NCT07498322

Brief Summary

This study, called the Chicago Data-driven Opioid use disorder Screening, Engagement, Treatment and Planning (C-DOSETaP) System, tests a new system of clinical care for patients with opioid use disorder (OUD) across a large health system. The main questions this study aims to answer are:

  1. 1.Does the C-DOSETaP System increase screening for patients with OUD;
  2. 2.Does the C-DOSETaP System improve continuity of health care for patients with OUD;
  3. 3.Does the C-DOSETaP System increase use of medications for opioid use disorder; and
  4. 4.Does the C-DOSETaP System reduce the number of opioid-related deaths in the neighborhoods served.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
271,031

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress11%
Jun 2026Jun 2029

First Submitted

Initial submission to the registry

March 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

March 13, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

Opioid Use Disorder (OUD)Natural language processing (NLP)Machine learning (ML)Medications for opioid use disorder (MOUD)health systemsArtificial Intelligence (AI)opioid misuseBuprenorphine

Outcome Measures

Primary Outcomes (3)

  • Number of people screened for OUD

    Aggregate rate of data-driven OUD screening across the health system

    Rolling measure of annual rates (12 months) measured over the implementation period.

  • Continuity of care for patients with OUD

    Continuity of care will be assessed through appointment follow-up and completion of referral to the next care site within 30 days.

    30 days and 12 months

  • Utilization of MOUD across the health system

    MOUD use will be measured as the number of patients actively on MOUD as a proportion of all patients within the health system and of those with documented OUD within the health system as defined by International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes.

    Baseline and 12 months

Secondary Outcomes (3)

  • Regional opioid-related mortality

    Baseline and 12 months

  • Regional OUD Screening

    Baseline and 12 months

  • Regional MOUD utilization

    Baseline and 12 months

Study Arms (1)

Patients with OUD

EXPERIMENTAL

Patients with opioid use disorder identified through C-DOSETaP system

Other: OUD screeningOther: MOUDOther: Continuity of care

Interventions

Completed screening for opioid use disorder

Patients with OUD
MOUDOTHER

Medication treatment for opioid use disorder

Patients with OUD

Facilitation of outpatient treatment linkages

Patients with OUD

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participant must be a patient seen at the University of Illinois Hospital and Clinics
  • Adults and adolescents age 16 or older

You may not qualify if:

  • \- Children younger than age 16

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Hospitals and Clinics (UI Health)

Chicago, Illinois, 60608, United States

Location

Related Publications (3)

  • 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
  • Shahid U, Parde N, Smith DL, Dickinson G, Bianco J, Thorpe D, Hota M, Afshar M, Karnik NS, Chhabra N. Development and Evaluation of Machine Learning Models for the Detection of Emergency Department Patients with Opioid Misuse from Clinical Notes. medRxiv [Preprint]. 2024 Dec 12:2024.12.11.24318875. doi: 10.1101/2024.12.11.24318875.

    PMID: 39711725BACKGROUND
  • Chhablani C, Shahid U, Parde N, Muslmani S, Hu H, Thorpe D, Afshar M, Karnik N, Chhabra N. Machine learning models to detect opioid misuse in emergency department patients at triage. Am J Emerg Med. 2026 Feb 26;104:17-23. doi: 10.1016/j.ajem.2026.02.037. Online ahead of print.

    PMID: 41785519BACKGROUND

Related Links

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Continuity of Patient Care

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesPrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Niranjan S. Karnik, MD, PhD

    UIC, College of Medicine

    PRINCIPAL INVESTIGATOR
  • Neeraj Chhabra, MD

    UIC, College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niranjan S. Karnik, MD, PhD

CONTACT

Neeraj Chhabra, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The C-DOSETaP system represents a health system-level approach to OUD screening, treatment engagement, and patient retention, which comprises multiple clinical contexts, including inpatient hospital-based care, emergency care, primary care, and specialist outpatient care. Screening activities across these domains will take advantage of digital AI classifiers using EHR data in the inpatient and emergency settings and self-report measures in the outpatient clinics. Results from the opioid misuse screeners will be integrated into local clinical workflows and data aggregated to a digital dashboard for use by the health system's OUD Command Center (OCC) to track referrals for OUD care, follow-up care, and prescriptions. Automated flags will alert the OCC for signs potentially indicative of patient dropout from OUD treatment including missed appointments by more than 48 hours, missed prescriptions, and and lack of any follow-up data. Flags will trigger outreach by peer-recovery specialists.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 27, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

A de-identified research dataset will be submitted to NIH data repository per the approved Data Management and Sharing Plan following R33 completion.

Locations