Technologically-Augmented Referrals to Mitigate Addiction Consequences (TARMAC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- The difference in proportions of participants who receive specialty care in the two arms.
研究概览
简要总结
The implementation of screening and intervention for substance use disorders, such as Screening Brief Intervention Referral to Treatment (SBIRT), in the primary care setting has faced several challenges. In the past, physicians have cited barriers such as lack of time, lack of access to treatment, and lack of financial resources.
To overcome some of the barriers to screening and prevention of substance use disorders, many researchers have begun to explore novel approaches using web-based and mobile technology. While the quality of evidence is often inconsistent, there is promising research to show that interventions utilizing web-based or mobile technology for alcohol and other substance abuse can be effective. Features such as tailored feedback have shown to be more effective than similar programs without feedback, and interventions that combine self-administered therapy in conjunction with therapist-direction interventions show greater reductions in addictive behavior.
In this project, the investigators proposed to enhance the Screening Brief Intervention Referral to Treatment (SBIRT) with a digital tool that aims to save physician time and improve patient adherence to treatment goals, through extensive use of shared decision making, patient self-monitoring and goal tracking, and real-time tailored patient feedback and text follow-up for patients. Increase the screening and referral of those patients at risk for substance use disorder (SUD) thereby increasing the number of patients receiving higher level substance use treatment.
A total of 500 patients will be screened and randomized into two groups. 250 in the Technology Augmented Treatment group (intervention group) and 250 in the control group. The Washington State University research team, lead by Dr. McPherson, will screen and recruit subjects at CHAS Valley Clinic in Spokane, WA. Subjects in both groups will be followed up for 30 days.
At the initial study enrollment visit, the intervention group will be asked questions on an iPad about their eligibility. After the initial visit, subjects in the intervention group will receive up to 4 texts/day on his/her phone that will ask questions about their health after the visit.
The control group will be asked questions on an iPad and will be given a call 30 days after to ask questions about their health.
详细描述
Study Objectives:
- Enhance the Screening Brief Intervention Referral to Treatment (SBIRT) with a digital tool that aims to save physicians time and improve patient adherence to treatment goals, through extensive use of shared decision making, patient self-monitoring, and goal tracking, and real-time tailored patient feedback via texting and phone follow up.
- Increase the screening and referral of patients at risk for substance use disorder (SUD), thereby increasing the number of patients receiving higher levels of substance use treatment.
Study Design:
This Randomized Controlled Trial will recruit a total of 500 patients with SUD from a primary care clinic. The patients will be randomized into one of two groups of 250 patients each. The Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) screen will be the risk stratification screen, as defined below in the inclusion criteria. The control group will receive the usual SBIRT care and the intervention group will receive the technology-enhanced SBIRT care. The high-risk SUD patients will be referred to Washington State University (WSU) affiliated specialty providers in the area.
The investigators' primary hypotheses are that compared with the control group, participants at 30 days:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be included if they:
- •Do not answer "Never'' for TASP1 Q2 or Q3, Q4 & Q
- •Age 21 or older.
- •Able to read and speak English.
- •Able to provide written informed consent.
- •Have access to a personal data enabled Mobile device for messaging.
排除标准
- •Participants will be excluded if they meet one or more of the following criteria:
- •Answer " "Never" for TAPS1 Q2 or Q3, Q4 & Q5
- •Currently in Substance abuse treatment.
- •Have had previous substance use disorder (SUD) diagnosis less than a year ago.
- •Were in a psychiatric hospital, or attempted suicide in the last 6 months.
- •Have any other medical or psychiatric condition that the PIs determine would compromise safe study participation (e.g., terminal medical condition, recent myocardial infarction).
- •Are pregnant.
- •In the clinic for urgent conditions.
结局指标
主要结局
The difference in proportions of participants who receive specialty care in the two arms.
时间窗: from baseline visit to day 30 follow up visit.
The investigators estimate that SBIRT intervention (Glass et al 2015) could result in 10% to 30% of patients receiving specialty care. The investigators computed power using the following assumptions: * Control arm with 20% participants receiving specialty care. * Intervention arm with 35% participants receiving specialty care. * Same number of participants in control and intervention. A sample of 197 participants in each of arms will be sufficiently powered to detect such differences between control and intervention arms.
次要结局
- Substance use levels at day 30 between the two arms.(From baseline visit to day 30 follow up visit.)