跳至主要内容
临床试验/NCT04527926
NCT04527926已完成不适用

Project STEPuP: A Prenatal Provider Education and Training Program to Improve Medication-assisted Treatment Use During Pregnancy and Maternal and Child Health Outcomes

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 1,022 人开始时间: 2020年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,022
试验地点
2
主要终点
Patient Medication-assisted treatment (MAT) utilization

研究概览

简要总结

This research will test the effectiveness of a prenatal provider education and training program designed to facilitate provider adoption of evidence-based practices for the treatment of OUD during pregnancy. Findings from this research will provide high quality evidence about how to increase evidence-based treatment for pregnant women with OUD and subsequent maternal-child health outcomes.

详细描述

The prevalence of opioid use disorder (OUD) during pregnancy has quadrupled over the past decade, as have maternal and neonatal morbidity and mortality related to substance use. Medication assisted treatment (MAT) use during pregnancy reduces adverse outcomes and is the recommended, evidence-based practice (EBP) for OUD treatment during pregnancy. Despite this, 40% of pregnant women with OUD do not receive MAT. Currently, there are no effective strategies to expand MAT access and availability for pregnant women, especially in rural, low-resource settings where maternal opioid use is disproportionately high. As an initial step to address this gap, the investigators engaged key stakeholders across a large health system in Pennsylvania to determine barriers and facilitators to expanding treatment services in high need, low-resource obstetric settings. The stakeholders identified a critical need for a women-centered, low resource, sustainable, provider-level intervention to facilitate the adoption of MAT in obstetric settings. Therefore, the investigators objective is to test the effectiveness of a prenatal provider education and training program designed to facilitate the adoption of EBP for OUD during pregnancy called Project STEPuP (Substance abuse Treatment and Education during pregnancy and Postpartum). Project STEPuP, grounded in preliminary and pilot work conducted by the research team, has 4 components designed to address barriers to MAT and EBP adoption: 1) a "hub and spoke," remotely supported provider education and training program, 2) addiction teleconsultation support, 3) case management and telepsychiatry support, and 4) a partnership with health system administrators and payers to address administrative and reimbursement related needs. To achieve this objective, the research team will conduct a cluster-randomized clinical trial across 12 obstetric sites in Pennsylvania and New York. Outcomes among 870 patients will be assessed during pregnancy, at delivery and through 1 year postpartum. The investigators central hypothesis is that Project STEPuP will facilitate EBP adoption, increase MAT utilization and improve health outcomes among pregnant and postpartum women with OUD and their children. Specifically, the investigators aim to: 1) Create organizational readiness to facilitate Project STEPuP implementation; 2) Assess the effect of Project STEPuP on provider adoption of EBP for OUD during pregnancy; and 3) Evaluate the effect of provider adoption of EBP on maternal and child health outcomes. The investigators research is significant by addressing the substantial knowledge gap of how to increase MAT use in pregnancy and innovative by examining the role that prenatal providers can play in expanding treatment access.

Study outcome measures refined in January 2024 to align with grant proposal and increase readability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • provides prenatal care (i.e. obstetricians, nurse midwives, advanced practice providers) at obstetric sites,
  • provides care to pregnant women with OUD
  • English speaking
  • Maternal and child outcome data will be collected from the Electronic Health Record (EHR) and individual patients will not be recruited to participate in the randomized controlled trial (RCT).
  • Inclusion criteria for a small subset of pregnant women will be recruited for a one-time qualitative interview (n=50):
  • meet The Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for OUD
  • received care at participating sites while pregnant during the study time period and
  • speak English

排除标准

  • 未提供

研究组 & 干预措施

Usual Care

Active Comparator

Standard of Care

干预措施: Usual Care (Behavioral)

STEPuP Intervention

Experimental

STEPuP interventions

干预措施: STEPuP Intervention (Behavioral)

结局指标

主要结局

Patient Medication-assisted treatment (MAT) utilization

时间窗: up to 1 year post delivery

As measured by total count of weeks in pregnancy with any Medications for Opioid Use Disorder (MOUD) either buprenorphine or methadone, use during pregnancy

Provider Provision of Buprenorphine

时间窗: up to 1 year post delivery

As measured by total number of patients within a prenatal practice with opioid use disorder that receive MOUD treatment (either buprenorphine or methadone)

次要结局

  • Mental Health Screening Rate(during pregnancy (up to 40 weeks))
  • Hepatitis C Virus (HCV) Screening Rate(during pregnancy (up to 40 weeks))
  • Human Immunodeficiency Virus (HIV) Screening Rate(during pregnancy (up to 40 weeks))
  • Breastfeeding Rate(delivery up to 1 year post delivery)
  • Contraceptive Utilization Rate(delivery up to 1 year post delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Krans, MD

Assistant Professor

University of Pittsburgh

研究点 (2)

Loading locations...

相似试验