- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06291090
A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision
April 27, 2026 updated by: University of Colorado, Denver
In Hospital Treatment of Opioid Use Disorder: Clinician Perspectives and Current Practices
The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD.
The intervention included nurse driven universal screening for unhealthy substance use with a social work referral for a brief intervention when indicted, electronic health record-embedded protocols to assess for opioid withdrawal and to direct buprenorphine initiation, methadone orders for opioid withdrawal symptoms, and embedded links for post discharge addiction treatment referral.
It also included clinician education and nursing education via video conference or in-person lectures.
The intervention was supported by the health system Chief Medical Officer and involved subject matters expertise and representation from nursing leaders, social work leaders, and hospital medicine leaders.
Outcomes assess include a pre/post implementation assessment of 1) change in buprenorphine prescribed in hospital and 2) discharge, 3) change in naloxone prescribed, 4) change in hospital based methadone prescribing, and 5) change in average clinical opioid withdrawal scale (COWS) score.
investigators also assessed a pre/post survey of hospitalists physicians and advanced practice providers to assess their perception of hospital based OUD treatment provision.
Study Type
Interventional
Enrollment (Actual)
400
Phase
- 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 Locations
-
-
Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Anschutz Medicl Campus
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Physicians, advanced practice providers, social workers, and nurses who work at any affiliated hospitals
Exclusion Criteria:
- none
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 |
Intervention / Treatment |
|---|---|
|
Experimental: OUD intervention
Participants received education on the diagnosis and management of OUD, have access to protocols to walk them through assessment of OUD using Diagnostic and Statistical Manual, fifth Edition (DSM)-5, COWS score to calculate severity of opioid withdrawal, buprenorphine or methadone initiation with pre-populated orders, and clickable links for OUD treatment referral post discharge.
|
Participants received education on the diagnosis and management of OUD, have access to protocols to walk them through assessment of OUD using Diagnostic and Statistical Manual, fifth Edition (DSM)-5, COWS score to calculate severity of opioid withdrawal, buprenorphine or methadone initiation with pre-populated orders, and clickable links for OUD treatment referral post discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in buprenorphine prescribing at hospital discharge
Time Frame: Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change
|
Change in rate of buprenorphine prescribing at hospital discharge among patients with OUD before and after intervention implementation
|
Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in rates of methadone prescribing during hospitalization
Time Frame: Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change
|
Change in rate of in hospital methadone prescribing among patients with OUD before and after intervention implementation
|
Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in average (mean) COWS score over time
Time Frame: Calculate mean monthly COWS scores over a three year time frame (including pre and post implementation) to assess for change
|
Change in rate of in mean COWS score among patients with OUD before and after intervention implementation
|
Calculate mean monthly COWS scores over a three year time frame (including pre and post implementation) to assess for change
|
|
Change in naloxone prescribing at hospital discharge
Time Frame: Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change
|
Change in rate of naloxone prescribing at hospital discharge among patients with OUD before and after intervention implementation
|
Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan L Calcaterra, MD, University of Colorado, Denver
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
- Calcaterra SL, Lockhart S, Natvig C, Mikulich S. Barriers to initiate buprenorphine and methadone for opioid use disorder treatment with postdischarge treatment linkage. J Hosp Med. 2023 Oct;18(10):896-907. doi: 10.1002/jhm.13193. Epub 2023 Aug 22.
- Calcaterra SL, Lockhart S, Natvig C, Mikulich-Gilbertson SK. Measuring the Impact of a Multi-Site In-Hospital Intervention for Opioid Use Disorder Treatment Provision: A Survey of Hospital-Based Clinicians. J Gen Intern Med. 2026 Mar;41(4):1048-1057. doi: 10.1007/s11606-025-09728-8. Epub 2025 Aug 27.
- Calcaterra SL, Lockhart S, Grimm E, Holtrop JS, Keniston A, Hoppe JA, Lebin JA, Binswanger IA. A mixed methods assessment of an electronic health record-embedded intervention with supportive education and outreach to increase in-hospital opioid use disorder treatment initiation. J Hosp Med. 2026 Feb 19. doi: 10.1002/jhm.70289. Online ahead of print.
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 (Actual)
January 18, 2023
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
May 1, 2025
Study Registration Dates
First Submitted
February 20, 2024
First Submitted That Met QC Criteria
February 26, 2024
First Posted (Actual)
March 4, 2024
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-0789
- K08DA049905 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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