Skip to content

Holistic Care Partner Program Feasibility and Acceptability

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06520566
Enrollment
55
Registered
2024-07-25
Start date
2024-07-15
Completion date
2026-08-18
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Care

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.

Interventions

BEHAVIORALHolistic 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 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.

Sponsors

NYU Langone Health
Lead SponsorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who complete the studyVisit 4 (9-12 months postpartum)
Theoretical Framework for Acceptability (TFA) questionnaire scoreVisit 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 visitsVisit 4 (9-12 months postpartum)
Attendance rate at lactation classesVisit 4 (9-12 months postpartum)
Attendance rate at the support groupVisit 4 (9-12 months postpartum)

Countries

United States

Contacts

CONTACTAudrey Lyndon, PhD, RNC, FAAN
al6148@nyu.edu212-992-5940
CONTACTGwendolyn Quinn, PhD
gwendolyn.quinn@nyulangone.org646-501-6878
PRINCIPAL_INVESTIGATORAudrey Lyndon, PhD, RNC, FAAN

NYU Langone Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026