Holistic Care Partner Program Feasibility and Acceptability

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Holistic care partner perinatal nurse navigation
  The nurse navigators assess patient medical, social, and structural needs at enrollment, 20-, 28-, and 36-weeks gestation; and at 1-week, and 3, 6, and 9 months postpartum. They provide coordination, support, and referrals, and enhanced communication with or escalate concerns to the primary physician as indicated. The nurse navigator tailors additional visits to the individual needs of the patients (for example, managing comorbidities, social isolation, breastfeeding support). Participants also

Первичные конечные точки

• Number of participants who complete the study [Срок оценки: Visit 4 (9-12 months postpartum)]
• Theoretical Framework for Acceptability (TFA) questionnaire score [Срок оценки: Visit 3 (6-12 weeks postpartum)]
• Attendance rate for nurse navigator visits [Срок оценки: Visit 4 (9-12 months postpartum)]
• Attendance rate at lactation classes [Срок оценки: Visit 4 (9-12 months postpartum)]
• Attendance rate at the support group [Срок оценки: Visit 4 (9-12 months postpartum)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT06520566 · 23-00821 · 1R21NR020960-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