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

Primary Purpose

Opioid Use, Opioid-use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bridge Clinic
Usual Care
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Usual Care

Bridge Clinic

Arm Description

Participants randomized to this arm will receive care as usual.

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

Outcomes

Primary Outcome Measures

Hospital length of stay
Overall index hospital length of stay measured in days

Secondary Outcome Measures

Cost
Total costs, and costs for each admission and care resource used measured in dollars
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
MAT prescription filled by participant
Reported buprenorphine-naloxone (or naltrexone) prescriptions filled
Readmissions and Emergency Department (ED) visits
Composite number of ED visits and readmissions
Hospital and ED free days
Days alive out of the hospital and/or ED
Mortality
Death in hospital or documented at 16-week follow up or in the medical record - dichotomous measurement
Recurrent opioid use
Reported recurrent opioid use and the approximate number of times of opioid use
Overdose
Any overdose self-reported at the 16-week follow up
Quality of Life - Schwartz Outcome Scale-10 (SOS10).
The SOS10 survey has ten questions scored on a 0 (never) to 6 (all or nearly all of the time) scale. A total score is computed as the sum across the 10 questions.

Full Information

First Posted
September 6, 2019
Last Updated
October 28, 2022
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04084392
Brief Title
Evaluating the Impact of the Bridge Clinic in Patients With Opioid Use Disorder
Official Title
Evaluating the Impact of the Bridge Clinic in Patients With Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
September 28, 2021 (Actual)
Study Completion Date
January 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid-use Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
335 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will receive care as usual.
Arm Title
Bridge Clinic
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.
Intervention Type
Other
Intervention Name(s)
Bridge Clinic
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Referral to an outpatient provider for addiction treatment.
Primary Outcome Measure Information:
Title
Hospital length of stay
Description
Overall index hospital length of stay measured in days
Time Frame
approximately 3 to 42 days
Secondary Outcome Measure Information:
Title
Cost
Description
Total costs, and costs for each admission and care resource used measured in dollars
Time Frame
16 weeks post-randomization
Title
Successful care linkage
Description
Dichotomous self-reported outcome of linkage to a MAT provider as defined by attending at least one visit with a MAT provider
Time Frame
16 weeks post-randomization
Title
MAT prescription filled by participant
Description
Reported buprenorphine-naloxone (or naltrexone) prescriptions filled
Time Frame
16 weeks post-randomization
Title
Readmissions and Emergency Department (ED) visits
Description
Composite number of ED visits and readmissions
Time Frame
16 weeks post-randomization
Title
Hospital and ED free days
Description
Days alive out of the hospital and/or ED
Time Frame
16 weeks post-randomization
Title
Mortality
Description
Death in hospital or documented at 16-week follow up or in the medical record - dichotomous measurement
Time Frame
16 weeks post-randomization
Title
Recurrent opioid use
Description
Reported recurrent opioid use and the approximate number of times of opioid use
Time Frame
16 weeks post-randomization
Title
Overdose
Description
Any overdose self-reported at the 16-week follow up
Time Frame
16 weeks post-randomization
Title
Quality of Life - Schwartz Outcome Scale-10 (SOS10).
Description
The SOS10 survey has ten questions scored on a 0 (never) to 6 (all or nearly all of the time) scale. A total score is computed as the sum across the 10 questions.
Time Frame
16 weeks post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Marcovitz, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34717736
Citation
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.
Results Reference
derived

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

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