SBIR-STTR Award

Fatal overdose from opioid misuse is one of the most pressing issues affecting the modern world. As one of the nation's leading preventable causes of death, a critical line of defense against opioid use disorder (OUD) must be standardized screening provided by the patient's primary care physician, psychiatrist, and/or counselor. Standardized screening methods for opioids, however, are simply inferior and no gold standards exist. Reform proposals call for improved technology for electronic screening to save time and improve standards of care. Moreover, the National Institute of Mental Health's Research Domain Criteria (RDoC) framework prescribes a focus on defining the underlying functional dynamics of OUD instead of using symptom-based tools as biomarkers for disease. Therefore, the present proposal aims to develop a validated, theoretically-guided tool, which provides clinicians with information beyond OUD symptoms. Reinforcer pathology is a measure of severity derived from the synergy between two distinct decision-making processes, 1) preference for immediately available small rewards (i.e., excessive delay discounting) and 2) over-valuation of substances such as opioid prescription pills (i.e., high behavioral economic demand). Paramount to this proposal, decades of research have concluded that delay discounting and demand are highly correlated with substance use severity and important predictors of OUD treatment success. In order to develop a feasible and acceptable reinforcer pathology-based mobile tablet application, BEST-OUD, for use in the clinic, the present proposal aims to recruit clinicians to provide feedback via semi-structured interview sessions (Aim 1), and integrate the BEST-OUD application into their practice (Aim 3a). Development, iteration, and maintenance of the app, including the user-interface and back end, secure database, score calculation, and associated web portal will be built and maintained by BEAM Diagnostics, Inc. (Aim 2). A total of three tool prototype iterations, based on clinician feedback, will be administered to clinic patients throughout the testing period to collect reinforcer pathology scores and patient feedback (Aim 3b). This reinforcement pathology assessment tool is innovative given its propensity to bypass self-report of past substance use behavior and OUD symptoms, and prospectively predict severity based on a theoretical framework, making this Phase I STTR application both timely and necessary.

Public Health Relevance Statement:
PROJECT NARRATIVE Currently, over 2 million Americans suffer from opioid use disorder (OUD), a disease characterized by significant impairment or distress, and many of these individuals will ultimately transition to stronger, illegal, and dangerous opioids such as heroin, yet the current standardized screening measures for opioid misuse in clinical practice are poor and test only symptoms of past behavior. Instead, and in response to National Institute of Health's call for increased translation of theoretically-based screening tools that examine core functions of substance use disorders, the reinforcer pathology framework examines an individual's decision- making processes about opioid use providing the clinician with more information about patient OUD severity and prospective risk. The current proposal seeks to develop and test the feasibility of a reinforcer pathology mobile tablet application to rapidly assess OUD severity and risk in the clinic, providing improved screening of vulnerable patients.

Project Terms:
Adoption; Affect; Back; Dorsum; Behavior; Cause of Death; Clinic Visits; Communities; Computers; Counselor; Professional counselor; Dangerousness; Data Collection; Decision Making; Diamorphine; Diacetylmorphine; Heroin; Diagnosis; Disorder; Disease; Feedback; Goals; Gold; indexing; Interview; Literature; Maintenance; Manuals; Methods; Modernization; Motivation; NIMH; National Institute of Mental Health; National Institutes of Health; NIH; United States National Institutes of Health; Nurse Practitioners; Orthopedic Surgical Profession; Orthopedic; Orthopedics; Pathology; Patients; Physicians; Physicians' Extenders; Doctor's Assistants; Physician Assistants; Primary Care Physician; Privatization; Psychiatrist; Psychiatry; Questionnaires; Reinforcement; Psychological reinforcement; Research; Rewards; Risk; Risk Factors; Software; Computer software; Standardization; Stigmatization; Substance Use Disorder; Tablets; Technology; Testing; Time; Translations; Measures; Schedule; Caring; base; reinforcer; improved; Clinical; Phase; psychologic; psychological; Series; Screening procedure; screening tools; Failure; Distress; insight; Alcohol or Other Drugs use; using substances; substance using; substance use; AOD use; Individual; Databases; data base; Data Bases; Opioid; Opiates; tool; instrument; Diagnostic; Severities; Clinic; Inferior; Visit; preference; American; experience; impression; Performance; success; synergism; Structure; Patient Self-Report; Self-Report; Self-control as a personality trait; self control; Reporting; Bypass; Impulsivity; Modeling; response; pill; Address; Symptoms; Consent; Data; Small Business Technology Transfer Research; STTR; Characteristics; Process; Development; developmental; discount; discounting; prospective; innovation; innovative; innovate; Impairment; prototype; Biological Markers; biomarker; biologic marker; bio-markers; product development; clinical practice; prescription opioid; prescription opiate; prescribed opioid; prescribed opiate; opioid medication; opiate medication; licit opioid; Secure; screening; Research Domain Criteria; RDoC; behavioral economics; prognostic value; prognostic utility; prognostic power; application programming interface; Assessment tool; Assessment instrument; web portal; internet portal; opioid use disorder; opiate use disorder; opioid use; opioid intake; opioid drug use; opioid consumption; opiate use; opiate intake; opiate drug use; opiate consumption; opioid overdose; opioid toxicity; opioid related overdose; opioid poisoning; opioid medication overdose; opioid intoxication; opioid induced overdose; opioid drug overdose; opiate related overdose; opiate overdose; opioid mortality; opioid related death; opioid overdose death; opioid deaths; opiate mortality; opiate deaths; recruit; patient screening; preventable death; preventable mortality; opioid misuse; opiate misuse; nonmedical opioid use; non-medical opioid use; screening guidelines; screening recommendations; recommended screening

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.

