Thursday, November 21, 2024 11/21/2024

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

Award Number: U01TR002628
ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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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 dissemination of the replication toolkit to leverage the platform of the CTSAs and NIDA Clinical Trials Network to build capacity for timely surveillance of opioid-related OD to facilitate prevention and treatment research and intervention.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$295,359 )
2025	2023	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	National Center for Advancing Translational Sciences	000	5	10/23/2024	NON-COMPETING CONTINUATION	-$295,359
														Subtotal = -$295,359

Issue Date FY: 2023 ( Subtotal = $711,645 )
2023	2023	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	National Center for Advancing Translational Sciences	001	5	6/15/2023	NON-COMPETING CONTINUATION	$711,645
2023	2022	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	National Center for Advancing Translational Sciences	000	4	5/31/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $711,645

Issue Date FY: 2022 ( Subtotal = $716,466 )
2022	2022	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	National Center for Advancing Translational Sciences	000	4	6/15/2022	NON-COMPETING CONTINUATION	$716,466
														Subtotal = $716,466

Issue Date FY: 2021 ( Subtotal = $724,111 )
2021	2021	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	National Center for Advancing Translational Sciences	001	3	6/8/2021	NON-COMPETING CONTINUATION	$724,111
2021	2020	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	National Center for Advancing Translational Sciences	000	2	12/3/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $724,111

Issue Date FY: 2020 ( Subtotal = $736,713 )
2020	2020	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	National Center for Advancing Translational Sciences	000	2	6/18/2020	NON-COMPETING CONTINUATION	$736,713
														Subtotal = $736,713

Issue Date FY: 2019 ( Subtotal = $778,563 )
2019	2019	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	National Center for Advancing Translational Sciences	000	1	8/6/2019	NEW	$778,563
														Subtotal = $778,563

Grand Total All Awards = $3,372,139

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

Award Number: U01TR002628

ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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