Postpartum Care in the NICU (PeliCaN) Transitions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Pennsylvania
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Number of participants who have attendance with a primary care provider by 6 months postpartum
Study Overview
Brief Summary
This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HUP postpartum patients who are at least 16 years old at the time their newborns' birth
- •Infant born at HUP
- •Preterm birth <34 weeks
- •English language speaking
Exclusion Criteria
- •Unable to read or sign informed consent
- •Parents of infants transferred into HUP NICU
- •If the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks
- •HUP postpartum patients who are less than 16 years of age at the time of their newborns' birth
Arms & Interventions
Doula Intervention
Participants randomized to the intervention will be offered doula support including care coordination to mental and medical health services in the neonatal intensive care unit (NICU), with a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.
Intervention: Doula Support (Other)
Control
Participants randomized to usual care will get the same care they normally would with their own provider, outside of research enrollment, and receive a resource guide with information about the importance of postpartum follow-up care.
Outcomes
Primary Outcomes
Number of participants who have attendance with a primary care provider by 6 months postpartum
Time Frame: 6 months
This will be assessed using the electronic health record and via survey and medical record review of outsider records.
Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum
Time Frame: 6 months
This will measured by the PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The symptom severity score ranges from 0-80 with 80 being a worse score.
Secondary Outcomes
- Difference in Depression scores at 6 months postpartum(6 months)
- Receipt of ACOG-recommended postpartum care by patient's designated provider(12 weeks postpartum)
Investigators
Heather Burris
Associate Professor of Pediatrics
University of Pennsylvania