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

初级保健中阿片类药物和其他物质使用障碍 (DIGITS) 的数字治疗：混合 III 型实施试验

• 批准号: 10560538
• 负责人: Joseph Edwin Glass
• 金额: $ 59.63万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10560538
• 关键词: Abstinence; Academy; Address; Adopted; Adoption; Behavioral; Buprenorphine; Caring; Cellular Phone; Classification; Clinic; Cognitive; Cognitive Therapy; Collaborations; Data; Dedications; Dose; Drug Use Disorder; Education; Effectiveness; Ensure; Epidemic; FDA approved; Face; Health system; Healthcare; Human; Hybrids; Individual; Intervention; Knowledge; Laboratories; Learning; Life; Literature; Medical; Medicine; Methods; Modeling; Observational Study; Opioid; Patients; Pear; Persons; Population; Primary Care; Randomized; Randomized, Controlled Trials; Research Design; Research Personnel; Running; Substance Use Disorder; Symptoms; System; Testing; Therapeutic; Traction; United States Food and Drug Administration; Visit; Washington; World Health; alcohol use disorder; behavioral health; buprenorphine treatment; care systems; compare effectiveness; computerized; cost; cost effectiveness; design; digital; digital health; digital treatment; effective intervention; effective therapy; effectiveness/implementation hybrid; evidence base; formative assessment; implementation barriers; implementation cost; implementation science; implementation strategy; implementation trial; improved; innovation; instrument; novel strategies; opioid mortality; opioid use disorder; population based; primary care clinic; primary care patient; primary care team; psychosocial; screening; smartphone application; substance use; success

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.

项目概要 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，美国食品药品监督管理局 政府批准了有史以来第一个针对任何医疗状况的数字疗法。治疗方法是reSET， 基于智能手机的治疗教育系统版本，这是一种计算机化的认知- SUD 的行为治疗。我们将研究在 PC 中实施 reSET，以潜在地改善对患者的护理 患有 SUD 的人，并作为如何在现实世界中可持续实施数字治疗的模型 卫生保健。数字化治疗可以将 SUD 疗法的覆盖范围扩大到更多人，并可以解决以下问题： 缺乏获得心理社会治疗的机会，这是开具丁丙诺啡处方（一种挽救生命的药物）的一个重大障碍 PC 中阿片类药物使用障碍 [OUD] 的治疗。先前的实施试验发现，数字 SUD 治疗 由于工作流程和成本负担，PC 中的研究未能持续，因此我们的研究设计和分析计划 关注这些问题。我们在华盛顿凯撒医疗机构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，并 解决文献中记录的先前实施挑战。在 2 家诊所试点后，我们将 采用 2x2 析因设计将 23 个诊所随机分为四种方法：(1) “标准实施”，这是一种 我们的交付系统合作伙伴之前使用的基于证据的实施策略； (2)“标准 外部促进的实施，”面向临床医生的实施策略；（3）“标准 与患者教练一起实施”，这是一种面向患者的实施策略，使用医疗助理来 支持患者采用和参与； (4)“两者的标准实施”。这些实现 策略在 PC 上有一些证据，但它们对现实世界中数字治疗实施的影响 没有被评估。具体目标是 (1) 评估面向临床医生（外部促进）和 面向患者（患者教练）的实施策略，以提高数字 SUD 的覆盖范围和保真度 PC 诊所的治疗，以及 (2) 比较每种实施方案的人群水平成本效益 增加患者的覆盖范围、忠诚度和禁欲的策略。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 前景广阔，但卫生系统缺乏证据来指导数字疗法的实施。这项研究将 评估并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有关如何最好地实施数字治疗的数据。