaders, providers, and patients will design and iteratively modify the process. In the pilot phase, a single-arm mixed- methods pilot trial will evaluate the process among patients and providers at two VA facilities. Feasibility will be evaluated by examining process uptake. Acceptability will be evaluated through semi-structured interviews with patients and providers based on Consolidated Framework for Implementation Research (CFIR) constructs. Health service use will be evaluated by analyzing data on patient characteristics, test utilization, and treatment contacts extracted from the electronic medical record. In the scale-up phase, the Virtual Point-of-Care Toxicology Testing Process will be summarized in a toolkit for VA-wide distribution. The toolkit will (1) identify tests meeting VA requirements; (2) develop education materials; (3) specify procedures for administering and analyzing tests; and (4) specify additional activities such as confirming results, ordering tests, and documenting results. Next Steps/Implementation. The Virtual Point-of-Care Toxicology Testing Toolkit will be disseminated using current VA addictions informational and didactic resources and venues. The toolkit will be operationalized for a future multisite, randomized hybrid trial evaluating the effectiveness of virtual toxicology testing compared to testing as usual.

背景阿片类药物使用障碍（MOUD）的药物治疗可以挽救生命，并越来越多地提供 虚拟的目前，60%的VA门诊成瘾治疗是通过视频进行的。大流行加速了这一进程 趋势，但它将通过多种VA政策来维持。然而，毒理学测试，一个主要组成部分， MOUD护理，目前需要亲自访问。需要一个虚拟的即时毒理学测试过程。 意义在当前的虚拟MOUD护理中，毒理学测试要么未完成，要么需要亲自进行 尿检，这是不方便和耻辱。虚拟床旁检测流程，可缓解 这些障碍，将通过这项研究得到发展。这样的过程会更容易被接受， 以患者为中心的护理，减少耻辱感，提高MOUD利用率和患者结局。本研究 我将直接解决VA的既定目标，以"改善MOUD的实施"和"了解如何解决 耻辱" 创新MOUD护理，其中包括（1）虚拟毒理学测试，（2）患者自我测试， 护理，和（3）口腔液测试试剂盒，是完全新颖的。目前还没有关于虚拟床旁毒理学的研究 在退伍军人中进行测试。此外，虚拟毒理学测试将推动其他创新成瘾 虚拟应急管理等治疗方法。 具体目标。本研究将为VA开发虚拟床旁毒理学测试过程。要求1 （预试点）将设计和迭代修改虚拟毒理学测试过程，该过程使用口腔液测试套件。 AIM 2（初探性试验）将通过评价过程的可行性、可接受性和近端效应， 提供者和患者的检测吸收、定性反馈和医疗服务使用。AIM 3（扩大规模）将（1） 准备虚拟床旁毒理学测试工具包，以及（2）为未来的多中心实施测试 随机试验 方法论混合方法将用于开发和评估测试过程，其中将使用口头- 常见药物滥用的液体测试。患者将在虚拟MOUD访视期间自行进行测试， 与供应商一起评估结果。在试点前阶段，VA范围内的临床/实验室负责人的利益相关者群体， 提供者和患者将设计并迭代地修改该过程。在试点阶段，一个单臂混合- 方法试点试验将在两个VA设施的患者和提供者中评估该过程。可行性将是 通过检查过程摄取进行评估。可接受性将通过半结构化访谈进行评估， 患者和供应商基于实施研究的综合框架（CFIR）结构。 将通过分析患者特征、测试利用和治疗的数据来评估卫生服务使用情况 从电子病历中提取的联系人。在扩展阶段，虚拟床旁 毒理学试验过程将总结在VA范围内分发的工具包中。该工具包将（1）确定 （2）制定教育材料;（3）规定管理程序， 分析测试;（4）指定附加活动，如确认结果、订购测试和记录 结果 后续步骤/实施。虚拟床旁毒理学测试工具包将通过 当前VA成瘾信息和教学资源和场地。该工具包将在2010年投入使用， 未来的多中心、随机混合试验，评估虚拟毒理学试验与 像往常一样测试。