Alcohol Use DisorderISTAPNCT04223011
Initiating Substance Use Disorder Treatment for Hospitalized Alcohol Use Disorder Patients
A study testing In-Hospital Recovery Coach Intervention in people with Alcohol Use Disorder, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- In-Hospital Recovery Coach Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- DSM-5 diagnosis of opioid use disorder
- Unable to provide informed consent due to mental status
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- In-Hospital Recovery Coach Intervention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Hospital Recovery Coach InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: In-Hospital Recovery Coach Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks following hospitalization discharge date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Mar 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Joji Suzuki, MD, Brigham and Women's Hospital
- Investigators
- Joji Suzuki, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223011
- Sponsor's protocol ID
- 2019P003863
- Other IDs
- 1K23DA042326-01A1
- Acronym
- ISTAP
- Status last verified
- Jul 2020
- First submitted
- 7 Jan 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiating Substance Use Disorder Treatment for Hospitalized Alcohol Use Disorder Patients: A Pilot Study of Recovery Coaches
- ClinicalTrials.gov ID
- NCT04223011
- Acronym / sponsor ID
- ISTAP / 2019P003863
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-Hospital Recovery Coach Intervention | Experimental | Behavioral: In-Hospital Recovery Coach InterventionAs this is a single-arm, open-label study, all subjects will receive the interventional arm, specifically in-hospital manualized sessions with the recovery coach. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- DSM-5 diagnosis of opioid use disorder
- Unable to provide informed consent due to mental status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Hospital Recovery Coach InterventionThe 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. | Behavioural | In-Hospital Recovery Coach Intervention |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joji Suzuki, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Hospital Recovery Coach Intervention in people with Alcohol Use Disorder, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment retention in substance use disorder treatment (time frame: 4 weeks following hospitalization discharge date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.