SBIR-STTR Award

Over 11 million Americans aged 12 or older reported opioid misuse in 2016. Over 40,000 people died due to opioid-related overdoses in 2016, up 345% from 2001 to 2016. Preventing the onset of opioid misuse is critical for young adults, who represent 2.5 million past year opioid misusers. Opioid misuse in this developmental period can negatively affect mental, physical, and social well-being and can lead to morbidity and mortality due to overdose. Young adults entering the workforce are especially susceptible to substance use. In the workplace, annual overdose deaths from the non-medical use of drugs or alcohol have risen by 38% from 2013 to 2016 and 70% of employers have reported negative consequences of opioid misuse. Despite these rates of use and negative consequences, only 24% of employers offer workplace prevention of these dangers. Construction trade workers have the highest proportional mortality ratio for premature death by opioid overdose. Broad normalization of pain, injury, musculoskeletal disorders, and psychological distress associated with chronic pain, safety conditions, job insecurity, and unsatisfactory work arrangements may contribute to opioid misuse among this workforce. At the present time, primary prevention efforts have not addressed the significant impact of opioid misuse on young adult construction trade workers. The objective of this study is to is to develop an optimized, highly effective and efficient mobile-friendly web-based intervention that is immediately scalable and focused on preventing opioid misuse among young adult construction trade workers. This Phase I study will use the Preparation phase of the Multiphase Optimization Strategy (MOST) approach which includes the development of a comprehensive, evidence-based framework that identifies causal pathways to intervene on which is essential to developing effective and sustainable behavioral interventions. This formative work will guide the development and assessment of a behavioral intervention that is feasible, culturally competent, and targets empirically established mediators. The specific aims of this study are to 1) Develop a storyboard for a behavioral intervention based on our theory- and expert- informed conceptual model; 2) Produce a fully functional intervention component prototype; and 3) Pilot test the intervention component prototype to assess preliminary scientific and technical merit as well as the validity of the conceptual model. Fulfillment of these aims will ultimately position the research team to propose a Phase II SBIR grant focused on an optimization trial(s) (i.e. identification of the most effective intervention components to be included in the full intervention) and rigorous evaluation of a feasible, technically sound, and commercially viable opioid misuse prevention program.

Public Health Relevance Statement:


Project narrative:
This project will significantly and positively contribute to a body of research aimed at preventing prescription opioid misuse among young adult construction trade workers. A conceptual model describing mediating risk and protective factors and their influence on intentions and behaviors associated with prescription opioid misuse will be revised, tested, and applied as a guiding framework for developing a storyboard for an effective, evidence-based prevention program. One fully functional intervention component prototype will be built and tested with construction trade worker participants for technical and scientific merit.

Project Terms:
Absenteeism; Adoption; Alcohols; Alcohol Chemical Class; Analgesics; painkiller; pain reliever; pain medication; pain killer; Antinociceptive Drugs; Antinociceptive Agents; Anodynes; Analgesic Preparation; Analgesic Drugs; Analgesic Agents; 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; Consultations; Diamorphine; Diacetylmorphine; Heroin; Feedback; Focus Groups; Foundations; Grant; Group Interviews; Health; Industry; Institutes; heavy metal lead; heavy metal Pb; Pb element; Lead; Morbidity; Morbidity - disease rate; mortality; musculoskeletal disorder; Musculoskeletal Diseases; National Institute for Occupational Safety and Health; Professional Positions; Jobs; Occupations; web based; online computer; On-Line Systems; Online Systems; Overdose; Painful; Pain; Primary Prevention; Public Health; Research; Risk Factors; Safety; sound; Testing; Time; Work; Workmens Compensation; Workmen's Compensation; Workmans Compensation; Workers' Compensation; falls; Mediating; Schedule; chronic pain; Workplace; work setting; Worksite; Work-Site; Work Place; Work Location; Job Site; Job Setting; Job Place; Job Location; Injury; base; premature; prematurity; Phase; Evaluation; Psyche structure; mental; Alcohol or Other Drugs use; using substances; substance using; substance use; AOD use; young adult; young adulthood; adult youth; Opioid; Opiates; Drug usage; drug use; Randomized Controlled Trials; randomized controlled study; Hour; Occupational; American; Performance; Participant; Prevention program; Prevention; Reporting; Positioning Attribute; Position; psychological distress; Modeling; theories; Intervention; interventional strategy; Intervention Strategies; preventing; prevent; Mediator of activation protein; Mediator of Activation; Mediator; Address; Data; Small Business Innovation Research Grant; Small Business Innovation Research; SBIR; Preparation; Development; developmental; Pathway interactions; pathway; Instruction; cost; Social Well-Being; social wellbeing; design; designing; Outcome; aged; addiction; addictive disorder; therapy design; treatment design; intervention design; therapy development; treatment development; intervention development; develop therapy; prototype; effective intervention; evidence base; nonmedical use; non-medical use; overdose death; surveillance data; phase 1 study; Phase I Study; prescription opioid; prescription opiate; prescribed opioid; prescribed opiate; opioid medication; opiate medication; licit opioid; arm; cognitive load; cognitive burden; negative affect; negative affectivity; 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; heroin use; heroin intake; protective factors; prescription opioid misuse; prescription opiate misuse; opioid prescription medication misuse; opioid medication misuse; opioid analgesic misuse; nonmedical use of prescription opioids; nonmedical use of prescription opiates; non-medical use of prescription opioids; non-medical use of prescription opiates; opioid misuse; opiate misuse; nonmedical opioid use; non-medical opioid use

