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

NCT04084392 | Completed Results

• 1 other identifier: 191269
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

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).

Conditions

Opioid Use; Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Hospital Length of Stay

  Overall index hospital length of stay measured in days

  approximately 3 to 42 days

Secondary Outcomes (10)

• Combined Cost of Index Admission and Subsequent Admissions During the Study Period

  16 weeks post-randomization

• Number of Participants With Successful Care Linkage

  16 weeks post-randomization

• Number of MAT Prescriptions Filled by Participant

  16 weeks post-randomization

• Readmissions and Emergency Department (ED) Visits

  16 weeks post-randomization

• Hospital and ED Free Days

  16 weeks post-randomization

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Participants randomized to this arm will receive care as usual.

Other: Usual Care

Bridge Clinic

ACTIVE COMPARATOR

Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.

Other: Bridge Clinic

Interventions

Bridge Clinic OTHER

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.

Bridge Clinic

Usual Care OTHER

Referral to an outpatient provider for addiction treatment.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• Marcovitz D, Dear ML, Donald R, Edwards DA, Kast KA, Le TDV, Shah MV, Ferrell J, Gatto C, Hennessy C, Buie R, Rice TW, Sullivan W, White KD, Van Winkle G, Wolf R, Lindsell CJ; Vanderbilt Learning Healthcare System Platform Investigators. Effect of a Co-Located Bridging Recovery Initiative on Hospital Length of Stay Among Patients With Opioid Use Disorder: The BRIDGE Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2356430. doi: 10.1001/jamanetworkopen.2023.56430.

  PMID: 38411964 DERIVED

• Marcovitz DE, White KD, Sullivan W, Limper HM, Dear ML, Buie R, Edwards DA, Chastain C, Kast KA, Lindsell CJ; Vanderbilt Learning Health System Investigators. Bridging Recovery Initiative Despite Gaps in Entry (BRIDGE): study protocol for a randomized controlled trial of a bridge clinic compared with usual care for patients with opioid use disorder. Trials. 2021 Oct 30;22(1):757. doi: 10.1186/s13063-021-05698-4.

  PMID: 34717736 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Dave Marcovitz
• Organization: Vanderbilt University Medical Center

david.marcovitz@vumc.org

615-936-3555

Study Officials

• David Marcovitz, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry, MD

Model Details: Programmatic evaluation - eligible participants will be individually randomized to either direct referral to a long-term outpatient addiction provider or referral to the Bridge Clinic while long-term outpatient addiction provider is located/identified.

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 10, 2019
• Study Start: November 25, 2019
• Primary Completion: September 28, 2021
• Study Completion: January 18, 2022
• Last Updated: July 10, 2024
• Results First Posted: April 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

Locations

US (1)