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Recruiting NCT06520566

Holistic Care Partner Program Feasibility and Acceptability

No phase Interventional Maternal Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Holistic care partner perinatal nurse navigation.
Who it may be relevant to
Registry conditions: Maternal Care. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Behavioral 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

Primary outcome measures

  • 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)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06520566 · 23-00821 · 1R21NR020960-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