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

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Postpartum Complication

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06273436

Pro00130902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,894 estimated patients

Sex: Female

Ages: 16 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,894 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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

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

Experimental group

Description:

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).

Treatment:

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