Recruiting

Telemedicine

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06218355

Conditions

Postpartum Complication

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Intensive Education

Enhanced Virtual Care

Study Details

Brief summary:

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.

Conditions

Postpartum Complication

Study ID

NCT06218355

Start date

Mar 1, 2024

Status verified date

Aug, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Postpartum women who deliver a live born infant at Parkland Hospital or Grady Health and receive postpartum care at dedicated community clinics.
  • Due to the nature of the study, all will be women, and all will be postpartum, thus of reproductive age. Postpartum women 18 years of age and older will be considered for inclusion if informed consent can be obtained.

Exclusion Criteria:

  • Postpartum women who do not deliver at Parkland Hospital or Grady Health will not receive postpartum care in the pre-specified community clinics for Parkland health systems.
  • Patients with a primary language other than English or Spanish.

Study Design

Enrollment

3500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Intensive Education

Intervention will consist of virtual education and communication through scheduled push notifications

Enhanced Virtual Care

Intervention will utilize a telehealth model consisting of "pull" approach of patient engagement.

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 and Locations

Central contacts

Jacqueline Catchings, PhD

214-648-7413jacqueline.catchings@utsouthwestern.edu

Lisa Moseley, RN

214-648-2591lisa.moseley@utsouthwestern.edu

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Anna Newton-Levinson, PhD, MPH

404-778-1377anewto3@emory.edu

Parkland Hospital

Recruiting

Dallas, Texas, United States, 75390

Contacts

Lisa Moseley, RN

214-648-2591lisa.moseley@utsouthwestern.edu

Jacqueline Catchings, PhD

214-648-7413jacqueline.catchings@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • telemedicine
  • hypertension
  • wound infection
  • readmission
  • metritis
  • mastitis
  • maternal mortality
  • postpartum complications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-09-02.