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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.T

Abstract

BACKGROUND

Patients with substance use disorders are overrepresented among general hospital inpatients, and their admissions are associated with longer lengths of stay and increased readmission rates. Amid the national opioid crisis, increased attention has been given to the integration of addiction with routine medical care in order to better engage such patients and minimize fragmentation of care. General hospital addiction consultation services and transitional, hospital-based "bridge" clinics have emerged as potential solutions. We designed the Bridging Recovery Initiative Despite Gaps in Entry (BRIDGE) trial to determine if these clinics are superior to usual care for these patients.

METHODS

This single-center, pragmatic, randomized controlled clinical trial is enrolling hospitalized patients with opioid use disorder (OUD) who are initiating medication for OUD (MOUD) in consultation with the addiction consult service. Patients are randomized for referral to a co-located, transitional, multidisciplinary bridge clinic or to usual care, with the assignment probability being determined by clinic capacity. The primary endpoint is hospital length of stay. Secondary endpoints include quality of life, linkage to care, self-reported buprenorphine or naltrexone fills, rate of known recurrent opioid use, readmission rates, and costs. Implementation endpoints include willingness to be referred to the bridge clinic, attendance rates among those referred, and reasons why patients were not eligible for referral. The main analysis will use an intent-to-treat approach with full covariate adjustment.

DISCUSSION

This ongoing pragmatic trial will provide evidence on the effectiveness of proactive linkage to a bridge clinic intervention for hospitalized patients with OUD initiating evidence-based pharmacotherapy in consultation with the addiction consult service.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04084392 . Registered on 10 September 2019. The study has been approved by the Vanderbilt Institutional Review Board. The current approved protocol is dated version May 12, 2021.

Authors+Show Affiliations

Vanderbilt University Medical Center, Vanderbilt Psychiatric Hospital, 1603 23rd Ave South, Nashville, TN, 37212, USA. david.marcovitz@vumc.org.Vanderbilt University Medical Center, Vanderbilt Psychiatric Hospital, 1603 23rd Ave South, Nashville, TN, 37212, USA.Vanderbilt University Medical Center, Vanderbilt Psychiatric Hospital, 1603 23rd Ave South, Nashville, TN, 37212, USA.Vanderbilt University Medical Center, Vanderbilt Psychiatric Hospital, 1603 23rd Ave South, Nashville, TN, 37212, USA.Vanderbilt University Medical Center, Vanderbilt Psychiatric Hospital, 1603 23rd Ave South, Nashville, TN, 37212, USA.Vanderbilt University Medical Center, Vanderbilt Psychiatric Hospital, 1603 23rd Ave South, Nashville, TN, 37212, USA.Vanderbilt University Medical Center, Vanderbilt Psychiatric Hospital, 1603 23rd Ave South, Nashville, TN, 37212, USA.Vanderbilt University Medical Center, Vanderbilt Psychiatric Hospital, 1603 23rd Ave South, Nashville, TN, 37212, USA.Vanderbilt University Medical Center, Vanderbilt Psychiatric Hospital, 1603 23rd Ave South, Nashville, TN, 37212, USA.Vanderbilt University Medical Center, Vanderbilt Psychiatric Hospital, 1603 23rd Ave South, Nashville, TN, 37212, USA.No affiliation info available

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

34717736

Citation

Marcovitz, David E., et al. "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, vol. 22, no. 1, 2021, p. 757.
Marcovitz DE, White KD, Sullivan W, et al. 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;22(1):757.
Marcovitz, D. E., White, K. D., Sullivan, W., Limper, H. M., Dear, M. L., Buie, R., Edwards, D. A., Chastain, C., Kast, K. A., & Lindsell, C. J. (2021). 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, 22(1), 757. https://doi.org/10.1186/s13063-021-05698-4
Marcovitz DE, et al. 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. PubMed PMID: 34717736.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Marcovitz,David E, AU - White,Katie D, AU - Sullivan,William, AU - Limper,Heather M, AU - Dear,Mary Lynn, AU - Buie,Reagan, AU - Edwards,David A, AU - Chastain,Cody, AU - Kast,Kristopher A, AU - Lindsell,Christopher J, AU - ,, Y1 - 2021/10/30/ PY - 2021/03/19/received PY - 2021/10/08/accepted PY - 2021/10/31/entrez PY - 2021/11/1/pubmed PY - 2021/11/3/medline KW - Bridge clinic KW - Opioid use disorder KW - Pragmatic clinical trial KW - Substance use disorder SP - 757 EP - 757 JF - Trials JO - Trials VL - 22 IS - 1 N2 - BACKGROUND: Patients with substance use disorders are overrepresented among general hospital inpatients, and their admissions are associated with longer lengths of stay and increased readmission rates. Amid the national opioid crisis, increased attention has been given to the integration of addiction with routine medical care in order to better engage such patients and minimize fragmentation of care. General hospital addiction consultation services and transitional, hospital-based "bridge" clinics have emerged as potential solutions. We designed the Bridging Recovery Initiative Despite Gaps in Entry (BRIDGE) trial to determine if these clinics are superior to usual care for these patients. METHODS: This single-center, pragmatic, randomized controlled clinical trial is enrolling hospitalized patients with opioid use disorder (OUD) who are initiating medication for OUD (MOUD) in consultation with the addiction consult service. Patients are randomized for referral to a co-located, transitional, multidisciplinary bridge clinic or to usual care, with the assignment probability being determined by clinic capacity. The primary endpoint is hospital length of stay. Secondary endpoints include quality of life, linkage to care, self-reported buprenorphine or naltrexone fills, rate of known recurrent opioid use, readmission rates, and costs. Implementation endpoints include willingness to be referred to the bridge clinic, attendance rates among those referred, and reasons why patients were not eligible for referral. The main analysis will use an intent-to-treat approach with full covariate adjustment. DISCUSSION: This ongoing pragmatic trial will provide evidence on the effectiveness of proactive linkage to a bridge clinic intervention for hospitalized patients with OUD initiating evidence-based pharmacotherapy in consultation with the addiction consult service. TRIAL REGISTRATION: ClinicalTrials.gov NCT04084392 . Registered on 10 September 2019. The study has been approved by the Vanderbilt Institutional Review Board. The current approved protocol is dated version May 12, 2021. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/34717736/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_ DB - PRIME DP - Unbound Medicine ER -