Holistic Care Partner Program Feasibility and Acceptability

NCT ID: NCT06520566

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2026-08-18

Brief Summary

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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.

Detailed Description

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Conditions

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Maternal Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

Holistic care partner perinatal nurse navigation

Intervention Type BEHAVIORAL

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.

Interventions

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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 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Audrey Lyndon, PhD, RNC, FAAN

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Audrey Lyndon, PhD, RNC, FAAN

Role: CONTACT

212-992-5940

Gwendolyn Quinn, PhD

Role: CONTACT

646-501-6878

Other Identifiers

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1R21NR020960-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-00821

Identifier Type: -

Identifier Source: org_study_id

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