NCT04084392

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

Completed NA Results posted Last updated 10 July 2024

What this trial tests

NA trial testing Bridge Clinic in Opioid Use in 335 participants. Completed in 18 January 2022.

Timeline

25 November 2019

Primary endpoint
28 September 2021

18 January 2022

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	335
Start date	25 November 2019
Primary completion	28 September 2021
Estimated completion	18 January 2022
Sites	1 location across United States

Drugs / interventions tested

• Bridge Clinic
• Usual Care

Conditions studied

• Opioid Use — all drugs for Opioid Use →
• Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Opioid Use or Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hospital Length of Stay Primary · approximately 3 to 42 days

Overall index hospital length of stay measured in days

Group	Value	95% CI
Usual Care	232.1	± 267.4
Bridge Clinic	215.0	± 236.1

Combined Cost of Index Admission and Subsequent Admissions During the Study Period Secondary · 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.

Group	Value	95% CI
Usual Care	1705.28	360.16 – 12146.33
Bridge Clinic	9481.93	1478.28 – 29376.14

Number of Participants With Successful Care Linkage Secondary · 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

Group	Value	95% CI
Usual Care	19
Bridge Clinic	45
Usual Care	13
Bridge Clinic	11

Number of MAT Prescriptions Filled by Participant Secondary · 16 weeks post-randomization

Reported buprenorphine-naloxone (or naltrexone) prescriptions filled

Group	Value	95% CI
Usual Care	1	0 – 6
Bridge Clinic	10	4 – 16

Readmissions and Emergency Department (ED) Visits Secondary · 16 weeks post-randomization

Composite number of ED visits and readmissions

Group	Value	95% CI
Usual Care	0	0 – 1
Bridge Clinic	0	0 – 1

Hospital and ED Free Days Secondary · 16 weeks post-randomization

Days alive out of the hospital and/or ED

Group	Value	95% CI
Usual Care	112	111 – 112
Bridge Clinic	112	107 – 112

Mortality Secondary · 16 weeks post-randomization

Death in hospital or documented at 16-week follow up or in the medical record.

Group	Value	95% CI
Usual Care	4
Bridge Clinic	2

Recurrent Opioid Use Secondary · 16 weeks post-randomization

The number of participants with recurrent opioid use.

Group	Value	95% CI
Usual Care	15
Bridge Clinic	23

Overdose Secondary · 16 weeks post-randomization

Any overdose self-reported at the 16-week follow up

Group	Value	95% CI
Usual Care	4
Bridge Clinic	1

Quality of Life - Schwartz Outcome Scale-10 (SOS10). Secondary · 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.

Group	Value	95% CI
Usual Care	41.5	32.5 – 54.25
Bridge Clinic	47	26 – 53.75

Opioid Use Within 30 Days Secondary · 30 days

Opioid use within 30 days as self-reported and assessed during the 16-week follow up phone call.

Group	Value	95% CI
Usual Care	2
Bridge Clinic	2
Usual Care	4
Bridge Clinic	0
Usual Care	7
Bridge Clinic	17

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of a Co-Located Bridging Recovery Initiative on Hospital Length of Stay Among Patients With Opioid Use Disorder: The BRIDGE Randomized Clinical Trial.
   Marcovitz D, Dear ML, Donald R, Edwards DA, et al · · 2024 · cited 8× · PMID 38411964 · DOI 10.1001/jamanetworkopen.2023.56430
2. 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.
   Marcovitz DE, White KD, Sullivan W, Limper HM, et al · · 2021 · cited 5× · PMID 34717736 · DOI 10.1186/s13063-021-05698-4