Chicago Data-driven Opioid Use Disorder Screening, Engagement, Treatment and Planning System (C-DOSETaP)

March 26, 2026 updated by: Niranjan Karnik, University of Illinois at Chicago

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Chicago Data-driven Opioid use disorder Screening, Engagement, Treatment and Planning (C-DOSETaP) System, tests an innovative approach leveraging healthcare data harmonization, digital tools, and clinical workflows to improve the care for patients with opioid use disorder (OUD) across a large health system serving a population heavily affected by the opioid overdose epidemic. The C-DOSETaP system will implement a diverse set of screening tools across the health systems' numerous clinical domains, improve healthcare engagement and utilization of OUD treatments, and pursue a data-forward approach leveraging electronic health record (EHR) data to track care delivery and engage with patients at risk for treatment dropout or failure.

The investigators hypothesize that implementation of the C-DOSETaP system alongside a locally developed system-level opioid response plan will result in: 1) increased OUD screening rates; 2) improved continuity of care; 3) increased utilization of medications for opioid use disorder (MOUD); and 4) reduced mortality in neighborhoods served by the primary study institution.

Primary Outcomes Three dimensions of OUD treatment and engagement will be assessed as primary outcomes for the study. The investigators will measure: 1) screening rates; 2) continuity of care; and 3) use of MOUD across the health system. Screening rates will be measured as the proportion of all patients with encounters in the health system that have a completed screening for opioid misuse within the preceding 12 months. Continuity of care will be assessed by appointment follow-up and completed referral to the next care site. Use of MOUD will be measured as the number of patients actively on MOUD as a proportion of all patients with documented OUD within the health system as defined by International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes.

Secondary Outcomes The investigators plan to evaluate aggregate impact of interventions and primary measures on OUD mortality reported in neighborhoods served by the primary study institution during the phased stepped wedge rollout across system-associated clinics. The secondary outcomes for this phase include quarterly opioid-related mortality by zip codes served by the primary institution.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
271031

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Niranjan S. Karnik, MD, PhD
  • Phone Number: (312) 273-0185
  • Email: nkarnik@uic.edu

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60608
        • University of Illinois Hospitals and Clinics (UI Health)
        • Contact:
        • Contact:
          • Niranjan S. Karnik, MD, PhD
          • Phone Number: 312-273-0185
          • Email: nkarnik@uic.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

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

Exclusion Criteria

- Children younger than age 16

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with OUD
Patients with opioid use disorder identified through C-DOSETaP system
Other: OUD screening
Completed screening for opioid use disorder
Other: MOUD
Medication treatment for opioid use disorder
Other: Continuity of care
Facilitation of outpatient treatment linkages

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of people screened for OUD
Time Frame: Rolling measure of annual rates (12 months) measured over the implementation period.
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
Time Frame: 30 days and 12 months
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
Time Frame: Baseline and 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Regional opioid-related mortality
Time Frame: Baseline and 12 months
Quarterly opioid-related mortality rate by zip codes served by the primary institution reported to the Illinois Department of Public Health
Baseline and 12 months
Regional OUD Screening
Time Frame: Baseline and 12 months
Quarterly opioid-related screening rates by zip codes served by the primary institution reported to the Illinois Department of Public Health
Baseline and 12 months
Regional MOUD utilization
Time Frame: Baseline and 12 months
Quarterly MOUD utilization rates by zip codes served by the primary institution reported to the Illinois Department of Public Health
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Niranjan S. Karnik, MD, PhD, UIC, College of Medicine
  • Principal Investigator: Neeraj Chhabra, MD, UIC, College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-0243
  • 1R61DA057629 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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