IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine (IMPACT)

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Complication
• Intervention / Treatment: Other: Intensive Education; Other: Enhanced Virtual Care

Detailed Description

This large, multi-center randomized controlled trial will compare two multi-component postpartum care models via hybrid type 1 design conducted in two phases. An initial phase (phase 1) will collect baseline data and ensure patient input into final study. In phase 2, women will be randomized. Comparators are evidenced- based approaches: (1) an intensive in-person education with virtual education via push notifications using an electronic health record web portal; (2) a telehealth model using serial encounters. The "push" approach using notifications directly contrasts with the "pull" approach using telehealth visits. Both models include home visit programs. The study population includes patients delivering in two urban, inner-city health systems: Parkland (Dallas, TX) and Grady Memorial (Atlanta, GA). The primary outcome is time from hospital discharge to diagnosis and treatment of a composite of complications in the first 6 weeks. Based upon pilot data, 2349 women will demonstrate a 40% reduction (9 to 5.4 days) with 80% power and two-sided alpha of 0.05. 3500 women will be enrolled (1000 in phase 1; 2500 in phase 2) with anticipated <5% attrition at 6 weeks. Inclusion will be women who deliver liveborn infants. Secondary outcomes include mental health disorders, emergency room visits, hospital admissions, patient knowledge, quality of life and satisfaction, provider satisfaction, and social determinants of health. Women will be followed for one year postpartum.

• Study Type: Interventional
• Enrollment (Estimated): 3500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacqueline Catchings, PhD; Phone Number: 214-648-7413; Email: jacqueline.catchings@utsouthwestern.edu
• Study Contact Backup: Name: Lisa Moseley, RN; Phone Number: 214-648-2591; Email: lisa.moseley@utsouthwestern.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
      • Emory University School of Medicine
      • Contact: Anna Newton-Levinson, PhD, MPH
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Contact: Jacqueline Catchings, PhD; Phone Number: 214-648-7413; Email: jacqueline.catchings@utsouthwestern.edu
      • Contact: Lisa Moseley, RN; Phone Number: 214-648-2591; Email: lisa.moseley@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Intensive Education; Intervention will consist of virtual education and communication through scheduled push notifications
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.	Other: Enhanced Virtual Care; Intervention will utilize a telehealth model consisting of "pull" approach of patient engagement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale	screening continuous, numerical; higher value consistent with great risk of postpartum depression	enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
Generalized Anxiety Disorder 7	screening tool, continuous, numerical, higher value consistent with higher risk of anxiety disorder	enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
Number of patients requiring emergency room visits, % preventable	continuous variable, preventability to be determined by preventability panel	Up to one year postpartum
Number of patients requiring hospital admissions, % preventable	continuous variable, preventability to be determined by preventability panel	Up to one year postpartum
Postpartum warning signs knowledge assessment, based on AWOHHN criteria	Percent scored correct out of 10 total questions	enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
PROMIS-29 questionnaire v 2.1	Scales 1-10 for each independent question, with numerical summary score	6 weeks and 1 year postpartum
Healthy People 2030 questionnaire	categorical variables selected by the participant	6 weeks and 1 year postpartum
PRAPARE questionnaire	categorical and dichotomous variables	6 weeks and 1 year postpartum
Short Assessment of Patient Satisfaction (SAPS)	Scale: Extremely dissatisfied to extremely satisfied Score Range is 0-28.	6 weeks and 1 year postpartum
Provider Satisfaction Survey (Quantitative)	Scale: Strong agree to strongly disagree; very good to very bad; often to never	Every 6 months throughout the study period
Systolic Blood Pressure	numerical, continuous	enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
Diastolic Blood Pressure	numerical, continuous	enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
Social Determinants of Health - Healthy People 2030 and PRAPARE questionnaire	qualitative data, each questions treated as dichotomous or categorical variables	enrollment, 6 weeks, 1 year postpartum
Long-term disease control - diabetes - hemoglobin A1c, LDL, HDL, total cholesterol, triglycerides	laboratory value - continuous variables	enrollment, 6 weeks, 3 months, and 1 year postpartum
Long-term disease control - hypertension - serum creatinine	laboratory value - continuous variable	enrollment, 6 weeks, 3 months, and 1 year postpartum
Long-term disease control - liver function test (AST, ALT)	laboratory value - continuous variables	enrollment, 6 weeks, 3 months, and 1 year postpartum
Long-term disease control - anemia - hemoglobin and hematocrit	laboratory value - continuous variables	enrollment, 6 weeks, 3 months, and 1 year postpartum

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Elaine Duryea, MD, University of Texas Southwestern Medical Center; Principal Investigator: David B Nelson, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: hypertension; wound infection; telemedicine; readmission; mastitis; maternal mortality; postpartum complications; metritis
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Infections; Death; Skin Diseases; Breast Diseases; Puerperal Disorders; Parental Death; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hypertension; Wound Infection; Maternal Death; Mastitis
• Other Study ID Numbers: STU-2023-0332; PCORI-MMM-2022C2-27680 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No