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Remote Brief Intervention and Referrals to Treatment Service for Alcohol (RBIRT)

Primary Purpose

Alcohol Abuse, Alcohol Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RBIRT
SBIRT
Sponsored by
Polaris Health Directions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse, Alcohol Dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • No reliable telephone access.
  • Does not speak English.
  • Already enrolled into the trial.

Sites / Locations

  • University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RBIRT

SBIRT

Arm Description

Telehealth model or the remote administration of SBIRT, a short term, brief intervention and referral to treatment for alcohol abuse.

Face-to-face intervention and referral to treatment for alcohol abuse.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
November 19, 2015
Last Updated
March 9, 2021
Sponsor
Polaris Health Directions
Collaborators
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT02622984
Brief Title
Remote Brief Intervention and Referrals to Treatment Service for Alcohol
Acronym
RBIRT
Official Title
Remote Brief Intervention and Referrals to Treatment Service for Alcohol
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polaris Health Directions
Collaborators
University of Massachusetts, Worcester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RBIRT
Arm Type
Experimental
Arm Description
Telehealth model or the remote administration of SBIRT, a short term, brief intervention and referral to treatment for alcohol abuse.
Arm Title
SBIRT
Arm Type
Active Comparator
Arm Description
Face-to-face intervention and referral to treatment for alcohol abuse.
Intervention Type
Behavioral
Intervention Name(s)
RBIRT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SBIRT
Intervention Description
Face to face standard intervention considered "treatment as usual."
Primary Outcome Measure Information:
Title
Change in alcohol use across the study period compared to baseline.
Description
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.
Time Frame
1,3, 6 months post Emergency Department (ED) visit
Secondary Outcome Measure Information:
Title
Changes in alcohol related consequences across the study period compared to baseline.
Description
Alcohol-related consequences will be measured by the Short Inventory of Problems (SIPs+6).
Time Frame
1,3,6 months post ED visit
Title
Changes in acute healthcare utilization at 6 months compared to baseline.
Description
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.
Time Frame
6 months post ED visit
Title
Compare the costs of both interventions: SBIRT and RBIRT.
Description
Intervention Cost data will be estimated by standard costing methods taking into account all of the costs associated with delivery of both interventions.
Time Frame
6 months post ED visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. No reliable telephone access. Does not speak English. Already enrolled into the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin D Boudreaux, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

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Remote Brief Intervention and Referrals to Treatment Service for Alcohol

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