PROJECT SUMMARY Opioid use disorder (OUD) is a major contributor to excessive disability, morbidity, and mortality in the United States. Currently, almost 10 million Americans misuse opioid substances and 2.7 million Americans suffer from OUD. In the past year alone, U.S. opioid overdose deaths have increased by nearly 30%, resulting in an annual mortality rate of >100,000, akin to a death every 5 minutes. Given the scope of the U.S. opioid epidemic, there is an essential need for proactive, routine, evidence-based OUD screening by an individual’s prescribing primary care provider or mental health clinicians. However, screening for opioid misuse is underperformed, laborious, and is susceptible to demand characteristics and concerns about stigmatizing the patient. To combat these issues, BEAM Diagnostics, Inc. developed Beacon-OUD, a commercializable digital screening tool for OUD. The tool is based on the theoretical behavioral framework of reinforcer pathology, a widely adopted behavioral economic approach to addictive behavior. Beacon-OUD is: (1) quick and easy-to-deliver to patients, with automated, standardized scoring to reduce time barriers; (2) accessible, easy-to-comprehend and self- administer; (3) non-stigmatizing and assesses risk without disclosing sensitive information; (4) oriented to current and future, not past, OUD behavior; and 5) interoperable and integrated with a patient’s medical record to improve the standards for OUD assessment and patient-centered care. In Phase I of this project, we conducted a clinical study, validating Beacon-OUD as demonstrating robust predictive accuracy of opioid misuse and receiving positive reports of feasibility and acceptability from providers. The goal of this Phase II SBIR is to extend Beacon-OUD’s development into a fully realized commercial product, both as a stand-alone tool and as an integrated tool within an electronic medical record (EMR) system at a large multi-site healthcare system serving approximately 1M outpatients per year. Aim 1 will optimize the user-experience and accessibility of Beacon-OUD as a product, produce comprehensive clinical reference materials, and complete a Spanish- language translation. Aim 2 will integrate Beacon-OUD into EPIC, a widely used electronic medical record system within a health system partner to improve usability, workflow capabilities, and record-keeping of opioid misuse directly in a patient’s medical chart. In addition, Aim 2 will launch education and implementation initiatives to promote Beacon-OUD’s use primary care. Finally, BEAM will complete an Exploratory Aim seeking to validate and expand Beacon-OUD’s clinical utility as a measurement-based care tool for OUD treatment prognosis. At the conclusion of this Phase II project, BEAM will have brought Beacon-OUD to market as a digital assessment for OUD measurement, both as a stand-alone product and an EMR-integrated version.

PROJECT NARRATIVE Fatal opioid overdose is one of the most pressing issues affecting the U.S., yet the current standardized screening measures for opioid misuse in clinical practice are under-performed, laborious, and susceptible to demand characteristics and concerns about stigmatizing the patient. To combat these issues, BEAM Diagnostics, Inc. developed Beacon-OUD, a digital opioid misuse assessment that efficiently produces an objective measure and prevents potential judgements related to patient status, circumstance, or bias. This proposal, an extension of a successful Phase I STTR, seeks to develop Beacon-OUD into a fully-realized product for use both as a stand-alone tool and as an EMR-integrated solution for large healthcare systems to maximize standardized opioid screening in a variety of healthcare settings.