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

Pregnancy Clinical Trial

— P?OPPY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05940688
• Other study ID #: 300009897
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: Rosylen "Roz" Quinney
• Phone: 205.934.1309
• Email: p3oppy[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 49 Years

Eligibility

Inclusion Criteria:

• Self Identifies as Non-Hispanic Black

• Between 16-49 years old

• Pregnant individuals between 8° - 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

Related Conditions & MeSH terms

• Disparities
• Infants
• Pregnancy

Intervention

Behavioral:
• Digital Health intervention
Health care information delivered via a link in a text message that is then opened in a secure browser.
• Community Health Worker
Health care information delivered via CHW.
• Digital Health Intervention plus Community Health Worker
Health care information delivered via DHI plus CHW

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (4)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	American Heart Association, ConnectionHealth, Memora Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Outpatient Prenatal Care Visits	Number of outpatient prenatal care and postpartum visits	Duration of pregnancy through 6 weeks postpartum
Secondary	Preterm Birth	Delivery of a neonate at less than 37 weeks	At birth
Secondary	Neonatal birthweight	Weight of neonate at birth	At birth
Secondary	Cesarean delivery	Occurrence of a cesarean birth	At birth
Secondary	Maternal blood transfusion	Transfusion of blood products	Duration of pregnancy through 6 weeks postpartum
Secondary	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)
Secondary	Vaccination rate	The number of recommended vaccinations for which the mother and newborn accepted	Pregnancy through 6 weeks postpartum / 6 weeks of life
Secondary	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
Secondary	Neonatal hospital readmission	Admission of a neonate to the hospital after discharge from the hospital after birth	Birth to 6 weeks of life