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

Not Applicable

Completed

• Conditions: Opioid Use; Opioid-use Disorder
• Interventions: Other: Usual Care; Other: Bridge Clinic

• Registration Number: NCT04084392
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-10
• Study Start: 2019-11-25
• Primary Completion: 2021-09-28
• Study Completion: 2022-01-18
• Results First Submitted: 2022-11-17
• Results First Submitted QC: 2023-09-29
• Results First Posted: 2024-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Participants randomized to this arm will receive care as usual.
Bridge Clinic	Bridge Clinic	Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.

Primary Outcome Measures

Name	Time	Method
Hospital Length of Stay	approximately 3 to 42 days	Overall index hospital length of stay measured in days

Secondary Outcome Measures

Name	Time	Method
Number of MAT Prescriptions Filled by Participant	16 weeks post-randomization	Reported buprenorphine-naloxone (or naltrexone) prescriptions filled
Number of Participants With Successful Care Linkage	16 weeks post-randomization	Dichotomous self-reported outcome of linkage to a MAT provider as defined by attending at least one visit with a MAT provider
Hospital and ED Free Days	16 weeks post-randomization	Days alive out of the hospital and/or ED
Readmissions and Emergency Department (ED) Visits	16 weeks post-randomization	Composite number of ED visits and readmissions
Overdose	16 weeks post-randomization	Any overdose self-reported at the 16-week follow up
Opioid Use Within 30 Days	30 days	Opioid use within 30 days as self-reported and assessed during the 16-week follow up phone call.
Quality of Life - Schwartz Outcome Scale-10 (SOS10).	16 weeks post-randomization	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.
Combined Cost of Index Admission and Subsequent Admissions During the Study Period	16 weeks post-randomization	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.
Mortality	16 weeks post-randomization	Death in hospital or documented at 16-week follow up or in the medical record.
Recurrent Opioid Use	16 weeks post-randomization	The number of participants with recurrent opioid use.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States