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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: In-Hospital Recovery Coach Intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment retention in substance use disorder treatment
Time Frame: 4 weeks following hospitalization discharge date
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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