Healing, Equity, Advocacy and Respect for Mamas (HEAR4Mamas)

Comparing Standard of Care Versus a Technology-Based Approach To Reduce Postpartum Emergency Department Visits

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Complication
• Intervention / Treatment: Other: H.E.A.R. for Mamas

Detailed Description

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 3 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a nurse advocate will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

• Study Type: Interventional
• Enrollment (Estimated): 2894
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Constance Guille, MD; Phone Number: 843-792-6489; Email: guille@musc.edu
• Study Contact Backup: Name: Ellen H Gomez, MA; Phone Number: 8439985635; Email: gomezel@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Constance Guille, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for Postpartum Women

• 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.

Exclusion Criteria for Postpartum Women

• 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.

Inclusion Criteria for Obstetric Providers and Hospital Administrators

- 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.

Exclusion Criteria for Obstetric Providers and Hospital Administrators

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; AIM (AIM Alliance for Innovation on Maternal Health) safety bundles delivered in-person
Experimental: Usual Care plus H.E.A.R. for Mamas; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes (PROs)	Secondary outcomes will include PROs which will be measured at the time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum.	time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Determinants of Health (SDoH), Patient Activation, Shared Decision Making	SDoH will be measured by the Accountable Health Communities-Health-Related Social Needs (HRSN) and includes assessment of economic instability, low social support, food scarcity etc.	HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum
Patient Activation	Patient activation will be measured by the Patient Activation Measure (PAM-10).	HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum
Shared Decision Making	Perception of the shared decision-making process will be measured by Shared Decision-Making Questionnaire (SDM-Q-9).	HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Patient-Centered Outcomes Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): March 30, 2030

Study Registration Dates

• First Submitted: January 27, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial (RCT); Patient-Reported Outcomes (PROs); Shared Decision Making (SDM); AIM (Alliance for Innovation on Maternal Health) safety bundles; Emergency Department (ED) visits; Patient Stakeholder Group (PSG); Study Advisory Committee (SAC)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies; Episodic Ataxia, Type 1
• Other Study ID Numbers: Pro00130902

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No