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Initiating Substance Use Disorder Treatment for Hospitalized Alcohol Use Disorder Patients (ISTAP)

Primary Purpose

Alcohol Use Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-Hospital Recovery Coach Intervention
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English speaking, adults aged 18-75
  • Diagnosis of DSM-5 alcohol use disorder, severe, actively using alcohol until the time of hospitalization
  • Not engaged in SUD treatment including 12-steps within 1 month of hospital admission
  • Are being referred to the BWH Bridge Clinic or the BWFH ARP for ongoing SUD treatment after discharge

Exclusion Criteria:

  • DSM-5 diagnosis of opioid use disorder
  • Unable to provide informed consent due to mental status

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

In-Hospital Recovery Coach Intervention

Arm Description

As this is a single-arm, open-label study, all subjects will receive the interventional arm, specifically in-hospital manualized sessions with the recovery coach.

Outcomes

Primary Outcome Measures

Treatment retention in substance use disorder treatment
Following discharge, the electronic health record of the participant will be examined to confirm whether the participant was successfully seen at the Brigham and Women's Hospital Bridge Clinic or the Brigham and Women's Faulkner Hospital Addiction Recovery Program by checking the visit notes. The proportion of participants who are successfully linked will be calculated.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2020
Last Updated
July 10, 2020
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04223011
Brief Title
Initiating Substance Use Disorder Treatment for Hospitalized Alcohol Use Disorder Patients
Acronym
ISTAP
Official Title
Initiating Substance Use Disorder Treatment for Hospitalized Alcohol Use Disorder Patients: A Pilot Study of Recovery Coaches
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Due to COVID-19, recruitment was halted before we were able to enroll participants. Currently we are unable to resume recruitment due to study staff changes.
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the impact of a manualized in-hospital recovery coach intervention on rates of post-discharge treatment retention and alcohol use among hospitalized patients with alcohol use disorder.
Detailed Description
Patients with alcohol use disorder (AUD) are susceptible to a variety of medical, psychiatric, and social complications, and utilize acute health services frequently; the prevalence of hospitalized patients with AUD is estimate to be between 16% and 26%. While the treatment for the acute complications of AUD such as withdrawal or seizures are treated adequately in the hospital setting, there is a growing recognition that hospitalizations should be utilized as opportunities to initiate treatment for the underlying substance use disorder that likely played a role in the hospitalization in the first place. A large majority (90%) of individuals with active AUD are not engaged with any formal treatment. A promising approach so far in engaging AUD patients has been Screening, Brief Intervention, and Referral to Treatment (SBIRT), particularly for at-risk drinkers (i.e. binge drinkers but not meeting criteria for AUD). However, studies of SBIRT alone is insufficient in reducing alcohol use in heavily dependent, hospitalized patients with alcohol use disorder. Engagement with hospital-based addiction consultation services is helpful with linkage to treatment after discharge, but nearly half of the referred patients never make it to their first appointment. Given the complex medical and psychosocial needs of hospitalized AUD patients, more research on care management interventions that focus on the transitions of care for AUD patients may be needed. There is a growing body of evidence for the benefits of recovery coaches, who provide peer-delivered support services, to help SUD patients in the community. Tracing their origin to mutual support groups to supplement traditional clinical services, recovery coaches are individuals with lived experience of recovery, and are referred to by a variety of names in the literature (i.e. consumer providers, peer support specialists, peer workers, peer mentors). Recovery coaches typically provide services in four domains: 1) emotional (demonstrate empathy, bolster confidence, and foster hope), 2) informational (share knowledge and help skill-building), 3) instrumental (provide assistance with housing, employment, transportation, etc.), and 4) affiliational (create community and sense of belonging). Studies of recovery coaches have demonstrated greater treatment retention, reduced substance use, and reduced inpatient utilization. However, no prior studies have examined the impact of recovery coaches specifically in improving hospitalized AUD patients link with outpatient treatment. As such, the aim of this study is to evaluate the impact of a in-hospital recovery coach intervention on rates of post-discharge treatment retention and alcohol use among hospitalized patients with alcohol use disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-Hospital Recovery Coach Intervention
Arm Type
Experimental
Arm Description
As this is a single-arm, open-label study, all subjects will receive the interventional arm, specifically in-hospital manualized sessions with the recovery coach.
Intervention Type
Behavioral
Intervention Name(s)
In-Hospital Recovery Coach Intervention
Intervention Description
The recovery coach will meet with the patient at least once during the hospital admission, during which he/she will reinforce the importance of continuing medication treatments, if initiated, as well as community and social supports for recovery and will discuss the plan for engaging in these services. This will include recommendations for suitable community resources for recovery services, or for housing, transportation, or other external barriers that may make it more difficult to engage in outpatient treatment. The recovery coach will encourage the participant to complete a relapse prevention plan, and help the patient organize post-discharge appointments and review medications. If applicable, family members and significant others will be encouraged to be present for these encounters.
Primary Outcome Measure Information:
Title
Treatment retention in substance use disorder treatment
Description
Following discharge, the electronic health record of the participant will be examined to confirm whether the participant was successfully seen at the Brigham and Women's Hospital Bridge Clinic or the Brigham and Women's Faulkner Hospital Addiction Recovery Program by checking the visit notes. The proportion of participants who are successfully linked will be calculated.
Time Frame
4 weeks following hospitalization discharge date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking, adults aged 18-75 Diagnosis of DSM-5 alcohol use disorder, severe, actively using alcohol until the time of hospitalization Not engaged in SUD treatment including 12-steps within 1 month of hospital admission Are being referred to the BWH Bridge Clinic or the BWFH ARP for ongoing SUD treatment after discharge Exclusion Criteria: DSM-5 diagnosis of opioid use disorder Unable to provide informed consent due to mental status
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joji Suzuki, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Initiating Substance Use Disorder Treatment for Hospitalized Alcohol Use Disorder Patients

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