跳至主要内容
临床试验/NCT04907045
NCT04907045已完成不适用

Digital Therapeutics for Opioids and Other Substance Use Disorders in Primary Care Pilot (DIGITS Trial Pilot)

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 1,552 人开始时间: 2021年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,552
试验地点
2
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

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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