Clinical trial NCT02622984: Remote Brief Intervention and Referrals to Treatment Service for Alcohol
Official title: Remote Brief Intervention and Referrals to Treatment Service for Alcohol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Abuse, Alcohol Dependence
Lead sponsor: Polaris Health Directions
Sponsor class: INDUSTRY
Collaborators: name: University of Massachusetts, Worcester
First posted: 2015-12-07
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in alcohol use across the study period compared to baseline.
timeFrame: 1,3, 6 months post Emergency Department (ED) visit
Secondary outcomes:
measure: Changes in alcohol related consequences across the study period compared to baseline.
timeFrame: 1,3,6 months post ED visit
measure: Changes in acute healthcare utilization at 6 months compared to baseline.
timeFrame: 6 months post ED visit
measure: Compare the costs of both interventions: SBIRT and RBIRT.
timeFrame: 6 months post ED visit
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Edwin D Boudreaux, PhD
role: PRINCIPAL_INVESTIGATOR
References: