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

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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.