Evaluating the Impact of the Bridge Clinic in Patients With Opioid Use Disorder

Opioid Use Clinical Trial

Official title:

Evaluating the Impact of the Bridge Clinic in Patients With Opioid Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084392
• Other study ID #: 191269
• Status: Completed
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: January 18, 2022

Study information

• Verified date: September 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine whether referral to the Bridge Clinic reduces overall index hospital length of stay when compared to direct referral to a long-term outpatient addiction provider for patients with active opioid use disorder (OUD) being considered for medications-for-addiction treatment (MAT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: January 18, 2022
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inpatients at VUH with active OUD being considered for MAT.
• Patient accepting a transitional prescription for buprenorphine-naloxone or IM naltrexone whose outpatient plans are not fixed

Exclusion Criteria:

• Deemed ineligible for referral to outpatient Bridge Clinic by the Addiction Consult Team (examples include but are not limited to patients with severe, active co-occurring psychiatric disorders requiring a higher level of psychiatric care or patients for whom methadone maintenance is deemed the best choice of MAT).
• Patients previously randomized in this study.

Related Conditions & MeSH terms

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

Intervention

Other:
• Bridge Clinic
Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
• Usual Care
Referral to an outpatient provider for addiction treatment.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Length of Stay	Overall index hospital length of stay measured in days	approximately 3 to 42 days
Secondary	Combined Cost of Index Admission and Subsequent Admissions During the Study Period	Total costs, and costs for each admission and care resource used measured in dollars. This includes the cost of the index hospital admission along with any subsequent admissions during the 16-week follow up period.	16 weeks post-randomization
Secondary	Number of Participants With Successful Care Linkage	Dichotomous self-reported outcome of linkage to a MAT provider as defined by attending at least one visit with a MAT provider	16 weeks post-randomization
Secondary	Number of MAT Prescriptions Filled by Participant	Reported buprenorphine-naloxone (or naltrexone) prescriptions filled	16 weeks post-randomization
Secondary	Readmissions and Emergency Department (ED) Visits	Composite number of ED visits and readmissions	16 weeks post-randomization
Secondary	Hospital and ED Free Days	Days alive out of the hospital and/or ED	16 weeks post-randomization
Secondary	Mortality	Death in hospital or documented at 16-week follow up or in the medical record.	16 weeks post-randomization
Secondary	Recurrent Opioid Use	The number of participants with recurrent opioid use.	16 weeks post-randomization
Secondary	Overdose	Any overdose self-reported at the 16-week follow up	16 weeks post-randomization
Secondary	Quality of Life - Schwartz Outcome Scale-10 (SOS10).	The Quality of Life - Schwartz Outcome Scale-10 (SOS10) survey has ten questions scored on a 0 (never) to 6 (all or nearly all of the time) scale that measures the broad domain of psychological well-being and quality of life. A total score is computed as the sum across the 10 questions. Therefore, the minimum total score is 0 (never) and the maximum score is 60 (all or nearly all of the time). Higher scores indicate greater well-being and psychological health. Therefore, higher scores are better.	16 weeks post-randomization
Secondary	Opioid Use Within 30 Days	Opioid use within 30 days as self-reported and assessed during the 16-week follow up phone call.	30 days