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

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).

Study Overview

• Status: Completed
• Conditions: Opioid Use; Opioid-use Disorder
• Intervention / Treatment: Other: Usual Care; Other: Bridge Clinic

• Study Type: Interventional
• Enrollment (Actual): 335
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Participants randomized to this arm will receive care as usual.	Other: Usual Care; Referral to an outpatient provider for addiction treatment.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Overall index hospital length of stay measured in days	approximately 3 to 42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overdose	Any overdose self-reported at the 16-week follow up	16 weeks post-randomization
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
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
Number of MAT Prescriptions Filled by Participant	Reported buprenorphine-naloxone (or naltrexone) prescriptions filled	16 weeks post-randomization
Readmissions and Emergency Department (ED) Visits	Composite number of ED visits and readmissions	16 weeks post-randomization
Hospital and ED Free Days	Days alive out of the hospital and/or ED	16 weeks post-randomization
Mortality	Death in hospital or documented at 16-week follow up or in the medical record.	16 weeks post-randomization
Recurrent Opioid Use	The number of participants with recurrent opioid use.	16 weeks post-randomization
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
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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: David Marcovitz, MD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): September 28, 2021
• Study Completion (Actual): January 18, 2022

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 191269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported will be made available (including data dictionaries) after deidentification.
• IPD Sharing Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No