Digital Treatments for Opioids and Other Substance Use Disorders (DIGITS) in Primary Care: A Hybrid Type-III Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18,430
- 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. The DIGITS Trial is a partnership between Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, and Kaiser Permanente Washington, a healthcare delivery system in Washington State.
In this study, the FDA-authorized reSET and reSET-O digital therapeutics will be implemented in Kaiser Permanente Washington primary care clinics. The study will evaluate the extent to which two implementation strategy interventions, health coaching and practice coaching, improve the implementation. Primary care clinics are randomized to receive these implementation strategy interventions. Each clinic will have a 12-month active implementation period beginning on its date of randomization. To study the continued use of reSET and reSET-O after the active implementation period is completed, a sustainment period of up 12 months will follow the active implementation period.
详细描述
Specific Aims of the DIGITS Trial are to:
- Estimate the effect of practice facilitation and health coaching implementation strategies in increasing the reach and fidelity of a digital therapeutic for substance use disorders in primary care clinics.
- Compare the population-level cost-effectiveness of each implementation strategy in increasing reach, fidelity, and abstinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
All outcomes are derived from secondary administrative data.
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
- •Patient Inclusion Criteria:
- •Had a primary care visit in a participating clinic during the active implementation period or sustainment period
- •Screened positive for substance use on the day of the visit or in the prior year
- •Adult aged 18 years or older at time of visit
- •Clinic Inclusion Criteria:
- •- At least 1 clinician trained in the use of reSET/reSET-O
排除标准
- •- Patients who have requested through their health system to opt out of research
- •Clinic Exclusion Criteria:
- •- Previously participated in a pilot implementation of reSET/reSET-O
研究组 & 干预措施
Standard Implementation
All primary care clinics will implement reSET and reSET-O using standard implementation approach.
干预措施: Standard implementation (Behavioral)
Standard Implementation Plus Health Coaching
The clinics 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
The clinics 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 Practice Facilitation
The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and a practice facilitator will provide the clinic with support for implementation.
干预措施: Standard implementation (Behavioral)
Standard Implementation Plus Practice Facilitation
The clinics in this arm will implement reSET and reSET-O with a standard implementation strategy and 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 clinics 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)
Standard Implementation Plus Health Coaching and Practice Facilitation
The clinics 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 clinics 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)
结局指标
主要结局
Reach of the Digital Therapeutic to Patients in the Primary Care Clinic
时间窗: 12 months
Patients who initiate the digital therapeutic, defined by instances in which patients open the app, enter the prescription code, and use a treatment module. The measure is reported as the number of patients reached per 10,000 patients, calculated at a clinic level.
Fidelity of Patients' Use of the Digital Therapeutic to Clinical Recommendations
时间窗: 15 months
Mean number of weeks during patients' 12-week prescription in which patients use 4 app modules/week and have visited a clinician in the past 30 days. This measure is reported as the number of patient weeks per 10,000 patients, calculated at a clinic level. For each patient, to identify whether a week was one with fidelity, we identify each patient's reSET activation date and examine for module use during the following 12 weeks. Possible followup for all patients in a clinic extends up to 15 months after the clinic's start date (allowing 12 months for active implementation plus an additional 12 weeks to examine fidelity for patients who are reached on the last day of active implementation).
次要结局
- Engagement(15 months)
- Economic Costs(37 months)