NCT06291090

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

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

Study Start

First participant enrolled

January 18, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 1, 2026

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

February 20, 2024

Last Update Submit

April 27, 2026

Conditions

Opioid Use Disorder

Keywords

opioid use disorderhospital

Outcome Measures

Primary Outcomes (1)

  • Change in buprenorphine prescribing at hospital discharge

    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 Outcomes (1)

  • Change in rates of methadone prescribing during hospitalization

    Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change

Other Outcomes (2)

  • Change in average (mean) COWS score over time

    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

    Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change

Study Arms (1)

OUD intervention

EXPERIMENTAL

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.

Behavioral: OUD treatment intervention

Interventions

OUD treatment interventionBEHAVIORAL

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.

OUD intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physicians, advanced practice providers, social workers, and nurses who work at any affiliated hospitals

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medicl Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

  • 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.

    PMID: 40866748RESULT

  • 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.

    PMID: 41715987RESULT

  • 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.

    PMID: 37608527RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Susan L Calcaterra, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This intervention will be implemented across 12 hospitals
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2024

First Posted

March 4, 2024

Study Start

January 18, 2023

Primary Completion

April 30, 2024

Study Completion

May 1, 2025

Last Updated

May 1, 2026

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)