Alcohol Abuse, Alcohol DependencePhase 2RBIRTNCT02622984
Remote Brief Intervention and Referrals to Treatment Service for Alcohol
A Phase 2 study testing RBIRT and SBIRT in people with Alcohol Abuse, Alcohol Dependence, run by Polaris Health Directions at 1 site in United States.
Trial summary
The traditional paradigm that relies upon training physicians and nurses or uses on-site interventionists to perform screening, brief intervention, and referral to treatment (SBIRT) for alcohol has proven unsustainable in most clinical settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse, Alcohol Dependence
- What is being tested?
- RBIRT and SBIRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2017to 31 Aug 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older.
- Presenting for care to the UMass Emergency Department.
- Screens positive for alcohol use above the NIAAA age and gender matched low risk drinking limits.
- AUDIT-10 score greater than 8 suggesting risk for an Alcohol Use Disorder.
Who cannot join
- Altered mental status (not alert, not oriented, psychotic, persistent intoxication).
- Patients who present as initially intoxicated but who are no longer intoxicated later in the visit can be approached.
- Currently in alcohol treatment.
- DAST-10 score greater than 3.
- Currently in state custody or pending legal action that might lead to imprisonment.
- Cannot paraphrase the study requirements.
Show all 9Show fewer
- No reliable telephone access.
- Does not speak English.
- Already enrolled into the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
The traditional paradigm that relies upon training physicians and nurses or uses on-site interventionists to perform screening, brief intervention, and referral to treatment (SBIRT) for alcohol has proven unsustainable in most clinical settings. The Remote Brief Intervention and Referral to Treatment (R-BIRT) for alcohol is an innovative telehealth service model with potential to improve public health through evidence based counseling for patients who exceed the NIAAA low risk drinking limits or have evidence of an Alcohol Use Disorder with professional and self-help treatment. For those that are appropriate, the R-BIRT service will provide facilitated referrals to specialized alcohol abuse treatment. The service model is being studied in the emergency department (ED) setting to demonstrate its utility in a medical setting with a very high prevalence of risky alcohol use and Alcohol Use Disorders; however, the model is relevant and will be accessible to a broad array of healthcare settings, including primary care practices. Our new model, the R-BIRT, challenges the prevailing paradigm and offers the promise of not only clinical efficacy but increased cost effectiveness as well.
Read the detailed description
Significance: The USPHSTF, SAMHSA, CDC, and NIAAA have affirmed the importance of screening in medical settings for alcohol consumption that exceeds the NIAAA low risk limits, brief educational and motivational counseling for those who screen positive or have other evidence of an Alcohol Use Disorder, and, when appropriate, referral to treatment (SBIRT). However, translation to clinical practice continues to be elusive. Polaris Health Directions (Small Business) and the University of Massachusetts Medical School (Research Institute) have partnered to solve this problem by creating the Remote Brief Intervention and Referral to Treatment service for alcohol (R-BIRT), a telehealth service for delivering evidence based alcohol brief interventions and referral to treatment during a medical encounter in a cost-effective, sustainable way.
Investigators: The investigators have extensive expertise in SBIRT for alcohol (Boudreaux, Bernstein); telehealth (Boudreaux); development, testing, and marketing of behavioral intervention technologies (Boudreaux, Harralson); comparative effectiveness trial design and analysis (Barton); and health economics (Sachs). Combined, the team has over 100 publications related to SBIRT and constituent technology domains.
Innovation: This Phase 2 STTR will pioneer telehealth delivery of SBIRT for alcohol. It will be flexible enough for a variety of medical settings, and will develop and expand software capable of facilitating both telehealth and in-person SBIRT delivery models. It will further innovate SBIRT research and clinical practice by exploring mechanisms of action, an objective rarely incorporated into SBIRT studies.
Approach: The design is a two arm, single blind (outcomes assessor), randomized, non-inferiority trial. Emergency department (ED) patients (n=356) who drink above the NIAAA low risk limits or have evidence of an Alcohol Use Disorder will be randomized to the telehealth model (R-BIRT) or a gold-standard in-person intervention (SBIRT) and followed for 6 months post-visit using a multi-method outcomes attainment plan. The study will establish the non-inferiority of the telehealth model compared to the in-person model in reducing alcohol use and alcohol related consequences, while showing that the telehealth model is the more cost effective of the two. Mechanisms of action, including patient knowledge of low risk drinking limits, motivation, self-efficacy, substance abuse treatment initiation, and self-help program engagement, will be examined.
