Clinical trial NCT06520566: Holistic Care Partner Program Feasibility and Acceptability
Official title: Holistic Care Partners: A Black Woman-led Nurse Navigation Program to Improve Care, Reduce Harm, and Enhance Perinatal Wellbeing for Black Birthing People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Care
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2024-07-25
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of participants who complete the study
timeFrame: Visit 4 (9-12 months postpartum)
measure: Theoretical Framework for Acceptability (TFA) questionnaire score
timeFrame: Visit 3 (6-12 weeks postpartum)
measure: Attendance rate for nurse navigator visits
timeFrame: Visit 4 (9-12 months postpartum)
measure: Attendance rate at lactation classes
timeFrame: Visit 4 (9-12 months postpartum)
measure: Attendance rate at the support group
timeFrame: Visit 4 (9-12 months postpartum)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Audrey Lyndon, PhD, RNC, FAAN
role: PRINCIPAL_INVESTIGATOR
References: