Healing, Equity, Advocacy and Respect for Mamas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: H.E.A.R. for Mamas.
- Who it may be relevant to
- Registry conditions: Postpartum Complication. Basic parameters: 16 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparing Standard of Care Versus a Technology-Based Approach To Reduce Postpartum Emergency Department Visits
Overview
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.
Interventions
- 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.
Primary outcome measures
- Emergency Department (ED) visits within six weeks postpartum [Time frame: Within six weeks following the delivery]
Secondary outcome measures (1)
- Patient Reported Outcomes (PROs) [Time frame: time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT06273436 · Pro00130902