Environment: With the success of the R-BIRT Phase 1 and other relevant projects, including previous large scale Phase 2 STTR clinical trials, Polaris and UMass have clearly established their capability of successfully carrying out this study, disseminating its results, and marketing the final product.
Impact: Because alcohol misuse, abuse, and dependence carries an enormous burden in both human suffering and healthcare costs, a strategy that provides high quality, evidence based care in a manner that is more cost effective and easier than existing models has potential to exert a substantial impact on public health.
- Conditions
- Alcohol Abuse, Alcohol Dependence
- Being tested
- RBIRT, SBIRT
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBIRTBehavioural
Intervention group will receive the telehealth or remote behavior intervention and referral for substance use (RBIRT). Other group will receive treatment as usual which is SBIRT.
SBIRTBehavioural
Face to face standard intervention considered "treatment as usual."
| Study group | Role | What they receive |
|---|---|---|
| RBIRT | Experimental | Telehealth model or the remote administration of SBIRT, a short term, brief intervention and referral to treatment for alcohol abuse. Receives: Behavioral: RBIRT |
| SBIRT | Active comparator | Face-to-face intervention and referral to treatment for alcohol abuse. Receives: Behavioral: SBIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alcohol use across the study period compared to baseline.
Consistent with the latest standards in ED SBIRT research, alcohol use will be measured by a one-week Timeline Follow-back (TLFB), which is a validated procedure wherein participants report the number of drinks they consumed each day for the past seven days using a protocol that facilitates recall. This will allow computation of drinks/week and drinking above the NIAAA low risk drinking limits.
Measured: 1,3, 6 months post Emergency Department (ED) visit
Secondary outcomes (3)
Changes in alcohol related consequences across the study period compared to baseline.
Alcohol-related consequences will be measured by the Short Inventory of Problems (SIPs+6).
Measured: 1,3,6 months post ED visit
Changes in acute healthcare utilization at 6 months compared to baseline.
The Cornell Services Index will be used to ascertain all outpatient and inpatient healthcare use, including substance abuse treatment. It will be modified to also assess self-help program engagement, such as Alcoholics Anonymous. Per our standard procedures used in other studies, self-reported substance abuse treatment initiation will be validated by contacting the treating provider.
Measured: 6 months post ED visit
Compare the costs of both interventions: SBIRT and RBIRT.
Intervention Cost data will be estimated by standard costing methods taking into account all of the costs associated with delivery of both interventions.
Measured: 6 months post ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study start22 Mar 2017
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Abuse, Alcohol DependenceStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polaris Health Directions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- Edwin D Boudreaux, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622984
- Sponsor's protocol ID
- 2R42AA02203503
- Acronym
- RBIRT
- Status last verified
- Mar 2020
- First submitted
- 19 Nov 2015
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Brief Intervention and Referrals to Treatment Service for Alcohol
- ClinicalTrials.gov ID
- NCT02622984
- Acronym / sponsor ID
- RBIRT / 2R42AA02203503
- Conditions
- Alcohol Abuse, Alcohol Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Polaris Health DirectionsIndustry (pharma, biotech, devices)
- Collaborators
- University of Massachusetts, Worcester
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 7 Dec 2015 (estimated)
- 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 traditional paradigm that relies upon training physicians and nurses or uses on-site interventionists to perform screening, brief intervention, and referral to treatment (SBIRT) for alcohol has proven unsustainable in most clinical settings. The Remote Brief Intervention and Referral to Treatment (R-BIRT) for alcohol is an innovative telehealth service model with potential to improve public health through evidence based counseling for patients who exceed the NIAAA low risk drinking limits or have evidence of an Alcohol Use Disorder with professional and self-help treatment. For those that are appropriate, the R-BIRT service will provide facilitated referrals to specialized alcohol abuse treatment. The service model is being studied in the emergency department (ED) setting to demonstrate its utility in a medical setting with a very high prevalence of risky alcohol use and Alcohol Use Disorders; however, the model is relevant and will be accessible to a broad array of healthcare settings, including primary care practices. Our new model, the R-BIRT, challenges the prevailing paradigm and offers the promise of not only clinical efficacy but increased cost effectiveness as well.
Detailed description
Significance: The USPHSTF, SAMHSA, CDC, and NIAAA have affirmed the importance of screening in medical settings for alcohol consumption that exceeds the NIAAA low risk limits, brief educational and motivational counseling for those who screen positive or have other evidence of an Alcohol Use Disorder, and, when appropriate, referral to treatment (SBIRT). However, translation to clinical practice continues to be elusive. Polaris Health Directions (Small Business) and the University of Massachusetts Medical School (Research Institute) have partnered to solve this problem by creating the Remote Brief Intervention and Referral to Treatment service for alcohol (R-BIRT), a telehealth service for delivering evidence based alcohol brief interventions and referral to treatment during a medical encounter in a cost-effective, sustainable way.