11.8 million Americans aged 12 or older reported opioid misuse in 2016. Over 40,000 people died due to opioid-related overdoses in 2016, up 345% from 2001 to 2016. Prescription opioids have historically served as an onboarding ramp to drugs with a high-risk of overdose, including heroin and the highly potent and accessible, fentanyl. Strikingly, 21 to 29 percent of patients prescribed opioids for chronic pain misuse or overuse them and individuals with a history of prescription opioid abuse are 40 times more likely to abuse heroin. In the workplace, prescription opioids for pain made up an average of 85% of prescribed pain medications according to state-level workers' compensation claims, and injured workers are issued opioid prescriptions at a rate three times the national average. Construction trade workers, a 95.9% male-dominated industry, exhibit the highest rates of opioid dispensing in workers' compensation claims and registered nurses and certified nursing assistants, made up of 90% women, report the greatest number of non-fatal work-related injuries. To date, no evidence-based interventions targeting industries with a high-risk for prescription opioid misuse and/or overuse, based on injury and prescribing rates, exist. Thus, there is a critical need for an engaging, scalable, evidence-based intervention for the prevention of prescription opioid misuse and/or overuse among high-risk workforce populations, namely, construction trade workers and employees in nursing. Evidence-based mHealth interventions are an effective intervention delivery method for high-risk health behavior interventions. The objective of this proposed research is to develop an optimized, highly effective, mHealth intervention designed to prevent prescription opioid use among workers in industries with a high risk for injury and opioid prescribing. The research and development performed in the proposed Phase II project will result in a fully designed, optimized, and evaluated, market-ready product to be implemented among high- risk industries. The specific aims of this study are to 1) Develop the remaining two fully functional intervention components targeting motivational factors associated with intentions to use prescription opioid medications for pain; 2) Optimize and evaluate the intervention lessons. At the completion of the proposed research and development, our expected outcome is to have demonstrated scientific and technical merit for the first evidence-based intervention for preventing prescription opioid misuse and/or overuse among workers of high- risk industries.

Public Health Relevance Statement:
PROJECT NARRATIVE This project will significantly and positively contribute to a body of research aimed at preventing prescription opioid misuse and overuse among vulnerable, industry specific workforces. This project will result in the development of an optimized mobile health prescription opioid misuse and overuse prevention intervention for construction workers, nurses, and nurse assistants. At the conclusion of the study, the optimized intervention will be readily available to organizations supporting the health of workers within at-risk industries.

