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Opioid Use DisorderNCT05745480

Natural Language Processing for Screening Opioid Misuse

An observational study of Opioid Use Disorder and Opioid Misuse, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a clinical study to implement and evaluate a hospital-wide, operational intervention for a real-time natural language processing (NLP)-driven clinical decision support (CDS) tool, called Substance Misuse Algorithm for Referral to Treatment Using Artificial Intelligence (SMART-AI). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Use Disorder, Opioid Misuse
What is being tested?
Opioid Misuse Screening with an Addiction Consult Service
How many people
47,502 participants
Where
1 siteUnited States
Study dates
6 Mar 2023to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults hospitalized at University of Wisconsin Hospital (UW Health)

Who may be able to join

  • Adults hospitalized at University of Wisconsin Hospital (UW Health)

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin Hospital (UW Health)

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: The Evaluation of a Real-time Natural Language Processing Decision Support Tool for Screening Opioid Misuse With Addiction Consult Intervention for Hospitalized Adults

This is a clinical study to implement and evaluate a hospital-wide, operational intervention for a real-time natural language processing (NLP)-driven clinical decision support (CDS) tool, called Substance Misuse Algorithm for Referral to Treatment Using Artificial Intelligence (SMART-AI). The SMART-AI CDS tool will be evaluated via implementation in the UW Health electronic health record (EHR). The CDS tool is meant for screening inpatient adults for opioid misuse as part of a best practice alert to nurses and providers for addiction consult service needs.

Read the detailed description

The clinical narrative in the electronic health record (EHR) carries valuable information for predictive analytics, but its free-text form is difficult to mine and analyze for clinical decision support (CDS). Large-scale clinical natural language processing (NLP) pipelines have focused on data warehouse applications for retrospective research efforts. There remains a paucity of evidence for implementing open-source NLP pipelines to provide interoperable and standardized CDS at the bedside for health operations.

Enterprise Analytics and Applied Data Science at UWHealth have helped the health system grow its IT infrastructure to support a data-driven Learning Health System (LHS) capable of Artificial Intelligence (AI)-augmented decision-making at the bedside.

This is a clinical study to implement and evaluate a hospital-wide, operational intervention for a real-time NLP-driven CDS tool, called Substance Misuse Algorithm for Referral to Treatment Using Artificial Intelligence (SMART-AI). The SMART-AI CDS tool will be evaluated via implementation in the UW Health electronic health record. The CDS tool is meant for screening inpatient adults for opioid misuse as part of a best practice alert to nurses and providers for addiction consult service needs. The tool is part of a quality improvement initiative with approvals from hospital committees, including the Clinical AI and Predictive Analytics Committee. The primary outcome was the percentage of inpatients who screened positive (or would have screened positive) based on the NLP CDS tool who received an addiction consult with any of the following interventions: (1) receipt of opioid use intervention or motivational interviewing (MI); (2) receipt of medication-assisted treatment (MAT); and/or (3) referral to substance use disorder treatment. The primary outcome will be reported as a percentage in the pre- and post-intervention periods and consisted of substance use screening and treatment service engagement for hospitalized patients screened for opioid misuse. Secondary outcomes included the 30-day unplanned hospital readmission rate. Criteria for unplanned hospital readmissions were adopted from the Centers for Medicare \& Medicaid Services.

Substance misuse is a common problem in hospitalized patients associated with poor health outcomes, but it is not prioritized and frequently unaddressed during routine care. Current approaches for screening at UW are not done and other health systems use structured diagnostic interviews that require additional staffing and effort during clinical care. Important details about substance use are captured in the clinical notes of the electronic health record but the data are difficult to mine and analyze. Natural language processing and machine learning can be trained to identify relevant findings in the notes to automatically screen patients with substance misuse.

The Investigators trained a convolutional neural network to screen and identify alcohol misuse, opioid misuse, and non-opioid drug misuse with high accuracy using ICD diagnostic codes and admission notes collected during clinical care. The derived algorithm is called Substance Misuse Algorithm for Referral to Treatment Using Artificial Intelligence (SMART-AI). The screening tool uses methods in natural language processing to screen hospitalized patients to prioritize care focused on their substance misuse. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3922677

SMART AI is more accurate than traditional rule-based systems. It uses machine learning and real-time data feeds to continuously monitor the electronic health record (EHR) data and stratify hospitalized patients by risk of unhealthy substance use.

UWHealth is an early adopter of Artificial Intelligence (AI)-driven clinical decision support (CDS) tools and plans to implement SMART-AI for screening unhealthy opioid use. The embedded EHR workflow also allows for an automated data transformation into our health system's data warehouse for analyzing measures to support a Plan Do Study Act (PDSA) operation, an integral component to a Learning Health System (LHS).

Enterprise Analytics and Applied Data Science at UWHealth have helped the health system grow its IT infrastructure to support a data-driven LHS capable of AI-augmented decision-making at the bedside and SMART-AI is one of the first use-cases for screening using natural language processing.

Aim 1: Examine the treatment effect of SMART-AI on patient health outcomes using a pragmatic clinical rollout design.

Study Design: The day of switching on the SMART-AI tool will mark the start of the implementation period. The tool will be evaluated in a PDSA cycle over several months of rollout to examine the primary outcome of addiction consults. The SMART-AI study intervention sample consisted of all hospitalized patients who screened positive for opioid misuse from the NLP CDS tool. The primary effectiveness measure was the percentage of hospitalized patients in the NLP CDS intervention sample who were screened positive for opioid misuse and who received an intervention by the inpatient addiction consult service. A control sample was derived by retrospectively applying the NLP CDS tool to all inpatient EHR records for the two years before the present study initiation in March 2023. Hospitalized patients who screened positive retrospectively under the NLP CDS tool will form the usual care control group.

