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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doula Intervention | Experimental | 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. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doula Support | Other | Doula support including care coordination to mental and medical health services in the NICU, with a warm handoff to a community doula to continue the support once infants leave the HUP NICU. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum | 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. | 6 months |
| Number of participants who have attendance with a primary care provider by 6 months postpartum | This will be assessed using the electronic health record and via survey and medical record review of outsider records. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Depression scores at 6 months postpartum | Edinburgh Postnatal Depression Scale, higher scores reflect higher risk of depression, ranges from 0-30. A score of 13 is indicative of high risk for depression. | 6 months |
| Receipt of ACOG-recommended postpartum care by patient's designated provider |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heather Burris, MD MPH | Contact | (215) 573-4916 | Burrish@chop.edu | |
| Niesha Darden | Contact | dardenn2@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heather Burris, MD MPH | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D047928 | Premature Birth |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D007752 | Obstetric Labor, Premature |
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Comparison between two groups, this will be coded as a Yes or No variable |
| 12 weeks postpartum |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |