IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine

NCT06218355 | Recruiting DMC

• 2 other identifiers: STU-2023-0332PCORI-MMM-2022C2-27680
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge

  Time to diagnosis and treatment of postpartum complications including hypertension, wound infection, and venous thromboembolism, measured in days. Lower value is considered better, representing timely care.

  Up to one year postpartum

Secondary Outcomes (17)

• Edinburgh Postnatal Depression Scale

  enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum

• Generalized Anxiety Disorder 7

  enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum

• Number of patients requiring emergency room visits, % preventable

  Up to one year postpartum

• Number of patients requiring hospital admissions, % preventable

  Up to one year postpartum

• Postpartum warning signs knowledge assessment, based on AWOHHN criteria

  enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum

Study Arms (2)

Intensive Education

ACTIVE COMPARATOR

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.

Other: Intensive Education

Enhanced Virtual Care

ACTIVE COMPARATOR

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.

Other: Enhanced Virtual Care

Interventions

Intensive Education OTHER

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

Intensive Education

Enhanced Virtual Care OTHER

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

Enhanced Virtual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postpartum women who deliver a live born infant at Parkland Hospital or Grady Health and receive postpartum care at dedicated community clinics.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Wound Infection; Mastitis; Maternal Death

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Infections; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elaine Duryea, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• David B Nelson, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Catchings, PhD

CONTACT

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

Lisa Moseley, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 23, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)