Holistic Care Partner Program Feasibility and Acceptability

N/ARecruitingNCT06520566

NYU Langone Health55 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Maternal Care

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants who complete the study

Time frame: 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.

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)

Holistic Care Partner Program Feasibility and Acceptability

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts