Clinical trial NCT06273436: Healing, Equity, Advocacy and Respect for Mamas
Official title: Leveraging Technology to Reduce Disparities and Improve Early Detection of and Timely Care for Postpartum Complications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Complication
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)
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-02-22
Enrollment: 2894
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Emergency Department (ED) visits within six weeks postpartum
timeFrame: Within six weeks following the delivery
Secondary outcomes:
measure: Patient Reported Outcomes (PROs)
timeFrame: time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum
Other outcomes:
measure: Social Determinants of Health (SDoH), Patient Activation, Shared Decision Making
timeFrame: HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum
measure: Patient Activation
timeFrame: HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum
measure: Shared Decision Making
timeFrame: HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: