Patient Navigator Plus Remote mHealth Adherence Support With Incentives to Improve Linkage and Retention Among Hospitalized Patients With Opioid and Methamphetamine Use Who Initiate Buprenorphine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Patient linkage to an outpatient program that provides medication for opioid use disorder
研究概览
简要总结
Polysubstance use involving opioids and methamphetamine is emerging as a new public health crisis. Patients with opioids and methamphetamine use often experience serious medical complications requiring hospitalization, which provides an opportunity to offer addiction treatment. Yet linkage to outpatient treatment post-discharge is suboptimal and methamphetamine exacerbates outcomes. The investigators propose to pilot test "MHealth Incentivized Adherence Plus Patient Navigation" (MIAPP) to promote treatment linkage and retention for patients with opioid use disorder (OUD) and methamphetamine use who initiate buprenorphine in the hospital. The investigators Aim is to perform a two-arm, pilot randomized clinical trial (n=40) comparing MIAPP + treatment-as-usual (TAU) versus TAU alone on outpatient medication for opioid use disorder (MOUD) linkage within 30 days (primary) and 90-day retention on medications (secondary) among hospitalized patients with OUD and methamphetamine use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Adult greater than or equal to 18 years of age
- •Admitted to Harborview Medical Center (HMC) on any inpatient service
- •Initiated on buprenorphine for OUD while in the hospital or at the time of discharge and planning to continue outpatient
- •Used methamphetamine within the past 30 days (any route of administration or frequency)
- •Willing to be randomized to video-DOT
- •Willing and able to use a smartphone (study can provide) and work with patient navigator
- •Discharge setting does not preclude the use of video-DOT (i.e., nursing home, inpatient psychiatry, etc.)
排除标准
- •Unable or unwilling to use smartphone (phones to be provided when needed)
- •Cognitive impairment (acute or chronic) resulting in inability to provide informed consent
- •Currently incarcerated and will discharge to jail or prison
- •Plans to discontinue buprenorphine in the near future (<3 months)
- •Lives far away such that cannot keep study visit at 30 days post-discharge
- •Not English speaking
- •Behavioral risk per discretion of research staff
研究组 & 干预措施
PN+mHealth
The intervention is patient navigation and mHealth in addition to treatment-as-usual. The intervention consists of a patient navigator (PN) with the mHealth adherence application facilitating telehealth visits, two-way chats, video-DOT, and delivery of financial incentives via smartphone for adherence and linkage to outpatient treatment within 30 days. Participants will be asked to upload medication adherence videos once a day over the 30 days post discharge from the hospital. Patients will be instructed to continue to take their medication as prescribed in any circumstance where they are unable to upload the video for any reason.
干预措施: Patient Navigation and mHealth (PN+mHealth) (Behavioral)
Treatment-as-usual (TAU)
TAU will be usual care that the Addiction Consult Service provides. It is comprised of a multidisciplinary team of professionals, including addiction medicine and addiction psychiatry physicians, nurses specializing in the treatment of OUD, substance use disorder counselors, peer recovery supports, and program coordinators.
结局指标
主要结局
Patient linkage to an outpatient program that provides medication for opioid use disorder
时间窗: 30 days post-discharge from hospital
Defined as documentation of an outpatient clinical encounter (either in-person or via telemedicine) where a medication for OUD (either buprenorphine, naltrexone, or methadone) was provided or prescribed.
次要结局
- Hospital readmission(90 days post-discharge from hospital)
- Retention on medication for opioid use disorder(90 days post-discharge from hospital)
- Emergency department visits(90 days post-discharge from hospital)
- Past 30-day opioid use(30 days post-discharge)
- Past 30-day methamphetamine use(30 days post-discharge)
研究者
Judith I. Tsui
Professor, School of Medicine, General Internal Medicine
University of Washington