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

为因严重注射相关感染而住院的阿片类药物使用障碍患者开发并试点测试一种新型远程密集门诊项目

• 批准号: 10510136
• 负责人: Joji Suzuki
• 金额: $ 18.51万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10510136
• 关键词: Abscess; Abstinence; Address; Aftercare; Ambulatory Care; Antibiotics; Behavior Therapy; Behavioral Mechanisms; Behavioral Model; Benchmarking; COVID-19 pandemic; Consultations; Coping Skills; Development; Educational process of instructing; Enrollment; Ensure; Evaluation; Evidence based treatment; Feedback; Goals; Hospitalization; Hospitals; Hour; Individual; Infection; Infective endocarditis; Inherited; Injections; Inpatients; Interruption; Intervention; Intravenous; Life; Medical; Modification; National Institute of Drug Abuse; Operative Surgical Procedures; Osteomyelitis; Outcome; Outpatients; Participant; Patients; Periodicity; Pharmaceutical Preparations; Phase; Pilot Projects; Public Health; Recovery; Research; Residential Treatment; Services; Site; Spinal; Testing; Time; Training; Treatment Efficacy; United States National Institutes of Health; addiction; behavior change; comorbidity; design; disorder later incidence prevention; effective therapy; efficacy trial; experience; feasibility testing; feasibility trial; handheld mobile device; high risk; illicit opioid; improved; innovation; mortality; novel; online delivery; opioid use; opioid use disorder; outpatient programs; patient population; peer; pilot test; primary outcome; programs; psychosocial wellbeing; recruit; reduced substance use; remote delivery; response; secondary outcome; therapy development; tool; treatment group

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.

项目概要摘要 阿片类药物使用障碍 (OUD) 的破坏性后果之一是严重的注射- 相关感染，例如感染性心内膜炎、脊髓脓肿和骨髓炎。 2008 年至 2014 年间，因这些危及生命的感染而住院的人数增加了一倍。 医院很容易为这些感染提供循证治疗，这是导致这些感染的潜在 OUD 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，这些患者的成瘾治疗通常是在出院后进行。 可能会错失良机，因为患有这些严重感染的患者需要 6 周或更长时间的治疗 住院接受静脉注射抗生素治疗的强化门诊计划（IOP）具有可靠的经验。 支持减少药物使用和促进戒酒，与住院和住院患者的影响类似 不幸的是，考虑到需要留在医院的住院患者，传统的 IOP 并不适合。 然而，医院和住院环境中的频繁中断仍然需要研究来开发和测试。 完全没有为住院 OUD 患者量身定制的 IOP。为了满足这一需求，我们将开展 NIH。 使用序贯探索性设计进行调整和试点的 1A/1B 阶段行为干预开发试验 测试在线 IOP 程序（“SmartIOP”），该程序允许使用移动设备远程进行强化治疗 在对患者来说最方便的时间使用设备 该计划在门诊环境中提供时，是 历时 6-12 周完成，包括异步视频模块和定期现场个体治疗 在第一阶段（第 1A 阶段），SmartIOP 将适应住院患者的独特需求。 通过对目前住院或既往有过住院史的 OUD 患者进行定性研究 因严重注射相关感染而住院，以获得有关内容和格式的反馈 计划将继续进行，直至主题达到饱和，然后进行初步修改。 新计划进行了试点测试，并在必要时进行了进一步修改。 为了确保干预措施的忠实实施，我们将在第二阶段（第 1B 阶段）进行。 将针对 10 名 OUD 患者进行一项试点研究，以评估干预措施的可行性和初步疗效 严重感染住院的可行性将通过招募和计划来确定。 根据先验基准完成任务 作为探索性结果，将评估初步功效。 通过检查出院后 OUD 相关结果，包括非法阿片类药物的使用和治疗 还将评估行为改变的可能机制。这项研究的结果将有所帮助。 为 II 期或 III 期疗效试验的设计提供信息。在 COVID-19 疫情之后，该研究仍将保持相关性。 鉴于住院 OUD 患者可用的成瘾治疗选择有限，因此大流行。