Postpartum Complication
Conditions
Keywords
AIM (Alliance for Innovation on Maternal Health) safety bundles, Randomized Controlled Trial (RCT), Emergency Department (ED) visits, Shared Decision Making (SDM), Patient-Reported Outcomes (PROs), Patient Stakeholder Group (PSG), Study Advisory Committee (SAC)
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.
Interventions
OTHERH.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.
Sponsors
Medical University of South Carolina
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 49 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department (ED) visits within six weeks postpartum | Within six weeks following the delivery | Percent of postpartum women with an ED visit that occurs within six weeks following delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes (PROs) | 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. |
Countries
United States
Contacts
CONTACTConstance Guille, MD
CONTACTEdie Douglas
Outcome results
None listed