- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04223011
Initiating Substance Use Disorder Treatment for Hospitalized Alcohol Use Disorder Patients (ISTAP)
July 10, 2020 updated by: Joji Suzuki, MD, Brigham and Women's Hospital
Initiating Substance Use Disorder Treatment for Hospitalized Alcohol Use Disorder Patients: A Pilot Study of Recovery Coaches
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: In-Hospital Recovery Coach Intervention
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment retention in substance use disorder treatment
Time Frame: 4 weeks following hospitalization discharge date
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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.
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4 weeks following hospitalization discharge date
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joji Suzuki, MD, Brigham and Women's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
January 7, 2020
First Submitted That Met QC Criteria
January 7, 2020
First Posted (Actual)
January 10, 2020
Study Record Updates
Last Update Posted (Actual)
July 14, 2020
Last Update Submitted That Met QC Criteria
July 10, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019P003863
- 1K23DA042326-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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