跳至主要内容
临床试验/NCT06520566
NCT06520566招募中不适用

Holistic Care Partners: A Black Woman-led Nurse Navigation Program to Improve Care, Reduce Harm, and Enhance Perinatal Wellbeing for Black Birthing People

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2024年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
55
试验地点
1
主要终点
Number of participants who complete the study

研究概览

简要总结

The study aims to build on the knowledge of the United States' ongoing maternal health crisis for Black birthing people. The study team will take a holistic focused approach to build on the experiences of Black women perinatal nurses, Black women/birthing people, and their care partners enrolled in the Holistic Care Partner Program (HCP) to understand the program's feasibility and acceptability. HCP was developed at NYU Langone Health by Blank women-led perinatal nurses to address the effects of obstetric racism and the associated fear of pregnancy and birth faced by Black women and birthing people. Utilizing a mixed-methods approach, the study will focus on understanding HCP's acceptability and feasibility via surveys and qualitative interviews with Black women and birthing people and their partners/support persons to identify strategies and recommendations for intervention improvement. Exploratory analysis of maternal and infant outcomes will be conducted using a propensity score matched historical control group.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Identify as Black or within the Black/African Diaspora
  • Enrolled in the HCP program while pregnant or within 6 weeks postpartum
  • Enrolled in the Faculty Group Practice at NYU Langone Health (NYULH) for obstetric care
  • Plan to give birth at NYULH Tisch or gave birth at NYULH Tisch if postpartum at screening.
  • Comfortable reading and/or speaking English (approximately 95% of Black women speak English)
  • Are 18 years or older

排除标准

  • Does not identify as Black or within the Black/African Diaspora
  • Did not enroll in the HCP program while pregnant or within 6 weeks postpartum.
  • Not enrolled in the FGP NYULH for obstetric care
  • Does not plan to give birth at NYULH Tisch or did not give birth at NYULH Tisch if postpartum at time of screening.
  • Is not 18 years or older
  • Multiple gestation
  • Significant fetal anomaly requiring exceptional care

研究组 & 干预措施

Black Birthing Patients enrolled in Holistic Care Partner Program (HCP)

Experimental

Black birthing patients enrolled in HCP will be invited to participate in a brief survey and/or a qualitative interview throughout 1 year of their enrollment.

干预措施: Holistic care partner perinatal nurse navigation (Behavioral)

结局指标

主要结局

Number of participants who complete the study

时间窗: Visit 4 (9-12 months postpartum)

Theoretical Framework for Acceptability (TFA) questionnaire score

时间窗: Visit 3 (6-12 weeks postpartum)

Anticipated and experienced acceptability will be measured using the Theoretical Framework for Acceptability questionnaire. This is a 13-item Likert-type questionnaire designed to assess acceptability of the intervention from the participants' perspective along the 7 component constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy). Total score ranges from 13-65, with higher scores indicating greater acceptability of the intervention.

Attendance rate for nurse navigator visits

时间窗: Visit 4 (9-12 months postpartum)

Attendance rate at lactation classes

时间窗: Visit 4 (9-12 months postpartum)

Attendance rate at the support group

时间窗: Visit 4 (9-12 months postpartum)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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