Investigators: The investigators have extensive expertise in SBIRT for alcohol (Boudreaux, Bernstein); telehealth (Boudreaux); development, testing, and marketing of behavioral intervention technologies (Boudreaux, Harralson); comparative effectiveness trial design and analysis (Barton); and health economics (Sachs). Combined, the team has over 100 publications related to SBIRT and constituent technology domains.
Innovation: This Phase 2 STTR will pioneer telehealth delivery of SBIRT for alcohol. It will be flexible enough for a variety of medical settings, and will develop and expand software capable of facilitating both telehealth and in-person SBIRT delivery models. It will further innovate SBIRT research and clinical practice by exploring mechanisms of action, an objective rarely incorporated into SBIRT studies.
Approach: The design is a two arm, single blind (outcomes assessor), randomized, non-inferiority trial. Emergency department (ED) patients (n=356) who drink above the NIAAA low risk limits or have evidence of an Alcohol Use Disorder will be randomized to the telehealth model (R-BIRT) or a gold-standard in-person intervention (SBIRT) and followed for 6 months post-visit using a multi-method outcomes attainment plan. The study will establish the non-inferiority of the telehealth model compared to the in-person model in reducing alcohol use and alcohol related consequences, while showing that the telehealth model is the more cost effective of the two. Mechanisms of action, including patient knowledge of low risk drinking limits, motivation, self-efficacy, substance abuse treatment initiation, and self-help program engagement, will be examined.
Environment: With the success of the R-BIRT Phase 1 and other relevant projects, including previous large scale Phase 2 STTR clinical trials, Polaris and UMass have clearly established their capability of successfully carrying out this study, disseminating its results, and marketing the final product.
Impact: Because alcohol misuse, abuse, and dependence carries an enormous burden in both human suffering and healthcare costs, a strategy that provides high quality, evidence based care in a manner that is more cost effective and easier than existing models has potential to exert a substantial impact on public health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBIRT | Experimental | Behavioral: RBIRTTelehealth model or the remote administration of SBIRT, a short term, brief intervention and referral to treatment for alcohol abuse. |
| SBIRT | Active comparator | Behavioral: SBIRTFace-to-face intervention and referral to treatment for alcohol abuse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older.
- Presenting for care to the UMass Emergency Department.
- Screens positive for alcohol use above the NIAAA age and gender matched low risk drinking limits.
- AUDIT-10 score greater than 8 suggesting risk for an Alcohol Use Disorder.
Key exclusion criteria (9 listed)
- Altered mental status (not alert, not oriented, psychotic, persistent intoxication).
- Patients who present as initially intoxicated but who are no longer intoxicated later in the visit can be approached.
- Currently in alcohol treatment.
- DAST-10 score greater than 3.
- Currently in state custody or pending legal action that might lead to imprisonment.
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 |
|---|---|---|
| RBIRTIntervention group will receive the telehealth or remote behavior intervention and referral for substance use (RBIRT). Other group will receive treatment as usual which is SBIRT. | Behavioural | RBIRT |
| SBIRTFace to face standard intervention considered "treatment as usual." | Behavioural | SBIRT |
Primary outcome
Change in alcohol use across the study period compared to baseline.
Time frame: 1,3, 6 months post Emergency Department (ED) visit
Consistent with the latest standards in ED SBIRT research, alcohol use will be measured by a one-week Timeline Follow-back (TLFB), which is a validated procedure wherein participants report the number of drinks they consumed each day for the past seven days using a protocol that facilitates recall. This will allow computation of drinks/week and drinking above the NIAAA low risk drinking limits.
3 secondary outcomes
Changes in alcohol related consequences across the study period compared to baseline.
Time frame: 1,3,6 months post ED visit
Changes in acute healthcare utilization at 6 months compared to baseline.
Time frame: 6 months post ED visit
Compare the costs of both interventions: SBIRT and RBIRT.
Time frame: 6 months post ED visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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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.
Edwin D Boudreaux, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RBIRT and SBIRT in people with Alcohol Abuse, Alcohol Dependence, run by Polaris Health Directions 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 9 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: finished, as of the sponsor's last update on 10 Mar 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in alcohol use across the study period compared to baseline. (time frame: 1,3, 6 months post Emergency Department (ED) visit). 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 10 Mar 2021.