The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 269
- 试验地点
- 21
- 主要终点
- Percent of Infants Diagnosed With Neonatal Abstinence Syndrome (NAS) Requiring Medication Treatment
研究概览
简要总结
Perinatal opioid use disorder (OUD) is a major health concern in the U.S. with significant impact on mothers, infants, and communities. Investigators at the University of Kentucky/UK HealthCare (UK) have developed a comprehensive clinical care model for perinatal OUD (known as UK-PATHways) that has demonstrated success in maternal and neonatal outcomes. The overreaching goals of the proposed project are to: 1) expand the reach of this successful clinical program to rural communities thereby improving access to integrated MAT prenatal care, 2) to reduce the impact of perinatal OUD in underserved rural areas of our state, and 3) to compare the relative effectiveness methods of delivery active elements of the UK-PATHways program for rural implementation (local group-support vs. telemedicine).
详细描述
The UK-PATHways program preliminary successes during the first three years are clear: enrolled mothers (n>200) have reduced relapse, increased treatment compliance, and improved neonatal outcomes when compared to non-enrolled OUD mothers. However, at this time, UK-PATHways is only available at the main healthcare campus in Lexington, KY. Many eligible patients reside great distances from our clinical home and some current patients travel hours to access this valuable resource. While Medication Assisted Therapy (MAT) has become increasingly available in our region, many of the components of the UK-PATHways program are not readily accessible in rural Central and Eastern Kentucky and the quality of programming with MAT treatment is not standardized in these locations. Furthermore, rural patients continue to face challenges related to stigma of their OUD and transportation difficulties if they desire more comprehensive services. The proposed study will evaluate the introduction of essential components of the UK-PATHways program into rural communities and identify the optimal intervention strategies for expansion of services and to improve the treatment of OUD for rural patients. Specific aims include the following: Aim 1) Conduct a randomized cluster trial using a 'hub and spoke' study design, comparing two delivery modes (local GROUP care vs TELEMEDICINE) for the delivery of a UK-PATHways based patient education curriculum at participating rural regional sites. Each regional site will be randomized to support one of two study arms: 1) Prenatal group care led by a perinatal nurse facilitator or substance use counselor with a peer support specialist (GROUP arm); or, 2) Telemedicine consultation with substance use counselor or perinatal nurse facilitator based at the 'hub' site (TELEMEDICINE arm); and Aim 2) Evaluate the relative effectiveness of each study arm on primary and secondary maternal and neonatal outcomes as compared to the established UK-PATHways program (UK PATHways: Hub) at the University of Kentucky.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at 6 to 32 weeks' gestational age
- •History of Opioid Use Disorder
- •Receiving Medication Assisted Therapy (buprenorphine products or methadone)
- •Obtaining prenatal care at one of eleven study sites located throughout Central and Eastern Kentucky
排除标准
- 未提供
研究组 & 干预措施
Telemedicine Education
This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (>500 deliveries/year) and 'low volume' (<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff.
干预措施: Telemedicine (Behavioral)
Group Care Education
This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (>500 deliveries/year) and 'low volume' (<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff.
干预措施: Group Care (Behavioral)
结局指标
主要结局
Percent of Infants Diagnosed With Neonatal Abstinence Syndrome (NAS) Requiring Medication Treatment
时间窗: up to 10 days postpartum
Medical records will be reviewed post-partum for treatment for NAS. Diagnosis of NAS will be made within 10 days of birth and treatment started based on standard of care. Data will be presented as the percent of infants born requiring therapy in each group.
次要结局
- Participant Quality of Life(28-32 weeks gestation)
- Number of Inappropriate Maternal Drug Screens at Delivery(Up to 10 days post-partum)
- Prenatal Engagement With Percent of Program Education Sessions Attended(Up to delivery, an average of 19 weeks)
- Prenatal Engagement With MAT Provider(Up to delivery, an average of 19 weeks)
- Prenatal Engagement in Prenatal Care(Up to delivery, an average of 19 weeks)
- Participants With Cigarette Dependency Over Time(Up to 60 weeks)
- Participants With Maternal Anxiety Over Time(Up to 60 weeks)
- Participants With Maternal Depression Over Time(Up to 60 weeks)
- Severity of Opioid Use Disorder(Intake visit (between 6-32 weeks gestation))
- Incidence of Hospitalization for Opioid Related Issues During the Study Period(up to 60 weeks)
- Change in Physical Condition of Infant Post-delivery by Apgar Score(Up to five minutes)
- Incidence of Pediatric Emergency Room (ER) Visits(birth-six months)
- Adherence to a Vaccine Schedule(Infant 3 months and 6 months of age)
- Engagement With Pediatric Care(Infant 3 month and 6 months of life)
- Infant Gross Motor Development(Infant at 6 months of age)
- Incidence of Relapse(Up to 60 weeks)
- Incidence of Opioid Overdose(Up to 60 weeks)
研究者
Wendy F Hansen
Professor
University of Kentucky