Effects of Remote Motivational Enhancement & MySafeRx on Post-Detox Engagement and Retention in B/N Treatment (MySafeRx) - RCT
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Effect of Remote Motivational Enhancement (RME) Sessions on Early Engagement in B/N Treatment
研究概览
简要总结
Opioid overdoses are a significant problem nationwide and novel interventions that can prevent overdose by improving Buprenorphine/ Naloxone (B/N) treatment for opioid use disorder are a public health priority. This study will both investigate the effects of starting remote motivational enhancement during inpatient detoxification on rates of engagement in B/N treatment and evaluate the impact of MySafeRx, a mobile device application which integrates remote motivational coaching with daily observed dosing from secure electronic pill dispensers at home via videoconference, on treatment retention and overdose prevention. Broad dissemination of this new intervention could help communities across the nation expand and advance their capacity to increase B/N treatment engagement and retention, enhance medication adherence, and prevent overdose.
详细描述
The objective of this study is to conduct a randomized controlled trial (RCT) to evaluate an innovative strategy among opioid use disorder patients being discharged from detox. This study will evaluate the extent to which remote motivational enhancement sessions via videoconference and the option for flexible daily dosing at home with MySafeRx can improve engagement and retention with B/N treatment after detox in a county where access to outpatient, take-home B/N prescriptions are more limited compared to in-person daily B/N dosing and treatment. This study seeks to expand our understanding about what works to prevent opioid overdose by incorporating a RCT evaluating the effects of remote motivational enhancement (RME) sessions provided via videoconferencing at an inpatient detox facility and during early treatment in order to increase treatment engagement with daily outpatient supervised-dosing of B/N. Participants will use an Android smartphone device to access the MySafeRx app and complete their daily motivational interview sessions. This study will generate new knowledge about the most effective way to prevent overdose and engage patients in B/N treatment with observed daily dosing.
The primary aim of this study is:
Engagement: To examine the effect of Remote Motivational Enhancement (RME) sessions + MySafeRx Inspire Flex versus information alone + ACTS Standard Care on early engagement in outpatient B/N treatment based on the number of daily doses of prescribed B/N during the first 5 weeks post-detox.
Hypothesis: Participants enrolled in RME + MySafeRx Inspire Flex arm will be engaged in outpatient B/N treatment with significantly higher number of daily doses of prescribed B/N during the first 5 weeks post-detox than the information alone arm.
Secondary Aims:
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18 to 65 years
- •opioid use disorder
- •stepping down from inpatient detox services
- •willing to engage in daily outpatient supervised dosing of B/N.
排除标准
- •cognitively impaired (Unable to complete consent quiz at 90% accuracy AND MOCA < 25/30 relative exclusion requiring PI approval, absolute exclusion for MOCA<21/30) (Nasreddine,et al., 2005)
- •homeless without any expressed interest in attaining housing after detox discharge
- •reporting active homicidal or suicidal ideation with an imminent plan
- •current mania or psychosis
- •expected incarceration in next 3 months (those that are incarcerated during the study will be removed from the study)
- •unable or unwilling to use a mobile device
- •medical contraindication to B/N
- •unable to complete baseline assessments
- •unstable medical illness who expect hospitalization in the next 3 months
- •pregnant women (if a patient becomes pregnant while participating in this study, they will be withdrawn)
- •prisoners
- •court-ordered individuals
- •is non-English speaking
结局指标
主要结局
Effect of Remote Motivational Enhancement (RME) Sessions on Early Engagement in B/N Treatment
时间窗: 5 weeks
To examine the effect of Remote Motivational Enhancement (RME) sessions + MySafeRx Inspire Flex versus information alone + ACTS Standard Care on early engagement in outpatient B/N treatment based on the number of daily doses of prescribed B/N during the first 5 weeks post-detox.
次要结局
- Opioid-Related Deaths(24 weeks)
- Illicit Opioid Use Measured by Urine Toxicology Screening(24 weeks)
- Proportion of days engaged in dosing of B/N during first 2 weeks.(2 weeks post discharge)