SBIR-STTR Award

Alcohol use disorder (AUD) contributes to excessive disability, morbidity, and mortality in the United States. As one of the nation?s leading preventable causes of death, the first line of defense against AUD must be standardized screening provided by the patient?s primary care physician, psychiatrist, and/or counselor. Standardized screening, however, is simply under-performed. 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 AUD 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 AUD 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 alcohol rewards (i.e., high behavioral economic demand). Paramount to this proposal, decades of research have concluded that delay discounting and demand are highly correlated with alcohol use severity and important predictors of AUD treatment success. In order to develop a feasible and acceptable reinforcer pathology-based mobile tablet application, BEACON, for use in the clinic, the present proposal aims to recruit clinicians to provide feedback via focus group sessions (Aim 1), and integrate the BEACON into their practice (Aim 3a), executed by BEAM Diagnostics, Inc. 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 Virginia Tech Carilion Research Institute (Aim 2). A total of three tool prototype iterations, based on clinician focus group feedback, will be administered to clinic patients throughout the testing period to collect reinforcer pathology scores and patient feedback (Aim 3b; BEAM Diagnostics, Inc). This reinforcement pathology assessment tool is innovative given its propensity to by-pass self-report of past drinking behavior AUD symptoms and prospectively predict severity based on a theoretical framework, making this Phase I STTR application both timely and necessary.

Project Terms:
Address; Adoption; alcohol availability; Alcohol consumption; alcohol misuse; alcohol reward; alcohol use disorder; Alcohols; application programming interface; Assessment tool; Back; base; Behavior; behavioral economics; Biological Markers; Caring; Cause of Death; Cessation of life; Characteristics; Clinic; Clinic Visits; Clinical; clinical practice; Communities; Computer software; Computers; Consent; Data; Data Collection; Databases; Decision Making; Development; Diagnosis; Diagnostic; disability; discount; discounting; Disease; Distress; drinking behavior; Educational Materials; Environment; experience; Failure; Feedback; Focus Groups; Goals; Gold; impression; improved; Impulsivity; indexing; Individual; innovation; insight; instrument; Internal Medicine; Literature; Maintenance; Manuals; Measures; Medical; Modeling; Morbidity - disease rate; mortality; Motivation; National Institute of Mental Health; Nurse Practitioners; Pathology; patient screening; Patient Self-Report; Patients; Performance; Phase; Physician Assistants; Physicians; Play; preference; Primary Care Physician; Primary Health Care; Privatization; Process; product development; Professional counselor; prognostic value; prospective; prototype; Provider; Psychiatrist; Psychiatry; psychologic; Psychological reinforcement; Questionnaires; recruit; reinforcer; Reporting; Research; Research Domain Criteria; Research Institute; response; Rewards; Risk; Role; Schedule; screening; Screening procedure; Secure; Self-control as a personality trait; Series; Severities; Small Business Technology Transfer Research; Standardization; Stigmatization; Substance Use Disorder; success; Symptoms; synergism; Tablets; Technology; Technology Transfer; Testing; Time; tool; Translations; United States; United States National Institutes of Health; Virginia; Visit; web portal;

Alcohol use disorder (AUD) contributes to excessive disability, morbidity, and mortality in the United States. As one of the nation’s leading causes of death, public health guidelines recommend consistent standardized alcohol screening. However, screening for alcohol 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, a commercializable alcohol misuse digital screening tool based on the theoretical framework of reinforcer pathology dedicated to increasing standardized screening without stigmatizing the patient. In Phase I of this project, we conducted a clinical study at a large multi-site healthcare system serving approximately 1M patients per year and validated Beacon as demonstrating robust predictive accuracy of alcohol misuse and positive reports of feasibility and acceptability from providers. The goal of this Phase II SBIR is to finalize Beacon’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. Aim 1 will iterate and optimize the user-experience and accessibility of Beacon as a product, develop nationally representative norming, produce comprehensive clinical reference materials, ensure offline capability, and Spanish-language translation. Aim 2 will be dedicated to integrating Beacon into EPIC, a widely used electronic medical record system within a healthsystem partner, to improve usability, workflow capabilities, and record-keeping of alcohol misuse directly into a patient’s medical chart. In addition, Aim 2 will launch a wave-style education and implementation initiative to promote Beacon’s use in three outpatient departments. Finally, BEAM will complete an Exploratory Aim seeking to validate Beacon as a measurement-based care tool. At the conclusion of this Phase II project, BEAM will brought Beacon to market as a digital screening app for AUD, both as a stand-alone product and an EMR-integrated version. Public Health Relevance Statement PROJECT NARRATIVE Alcohol use disorder (AUD) are major contributors to disability, morbidity, and mortality, yet the current standardized screening measures 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, a commercializable alcohol misuse digital screening tool based on the theoretical framework of reinforcer pathology dedicated to increasing screening without stigmatizing the patient. This proposal, an extension of a successful Phase I STTR, seeks to develop Beacon 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 screening in a variety of healthcare environments.