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: 9902391
• 负责人: Joseph Edwin Glass
• 金额: $ 74.33万
• 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 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9902391
• 关键词: Abstinence; Academy; Address; Adopted; Adoption; Alcohol or Other Drugs use; Behavioral; Buprenorphine; Caring; Cellular Phone; Clinic; Cognitive; Cognitive Therapy; Data; Dose; Drug usage; Effectiveness; Ensure; Epidemic; FDA approved; Face; Health; Health system; Healthcare; Human; Hybrids; Individual; Intervention; Knowledge; Laboratories; Learning; Life; Literature; Medical; Medicine; Methods; Modeling; Observational Study; Opioid; Patient Care; Patients; Pear; Population; Primary Health Care; Randomized; Randomized Controlled Trials; Research Design; Research Personnel; Running; Savings; Substance Use Disorder; Symptoms; System; Testing; Therapeutic; Traction; United States Food and Drug Administration; Visit; Washington; alcohol use disorder; base; behavioral health; buprenorphine treatment; care systems; compare effectiveness; computerized; cost; cost effectiveness; design; digital; effective intervention; effective therapy; effectiveness implementation study; evidence base; implementation science; implementation strategy; implementation trial; improved; innovation; instrument; novel strategies; opioid mortality; opioid use disorder; population based; psychosocial; screening; smartphone Application; success; Abstinence; Academy; Address; Adopted; Adoption; Alcohol or Other Drugs use; Behavioral; Buprenorphine; Caring; Cellular Phone; Clinic; Cognitive; Cognitive Therapy; Data; Dose; Drug usage; Effectiveness; Ensure; Epidemic; FDA approved; Face; Health; Health system; Healthcare; Human; Hybrids; Individual; Intervention; Knowledge; Laboratories; Learning; Life; Literature; Medical; Medicine; Methods; Modeling; Observational Study; Opioid; Patient Care; Patients; Pear; Population; Primary Health Care; Randomized; Randomized Controlled Trials; Research Design; Research Personnel; Running; Savings; Substance Use Disorder; Symptoms; System; Testing; Therapeutic; Traction; United States Food and Drug Administration; Visit; Washington; alcohol use disorder; base; behavioral health; buprenorphine treatment; care systems; compare effectiveness; computerized; cost; cost effectiveness; design; digital; effective intervention; effective therapy; effectiveness implementation study; evidence base; implementation science; implementation strategy; implementation trial; improved; innovation; instrument; novel strategies; opioid mortality; opioid use disorder; population based; psychosocial; screening; smartphone Application; 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.

项目摘要 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处理 在初级保健（PC）中，o o o o o opioid和其他物质使用障碍（SUD）。 2017年，美国食品和毒品 政府批准了有史以来第一种用于任何医疗状况的数字疗法。该疗法是重置的，一个 基于智能手机的治疗教育系统的版本，该系统是计算机化的认知 - SUD的行为处理。我们将研究将重置重置为PC的实施，以便改善护理 有泡沫的人，也是如何可持续地将数字处理实施到现实世界中的模型 卫生保健。数字疗法可以将SUD疗法的影响范围扩展到更多人，并可以解决 缺乏进入社会心理治疗的机会，这是丁丙诺啡处方的重大障碍（一种挽救生命 PC中的阿片类药物使用障碍的治疗[OUD]）。事先实施试验发现数字SUD处理 在PC中没有部分持续，部分原因是Burnens的成本，因此我们的研究设计和分析计划 专注于这些问题。我们在Kaiser Permanente Washington的交付系统合作伙伴致力于 与我们合作研究在华盛顿州的25个PC诊所实施重置的策略以及 解决文献中记录的先前实施挑战。在2个诊所驾驶后，我们将 2x2阶乘设计中的23个诊所与四种方法：（1）“标准实施”，这是一个 我们的交付系统合作伙伴先前使用的基于证据的实施策略； （2）“标准 与外部设施实施，“面向临床的实施策略；（3）“标准 使用患者教练实施，“使用医疗助理的面向患者的实施策略 支持患者的收养和参与； （4）“两者的标准实施”。这些实现 策略在PC中有一些证据，但是它们对数字处理的实际实施的影响 未进行评估。具体目的是（1）估计临床面向（外部促进）和 面向患者（患者教练）实施策略，以增加数字SUD的覆盖范围和忠诚度 PC诊所的治疗以及（2）比较每个实施的人口级成本效益 患者的范围​​，忠诚度和戒酒的策略。影响：研究人员和卫生系统确实 不知道如何吸引大量的OUD和其他SUD患者。数字处理是 有希望的，但卫生系统缺乏指导数字疗法实施的证据。这项研究会 估计和比较面向临床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处理的数据。