TY - JOUR
T1 - Bridging Recovery Initiative Despite Gaps in Entry (BRIDGE)
T2 - study protocol for a randomized controlled trial of a bridge clinic compared with usual care for patients with opioid use disorder
AU - Vanderbilt Learning Health System Investigators
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 - Bernard, Gordon
AU - Dittus, Bob
AU - Gatto, Cheryl
AU - Harrell, Frank
AU - Harris, Paul
AU - Hartert, Tina
AU - Ivory, Cathy
AU - Hayman, Jim
AU - Johnson, Kevin
AU - Kleinpell, Ruth
AU - Kripalani, Sunil
AU - Luther, Patrick
AU - Piano, Mariann
AU - Pulley, Jill
AU - Rice, Todd
AU - Rothman, Russell
AU - Semler, Matt
AU - Dwyer, Shon
AU - Steaban, Robin
AU - Nantais, Thomas
AU - Walker, Philip
AU - Weitkamp, Asli
AU - Wilkins, Consuelo
AU - Wright, Adam
AU - Zuckerman, Autumn
N1 - Funding Information:
The project described was supported by the Vanderbilt Institute for Clinical and Translational Research (VICTR) Learning Healthcare System Platform under CTSA award No. UL1 TR002243 from the National Center for Advancing Translational Sciences. Its contents are solely the responsibility of the authors and do not necessarily represent official views of the National Center for Advancing Translational Sciences or the National Institutes of Health.
Funding Information:
The trial is being conducted within the Vanderbilt Learning Healthcare System. The authors thank the patients and the clinical care teams at Vanderbilt University Medical Center for making this study possible. The Vanderbilt Learning Health System Investigators study group is comprised of Gordon Bernard, Bob Dittus, Cheryl Gatto, Frank Harrell, Paul Harris, Tina Hartert, Cathy Ivory, Jim Hayman, Kevin Johnson, Ruth Kleinpell, Sunil Kripalani, Patrick Luther, Mariann Piano, Jill Pulley, Todd Rice, Russell Rothman, Matt Semler, Shon Dwyer, Robin Steaban, Thomas Nantais, Philip Walker, Asli Weitkamp, Consuelo Wilkins, Adam Wright, and Autumn Zuckerman. The Vanderbilt Learning Healthcare System Investigators study group provides generalized oversight for project development, ensures alignment with institutional priority, attempts to maximize pragmatism, and offers tailored regulatory guidance. The study was approved by the local Institutional Review Board. Results will be submitted for publication, presented at national conferences, and will guide local practice decisions.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
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.govNCT04084392. 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.
AB - 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.govNCT04084392. 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.
KW - Bridge clinic
KW - Opioid use disorder
KW - Pragmatic clinical trial
KW - Substance use disorder
UR - http://www.scopus.com/inward/record.url?scp=85118617655&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85118617655&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05698-4
DO - 10.1186/s13063-021-05698-4
M3 - Article
C2 - 34717736
AN - SCOPUS:85118617655
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 757
ER -