Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Feasibility Study Aims To assess the feasibility of the digital health (DHI) and community health worker (CHW) interventions by assessing participant acceptance and use of the intervention. To assess study enrollment to determine appropriateness and usefulness of the inclusion and exclusion criteria to estimate enrollment duration in the planned trial. To determine the number of prenatal visits and the incidence of some of the maternal and neonatal outcomes (ones with higher prevalence) or surrogate outcomes that will be targeted in the planned factorial design randomized controlled trial. (Data will be collected on all relevant maternal and neonatal outcomes. The randomized feasibility design will allow for effect size estimates of the intervention on the incidence of maternal and neonatal outcomes, which will aid in determining the appropriate target outcomes as well as power calculation of the more definitive trial.) 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. The objective of this pilot study is to determine if it is feasible to randomize and implement digital health and community health worker interventions. Design Summary The investigators will challenge existing care paradigms by testing the effectiveness of integrating innovative platforms into the existing healthcare system, including existing digital health and community health worker programs from within the EQUATE consortium, to eliminate critical barriers to equitable healthcare access. After seeking input from a Community Advisory Board, these interventions will be refined and deployed for pilot testing. Individuals in Non-Hispanic Black communities at the highest risk of adverse pregnancy outcomes which were historically underrepresented in clinical research due to structural racism will be included. The investigative team employs experts across the community, maternal, and infant health continuum. For this pilot, 40 eligible participants will be randomized, 10 to usual care, 10 to DHI, 10 to CHW, and 10 to DHI + CHW

Official Title
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Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study

Conditions
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Pregnancy, Infants, Disparities

Intervention / Treatment
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* Behavioral: Digital Health intervention
* Behavioral: Community Health Worker
* Behavioral: Digital Health Intervention plus Community Health Worker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self Identifies as Non-Hispanic Black Between 16-49 years old Pregnant individuals between 8⁰ - 22⁶ weeks gestational age Live singleton or dichorionic twin gestation Dating sonogram at <23 weeks gestation Area Deprivation Index (ADI) National 4th or 5th Quintile Planning to deliver at UAB Hospital Speaks and writes in English No indication for delivery at the time of enrollment Exclusion Criteria: Declines randomization Speaks or writes in languages other than English Currently incarcerated Fetal demise diagnosed prior to enrollment Known major structural chromosomal abnormalities prior to enrollment

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study is a pilot randomized trial (n=40) randomizing eligible participants to usual care (n=10), or usual care plus a digital health intervention (n=10), or usual care plus a community health worker intervention (n=10), or usual care plus both a digital health intervention and a community health worker intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Health Intervention<br>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. | Behavioral: Digital Health intervention<br>* Health care information delivered via a link in a text message that is then opened in a secure browser.<br>* Other names: DHI;|
| Experimental: Community health worker (CHW)<br>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 their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board. | Behavioral: Community Health Worker<br>* Health care information delivered via CHW.<br>* Other names: CHW;|
| Experimental: DHI Plus CHW<br>This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions. | Behavioral: Digital Health Intervention plus Community Health Worker<br>* Health care information delivered via DHI plus CHW<br>|
| No Intervention: Usual Care<br>This group will receive routine prenatal care services. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant acceptance of randomization arm / intervention | Participant acceptance is defined as a yes response to this question: I would recommend the care I received to someone in a similar situation. | From randomization to 6 weeks postpartum | 
| Participant use of digital health and/or community health worker interventions | Use of the intervention for the digital health arm(s) is defined as the % of opened text messages. Use of the intervention for the community health worker arm(s) is defined as the % of planned sessions in which the participant engages with the community health worker. | From randomization to 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 
| Vaccination rate | The number of recommended vaccinations for which the mother and newborn accepted | Pregnancy through 6 weeks postpartum / 6 weeks of life | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy outcomes, Health inequities