Remote Brief Intervention and Referrals to Treatment Service for Alcohol

NCT02622984 | Completed Phase 2

• 1 other identifier: 2R42AA02203503
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse, Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

• 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.

  1,3, 6 months post Emergency Department (ED) visit

Secondary Outcomes (3)

• Changes in alcohol related consequences across the study period compared to baseline.

  1,3,6 months post ED visit

• Changes in acute healthcare utilization at 6 months compared to baseline.

  6 months post ED visit

• Compare the costs of both interventions: SBIRT and RBIRT.

  6 months post ED visit

Study Arms (2)

RBIRT

EXPERIMENTAL

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

Behavioral: RBIRT

SBIRT

ACTIVE COMPARATOR

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

Behavioral: SBIRT

Interventions

RBIRT BEHAVIORAL

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.

RBIRT

SBIRT BEHAVIORAL

Face to face standard intervention considered "treatment as usual."

SBIRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Polaris Health Directions: lead
• University of Massachusetts, Worcester: collaborator

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Edwin D Boudreaux, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 7, 2015
• Study Start: March 22, 2017
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: March 10, 2021

Record last verified: 2020-03

Locations

US (1)