A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision

Opioid Use Disorder Clinical Trial

Official title:

In Hospital Treatment of Opioid Use Disorder: Clinician Perspectives and Current Practices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06291090
• Other study ID #: 22-0789
• Secondary ID: K08DA049905
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: Susan L Calcaterra, MD
• Phone: 24877035947
• Email: susan.calcaterra[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 1, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• OUD treatment 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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medicl Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in average (mean) COWS score over time	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
Other	Change in naloxone prescribing at hospital discharge	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
Primary	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	Change in rates of methadone prescribing during hospitalization	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