# Enhancing Infrastructure for Clinical and Translational Research to Address the Opioid Epidemic

> **NIH NIH U01** · MEDICAL UNIVERSITY OF SOUTH CAROLINA · 2020 · $736,713

## Abstract

PROJECT SUMMARY
Up-to-date information about non-fatal overdose emergency department (ED) encounters can provide critical
information about the evolution of the opioid epidemic and response of the healthcare system and is an
essential to planning of clinical trials to address the problems underlying this epidemic. Establishing a platform
that delivers high positive predictive value for opioid-related overdose (OD) using a combination of coded and
natural language terms in electronic health records (EHRs) is an essential step toward the large-scale
surveillance necessary to evaluate the pragmatic effectiveness of numerous systemic and policy-based efforts
and to create the infrastructure for large scale trials to reduce drug-related mortality and morbidity. However, to
date, localized and federal efforts have been largely based on discrete ICD-10 code data or have had time lags
of one-to-three years for more detailed data. Perhaps more Importantly, they have not had the capacity for
planning and feasibility assessment for clinical and translational research at specific sites. We propose
foundational work to create an inter-institutional research database and network focused on patients
presenting to EDs with opioid-related OD. To create this network, we will extend previous work to develop: (1)
an e-phenotype for case identification in the ED based on EHR data, and (2) combine this with a data
dictionary and coded data extraction tools, and natural language processing (NLP) algorithms, to obtain
additional data from EHRs; tools for primary capture of data during clinical care; and tools for integration of
data on social determinants of health. This will allow for a more thorough characterization of individuals
presenting to EDs with opioid-related OD including: demographics, comorbidities, OD agent and source,
intentionality of the OD, ED treatment and discharge disposition. Through refinement and automation, the data
extraction process will be extended to a set of pilot CTSA Accrual to Clinical Trials (ACT) Network sites and
then potentially to other CTSA's nation-wide. This new functionality focuses on providing a platform to
accelerate research. To accomplish this work, our Specific Aims are to: 1) Demonstrate the feasibility of
extending the ACT Network data model and infrastructure to monitor the opioid epidemic using ED data, 2)
Create a prototype opioid overdose monitoring and response network across participating institutions and a
toolkit for other CTSA sites to join the network, and 3) Demonstrate potential usefulness of the network in
monitoring the opioid epidemic and in planning clinical trials. This proposal is innovative as it aims to develop a
feasible and effective near real time means of monitoring opioid-related OD presentation in EDs across the
country to inform point-of-care service delivery, prevention and treatment intervention development and
evaluation. Downstream, the application of project deliverables include disseminat...

## Key facts

- **NIH application ID:** 9989930
- **Project number:** 5U01TR002628-02
- **Recipient organization:** MEDICAL UNIVERSITY OF SOUTH CAROLINA
- **Principal Investigator:** LESLIE A. LENERT
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $736,713
- **Award type:** 5
- **Project period:** 2019-08-06 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9989930

## Citation

> US National Institutes of Health, RePORTER application 9989930, Enhancing Infrastructure for Clinical and Translational Research to Address the Opioid Epidemic (5U01TR002628-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9989930. Licensed CC0.

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