Evaluating the Usability, Efficacy and Commercial Utility of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Retention in treatment
研究概览
简要总结
Buprenorphine Evaluation and Telehealth Study (BEaTS)
Comparison of retention in care between telehealth-based care and treatment as usual.
详细描述
Evaluating the Usability, Efficacy and Commercial Utility of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
Phase I, Aim I: Completed (R44 DA050354). Advance Boulder Care's mobile platform development and obtain usability feedback from individuals with prior OUD treatment. Aim 1 was successfully completed during Phase I, meeting milestones for improving product usability and satisfaction while reducing treatment barriers.
Phase II, Aim 2: Compare study participants who enroll in Boulder Care (n = 100) to participants who enroll in treatment as usual (i.e., office-based buprenorphine) (n = 100) and assess buprenorphine retention at 48 weeks (primary outcome) and monitor a) transition from referral to treatment, b) care continuity, c) engagement in care, and d) satisfaction with care (secondary outcomes).
Phase II, Aim 3: Compare study participants who enroll in Boulder Care (n = 100) to participants who enroll in treatment as usual (i.e., office-based buprenorphine) (n = 100) and assess at baseline, 4, 12, 24, 36, and 48 weeks post treatment initiation opioid use (primary outcome) and monitor employment, housing stability, and criminal justice involvement (secondary outcomes).
Phase II Approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •18 years of age or older with a diagnosis of OUD
- •Within 45 days of seeking buprenorphine prescription
- •Have a working smartphone
- •Speaks and understands English
排除标准
- •Untreated mental or medical health conditions that, in the opinion of the patient, would preclude study participation
- •History of allergic reaction to buprenorphine
- •Impending incarceration
- •Plans to move out of Oregon in next 12 months
结局指标
主要结局
Retention in treatment
时间窗: 48 weeks
The primary Goal of the Phase II project is to compare participant retention in buprenorphine treatment for opioid use disorder (OUD) at 48 weeks for participants enrolled in Boulder Care (n=l00) to participants enrolled in treatment-as-usual (TAU) from OHSU (Oregon Health \& Science University) clinics (n=100). Retention in treatment will be assessed through the Electronic Medical Record for each patient and whether there is an active buprenorphine prescription for the patient at 48 weeks of care. Because of the protocols for each clinic, such a prescription will indicate that treatment is active for a given participant. This is the most direct way to assess ongoing buprenorphine treatment as Oregon law prohibits use of its Prescription Drug Monitoring Program for research.
次要结局
- Participant satisfaction(48 weeks)
- Changes in risk factors for substance use and for protective factors that support recovery(48 weeks)
- Changes in cravings, health perception, and health care utilization(48 weeks)
- Changes in demographics i.e., employment, education, housing, etc(48 weeks)