NCT04223011

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

January 7, 2020

Last Update Submit

July 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks following hospitalization discharge date

Study Arms (1)

In-Hospital Recovery Coach Intervention

EXPERIMENTAL

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.

Behavioral: In-Hospital Recovery Coach Intervention

Interventions

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.

In-Hospital Recovery Coach Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Joji Suzuki, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Addiction Psychiatry

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 10, 2020

Study Start

March 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations