Digital treatments for opioids and other substance use disorders (DIGITS) in primary care: A hybrid type-III implementation trial

项目摘要 这项拟议的研究解决了一个关键的知识差距：如何最好地实施数字治疗， 初级保健（PC）中的阿片类药物和其他物质使用障碍（SUD）。2017年，美国食品和药物管理局 政府批准了第一个数字治疗任何医疗条件。治疗剂是reSET， 基于智能手机的治疗教育系统，这是一个计算机化的认知， SUD的行为治疗。我们将研究在PC中实施reSET，以潜在地改善以下患者的护理 SUD患者，并作为如何将数字治疗可持续地应用于现实世界的模型 健康护理数字治疗可以将SUD治疗的范围扩大到更多的人，并可以解决 缺乏获得心理社会治疗的机会，这是丁丙诺啡处方的一个重大障碍（一种挽救生命的药物）， 治疗阿片类药物使用障碍[OUD]）。之前的一项实施试验发现，数字SUD治疗 由于工作流程和成本负担的原因，我们的研究设计和分析计划没有持续进行 关注这些问题。我们在Kaiser Permanente华盛顿的交付系统合作伙伴致力于 与我们合作，研究在华盛顿州25家PC诊所实施reSET的策略， 解决文献中记录的先前实施挑战。在2个诊所试点后，我们将 将23家诊所随机分为四种方法：（1）“标准实施”，即 我们的交付系统合作伙伴以前采用的循证实施战略;（2）“标准 外部促进实施，”面向临床医生的实施策略;（3）“标准 实施与病人教练”，一个面向病人的实施战略，使用医疗助理， 支持患者采用和参与;以及（4）“两者的标准实施”。这些实现 策略在PC中有一些证据，但它们对数字治疗的现实世界实施的影响 没有被评估。具体目的是（1）评估面向临床医生（外部促进）的效果， 面向患者（患者教练）的实施策略，以增加数字SUD的覆盖范围和保真度 在PC诊所治疗，（2）比较人口水平的成本效益，每一个实施 提高患者的接触率、忠诚度和禁欲度的策略。影响：研究人员和卫生系统确实 不知道如何接触大量OUD和其他SUD患者。数字治疗是 这是一个很有前途的计划，但卫生系统缺乏证据来指导数字疗法的实施。本研究将 评估和比较面向临床医生和面向患者的实施策略的有效性， 为卫生系统领导者提供如何最好地实施数字治疗的数据。

PROJECT SUMMARY The proposed study addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders (SUDs) in primary care (PC). In 2017, the US Food and Drug Administration approved the first ever digital therapeutic for any medical condition. The therapeutic is reSET, a smartphone-based version of the Therapeutic Educational System, which is a computerized cognitive- behavioral treatment for SUDs. We will study implementation of reSET into PC to potentially improve care for people with SUDs, and as a model for how to sustainably implement digital treatments into real-world healthcare. Digital treatments could extend the reach of SUD therapy to more people and could address the lack of access to psychosocial treatment, a significant barrier to buprenorphine prescribing (a life-saving treatment for opioid use disorders [OUD]) in PC. A prior implementation trial found that a digital SUD treatment in PC was not sustained in part because of workflow and cost burdens so our study design and analytic plan focus on these issues. Our delivery system partners in Kaiser Permanente Washington are committed to collaborating with us to study strategies for implementing reSET in 25 PC clinics in Washington State and to address prior implementation challenges documented in the literature. After piloting in 2 clinics, we will randomize 23 clinics in a 2x2 factorial design to four approaches: (1) “standard implementation,” which is an evidence-based implementation strategy previously used by our delivery system partners; (2) “standard implementation with external facilitation,” a clinician-facing implementation strategy; (3) “standard implementation with patient coach,” a patient-facing implementation strategy using medical assistants to support patient adoption and engagement; and (4) “standard implementation with both.” These implementation strategies have some evidence in PC, but their impact on real-world implementation of a digital treatment has not been evaluated. Specific Aims are to (1) Estimate the effect of clinician-facing (external facilitation) and patient-facing (patient coach) implementation strategies in increasing the reach and fidelity of a digital SUD treatment in PC clinics, and (2) compare the population-level cost-effectiveness of each implementation strategy in increasing reach, fidelity, and abstinence by patients. IMPACT: Researchers and health systems do not know how to reach large numbers of patients with OUDs and other SUDs. Digital treatments are promising, but health systems lack evidence to guide implementation of digital therapies. This study will estimate and compare the effectiveness of clinician-facing and patient-facing implementation strategies, providing health system leaders with data on how to best implement digital treatments.