NCT03833804

Brief Summary

The investigators propose to develop an open-source, publicly available machine learning model that health systems could download and apply to their electronic health record data marts to screen for substance misuse in their patients. The investigators hypothesize that the natural language processing algorithm can provide a standardized and interoperable approach for an automated daily screen on all hospitalized patients and provide better implementation fidelity for screening, brief intervention, and referral to treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64,996

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

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, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
3.6 years until next milestone

Study Start

First participant enrolled

September 19, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 24, 2025

Completed
Last Updated

October 24, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

February 6, 2019

Results QC Date

September 9, 2025

Last Update Submit

October 14, 2025

Conditions

Keywords

natural language processingmachine learningartificial intelligenceclinical decision supportunhealthy alcohol useopioid use disorderillicit drug use

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients That Had a Universal Screen Positive and Received SBIRT (Screening, Brief Intervention, or Referral to Treatment)

    The primary outcome is the proportion of patients who received SBIRT after a positive universal screen for being at risk for substance misuse. The design is an interrupted time-series prospective observational study.

    24 months

Secondary Outcomes (1)

  • All-cause Re-hospitalizations Following 6-months From the Index Hospital Encounter

    12 months enrollment with 6 months follow-up for rehospitalization

Study Arms (2)

SMART-AI: NLP (natural language processing) pre-screen

EXPERIMENTAL

Automated processing of clinical notes collected during routine care in first 24 hours of hospital admission to identify individuals at-risk for substance misuse to receive standard-of-care full screening and assessment, brief intervention, or referral to treatment (SBIRT) intervention.

Other: Processing of clinical notes in the EHR data collected during routine care

Usual Care

NO INTERVENTION

Data collected before the intervention began

Interventions

Clinical notes collected in the first day of hospital admission during usual care as input to natural language processing and machine learning algorithm.

SMART-AI: NLP (natural language processing) pre-screen

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 years old to 89 years old
  • Inpatient status during hospitalization
  • Length of stay greater than 24 hours

You may not qualify if:

  • Cannot participate in the usual care SBIRT intervention
  • Death or obtunded during first 24 hours of admission
  • Discharged against medical advice
  • Transferred from another acute care hospital
  • Transferred to another acute care hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

  • Afshar M, Phillips A, Karnik N, Mueller J, To D, Gonzalez R, Price R, Cooper R, Joyce C, Dligach D. Natural language processing and machine learning to identify alcohol misuse from the electronic health record in trauma patients: development and internal validation. J Am Med Inform Assoc. 2019 Mar 1;26(3):254-261. doi: 10.1093/jamia/ocy166.

  • Rojas JC, Joyce C, Markossian TW, Chaudhari V, McClintic MR, Castro F, Fairgrieve AJ, Dligach D, Oguss MK, Churpek MM, Nikolaides J, Afshar M. Clinical Implementation of an AI Algorithm for Substance Misuse Screening in Hospitalized Adults. medRxiv [Preprint]. 2025 Nov 19:2025.11.17.25340323. doi: 10.1101/2025.11.17.25340323.

  • Joyce C, Markossian TW, Nikolaides J, Ramsey E, Thompson HM, Rojas JC, Sharma B, Dligach D, Oguss MK, Cooper RS, Afshar M. The Evaluation of a Clinical Decision Support Tool Using Natural Language Processing to Screen Hospitalized Adults for Unhealthy Substance Use: Protocol for a Quasi-Experimental Design. JMIR Res Protoc. 2022 Dec 19;11(12):e42971. doi: 10.2196/42971.

Related Links

MeSH Terms

Conditions

Substance-Related DisordersOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Results Point of Contact

Title
Majid Afshar, MD
Organization
UW School of Medicine and Public Health

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking as the manual screen is already part of usual care and the automated screen will become usual care in the post-period of the pre-post design.
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Model Details: Quasi-experimental design as an interrupted time series
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2019

First Posted

February 7, 2019

Study Start

September 19, 2022

Primary Completion

September 19, 2024

Study Completion

September 19, 2024

Last Updated

October 24, 2025

Results First Posted

October 24, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

The patient data are protected health information and unavailable to public but the algorithm will be shared. The investigators will serialize our best models developed using either pickle (a Python native mechanism for object serialization) or joblib (https://pythonhosted.org/joblib/) and write software that will be capable of reloading them and making predictions. The software will be distributed via github.com or similar web-based software hosting service.

Shared Documents
ANALYTIC CODE
Time Frame
12 months after completion of study and available for at least five years on github.com
More information

Locations