Clinical trial NCT04084392: 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
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Opioid-use Disorder
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


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.

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: approximately 3 to 42 days
Secondary outcomes:
measure: Combined Cost of Index Admission and Subsequent Admissions During the Study Period
timeFrame: 16 weeks post-randomization
measure: Number of Participants With Successful Care Linkage
timeFrame: 16 weeks post-randomization
measure: Number of MAT Prescriptions Filled by Participant
timeFrame: 16 weeks post-randomization
measure: Readmissions and Emergency Department (ED) Visits
timeFrame: 16 weeks post-randomization
measure: Hospital and ED Free Days
timeFrame: 16 weeks post-randomization
measure: Mortality
timeFrame: 16 weeks post-randomization
measure: Recurrent Opioid Use
timeFrame: 16 weeks post-randomization
measure: Overdose
timeFrame: 16 weeks post-randomization
measure: Quality of Life - Schwartz Outcome Scale-10 (SOS10).
timeFrame: 16 weeks post-randomization
measure: Opioid Use Within 30 Days
timeFrame: 30 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David Marcovitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.