Digital Therapeutics for Opioids and Other Substance Use Disorders in Primary Care Pilot (DIGITS Trial Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,552
- 试验地点
- 1
- 主要终点
- Reach of the Digital Therapeutic to Patients in the Primary Care Clinic
研究概览
简要总结
The DIGITS Trial addresses a critical knowledge gap: How to best implement digital treatments for opioids and other substance use disorders in primary care. In this pilot study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. The pilot is comprised of a 3-month period in which a standard approach to implementing reSET and reSET-O is applied in the two primary care clinics "standard implementation", followed by a second 3-month period in which the study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing) in the same clinics. This study will also pilot economic data collection tools and collect qualitative data for a formative evaluation. The analytic goals are to inform the statistical design and data collection processes for the subsequent cluster-randomized DIGITS Trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Had a primary care visit in a participating clinic during the pilot
- •Screened positive for substance use
- •Adult aged 18 years or older at time of visit
排除标准
- 未提供
研究组 & 干预措施
Standard Implementation Plus Health Coaching
The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O.
干预措施: Health Coaching (Behavioral)
Standard Implementation Plus Health Coaching
The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O.
干预措施: Standard Implementation (Behavioral)
Standard Implementation Plus Health Coaching and Practice Facilitation
The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O. Additionally, a practice facilitator will provide the clinic with support for implementation.
干预措施: Health Coaching (Behavioral)
Standard Implementation Plus Health Coaching and Practice Facilitation
The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O. Additionally, a practice facilitator will provide the clinic with support for implementation.
干预措施: Practice Facilitation (Behavioral)
Standard Implementation Plus Health Coaching and Practice Facilitation
The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O. Additionally, a practice facilitator will provide the clinic with support for implementation.
干预措施: Standard Implementation (Behavioral)
结局指标
主要结局
Reach of the Digital Therapeutic to Patients in the Primary Care Clinic
时间窗: 6 months
The proportion of patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module
Fidelity of Patients Use of the Digital Therapeutic to Clinical Recommendations
时间窗: 9 months
Mean number of weeks in which patients use 4 app modules/week and have visited a clinician in the past month
次要结局
- Effectiveness(9 months)