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NCT Number: NCT06273436

Healing, Equity, Advocacy and Respect for Mamas

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.

Recruiting

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Key information

Age range

16 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Constance Guille, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Emergency Department (ED) visits within six weeks postpartum

    Time frame: Within six weeks following the delivery

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

Secondary outcomes

  1. Patient Reported Outcomes (PROs)

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

    Secondary outcomes will include PROs which will be measured at the time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum.

Other outcomes

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

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

    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.

  2. Patient Activation

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

    Patient activation will be measured by the Patient Activation Measure (PAM-10).

  3. Shared Decision Making

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

    Perception of the shared decision-making process will be measured by Shared Decision-Making Questionnaire (SDM-Q-9).

Study contacts

Contact information is provided by the study sponsor or research team.

Constance Guille, MD

CONTACT

[email protected]

843-792-6489

Edie Douglas

CONTACT

[email protected]

8439985635

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: HEAR4Mamas

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Feb 22, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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