Healing, Equity, Advocacy and Respect for Mamas

ConditionPostpartum Complication

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age16-49

SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

2,894 Participants

are divided into 2 treatment groups

Group A: Usual CareNo intervention 0 interventions

Group B: Usual Care plus H.E.A.R. for MamasExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Emergency Department (ED) visits within six weeks postpartum

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

Time frame

Within six weeks following the delivery

Secondary outcomes

Patient Reported Outcomes (PROs)

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

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

Other outcomes

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

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

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

Shared Decision Making

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

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov

Apply now