Holistic Care Partner Program Feasibility and Acceptability

NCT06520566 | Recruiting

• 2 other identifiers: 23-008211R21NR020960-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Care

Outcome Measures

Primary Outcomes (5)

• Number of participants who complete the study

  Visit 4 (9-12 months postpartum)

• Theoretical Framework for Acceptability (TFA) questionnaire score

  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.

  Visit 3 (6-12 weeks postpartum)

• Attendance rate for nurse navigator visits

  Visit 4 (9-12 months postpartum)

• Attendance rate at lactation classes

  Visit 4 (9-12 months postpartum)

• Attendance rate at the support group

  Visit 4 (9-12 months postpartum)

Study Arms (1)

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

EXPERIMENTAL

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.

Behavioral: Holistic care partner perinatal nurse navigation

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

• Audrey Lyndon, PhD, RNC, FAAN

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Audrey Lyndon, PhD, RNC, FAAN

CONTACT

212-992-5940; al6148@nyu.edu

Gwendolyn Quinn, PhD

CONTACT

646-501-6878; gwendolyn.quinn@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 25, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): August 18, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data and who provide a methodologically sound proposal will be provided access upon reasonable request. Requests should be directed to al6148@nyu.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)