SBIR-STTR Award

The Development and Evaluation of of Video Based Directly Observed Therapy for Office Based Treatment of Opioid Use Disorders with Buprenorphine is a project to develop a sustainable scalable and patient centered mobile health mHealth platform comprised of a patient facing mobile application and provider facing web portal for opioid use disorder treatment Methadone clinics are based on a directly observed therapy model for treatment where a health care worker visually confirms medication ingestion but there are not enough methadone clinics which require federal oversight to support the care needs of over million patients with opioid use disorders and many persons choose not seek treatment in such settings for fear of being stigmatized Since persons with opioid use disorders who desire medication assisted treatment can be treated with buprenorphine which has also been shown to be efficacious Buprenorphine treatment can occur in any medical office based setting is prescribed by any physician who seeks to become waivered and is taken by patients at home unsupervised Office based buprenorphine programs can significantly expand access to care but face similar capacity constraints with providing the frequent often weekly routine care and monitoring needed for this population during initial months of treatment Furthermore without visual confirmation of medication ingestion providers remain unsure if patients divert part or all of their buprenorphine medication Medication diversion risks and care retention challenges provide significant barriers to scaling office based buprenorphine programs to help combat the opioid epidemic This proposal will develop the technical and logistical workflow needs to implement a video based DOT application miDOT for office based buprenorphine monitoring during the initial months of care In Phase I we will configure miDOT to confirm medication ingestion of buprenorphine as well as provide digital support and patient engagement tools including HIPAA secure in app chat cravings reporting and appointment reminders In Phase II we will perform a pilot randomized trial of video based DOT compared to treatment as usual TAU for office based buprenorphine treatment to assess differences in addiction treatment outcomes Upon completion of Phases I and II we will be poised to expand the research to either a larger Phase III efficacy study or an implementation study of effectiveness in the real world setting through commercial partnerships developed over the course of this project To the best of our knowledge this will be the first evaluation of video based DOT in office based buprenorphine care The proposed study will develop and evaluate the effectiveness of video based directly observed therapy DOT in office based buprenorphine programs to improve care during initial months of treatment Video based DOT offers the benefit of patient and provider convenience by removing the need for frequent in person visits and has the potential for reduced stigma and better treatment outcomes due to improved adherence from a disease that disproportionately affects vulnerable populations The proposal will configure a video based DOT platform evaluate its effectiveness in securing medication ingestion and care retention for illicit opiate users and solidify routes of sustainable commercial viability with commercial partners

The Development and Evaluation of of Video-­Based Directly Observed Therapy for Office-­Based Treatment of Opioid Use Disorders with Buprenorphine is a project to develop a sustainable, scalable, and patient-­centered mobile health (mHealth) platform, comprised of a patient-­facing mobile application and provider-­facing web portal, for opioid use disorder treatment. Methadone clinics are based on a directly observed therapy model for treatment, where a health care worker visually confirms medication ingestion, but there are not enough methadone clinics (which require federal oversight) to support the care needs of over 2 million patients with opioid use disorders, and many persons choose not seek treatment in such settings for fear of being stigmatized. Since 2002, persons with opioid use disorders who desire medication assisted treatment can be treated with buprenorphine, which has also been shown to be efficacious. Buprenorphine treatment can occur in any medical office based setting, is prescribed by any physician who seeks to become waivered, and is taken by patients at home unsupervised. Office-­based buprenorphine programs can significantly expand access to care but face similar capacity constraints with providing the frequent, often weekly, routine care and monitoring needed for this population during initial months of treatment. Furthermore, without visual confirmation of medication ingestion, providers remain unsure if patients divert part or all of their buprenorphine medication. Medication diversion risks and care retention challenges provide significant barriers to scaling office-­based buprenorphine programs to help combat the opioid epidemic. This proposal will develop the technical and logistical workflow needs to implement a video-­based DOT application, miDOT, for office-­based buprenorphine monitoring during the initial months of care. In Phase I, we will configure miDOT to confirm medication ingestion of buprenorphine as well as provide digital support and patient engagement tools, including HIPAA-­secure in-­app chat, cravings reporting, and appointment reminders. In Phase II, we will perform a pilot randomized trial of video-­based DOT compared to treatment as usual (TAU) for office-­based buprenorphine treatment to assess differences in addiction treatment outcomes. Upon completion of Phases I and II, we will be poised to expand the research to either a larger, Phase III efficacy study, or an implementation study of effectiveness in the real-­ world setting through commercial partnerships developed over the course of this project. To the best of our knowledge, this will be the first evaluation of video-­based DOT in office-­based buprenorphine care.

Public Health Relevance Statement:
The proposed study will develop and evaluate the effectiveness of video-based directly observed therapy (DOT) in office-based buprenorphine programs to improve care during initial months of treatment. Video-based DOT offers the benefit of patient and provider convenience by removing the need for frequent, in-person visits and has the potential for reduced stigma and better treatment outcomes due to improved adherence from a disease that disproportionately affects vulnerable populations. The proposal will configure a video-based DOT platform, evaluate its effectiveness in securing medication ingestion and care retention for illicit opiate users, and solidify routes of sustainable commercial viability with commercial partners.

Project Terms:
Abstinence; addiction; Adherence; Adult; Adverse effects; Affect; American; Appointment; base; Buprenorphine; buprenorphine treatment; Caring; Case Management; Clinic; combat; Computer software; cost; craving; Custom; Data; design; Development; digital; Directly Observed Therapy; Disease; Dose; Dropout; Drops; Effectiveness; Effectiveness of Interventions; efficacy study; Ensure; Epidemic; Euphoria; Evaluation; Face; FDA approved; Feasibility Studies; Fright; Funding; Health; Health Insurance Portability and Accountability Act; Health Personnel; Health Services Accessibility; Hepatitis C; Heroin; HIV/HCV; Home environment; illicit drug use; illicit opioid; improved; infectious disease treatment; Ingestion; injection drug use; innovation; Internet; Interview; Laws; Lead; Logistics; Medical; medication compliance; medication-assisted treatment; Methadone; methadone clinic/center; methadone treatment; mHealth; mobile application; Modeling; Monitor; Morbidity - disease rate; mortality; Needs Assessment; new technology; Opioid; Opioid agonist; opioid agonist therapy; opioid epidemic; opioid overdose; opioid treatment program; opioid use; opioid use disorder; Opioid user; Outcome; Overdose; patient engagement; patient oriented; patient population; Patients; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacotherapy; Phase; phase III trial; Physicians; Pilot Projects; pilot trial; Population; prescription opioid; prevent; Primary Health Care; programs; Provider; randomized trial; Reporting; Research; Research Infrastructure; retention rate; Risk; Route; routine care; satisfaction; Secure; Sedation procedure; Site; social stigma; Specialist; Stigmatization; Structure; Technology; Testing; tool; treatment as usual; Treatment outcome; United States; Virus Diseases; Visit; Visual; Vulnerable Populations; waiver; web portal; Work