跳至主要内容
临床试验/NCT05609669
NCT05609669进行中(未招募)不适用

Continuous And Data-drivEN CarE (CADENCE)

University of South Florida2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
10
试验地点
2
主要终点
Decreased pharmacologically treated NOWS

研究概览

简要总结

The proposed project seeks to use public health and clinical data on opioid use disorders (OUD) outcomes for mother and infants, which is the leading cause of death to mothers one year after deliver and can lead to neonatal withdrawal syndrome (NOWS) and other poor outcomes. Insufficient or incomplete data about OUD and lack of integrated programs for OUD treatment during pregnancy can be barriers to providing optimal care to mothers and infants.

详细描述

Maternal opioid use disorder (OUD) is the leading cause of maternal mortality in the first year after delivery nationwide. OUD also contributes substantially to out-of-home placements in the child welfare system. Medication for OUD (MOUD) is the primary standard of treatment, however, access to MOUD and prenatal care is limited, siloed, and fragmented in Florida. Gaps in access to and continuity of healthcare (prenatal, postpartum, pediatric, pharmacological and behavioral health) and other services for mothers in OUD recovery lead to poor outcomes for parent, child and family. There is also insufficient data integration, due to inconsistent data collection methods or use of diagnostic codes, to identify mother-infant dyads affected by OUD that could inform optimal care at the local level. Single-site studies that integrate substance use disorder programs in pregnancy have been shown to improve neonatal and maternal outcomes. With that in mind, the long-term goal of this study is to leverage high-quality local and timely data to improve OUD outcomes before, during, and after pregnancy with an integrated care approach that can be replicated throughout the state. The objective of the proposed project is to consolidate multiple streams of public health and clinical healthcare data to analyze equitable access and outcomes for families affected by maternal OUD for use in quality improvement cycles to rapidly refine our integrated CADENCE (Continuous and Data-Driven Care) Program. Our central hypothesis is that integrated, continuous, data-driven care will improve CADENCE patient outcomes. We will test this hypothesis through the following aims: 1) create an interactive data dashboard for maternal, neonatal, and infant outcomes for pregnancies affected by OUD; 2) pilot the CADENCE program and rapidly refine using a data-driven approach.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients with known opioid use disorder over the age of 18 years old who are pregnant

排除标准

  • Patients without opioid use disorder, less than 18 years old, incarcerated, or non-pregnant

结局指标

主要结局

Decreased pharmacologically treated NOWS

时间窗: At delivery

Medication clinically required for NOWS (yes/no)

MOUD at delivery hospitalization

时间窗: At delivery hospitalization

Patients on subutex or methadone treatment at delivery hospitalization (yes/no)

次要结局

  • Hospital length of stay (neonate)(At delivery hospitalization)
  • First trimester entry to prenatal care(Prenatal care, up to 40 weeks)
  • Prenatal care adequacy(Prenatal care, up to 40 weeks)
  • Breastfeeding at discharge(At delivery hospitalization)
  • Enrollment in community supports and services.(Prenatal up to 1 year old)
  • Hepatitis C screening(Prenatal care, up to 40 weeks)
  • NICU admissions(At delivery hospitalization)
  • Department of Children and Families out-of-home placement(At delivery hospitalization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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