Public Health Relevance Statement:
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.

Project Terms:
Outcome; discounting; Impairment; interoperability; usability; prototype; commercialization; combat; evidence base; routine practice; clinical practice; Secure; screenings; screening; behavioral economics; Limited English Proficiency; Assessment instrument; Assessment tool; opiate use disorder; opioid use disorder; improved outcome; disparity in care; disparity in healthcare; health care inequality; health care inequity; healthcare disparity; healthcare inequality; healthcare inequity; health care disparity; predict relapse; relapse prediction; relapse risk; clinical development; opiate crisis; opioid crisis; opioid epidemic; opiate overdose; opiate related overdose; opioid drug overdose; opioid induced overdose; opioid intoxication; opioid medication overdose; opioid poisoning; opioid related overdose; opioid toxicity; opioid overdose; opiate deaths; opiate mortality; opioid deaths; opioid overdose death; opioid related death; opioid mortality; healthcare settings; health care settings; provider barriers; provider-level barriers; non-medical opioid use; nonmedical opioid use; opiate misuse; opioid misuse; COVID crisis; COVID epidemic; COVID pandemic; COVID-19 crisis; COVID-19 epidemic; COVID-19 global health crisis; COVID-19 global pandemic; COVID-19 health crisis; COVID-19 public health crisis; COVID19 crisis; COVID19 epidemic; COVID19 global health crisis; COVID19 global pandemic; COVID19 health crisis; COVID19 pandemic; COVID19 public health crisis; SARS-CoV-2 epidemic; SARS-CoV-2 global health crisis; SARS-CoV-2 global pandemic; SARS-CoV-2 pandemic; SARS-CoV2 epidemic; SARS-CoV2 pandemic; SARS-coronavirus-2 epidemic; SARS-coronavirus-2 pandemic; Severe Acute Respiratory Syndrome CoV 2 epidemic; Severe Acute Respiratory Syndrome CoV 2 pandemic; Severe acute respiratory syndrome coronavirus 2 epidemic; Severe acute respiratory syndrome coronavirus 2 pandemic; corona virus disease 2019 epidemic; corona virus disease 2019 pandemic; coronavirus disease 2019 crisis; coronavirus disease 2019 epidemic; coronavirus disease 2019 global health crisis; coronavirus disease 2019 global pandemic; coronavirus disease 2019 health crisis; coronavirus disease 2019 pandemic; coronavirus disease 2019 public health crisis; coronavirus disease crisis; coronavirus disease epidemic; coronavirus disease pandemic; coronavirus disease-19 global pandemic; coronavirus disease-19 pandemic; severe acute respiratory syndrome coronavirus 2 global health crisis; severe acute respiratory syndrome coronavirus 2 global pandemic; COVID-19 pandemic; patient health record; patient medical record; patient health information; acceptability and feasibility; Prognosis; primary care provider; Primary Care; digital tool; electronic medical record system; EMR system; electronic medical system; digital platform; digital assessment; Adoption; Affect; Behavior Disorders; behavioral disorder; Behavioral Sciences; Clinical Research; Clinical Study; Communication; Cessation of life; Death; Decision Making; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Education; Educational aspects; Family Practice; family medicine; Feedback; Future; Goals; Healthcare Systems; Health Care Systems; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Interview; Judgment; Language; Literature; Marketing; Mental Health; Mental Hygiene; Psychological Health; Methodology; Morbidity - disease rate; Morbidity; mortality; Outpatients; Out-patients; Pathology; Patients; Play; Recommendation; Psychological reinforcement; Reinforcement; Rewards; Role; social role; Science; Self Administration; Self Administered; medical specialties; Specialty; Standardization; Stigmatization; Substance Use Disorder; substance use and disorder; Tablets; Testing; Time; Translating; Translations; translation; United States; Computerized Medical Record; Electronic Medical Record; Measures; Addictive Behavior; health care; Healthcare; Risk Assessment; Caring; reinforcer; improved; Site; Clinical; Phase; Medical; Susceptibility; Predisposition; screening tools; Screening procedure; disability; insight; Individual; Opiates; Opioid; Measurement; Technology Transfer; Patient-Centered Care; uptake; tool; instrument; Diagnostic; Adopted; Severities; Visit; American; experience; Family health status; Family Health; Health Insurance Portability and Accountability Act; HIPAA; Kennedy Kassebaum Act; PL 104-191; PL104-191; Public Law 104-191; United States Health Insurance Portability and Accountability Act; Structure; disorder risk; disease risk; Reporting; Positioning Attribute; Position; Modeling; Provider; preventing; prevent; Address; Health system; Educational Materials; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; patient oriented outcomes; Security; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Small Business Technology Transfer Research; STTR; Characteristics; Process; Development; developmental; point of care; Behavioral; Output; digital; Clinical assessments