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

August 28, 2026 updated by: Elaine Duryea, University of Texas Southwestern Medical Center
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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) under the direction of Drs. Duryea and Nelson (UT Southwestern PIs) and Grady Memorial (Atlanta, GA) under the direction of Dr. Newton-Levinson (Emory PI). 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge
Time Frame: Up to one year postpartum
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Edinburgh Postnatal Depression Scale
Time Frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
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
Time Frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
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
Time Frame: Up to one year postpartum
continuous variable, preventability to be determined by preventability panel
Up to one year postpartum
Number of patients requiring hospital admissions, % preventable
Time Frame: Up to one year postpartum
continuous variable, preventability to be determined by preventability panel
Up to one year postpartum
Postpartum warning signs knowledge assessment, based on AWOHHN criteria
Time Frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
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
Time Frame: 6 weeks and 1 year postpartum
Scales 1-10 for each independent question, with numerical summary score
6 weeks and 1 year postpartum
Healthy People 2030 questionnaire
Time Frame: 6 weeks and 1 year postpartum
categorical variables selected by the participant
6 weeks and 1 year postpartum
PRAPARE questionnaire
Time Frame: 6 weeks and 1 year postpartum
categorical and dichotomous variables
6 weeks and 1 year postpartum
Short Assessment of Patient Satisfaction (SAPS)
Time Frame: 6 weeks and 1 year postpartum
Scale: Extremely dissatisfied to extremely satisfied Score Range is 0-28.
6 weeks and 1 year postpartum
Provider Satisfaction Survey (Quantitative)
Time Frame: Every 6 months throughout the study period
Scale: Strong agree to strongly disagree; very good to very bad; often to never
Every 6 months throughout the study period
Systolic Blood Pressure
Time Frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
numerical, continuous
enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
Diastolic Blood Pressure
Time Frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
numerical, continuous
enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
Social Determinants of Health - Healthy People 2030 and PRAPARE questionnaire
Time Frame: enrollment, 6 weeks, 1 year postpartum
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
Time Frame: enrollment, 6 weeks, 3 months, and 1 year postpartum
laboratory value - continuous variables
enrollment, 6 weeks, 3 months, and 1 year postpartum
Long-term disease control - hypertension - serum creatinine
Time Frame: enrollment, 6 weeks, 3 months, and 1 year postpartum
laboratory value - continuous variable
enrollment, 6 weeks, 3 months, and 1 year postpartum
Long-term disease control - liver function test (AST, ALT)
Time Frame: enrollment, 6 weeks, 3 months, and 1 year postpartum
laboratory value - continuous variables
enrollment, 6 weeks, 3 months, and 1 year postpartum
Long-term disease control - anemia - hemoglobin and hematocrit
Time Frame: enrollment, 6 weeks, 3 months, and 1 year postpartum
laboratory value - continuous variables
enrollment, 6 weeks, 3 months, and 1 year postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elaine Duryea, MD, University of Texas Southwestern Medical Center
  • Principal Investigator: David B Nelson, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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