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OpenTrials
Completed

NCT Number: NCT04084392

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).

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Key information

Conditions

Opioid Use Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Opioid-use Disorder Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bridge Clinic

Other

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 Care

Other

Referral to an outpatient provider for addiction treatment.

Primary outcomes

  1. Hospital Length of Stay

    Time frame: approximately 3 to 42 days

    Overall index hospital length of stay measured in days

Secondary outcomes

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

    Time frame: 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.

  2. Number of Participants With Successful Care Linkage

    Time frame: 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

  3. Number of MAT Prescriptions Filled by Participant

    Time frame: 16 weeks post-randomization

    Reported buprenorphine-naloxone (or naltrexone) prescriptions filled

  4. Readmissions and Emergency Department (ED) Visits

    Time frame: 16 weeks post-randomization

    Composite number of ED visits and readmissions

  5. Hospital and ED Free Days

    Time frame: 16 weeks post-randomization

    Days alive out of the hospital and/or ED

  6. Mortality

    Time frame: 16 weeks post-randomization

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

  7. Recurrent Opioid Use

    Time frame: 16 weeks post-randomization

    The number of participants with recurrent opioid use.

  8. Overdose

    Time frame: 16 weeks post-randomization

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

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

    Time frame: 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.

  10. Opioid Use Within 30 Days

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 10, 2019
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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