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临床试验/NCT05365815
NCT05365815招募中不适用

Black Midwives for Black Women: Maternity Care to Improve Trust and Attenuate Structural Racism

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2022年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
432
试验地点
2
主要终点
Patient Engagement-Postnatal adequacy

研究概览

简要总结

This study is being conducted to determine if a multi-level intervention for delivering maternity care can improve patient trust and engagement among Black birthing people.

详细描述

Low-risk pregnant participants will be randomized into Melanated Group Midwifery Care or usual individualized obstetric care. In Melanated Group Midwifery Care (MGMC), Black women will receive prenatal care from a Black midwife in groups with the same 8-10 other Black women throughout pregnancy. In pregnancy and into the first year postpartum, MGMC patients will stay connected to the health system through a proactive care coordinator, who is a Black licensed nurse. For the first year after giving birth, patients in MGMC will also be supported by a trained postpartum doula.

All participants (intervention and usual care groups) will complete study measures that include validated surveys on patient trust, respect and engagement at 6 time points:

  • 3 time points in pregnancy [baseline (<20 weeks), 26-28 weeks, and 35- 37 weeks] and
  • 3 in the postpartum at 2-, 6-, and 12-months
  • Additional qualitative interviews will be done to track the care received by medically and socially complex patients, including all who experience a severe maternal morbidity.

The investigators will also document how MGMC gets embedded in practice through a qualitative process evaluation.

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
Double (Investigator, Outcomes Assessor)

盲法说明

The research team working on the effectiveness evaluation of group care is blinded to study condition and is charged with collecting the Aim 1 effectiveness data from the individuals.

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Patient Engagement-Postnatal adequacy

时间窗: 1 year postpartum (T6)

Appropriate number (yes/no) and timing of postnatal visits (yes/no) documented in electronic medical record

Patient Engagement-Prenatal Adequacy

时间窗: Birth (T3)

Appropriate number (yes/no) and timing of prenatal visits (yes/no) documented in electronic medical records

Patient Engagement-Prenatal Adherence

时间窗: Birth (T3)

Five tests completed during prenatal period (yes/no), documented in electronic medical record

次要结局

  • Provider Trust(Change from baseline through 12 months postpartum (T6))
  • Patient Satisfaction(Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4))
  • Patient activation(Change from baseline through 12 months postpartum (T6))
  • Patient Autonomy(Change from baseline through 12 months postpartum (T6))
  • Mental Well Being(Change from baseline through 12 months postpartum (T6))
  • Respectful Care(Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4))

研究者

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

Kylea Laina Liese

Assistant Professor

University of Illinois at Chicago

研究点 (2)

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