Remote Brief Intervention and Referrals to Treatment Service for Alcohol
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Change in alcohol use across the study period compared to baseline.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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.
结局指标
主要结局
Change in alcohol use across the study period compared to baseline.
时间窗: 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.
次要结局
- 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)