Being tested
Opioid Misuse Screening with an Addiction Consult Service
Keywords
Natural Language Processing (NLP), electronic health record (EHR), clinical decision support (CDS), Quality Improvement
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opioid Misuse Screening with an Addiction Consult ServiceOther

    Opioid Misuse Screening with an addiction consult service for brief intervention/motivational interviewing (MI), medication assisted treatment (MAT), or referral to substance use treatment as an outpatient.

Study groups in NCT05745480
Study groupRoleWhat they receive
Pre-Intervention Period: Usual Care with Ad-Hoc Addiction ConsultsUW Hospital launched an Addiction Medicine inpatient consult service in 1991 to address the high prevalence of substance use disorders in hospitalized adults. Currently, a single screening item queries 'marijuana or other recreational drug use,' but no formal screening process was in place specifically targeting opioid misuse. For patients at risk of an opioid use disorder, the practice was ad-hoc consultations at the discretion of the primary provider.
Post-Intervention Period: Artificial intelligence-driven clinical decision supportThe technical architecture that enabled the real-time, NLP CDS tool incorporated industry-leading and emerging technological capabilities. The NLP CDS infrastructure exports the notes from the EHR, organizes them and feeds them into an NLP pipeline, inputed the processed text features into the opioid screener deep learning model, and delivered the resultant scores back to the bedside electronic health record as a best practice alert.
Receives: Other: Opioid Misuse Screening with an Addiction Consult Service

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of inpatients who screened positive (or would have screened positive) based on the NLP CDS tool who received an addiction consult

    Percentage of inpatients who screened positive (or would have screened positive) based on the NLP CDS tool who received an addiction consult with any of the following interventions: (1) receipt of opioid use intervention or motivational interviewing (MI); (2) receipt of medication-assisted treatment (MAT); and/or (3) referral to substance use disorder treatment.

    Measured: Up to 6 months

Secondary outcomes (1)
  1. 30-day unplanned hospital readmission rate

    Criteria for unplanned hospital readmissions were adopted from the Centers for Medicare \& Medicaid Services.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2023
  2. Study start6 Mar 2023
  3. Primary completion1 Nov 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
47,502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05745480
Sponsor's protocol ID
2022-0384
Other IDs
Pulmonary Medicine
Status last verified
Jan 2024
First submitted
6 Feb 2023
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Afshar M, Sharma B, Dligach D, Oguss M, Brown R, Chhabra N, Thompson HM, Markossian T, Joyce C, Churpek MM, Karnik NS. Development and multimodal validation of a substance misuse algorithm for referral to treatment using artificial intelligence (SMART-AI): a retrospective deep learning study. Lancet Digit Health. 2022 Jun;4(6):e426-e435. doi: 10.1016/S2589-7500(22)00041-3.

    PubMed 35623797
  • Sharma B, Dligach D, Swope K, Salisbury-Afshar E, Karnik NS, Joyce C, Afshar M. Publicly available machine learning models for identifying opioid misuse from the clinical notes of hospitalized patients. BMC Med Inform Decis Mak. 2020 Apr 29;20(1):79. doi: 10.1186/s12911-020-1099-y.

    PubMed 32349766
  • Protocol for a Real-Time Electronic Health Record Implementation of a Natural Language Processing and Deep Learning Clinical Decision Support Tool: A Use-Case for an Opioid Misuse Screener in Hospitalized Adults Majid Afshar, Sabrina Adelaine, Felice Resnik, Marlon P. Mundt, John Long, Margaret Leaf, Theodore Ampian, Graham J Wills, Benjamin Schnapp, Michael Chao, Randy Brown, Cara Joyce, Brihat Sharma, Dmitriy Dligach, Elizabeth S. Burnside, Jane Mahoney, Matthew M Churpek, Brian W. Patterson, Frank Liao doi: https://doi.org/10.1101/2022.12.04.22282990

  • Afshar M, Resnik F, Joyce C, Oguss M, Dligach D, Burnside ES, Sullivan AG, Churpek MM, Patterson BW, Salisbury-Afshar E, Liao FJ, Goswami C, Brown R, Mundt MP. Clinical implementation of AI-based screening for risk for opioid use disorder in hospitalized adults. Nat Med. 2025 Jun;31(6):1863-1872. doi: 10.1038/s41591-025-03603-z. Epub 2025 Apr 3.

    PubMed 40181180
  • Afshar M, Resnik F, Joyce C, Oguss M, Dligach D, Burnside E, Sullivan A, Churpek M, Patterson B, Salisbury-Afshar E, Liao F, Brown R, Mundt M. Outcomes and Cost-Effectiveness of an EHR-Embedded AI Screener for Identifying Hospitalized Adults at Risk for Opioid Use Disorder. Res Sq [Preprint]. 2024 Oct 14:rs.3.rs-5200964. doi: 10.21203/rs.3.rs-5200964/v1.

    PubMed 39483915
  • Afshar M, Adelaine S, Resnik F, Mundt MP, Long J, Leaf M, Ampian T, Wills GJ, Schnapp B, Chao M, Brown R, Joyce C, Sharma B, Dligach D, Burnside ES, Mahoney J, Churpek MM, Patterson BW, Liao F. Deployment of Real-time Natural Language Processing and Deep Learning Clinical Decision Support in the Electronic Health Record: Pipeline Implementation for an Opioid Misuse Screener in Hospitalized Adults. JMIR Med Inform. 2023 Apr 20;11:e44977. doi: 10.2196/44977.

    PubMed 37079367

Questions about this trial

What is this clinical trial studying?

An observational study of Opioid Use Disorder and Opioid Misuse, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of inpatients who screened positive (or would have screened positive) based on the NLP CDS tool who received an addiction consult (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05745480, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.

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