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

Not Applicable

Completed

• Conditions: Pregnancy; Infants; Disparities

• Registration Number: NCT05940688
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

Feasibility Study Aims

1. To assess the feasibility of the digital health (DHI) and community health worker (CHW) interventions by assessing participant acceptance and use of the intervention.

2. To assess study enrollment to determine appropriateness and usefulness of the inclusion and exclusion criteria to estimate enrollment duration in the planned trial.

3. 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

Study Timeline

• Study First Submitted: 2023-06-25
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-11
• Study Start: 2023-07-17
• Primary Completion: 2024-06-30
• Status Verified: 2024-07
• Study Completion: 2024-07-01
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participant acceptance of randomization arm / intervention	From randomization to 6 weeks postpartum	Participant acceptance is defined as a yes response to this question: "I would recommend the care I received to someone in a similar situation."
Participant use of digital health and/or community health worker interventions	From randomization to 6 weeks postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Neonatal birthweight	At birth	Weight of neonate at birth
Neonatal hospital readmission	Birth to 6 weeks of life	Admission of a neonate to the hospital after discharge from the hospital after birth
Outpatient Prenatal Care Visits	Duration of pregnancy through 6 weeks postpartum	Number of outpatient prenatal care and postpartum visits
Maternal blood transfusion	Duration of pregnancy through 6 weeks postpartum	Transfusion of blood products
Vaccination rate	Pregnancy through 6 weeks postpartum / 6 weeks of life	The number of recommended vaccinations for which the mother and newborn accepted
Maternal postpartum readmission	From discharge from the delivery-associated hospitalization to 6 weeks postpartum	Admission of the mother to the hospital after discharge from the delivery-associated hospitalization
Breastfeeding intent	From randomization to delivery of the infant(s)	Participant's self-reported intent of whether or not to express breast milk upon admission to the delivery-associated hospitalization
Preterm Birth	At birth	Delivery of a neonate at less than 37 weeks
Cesarean delivery	At birth	Occurrence of a cesarean birth

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States