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| ID | Type | Description | Link |
|---|---|---|---|
| 22HERNPMI985239 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| ConnectionHealth | UNKNOWN |
| Memora Health | UNKNOWN |
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The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes. In this trial, 400 non-Hispanic Black participants will be randomized to see if 2 promising interventions (digital health interventions and community health workers) reduce adverse pregnancy outcomes.
The aim of this trial is to assess whether an existing Digital Heath Intervention (DHI) and/or a Community Health Worker (CHW) Intervention will reduce adverse maternal and perinatal outcomes. A 2 x 2 factorial randomized controlled trial of Non-Hispanic Black (NHB) patients living in high area deprivation index (ADI) communities will be conducted. Participants (n=400) will be randomized 1:1:1:1 to one of 4 arms: 1) standard prenatal care (PNC) alone, or 2) standard PNC plus DHI, or 3) standard PNC plus CHW, or 4) standard PNC, plus DHI and CHW.
The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The promise of digital health and community health worker engagement makes PᵌOPPY interventions potentially transformative, sustainable, and scalable for Non-Hispanic Black mothers and their infants from under-served communities in Alabama and beyond.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Health Intervention (DHI) | Experimental | This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower. |
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| Community health worker (CHW) | Experimental | Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through 12 weeks postpartum. The intervention has been modified by the POPPY Study Team and Community Advisory Board |
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| DHI Plus CHW | Experimental | This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions. |
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| Usual Care | No Intervention | This group will receive routine prenatal care services. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Health intervention | Behavioral | Health care information delivered via a link in a text message that is then opened in a secure browser. |
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| Measure | Description | Time Frame |
|---|---|---|
| Weighted Adverse Outcome Score (WAOS) | WAOS, calculated by adding the weights of all adverse events divided by the total number of deliveries. Maternal death=750, Neonatal death=400, Uterine rupture=100, Maternal ICU Admission=65, Birth trauma=60, Unanticipated operative procedure=40, NICU Admission=35, 5-minute Apgar <7=25, Maternal blood transfusion=20, and 4th degree perineal lacerations=5. | [Time Frame: From randomization to 6 weeks postpartum] |
| Measure | Description | Time Frame |
|---|---|---|
| Outpatient Prenatal Care Visits | Number of outpatient prenatal care and postpartum visits | Duration of pregnancy through 6 weeks postpartum |
| Preterm Birth | Delivery of a neonate at less than 37 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosylen "Roz" Quinney | Contact | 205.934.1309 | rquinney@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Sinkey, MD | University of Alabama at Birmingham | Principal Investigator |
| Wally Carlo, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
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Study is a randomized trial (n=400) randomizing eligible participants to usual care (n=100), or usual care plus a digital health intervention (n=100), or usual care plus a community health worker intervention (n=100), or usual care plus both a digital health intervention and a community health worker intervention (n=100).
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| Community Health Worker | Behavioral | Health care information delivered via CHW. |
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| Digital Health Intervention plus Community Health Worker | Behavioral | Health care information delivered via DHI plus CHW |
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| At birth |
| Neonatal birthweight | Weight of neonate at birth | At birth |
| Cesarean delivery | Occurrence of a cesarean birth | At birth |
| Maternal blood transfusion | Transfusion of blood products | Duration of pregnancy through 6 weeks postpartum |
| Breastfeeding intent | Participant's self-reported intent of whether or not to express breast milk upon admission to the delivery-associated hospitalization | From randomization to delivery of the infant(s) |
| Maternal postpartum readmission | Admission of the mother to the hospital after discharge from the delivery-associated hospitalization | From discharge from the delivery-associated hospitalization to 6 weeks postpartum |
| Neonatal hospital readmission | Admission of a neonate to the hospital after discharge from the hospital after birth | Birth to 6 weeks of life |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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