Assessing the Clinical and Cost-Effectiveness of a Virtual PEth-based Contingency Management for Adults with AUD

评估针对成人 AUD 的基于虚拟 PEth 的应急管理的临床和成本效益

基本信息

批准号：
10717985
负责人：
Nathalie Hill-Kapturczak
金额：
$ 71.6万
依托单位：
WASHINGTON STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-15 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10717985
关键词：
Abstinence Adult Affect Aftercare Alcohol consumption Alcohols American Biological Biological Markers Blood Blood specimen COVID-19 pandemic Caring Clinical Clinical effectiveness Cognitive Therapy Collection Cost Effectiveness Analysis Devices Drug usage Effectiveness Emotional Frequencies Glucuronides Health Care Costs Health Care Sector Heavy Drinking Incentives Individual Intervention Legal Length Longitudinal Studies Medical Care Costs Medical Device Mental Health Modeling Monitor National Institute on Alcohol Abuse and Alcoholism Observational Study Outcome Outcome Assessment Participant Patient Self-Report Patients Persons Phase Policy Maker Prediction of Response to Therapy Predictive Factor Productivity Psychological reinforcement Public Health Quality-Adjusted Life Years Randomized Reporting Research Resources Sampling Savings Smoking Stigmatization Substance Use Disorder Testing Time Treatment outcome Urine Visit Vocation addiction alcohol abstinence alcohol intervention alcohol use disorder blood-based biomarker cigarette smoking contingency management cost cost effective cost effectiveness drinking economic evaluation effective intervention executive function experience feasibility trial follow-up improved incentive salience intervention participants long term abstinence long term recovery novel novel strategies pandemic disease phosphatidylethanol physical conditioning pilot trial primary outcome programs recruit reinforcer safety net satisfaction secondary outcome social stigma telehealth treatment as usual virtual

项目摘要

PROJECT SUMMARY/ABSTRACT In 2020, 28.3 million Americans experienced an alcohol use disorder (AUD); yet only 25% of these people received treatment. During the pandemic, 60% of patients with a substance use disorder reported receiving telehealth-based care for their addiction. The pivot to telehealth provides an opportunity to overcome the barriers to access and retention that affect in-person care (e.g., inconvenience, stigma). In contingency management (CM), people receive tangible reinforcers in exchange for submitting biological samples to verify abstinence. CM is ideal for telehealth delivery and initial studies of telehealth models demonstrated reductions in alcohol use. At the same time, these models have limitations. They require wearing a transdermal monitor or submitting multiple breath samples daily. As a result, these approaches are costly, burdensome, and stigmatizing which limits their feasibility. In part due to limitations of these biomarkers, current CM models are brief, averaging about 12 weeks, despite evidence suggesting that longer CM interventions result in better post-treatment outcomes. Therefore, the overall objective of our program of research is to utilize phosphatidylethanol (PEth), a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a feasible telehealth-based 26-week CM intervention. In a pilot trial, we developed a telehealth-based PEth CM intervention where participants used a medical device, the TASSO-M20 to self-collect blood for PEth testing under the observation of research staff over Zoom. This intervention used a two-phase approach where the frequency of PEth testing and reinforcement was decreased from once a week, to as infrequently as every four weeks once participants achieved a PEth level consistent with two to four weeks of abstinence (< 20 ng/mL). Seventy-one percent of CM participants achieved >4 weeks of abstinence versus 21% of the treatment as usual (TAU) group, and 43% of CM participants achieved >24 weeks of abstinence compared to 0% of the TAU group (p < 0.05). Based on these promising results, we now propose to test our telehealth PEth-based CM model in a sample of adults with AUD (n=200), recruited via online platforms by randomizing individuals to six months of 1) an online cognitive behavioral therapy for AUD (CBT4CBT) and telehealth PEth-based CM (CM condition) or 2) CBT4CBT and reinforcers for submitting blood samples (no abstinence required) (control condition). We will assess group differences in PEth-defined abstinence and regular excessive drinking (PEth ³ 200 ng/mL), and alcohol-related harms (e.g., smoking, drug use). We will address important gaps in CM research by assessing outcomes during a 12-month follow-up, which is much longer than most previous CM studies; using a conceptual model to identify predictors of post-treatment abstinence. The primary barrier to the dissemination of our model is the cost of PEth testing and CM reinforcers. We will conduct an economic analysis to place these costs in the context of downstream CM-associated cost- offsets and improvements in personal and public health. If our model increases alcohol abstinence and is cost- effective it could reach millions of Americans with AUD that cannot or do not seek in-person care.

项目概要/摘要 2020 年，2830 万美国人患有酒精使用障碍 (AUD)，但其中只有 25%；在大流行期间，60% 的药物滥用患者报告接受了治疗。基于远程医疗的护理为他们的成瘾提供了一个克服障碍的机会。影响面对面护理的访问和保留（例如，不便、耻辱）。 (CM)，人们通过提交生物样本来验证 CM 戒断，从而获得有形的强化物。是远程医疗服务的理想选择，远程医疗模型的初步研究表明可以减少饮酒。同时，这些模型也有局限性，它们需要佩戴透皮监测器或提交多个。因此，这些方法成本高昂、繁琐且容易受到侮辱，这限制了它们的应用。部分由于这些生物标志物的局限性，当前的 CM 模型很简短，平均约为 12 周，尽管有证据表明，较长时间的 CM 干预会带来更好的治疗后结果，因此，我们研究计划的总体目标是利用磷脂酰乙醇 (PEth)，一种基于血液的生物标志物可以检测长达 28 天的饮酒情况，以提供可行的基于远程医疗的 26 周 CM 干预。在一项试点试验中，我们开发了一种基于远程医疗的 PEth CM 干预措施，参与者使用医疗设备， TASSO-M20 在研究人员通过 Zoom 的观察下自行采集血液进行 PEth 测试。干预采用两阶段方法，减少 PEth 测试和强化的频率一旦参与者达到一致的 PEth 水平，从每周一次到每四个星期一次 71% 的 CM 参与者禁欲超过 4 周（< 20 ng/mL）。戒断率与照常治疗 (TAU) 组的 21% 相比，43% 的 CM 参与者达到 >24 与 0% 的 TAU 组相比，戒酒周数 (p < 0.05) 基于这些有希望的结果，我们现在。建议在通过在线招募的 AUD 成年人 (n=200) 样本中测试我们基于 PEth 的远程医疗 CM 模型平台将个体随机分配到六个月的 1) AUD 在线认知行为疗法 (CBT4CBT) 和基于 PEth 的远程医疗 CM（CM 状况）或 2) CBT4CBT 和提交血液的强化剂样本（无需禁欲）（对照条件）我们将评估 PEth 定义的组间差异。戒酒和经常过量饮酒 (PEth ³ 200 ng/mL)，以及与酒精相关的危害（例如吸烟、吸毒）我们将通过评估 12 个月的随访结果来解决 CM 研究中的重要差距。比大多数以前的 CM 研究要长得多；使用概念模型来确定治疗后的预测因素传播我们模型的主要障碍是 PEth 测试和 CM 强化剂的成本。我们将进行经济分析，将这些成本置于下游 CM 相关成本的背景下如果我们的模型提高了戒酒率并且成本低廉，那么它可以抵消并改善个人和公共健康。它有效地可以惠及数百万持有澳元但无法或不寻求面对面护理的美国人。