Development of the Building Efficacy for Successful Tapering (BEST) Program

摘要 超过1亿美国人患有慢性疼痛。使用慢性阿片类药物治疗（COT）疼痛， 急剧增加，阿片类药物滥用，滥用，与其他药物的危险相互作用， 吸毒过量和死亡随着对COT令人担忧的影响的担忧增加，监管努力 也增加了，包括医学监督的阿片类药物减量。渐缩对许多患者来说是令人生畏的 他们缺乏自我效能和疼痛管理技能，无法成功地驾驭这一过程。根据 班杜拉，自我效能是指相信一个人可以成功地执行必要的行动， 在给定情况下实现期望的结果（例如，逐渐变细）。拟议的第一阶段SBIR项目将 包括初步开发和试点测试的在线建筑功效成功锥形 （最佳）节目。BEST计划是疼痛自我管理原则的实际应用， 针对逐渐减少的过程。BEST旨在通过培训患者， 系统地抽样和测试各种基于证据的非阿片类药物疼痛管理策略， 发展出一整套经过个人审核的技巧患者将学习循证策略（“疼痛 减少者”）源自疼痛自我管理的认知行为、动机和人际关系模型， 包括关注情绪的、行为的、认知的和注意力的技术。计划参与者将确定 并系统地测试和跟踪他们的自定义列表中的“止痛药”从这些类别。一个报告 功能将帮助患者可视化进展，深入了解他们最有益的策略，并建立 基于表现的自我效能感此外，当患者将数据输入BEST程序时，随着时间的推移， 系统将能够使用这些数据来提供客户推荐。如果发现有效， 该计划将填补慢性疼痛治疗的重大空白，帮助患者自信地从 （c）禁止使用类阿片，避免误用/滥用的陷阱，并提高替代治疗的可接受性。 第一阶段项目将包括1）内容开发，2）网页设计和软件开发，3） 形成性评价/可用性测试和翻修（N=10例接受医学监督的阿片类药物治疗的患者） 逐渐减少）和4）一项初步随机对照试验（N=60例随机接受阿片类药物逐渐减少的患者 分配到最佳方案或家庭护理）。RCT将提供1）效应量的初步估计 疼痛自我效能、强度、干扰和阿片类药物滥用自我报告的项目相关变化，以及 2)程序可接受性的证据。成功的结果将为第二阶段奠定基础， 涉及添加几项程序增强功能，包括移动的版本、临床医生门户网站，以监测 患者进展和附加跟踪功能。第二阶段将进行一项全面的随机试验， 在大样本中，在延长的随访期内对更广泛结局的有效性。

ABSTRACT Over 100 million Americans suffer from chronic pain. The use of chronic opioid therapy (COT) for pain has increased dramatically, as have reports of opioid misuse, abuse, dangerous interactions with other drugs, overdose, and death. As concerns over the alarming effects of COT have risen, regulatory efforts have increased as well, including medically supervised opioid tapering. Tapering can be daunting to many patients who lack the self-efficacy and pain management skills to successfully navigate the process. According to Bandura, self-efficacy refers to the belief that one can successfully perform the necessary actions to achieve a desired outcome in a given situation (e.g., tapering). The proposed Phase I SBIR project will include the preliminary development and pilot testing of the online Building Efficacy for Successful Tapering (BEST) program. The BEST Program is a practical application of pain self-management principles specifically targeting the tapering process. BEST is designed to enhance self-efficacy for tapering by training the patient to systematically sample and test a variety of evidence-based non-opioid pain management strategies in order to develop a repertoire of personally vetted techniques. Patients will learn evidence-based strategies (“pain reducers”) derived from cognitive-behavioral, motivational, and interpersonal models of pain self-management, including emotion-focused, behavioral, cognitive, and attentional techniques. Program participants will identify and systematically test and track their custom list of “pain reducers” from these categories. A reporting function will help patients to visualize progress, gain insight into their most beneficial strategies, and build performance-based self-efficacy. Moreover, as the patient enters data into the BEST program, over time the system will be capable of using those data to offer custom recommendations. If found effective, the BEST Program will fill a significant gap in chronic pain treatment by helping patients to confidently transition from the use of opioids, avoid the pitfalls of misuse/abuse, and heighten the acceptability of alternative treatments. The Phase I project will include 1) content development, 2) web design and software development, 3) formative evaluation/usability testing and revision (N=10 patients undergoing medically supervised opioid tapering), and 4) a pilot randomized controlled trial (N=60 patients undergoing opioid tapering randomly assigned to the BEST Program or to Usual Care). The RCT will provide 1) preliminary estimates of effect sizes for program-related changes in pain self-efficacy, intensity, interference, and self-report of opioid misuse, and 2) evidence of program acceptability. Successful results would lay the groundwork for Phase II, which would involve the addition of several Program enhancements, including a mobile version, a clinician portal to monitor patient progress, and additional tracking features. A full scale RCT would be conducted in Phase II to examine efficacy for a broader range of outcomes in a large sample over an extended follow-up period.