Developing and pilot testing a novel remotely delivered intensive outpatient program for individuals with opioid use disorder hospitalized with serious injection-related infections

项目摘要摘要 阿片使用障碍(OUD)的破坏性后果之一是发展成严重的注射- 相关感染，如感染性心内膜炎、脊髓脓肿和骨髓炎。全国范围内， 2008至2014年间，因这些危及生命的感染而住院的人数翻了一番。即使 医院很容易为这些感染提供循证治疗，这是导致 首先，由于医院缺乏成瘾治疗专业知识，感染往往得不到解决。 因此，对这些患者的成瘾治疗通常在出院后提供。这一延迟 可能意味着错失了机会，因为这些严重感染的患者需要6周或更长时间的 住院接受静脉注射抗生素。强化门诊计划(IOP)具有可靠的经验 支持减少药物使用和促进禁欲，对住院患者和住院患者的影响类似 治疗。不幸的是，考虑到需要留在医院，传统的IOP不适合住院患者 医院和频繁的中断继承了住院环境。然而，研究要开发和测试 为住院的OUD患者量身定做的眼压完全不存在。为了满足这一需求，我们将进行一次NIH 使用序贯探索性设计的A/1B阶段行为干预开发试验以适应和试点 测试在线IOP程序(“SmartIOP”)，该程序允许使用移动设备远程提供强化治疗 在患者最方便的时间使用该设备。该计划在门诊环境中提供时，是 在6-12周内完成，包括异步视频模块和定期现场个体化治疗 会话。在第一阶段(阶段1A)，SmartIOP将适应住院患者的独特需求 通过对目前住院或有既往病史的患者进行定性研究 严重注射相关感染住院，以获得关于 程序。招聘将继续进行，直到达到主题饱和。然后将进行初始修改， 新的试点计划进行了测试，并在必要时进行了进一步的修改。培训材料和忠诚度工具 以确保干预措施的忠实管理将得到发展。在第二阶段(1B阶段)，我们 将对10名OUD患者进行初步研究，以评估干预的可行性和初步效果 因严重感染入院治疗。可行性将通过审查招聘和计划来确定 根据先验基准完成。作为探索性结果，将对初步疗效进行评估。 通过检查出院后与OUD相关的结果，包括非法阿片类药物的使用和治疗 留存。还将评估行为改变的可能机制。这项研究的结果将有助于 告知第二阶段或第三阶段疗效试验的设计。在新冠肺炎之后，这一研究方向仍将具有现实意义 鉴于住院的OUD患者可用的成瘾治疗选择有限，大流行。

Project Summary Abstract One of the devastating consequences of opioid use disorder (OUD) is the development of serious injection- related infections, such as infective endocarditis, spinal abscesses, and osteomyelitis. Nationally, hospitalizations for these life-threatening infections have doubled between 2008 and 2014. Even though hospitals readily provide evidence-based treatments for these infections, the underlying OUD that caused the infection in the first place often go unaddressed due to the lack of addiction treatment expertise in hospitals. Therefore, addiction treatment for these patients is typically offered after discharge from the hospital. This delay may represent a missed opportunity because patients with these serious infections require 6 weeks or more of hospitalization to receive intravenous antibiotics. Intensive outpatient programs (IOPs) have robust empirical support in reducing substance use and promoting abstinence, similar in impact to inpatient and residential treatment. Unfortunately, conventional IOPs are ill-suited for hospitalized patients given the need to remain in the hospital and the frequent interruptions inherit to the inpatient setting. However, research to develop and test an IOP tailored for hospitalized OUD patients is entirely absent. To address this need, we will conduct a NIH stage 1A/1B behavioral intervention development trial using a sequential exploratory design to adapt and pilot test an online IOP program (“SmartIOP”) that allows intensive treatment to be remotely delivered using a mobile device at a time that is most convenient for the patient. The program, when offered in the outpatient setting, is completed over 6-12 weeks, consisting of asynchronous video modules and periodic live individual therapy sessions. In the first phase (Stage 1A), SmartIOP will be adapted to the unique needs of hospitalized patients by conducting a qualitative study of OUD patients who are currently hospitalized or have had a prior hospitalization for serious injection-related infections to obtain feedback about the content and format of the program. Recruitment will continue until thematic saturation is reached. Initial modifications will then be made, the new program pilot tested, and further modifications made if necessary. Training materials and fidelity tools to ensure the faithful administration of the intervention will be developed. In the second phase (Stage 1B), we will conduct a pilot study to assess the intervention’s feasibility and preliminary efficacy with 10 OUD patients hospitalized with serious infections. Feasibility will be determined by examining recruitment and program completion according to a priori benchmarks. As an exploratory outcome, preliminary efficacy will be assessed by examining OUD-related outcomes after discharge from the hospital including illicit opioid use and treatment retention. Possible mechanisms of behavior change will also be assessed. The results of this study will help inform the design of a Stage II or III efficacy trial. This line of research will remain relevant after the COVID-19 pandemic given the limited options of addiction treatment available to hospitalized OUD patients.