Healing, Equity, Advocacy and Respect for Mamas

NCT ID: NCT06273436

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2894 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-28
• Study Completion Date: 2030-03-30

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.

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.

Conditions

Postpartum Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

H.E.A.R. for Mamas

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Constance Guille

Professor - Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Constance Guille, MD

Role: CONTACT

guille@musc.edu

843-792-6489

Ellen H Gomez, MA

Role: CONTACT

gomezel@musc.edu

8439985635

Facility Contacts

Constance Guille, MD

Role: primary

Other Identifiers

Pro00130902

Identifier Type: -

Identifier Source: org_study_id