Opioid UseNCT04084392
Evaluating the Impact of the Bridge Clinic in Patients With Opioid Use Disorder
A study testing Bridge Clinic in people with Opioid Use and Opioid-use Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Opioid-use Disorder
- What is being tested?
- Bridge Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2019to 18 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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
- Being tested
- Bridge Clinic, Usual Care
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridge ClinicOther
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.
Usual CareOther
Referral to an outpatient provider for addiction treatment.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Participants randomized to this arm will receive care as usual. Receives: 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. Receives: Other: Bridge Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Overall index hospital length of stay measured in days
Measured: approximately 3 to 42 days
Secondary outcomes (10)
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.
Measured: 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
Measured: 16 weeks post-randomization
Number of MAT Prescriptions Filled by Participant
Reported buprenorphine-naloxone (or naltrexone) prescriptions filled
Measured: 16 weeks post-randomization
Readmissions and Emergency Department (ED) Visits
Composite number of ED visits and readmissions
Measured: 16 weeks post-randomization
Hospital and ED Free Days
Days alive out of the hospital and/or ED
Measured: 16 weeks post-randomization
Mortality
Death in hospital or documented at 16-week follow up or in the medical record.
Measured: 16 weeks post-randomization
Recurrent Opioid Use
The number of participants with recurrent opioid use.
Measured: 16 weeks post-randomization
Overdose
Any overdose self-reported at the 16-week follow up
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start25 Nov 2019
- Primary completion28 Sep 2021
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Marcovitz, Vanderbilt University Medical Center
- Investigators
- David Marcovitz, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084392
- Sponsor's protocol ID
- 191269
- Status last verified
- Jul 2024
- First submitted
- 6 Sep 2019
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported will be made available (including data dictionaries) after deidentification.
Publications
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.
PubMed 38411964Marcovitz 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.
PubMed 34717736
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of the Bridge Clinic in Patients With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04084392
- Acronym / sponsor ID
- 191269
- Conditions
- Opioid Use, Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Posted 1 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareParticipants randomized to this arm will receive care as usual. |
| Bridge Clinic | Active comparator | Other: Bridge ClinicParticipants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bridge ClinicReferral 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. | Other | Bridge Clinic |
| Usual CareReferral to an outpatient provider for addiction treatment. | Other | Usual Care |
Primary outcome
Hospital Length of Stay
Time frame: approximately 3 to 42 days
Overall index hospital length of stay measured in days
10 secondary outcomes
Combined Cost of Index Admission and Subsequent Admissions During the Study Period
Time frame: 16 weeks post-randomization
Number of Participants With Successful Care Linkage
Time frame: 16 weeks post-randomization
Number of MAT Prescriptions Filled by Participant
Time frame: 16 weeks post-randomization
Readmissions and Emergency Department (ED) Visits
Time frame: 16 weeks post-randomization
Hospital and ED Free Days
Time frame: 16 weeks post-randomization
Mortality
Time frame: 16 weeks post-randomization
Recurrent Opioid Use
Time frame: 16 weeks post-randomization
Overdose
Time frame: 16 weeks post-randomization
Quality of Life - Schwartz Outcome Scale-10 (SOS10).
Time frame: 16 weeks post-randomization
Opioid Use Within 30 Days
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38411964Marcovitz 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.
- Derived from this study: PubMed 34717736Marcovitz 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported will be made available (including data dictionaries) after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Marcovitz, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bridge Clinic in people with Opioid Use and Opioid-use Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Length of Stay (time frame: approximately 3 to 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084392, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.