Millions of people in the US misuse opioids each year, leading to thousands of deaths and costing billions of dollars in total economic burden. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common and associated with poor outcomes. This STTR Fast Track proposal is designed to increase rates of Suboxone (buprenorphine/naloxone) treatment initiation and adherence among OUD patients recruited from emergency and inpatient acute care. To accomplish these aims, the project will enhance the Opioid Addiction Recovery Support (OARS), an existing Q2i company technology, with a new evidence-based reward, contingency management (CM) function. CM interventions systematically reward (reinforce) specific behaviors like treatment initiation and adherence with therapy attendance and drug-free urine tests, and are highly efficacious. An OARS solution enhanced with a CM component (OARS+CM) that allows for the automatic calculation, delivery, and redemption of rewards contingent on objective evidence of treatment behaviors may be key to improving Suboxone initiation and adherence. In Phase 1 of this proposal, the existing OARS clinician portal and patient mobile application will be modified to accommodate entry into the software system from an acute care setting and to automatically manage and deliver rewards to create OARS+CM using patient-centered design principles. Usability sessions with OUD patients and other key stakeholders will inform design. Primary usability outcomes will be examined and the program iteratively updated. On meeting milestones, there will be proof-of-concept pilot of usability, acceptability, and effects on initial behavior targets with approximately 20 patients and at least 4 providers. On meeting milestones, a RCT will follow, in which acute care OUD patients appropriate for outpatient Suboxone (N = 150) are recruited and allocated to one of three study conditions: 1) treatment as usual (TAU), comprised of screening, brief intervention, and referral to treatment by a trained clinician, 2) OARS, and 3) OARS+CM. The active intervention window for the two intervention groups will be 12 weeks. Patients will be onboarded prior to discharge from acute care. In the outpatient Suboxone setting, data on treatment adherence and opioid use will be captured from clinical records for six months. Telephone follow-up assessments and vital statics registry reviews will be at month 1, month 3 (end-of-study intervention period), and month 6. Primary Suboxone treatment initiation outcomes will be scheduling and completing the Suboxone intake. Primary Suboxone treatment outcomes will be sustained abstinence at Month 6 and longest duration of abstinence. Analysis will examine data on cost avoidance and cost savings through reduced acute care visits between study conditions.
Public Health Relevance Statement: PROJECT NARRATIVE-Public Health Relevance Increasing the demand and reach of effective Medication Assistance Treatment (MAT) for opioid use disorder (OUD) is critical to decreasing OUD associated morbidity, mortality, and economic consequences. The technology breakthrough to be studied in this project will give individuals with OUD access to a smartphone application designed to help support initiation and adherence with MAT treatment regimens through patient- oriented educational and monitoring features, as well as a new evidence-based reward function shown in other research to promote treatment adherence, improve abstinence, and improve other health outcomes. The intervention will aim to facilitate the entire treatment trajectory, starting with initial transition from an acute care setting to outpatient MAT initiation and continuing through successful transition to maintenance.
Project Terms: Ambulatory Care; outpatient treatment; Outpatient Care; Behavior; Behavior Therapy; behavioral intervention; behavior intervention; Conditioning Therapy; Behavioral Treatment; Behavioral Therapy; Behavioral Modification; Behavioral Conditioning Therapy; Behavior Treatment; Behavior Modification; Behavior Conditioning Therapy; cost effectiveness; Death; Cessation of life; drug/agent; Pharmaceutic Preparations; Medication; Drugs; Pharmaceutical Preparations; Economics; Educational aspects; Education; Emergencies; Emergency Situation; Feedback; Health; indexing; Inpatients; interventions research; interventional study; interventional research; intervention research; Intervention Studies; Maintenance; detoxification; Metabolism of Toxic Agents; Metabolic Drug Detoxications; Drug Metabolic Detoxification; Drug Metabolic Detoxication; Methods; Morbidity; Morbidity - disease rate; mortality; Persons; Out-patients; Outpatients; Patients; Records; Registries; Research; Rewards; Software; Computer software; Technology; Phone; Telephone; Testing; Treatment Schedule; Treatment Regimen; Treatment Protocols; Urine Urinary System; Urine; Work; Treatment outcome; Cost Savings; Healthcare Team; Health Care Team; Medical Care Team; Schedule; Caring; base; improved; Acute; Clinical; Phase; Training; Individual; Recovery; Opioid; Opiates; Patient Recruitments; participant recruitment; Randomized Controlled Trials; randomized controlled study; tool; programs; Protocols documentation; Protocol; System; Opiate Addiction; opioid dependent; opioid dependence; opioid addiction; Opiate Dependence; Visit; meetings; preference; Accident and Emergency department; Emergency room; Emergency Department; experience; novel; Participant; contingency management; Devices; Positioning Attribute; Position; Intervention; interventional strategy; Intervention Strategies; Provider; Adherence; Data; Economic Burden; Intake; Randomized; randomly assigned; randomization; randomisation; Small Business Technology Transfer Research; STTR; Update; Monitor; cost; software systems; design; designing; Outcome; Population; innovation; innovative; innovate; Abstinence; patient oriented; patient centered; user centered design; usability; public health relevance; evidence base; group intervention; patient population; treatment as usual; usual care; treatment adherence; screening, brief intervention, referral, and treatment; screening, brief intervention, and referral to treatment; SBIRT; follow up assessment; followup assessment; flexibility; flexible; mHealth; mobile health; m-Health; mobile application; mobile app; Emergency department visit; Emergency room visit; Emergency care visit; ER visit; ED visit; opioid use disorder; opiate use disorder; medication-assisted treatment; opioid use; opioid intake; opioid drug use; opioid consumption; opiate use; opiate intake; opiate drug use; opiate consumption; recruit; smartphone Application; iPhone Application; iPhone App; iOS application; iOS app; Smartphone App; Smart Phone Application; Smart Phone App; Cellular Phone Application; Cellular Phone App; Cell phone App; Cell Phone Application; Android Application; Android App; Suboxone; buprenorphine/naloxone; buprenorphine-naloxone; buprenorphine with naloxone; buprenorphine and naloxone; buprenorphine + naloxone; Zubsolv; Bunavail; opioid misuse; opiate misuse; nonmedical opioid use; non-medical opioid use
