NCT05745480

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47,502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 23, 2025

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

February 6, 2023

Last Update Submit

April 18, 2025

Conditions

Keywords

Natural Language Processing (NLP)electronic health record (EHR)clinical decision support (CDS)Quality Improvement

Outcome Measures

Primary Outcomes (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.

    Up to 6 months

Secondary Outcomes (1)

  • 30-day unplanned hospital readmission rate

    Up to 6 months

Study Arms (2)

Pre-Intervention Period: Usual Care with Ad-Hoc Addiction Consults

UW 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 support

The 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.

Other: Opioid Misuse Screening with an Addiction Consult Service

Interventions

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.

Post-Intervention Period: Artificial intelligence-driven clinical decision support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults hospitalized at University of Wisconsin Hospital (UW Health)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital (UW Health)

Madison, Wisconsin, 53792, United States

Location

Related Publications (5)

  • 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.

    PMID: 35623797BACKGROUND
  • 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.

    PMID: 32349766BACKGROUND
  • 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.

    PMID: 37079367BACKGROUND
  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Majid Afshar

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 27, 2023

Study Start

March 6, 2023

Primary Completion

November 1, 2023

Study Completion

December 31, 2023

Last Updated

April 23, 2025

Record last verified: 2024-01

Locations