Holistic Care Partner Program Feasibility and Acceptability

Recruiting

• Conditions: Maternal Care

• Registration Number: NCT06520566
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-15
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25
• Primary Completion: 2026-08-18
• Study Completion: 2026-08-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Black Birthing Patients in HCP Inclusion Criteria:

In order to be eligible to participate in this study, a patient must meet all of the following 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

Control group Inclusion Criteria:

1. Identify as Black or within the Black/African Diaspora
2. Enrolled in the Faculty Group Practice ant NYULH for obstetric care
3. Gave Birth at NYULH
4. Matched to an HCP participant by variables used in propensity score matching algorithm (e.g. age, gestational age at delivery, co-morbidities)
5. Are 18 years or older

Partner or Support Person Inclusion Criteria:

In order to be eligible to participate in this study, a partner or support person one of the following criteria:

1. Identify as the partner or support person of an enrolled Black birthing person
2. Are 18 years or older

Exclusion Criteria

Black Birthing Patients in HCP Exclusion Criteria:

A patient that meets any of the following criteria will be excluded from participation in the study:

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

Control Group Exclusion Criteria:

1. Does not identify as Black or within the Black/African Diaspora
2. Not enrolled in the FGP NYULH for obstetric care
3. Enrolled in the HCP program
4. Did not give birth at NYULH Tisch
5. Is not 18 years or older
6. Multiple gestation
7. Significant fetal anomaly requiring exceptional care

Partner/Support persons Exclusion Criteria:

A partner/support person that meets the following criteria will be excluded from participation in the study:

1. Does not identify as the partner or support person of an enrolled Black birthing person.
2. Is not 18 years or older

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of engagement with video visits	Visit 4 (9-12 months postpartum)
Rate of engagement with education	Visit 4 (9-12 months postpartum)
Retention rate	End of study participation (up to 1 year)	Primary feasibility will be measured by a retention rate of ≥75%
Theoretical Framework for Acceptability (TFA) questionnaire score	Visit 3 (6-12 weeks postpartum)	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.
Rate of engagement with support groups	Visit 4 (9-12 months postpartum)

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States