Healing, Equity, Advocacy and Respect for Mamas

NCT06273436 | Recruiting DMC

• 1 other identifier: Pro00130902
• Study Type: interventional
• Target: 2,894
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities.

Conditions

Postpartum Complication

Keywords

AIM (Alliance for Innovation on Maternal Health) safety bundles; Randomized Controlled Trial (RCT); Emergency Department (ED) visits; Shared Decision Making (SDM); Patient-Reported Outcomes (PROs); Patient Stakeholder Group (PSG); Study Advisory Committee (SAC)

Outcome Measures

Primary Outcomes (1)

• Emergency Department (ED) visits within six weeks postpartum

  Percent of postpartum women with an ED visit that occurs within six weeks following delivery

  Within six weeks following the delivery

Secondary Outcomes (1)

• Patient Reported Outcomes (PROs)

  time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum

Other Outcomes (3)

• Social Determinants of Health (SDoH), Patient Activation, Shared Decision Making

  HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum

• Patient Activation

  HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum

• Shared Decision Making

  HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum

Study Arms (2)

Usual Care

NO INTERVENTION

AIM (AIM Alliance for Innovation on Maternal Health) safety bundles delivered in-person

Usual Care plus H.E.A.R. for Mamas

EXPERIMENTAL

H.E.A.R. for Mamas is designed to provide the AIM (Alliance for Innovation on Maternal Health) Postpartum Discharge Transition education systematically and to frequently monitor women for signs and symptoms of postpartum complications using simple, patient-centered technology (text/phone).

Other: H.E.A.R. for Mamas

Interventions

H.E.A.R. for Mamas OTHER

H.E.A.R. for Mamas is a patient and provider informed, multicomponent intervention that uses simple text/phone-based screenings to systematically and frequently monitor women for postpartum complications, chronic conditions and SDoH (Social Determinants of Health) and provides patients with immediate feedback and recommendations based on their screenings.

Usual Care plus H.E.A.R. for Mamas

Eligibility Criteria

• Age: 16 Years - 49 Years
• Gender Eligibility Details: Postpartum woman within approximately 2 weeks of delivery Aged 16-49 years old.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Postpartum woman within approximately 2 weeks of delivering a baby of gestational age ≥ 26 weeks in South Carolina.
• Aged 16-49 years old.
• Insured by Medicaid.

You may not qualify if:

• Plans to relocate outside of SC anytime during the postpartum year.
• Plans to discontinue Medicaid health insurance during the postpartum year.
• Speaks a language other than English or Spanish.
• Incarcerated/pending incarceration during peripartum period.
• Currently institutionalized.
• Enrolled in current MUSC study funded by PCORI (#Pro00123833)
• Does not have and/or does not wish to use their personal cell phone for the study.
• \- OB provider working at a delivery hospital in SC and directly involved in the care of postpartum women; or hospital administrator working in a delivery hospital in SC and job responsibilities relate to the postpartum unit.
• Less than 1 month of HEAR 4 Mamas experience if involved in the hospital where participants are recruited from.
• Unable or unwilling to commit to completing surveys or an interview.
• Speaking a language other than English.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Episodic Ataxia, Type 1; Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Constance Guille, MD

CONTACT

843-792-6489; guille@musc.edu

Ellen H Gomez, MA

CONTACT

8439985635; gomezel@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Faculty

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 22, 2024
• Study Start: May 28, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): March 30, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

US (1)