跳至主要内容
临床试验/NCT06160349
NCT06160349
Enrolling By Invitation
不适用

EnCoRe MoMS Aim 3: Engaging Communities to Reduce Morbidity From Maternal Sepsis

Columbia University3 个研究点 分布在 1 个国家目标入组 200 人2023年7月20日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Maternal Sepsis
发起方
Columbia University
入组人数
200
试验地点
3
主要终点
Integrative Supportive Care Model
状态
Enrolling By Invitation
最后更新
3个月前

概览

简要总结

Sepsis is the second leading cause of maternal death in the U.S. For racial and ethnic minoritized birthing people, especially those who are Black, living in poverty, and from underserved communities, labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary observational study is to establish a novel maternal care continuity model to reduce sepsis- related death and disability and increase maternal health equity.

详细描述

Maternal sepsis is the second leading cause of maternal death, major cause of morbidity, and preventable in most cases. Labor, birth, and postpartum are periods of increased sepsis risk, particularly for racial and ethnic minoritized birthing people. With extensive community partnerships and community organized leadership advisory board (CoLAB), EnCoRe MoMS: Engaging Communities to Reduce Morbidity from Maternal Sepsis (Aim 3) Conduct a co-design process and qualitative study to explore the experiences, needs, and perceived solutions for maternal care continuity, sepsis prevention, and promotion of equity in postpartum. In the UG3 phase, robust community engagement and research infrastructures were established to: 3a. (3a.1) Refine the CoLAB and co-design process; (3a.2) Conduct in-depth individual patient interviews (IDIs) and focus group discussions (FGDs) with community and hospital stakeholders from one site to explore the lived experiences and perspectives of SDOH on care access/quality, outcome disparities, and solutions for care continuity. In the UH3 phase, the investigators will engage the community toAim 3b. (3b.1) Complete qualitative patient IDIs and stakeholder FGDs for the three additional hospital sites; (3b.2) Co-design an integrative supportive care model, with our community partner co-lead, CoLAB, and results from other aims, that entails maternal sepsis community engagement, care linkages, education, services, and policy efforts. The resulting model can be scaled to hospitals and communities with lesser resources and applied to other preventable causes of severe maternal morbidity.

注册库
clinicaltrials.gov
开始日期
2023年7月20日
结束日期
2026年9月30日
最后更新
3个月前
研究类型
Observational
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Dena Goffman

Ellen Jacobson Levine and Eugene Jacobson Professor of Women's Health (in Obstetrics and Gynecology)

Columbia University

入排标准

入选标准

  • Patient Interviews:
  • Speak Spanish or English
  • Be 18 years or older
  • Have a birthing experience in Columbia, Allen, Lincoln, or Harlem Hospitals within the past 8 weeks of enrollment
  • Have had at least one early warning sign or risk factor for infection present during their pregnancy, delivery, or postpartum
  • Community Stakeholder Focus Groups:
  • Speak English or Spanish
  • Be 18 years or older
  • Have academic/professional background relevant to maternal health in New York City.

排除标准

  • Patient Interviews
  • Under 18 years old
  • Speaks a language other than Spanish or English
  • Gave birth in a hospital other than Columbia, Allen, Lincoln, or Harlem Hospitals
  • Did not have had at least one early warning sign or risk factor for infection present during their pregnancy, delivery, or postpartum
  • Community Stakeholder Focus Groups
  • Under 18 years old
  • Speaks a language other than Spanish or English
  • Does not have a academic/professional background relevant to maternal health in New York City.

结局指标

主要结局

Integrative Supportive Care Model

时间窗: 2023-2025

Patient and community stakeholder feedback regarding lived experiences and perspectives of the impact of SDOH on care access and quality will be assessed by questionnaire.

研究点 (3)

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