Project Terms:
Opiate Dependence; opioid addiction; opioid dependence; opioid dependent; Opiate Addiction; American; Employee; Heroin Abuse; R.N.; Registered nurse; Prevention; Reporting; Modeling; Sampling; Intervention Strategies; interventional strategy; Intervention; preventing; prevent; Address; Dose; Data; NIDA; National Institute on Drug Abuse; National Institute of Drug Abuse; Preventative intervention; intervention for prevention; prevention intervention; preventional intervention strategy; preventive intervention; randomisation; randomization; randomly assigned; Randomized; Development; developmental; Behavioral; injured; digital; design; designing; Outcome; Expectancy; Population; aged; innovation; innovate; innovative; Evidence based intervention; therapy design; intervention design; treatment design; prototype; high risk; effective intervention; evidence base; prescription opioid abuse; opioid medication abuse; opioid prescription drug abuse; prescription opiate abuse; prescription opioid; licit opioid; opiate medication; opioid medication; prescribed opiate; prescribed opioid; prescription opiate; mHealth; m-Health; mobile health; mobile application; mobile app; mobile device application; opioid use disorder; opiate use disorder; substance misuse prevention; prevent substance misuse; opioid use; opiate consumption; opiate drug use; opiate intake; opiate use; opioid consumption; opioid drug use; opioid intake; pain symptom; painful symptom; experimental study; experiment; experimental research; opioid epidemic; opiate crisis; opioid crisis; opioid overdose; opiate overdose; opiate related overdose; opioid drug overdose; opioid induced overdose; opioid intoxication; opioid medication overdose; opioid poisoning; opioid related overdose; opioid toxicity; recruit; patient-clinician communication; patient-doctor communication; patient-provider communication; overdose risk; prescription opioid misuse; non-medical use of prescription opiates; non-medical use of prescription opioids; nonmedical use of prescription opiates; nonmedical use of prescription opioids; opioid analgesic misuse; opioid medication misuse; opioid prescription medication misuse; prescription opiate misuse; opioid misuse; non-medical opioid use; nonmedical opioid use; opiate misuse; opioid overuse; multiple data sources; COVID-19 pandemic; 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; multiphase optimization strategy; chronic pain management; chronic pain control; chronic pain intervention; chronic pain therapy; chronic pain treatment; treat chronic pain; Helping to End Addiction Long-term; HEAL Initiative; Helping End Addiction Long-term; Helping End Addiction Longterm; Helping to End Addiction Longterm; intervention delivery; pilot test; Overdose reversal; reverse overdose; Adult; 21+ years old; Adult Human; adulthood; Analgesics; Analgesic Agents; Analgesic Drugs; Analgesic Preparation; Anodynes; Antinociceptive Agents; Antinociceptive Drugs; pain killer; pain medication; pain reliever; painkiller; Opioid Analgesics; opiate analgesia; opiate analgesic; opiate pain medication; opiate pain reliever; opioid analgesia; opioid anesthetic; opioid pain medication; opioid pain reliever; opioid painkiller; Back; Dorsum; Behavior Therapy; Behavior Conditioning Therapy; Behavior Modification; Behavior Treatment; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Conditioning Therapy; behavior intervention; behavioral intervention; Centers for Disease Control and Prevention (U.S.); CDC; Centers for Disease Control; Centers for Disease Control and Prevention; United States Centers for Disease Control; United States Centers for Disease Control and Prevention; Heroin; Diacetylmorphine; Diamorphine; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Exhibits; Fentanyl; Actiq; Duragesic; Fentanest; Fentyl; Phentanyl; Fracture; bone fracture; Goals; Health; Health behavior; health related behavior; Recording of previous events; History; Incidence; Industry; Laws; male; Mental Health; Mental Hygiene; Psychological Health; Methods; mortality; Motivation; Musculoskeletal Diseases; musculoskeletal disorder; Myocardial Infarction; Cardiac infarction; Myocardial Infarct; cardiac infarct; coronary attack; coronary infarct; coronary infarction; heart attack; heart infarct; heart infarction; Naloxone; Persons; National Institute for Occupational Safety and Health; NIH; National Institutes of Health; United States National Institutes of Health; nurse; Nurses; Nursing; Nursing Field; Nursing Profession; Discipline of Nursing; Overdose; Painful; Pain; Patients; QOL; Quality of life; Ramp; Recommendation; Research; Development and Research; R & D; R&D; research and development; Risk; Safety; Technology; Testing; Time; Woman; Work; Workers' Compensation; Workmans Compensation; Workmen's Compensation; Workmens Compensation; Privacy; Drug Monitoring; Withdrawal Symptom; chronic pain; Caring; Law Enforcement; Workplace; Job Location; Job Place; Job Setting; Job Site; Work Location; Work Place; Work-Site; Worksite; work setting; Guidelines; Injury; injuries; base; improved; Acute Pain; Phase; Ensure; Training; Individual; Opiates; Opioid; Policies; Funding; Knowledge; programs