Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Location status: Recruiting
Location contact
Constance Guille, MD
CONTACT
NCT Number: NCT06273436
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.
Interested in participating?
Request Info16 year–49 year
Female
Interventional
Not applicable
Charleston, South Carolina, 29425, United States
Location status: Recruiting
Constance Guille, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Postpartum Women
Exclusion criteria
for Postpartum Women
Inclusion criteria
for Obstetric Providers and Hospital Administrators
Exclusion criteria
for Obstetric Providers and Hospital Administrators
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.
Time frame: Within six weeks following the delivery
Percent of postpartum women with an ED visit that occurs within six weeks following delivery
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.
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.
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).
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).
Contact information is provided by the study sponsor or research team.
Constance Guille, MD
CONTACT
Edie Douglas
CONTACT
Medical University of South Carolina
Other
Comparing Standard of Care Versus a Technology-Based Approach To Reduce Postpartum Emergency Department Visits
Acronym: HEAR4Mamas
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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