NYU Langone Health
New York, 10016, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06520566
Holistic Care Partner Program Feasibility and Acceptability
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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
Treatment and study plan
Holistic care partner perinatal nurse navigation
BehavioralThe 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 have access to a Black woman-led support group during pregnancy and the first postpartum year, and access to Black woman-led childbirth and lactation classes.
Primary outcomes
-
Number of participants who complete the study
Time frame: Visit 4 (9-12 months postpartum)
-
Theoretical Framework for Acceptability (TFA) questionnaire score
Time frame: 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
Time frame: Visit 4 (9-12 months postpartum)
-
Attendance rate at lactation classes
Time frame: Visit 4 (9-12 months postpartum)
-
Attendance rate at the support group
Time frame: Visit 4 (9-12 months postpartum)
Study contacts
Contact information is provided by the study sponsor or research team.
Audrey Lyndon, PhD, RNC, FAAN
CONTACT
Gwendolyn Quinn, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
NYU Langone Health
Other
Collaborators
- National Institute of Nursing Research (NINR)
Registry information
Official study title
Holistic Care Partners: A Black Woman-led Nurse Navigation Program to Improve Care, Reduce Harm, and Enhance Perinatal Wellbeing for Black Birthing People
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 25, 2024
- Registry last updated
- Jun 2, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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