IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06218355
Status
Recruiting
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Conditions

  • Postpartum Complication

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Intensive Education — OTHER
    Intervention will consist of virtual education and communication through scheduled push notifications
  • Enhanced Virtual Care — OTHER
    Intervention will utilize a telehealth model consisting of "pull" approach of patient engagement.

Study Details

The purpose of this study is to compare two complex, multi-component evidence-based postpartum interventions in underserved populations of lower socioeconomic status in an effort to reduce maternal morbidity and mortality.

Key Dates

Start date
Mar 1, 2024
Status verified
Mar 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
3,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Intensive Education
    Women enrolled in the intensive education care model participate in intensive in-person education as well as ongoing virtual education via the electronic health record web portal in the form of strategically timed "pushes" of relevant and digestible educational elements via a "Care Companion." These virtual education "pushes" will include "to do" list reminders to check vital signs and submit them for review to the care team. Positive reinforcement will be provided when tasks are completed.
  • Active Comparator: Enhanced Virtual Care
    Women in the enhanced virtual care model will receive scheduled telehealth visits on the platform of their choice - either via video or audio-only synchronous visits. Patients in the virtual care model will check vital signs with home devices during the telehealth visit and report them directly to the provider. This "pull" approach to data collection directly contrasts with the "push" approach of comparator #1.

Primary Outcome Measure

Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge [ Time Frame: Up to one year postpartum ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University School of MedicineAtlantaGeorgia30322
Anna Newton-Levinson, PhD, MPH
University of Texas Southwestern Medical CenterDallasTexas75390
Lisa Moseley, RN
[email protected]
214-648-2591
Jacqueline Catchings, PhD
[email protected]
214-648-7413

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Emory University School of Medicine· Atlanta, GAUniversity of Texas Southwestern Medical Center· Dallas, TX

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