Holistic Care Partner Program Feasibility and Acceptability

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06520566
Status
Recruiting

Conditions

  • Maternal Care

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Holistic care partner perinatal nurse navigation — 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.

Study Details

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.

Key Dates

Start date
Jul 15, 2024
Status verified
May 2026
Primary completion
Aug 18, 2026
Completion
Aug 18, 2026

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: 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.

Primary Outcome Measure

Number of participants who complete the study [ Time Frame: Visit 4 (9-12 months postpartum) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY