Holistic Care Partner Program Feasibility and Acceptability
ConditionMaternal Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Holistic care partner perinatal nurse navigation
BehavioralThe 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.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Black Birthing Patients enrolled in Holistic Care Partner Program (HCP)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants who complete the study
Time frame
Visit 4 (9-12 months postpartum)2
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)3
Attendance rate for nurse navigator visits
Time frame
Visit 4 (9-12 months postpartum)4
Attendance rate at lactation classes
Time frame
Visit 4 (9-12 months postpartum)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov