Clinical trial NCT05940688: Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study
Official title: Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Infants
Disparities
Keywords: Pregnancy outcomes
Health inequities
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: ConnectionHealth
name: Memora Health
First posted: 2023-07-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Participant acceptance of randomization arm / intervention
timeFrame: From randomization to 6 weeks postpartum
measure: Participant use of digital health and/or community health worker interventions
timeFrame: From randomization to 6 weeks postpartum
Secondary outcomes:
measure: Outpatient Prenatal Care Visits
timeFrame: Duration of pregnancy through 6 weeks postpartum
measure: Preterm Birth
timeFrame: At birth
measure: Neonatal birthweight
timeFrame: At birth
measure: Cesarean delivery
timeFrame: At birth
measure: Maternal blood transfusion
timeFrame: Duration of pregnancy through 6 weeks postpartum
measure: Breastfeeding intent
timeFrame: From randomization to delivery of the infant(s)
measure: Vaccination rate
timeFrame: Pregnancy through 6 weeks postpartum / 6 weeks of life
measure: Maternal postpartum readmission
timeFrame: From discharge from the delivery-associated hospitalization to 6 weeks postpartum
measure: Neonatal hospital readmission
timeFrame: Birth to 6 weeks of life
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Rachel Sinkey, MD
role: PRINCIPAL_INVESTIGATOR
References: