Technology Improving Success of Medication-Assisted Treatment in Primary Care - Phase 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Q2i, LLC
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Feasibility for primary care providers (PCPs)
研究概览
简要总结
With over 72,000 overdose deaths in 2017, of which 47,600 are attributable to opioid overdose, the opioid epidemic has become North America's most widespread behavioral public health problem. Medication-assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious. The Opioid Addiction Recovery Support (OARS), comprised of a healthcare team portal connected to a patient mobile application, provides opioid-related education, promotes connectedness with clinicians, and tracks MAT treatment progress. This study will conduct interviews with patients that will inform optimal design of OARS, assess the efficacy of OARS in improving MAT outcomes in primary care settings, and evaluate the sustainability and return on investment.
It joins an outstanding scientific team at University of California, Los Angeles and a small business that has developed, Opioid Addiction Recovery Support (OARS) -- a software platform that by integrating with the Electronic Health Record (EHR) improves clinical management of patients by primary care providers (PCPs) treating patients with OUD using MAT. OARS platform uses a dashboard to show the real-time measurement of patient achievements in recovery. It provides opportunities for patients to interact with their PCPs, allowing for better connection to and support from their PCPs. OARS platform features artificial intelligence to analyze information from the EHR and from patients to provide a relapse risk assessment for patients receiving MAT for OUD, an innovation that sets OARS apart from other software solutions. The goal of Phase 1 was to modify the OARS platform for use in primary care settings by conducting interviews with Primary Care Physicians (PCPs) (N=20) and their patients with OUD (N=40) in primary care settings to collect data on feasibility and acceptability of engaging with OARS to inform the user-centered design of OARS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •For PCPs: (1) physician, nurse practitioner, or physician's assistant in any area within primary care; (2) in possession of valid DATA-2000 waiver; (3) currently treating more than two patients with OUD using oral buprenorphine-naloxone product; (4) willing to distribute study materials to their patients describing the research and providing options for their participation.
- •For patient participants: (1) diagnosed and treated using MAT within primary care setting (i.e., family medicine, internal medicine, adolescent medicine, pediatrics, obstetrics/gynecology, geriatrics, infectious diseases, emergency department, non-cancer pain management
排除标准
- •For PCPs: (1) specialization outside primary care (e.g., psychiatry, neurology, etc) or provider works in specialized setting (e.g., addiction treatment programs; mental health clinic); (2) not treating patients with OUD with oral buprenorphine-naloxone product (e.g., long-acting naltrexone or buprenorphine injections); (3) Individual interviews with physicians and their patients to discuss initially barriers and challenges to MAT for patients with OUD seen in primary care settings.
- •For patient participants: (1) MAT delivered in specialty care settings (i.e., psychiatry, substance abuse treatment programs).
结局指标
主要结局
Feasibility for primary care providers (PCPs)
时间窗: From week 1 to week 4.
Frequency of days of engagement per week and use of interactive features does not reduce over 20%.
Acceptability for patients
时间窗: At week 4.
No more than 20% of qualitative mentions that describe barriers or dissatisfactions with using OARS platform).
Feasibility for patients
时间窗: From week 1 to week 4.
Frequency of days of engagement per week and use of interactive features does not reduce over 20%.
Acceptability for PCPs
时间窗: At week 4.
No more than 20% of qualitative mentions that describe barriers or dissatisfactions with using OARS platform).
次要结局
- System Usability Scale for patients(At week 4.)
- System Usability Scale for providers(At week 4.)