Postpartum ComplicationIMPACTNCT06218355
IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
A study testing Intensive Education and Enhanced Virtual Care in people with Postpartum Complication, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Complication
- What is being tested?
- Intensive Education and Enhanced Virtual Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2024to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30322
Anna Newton-Levinson, PhD, MPH, 404-778-1377, anewto3@emory.edu
- Recruiting
Parkland Hospital
Dallas, Texas, 75390
Lisa Moseley, RN, 214-648-2591, lisa.moseley@utsouthwestern.edu
Jacqueline Catchings, PhD, 214-648-7413, jacqueline.catchings@utsouthwestern.edu
About this study
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.
Read the 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.
- Conditions
- Postpartum Complication
- Being tested
- Intensive Education, Enhanced Virtual Care
- Keywords
- telemedicine, hypertension, wound infection, readmission, metritis, mastitis, maternal mortality, postpartum complications
- Medical subject headings
- Hypertension, Wound Infection, Mastitis, Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive EducationOther
Intervention will consist of virtual education and communication through scheduled push notifications
Enhanced Virtual CareOther
Intervention will utilize a telehealth model consisting of "pull" approach of patient engagement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enhanced Virtual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one year postpartum
Secondary outcomes (17)
Edinburgh Postnatal Depression Scale
screening continuous, numerical; higher value consistent with great risk of postpartum depression
Measured: 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
Measured: 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
Measured: Up to one year postpartum
Number of patients requiring hospital admissions, % preventable
continuous variable, preventability to be determined by preventability panel
Measured: Up to one year postpartum
Postpartum warning signs knowledge assessment, based on AWOHHN criteria
Percent scored correct out of 10 total questions
Measured: 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
Measured: 6 weeks and 1 year postpartum
Healthy People 2030 questionnaire
categorical variables selected by the participant
Measured: 6 weeks and 1 year postpartum
PRAPARE questionnaire
categorical and dichotomous variables
Measured: 6 weeks and 1 year postpartum
Short Assessment of Patient Satisfaction (SAPS)
Scale: Extremely dissatisfied to extremely satisfied Score Range is 0-28.
Measured: 6 weeks and 1 year postpartum
Provider Satisfaction Survey (Quantitative)
Scale: Strong agree to strongly disagree; very good to very bad; often to never
Measured: Every 6 months throughout the study period
Systolic Blood Pressure
numerical, continuous
Measured: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
Diastolic Blood Pressure
numerical, continuous
Measured: 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
Measured: enrollment, 6 weeks, 1 year postpartum
Long-term disease control - diabetes - hemoglobin A1c, LDL, HDL, total cholesterol, triglycerides
laboratory value - continuous variables
Measured: enrollment, 6 weeks, 3 months, and 1 year postpartum
Long-term disease control - hypertension - serum creatinine
laboratory value - continuous variable
Measured: enrollment, 6 weeks, 3 months, and 1 year postpartum
Long-term disease control - liver function test (AST, ALT)
laboratory value - continuous variables
Measured: enrollment, 6 weeks, 3 months, and 1 year postpartum
Long-term disease control - anemia - hemoglobin and hematocrit
laboratory value - continuous variables
Measured: enrollment, 6 weeks, 3 months, and 1 year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Emory University
- Responsible party
- Principal investigator, Elaine Duryea, University of Texas Southwestern Medical Center
- Investigators
- Elaine Duryea, MD, Principal investigator, University of Texas Southwestern Medical CenterDavid B Nelson, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218355
- Sponsor's protocol ID
- STU-2023-0332
- Other IDs
- PCORI-MMM-2022C2-27680
- Acronym
- IMPACT
- Status last verified
- Aug 2026
- First submitted
- 21 Dec 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang R, Boulet SL, Nelson DB, Goedken P, Catchings J, McIntire D, Platner M, Martin RB, Spong CY, Duryea EL. Improving Maternal Postpartum Access to Care through Telemedicine (IMPACT): A multi-center randomized controlled trial of postpartum interventions to improve access and outcome. Contemp Clin Trials. 2025 May;152:107882. doi: 10.1016/j.cct.2025.107882. Epub 2025 Mar 14.
PubMed 40090665
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
- ClinicalTrials.gov ID
- NCT06218355
- Acronym / sponsor ID
- IMPACT / STU-2023-0332
- Conditions
- Postpartum Complication
- Keywords
- telemedicine, hypertension, wound infection, readmission, metritis, mastitis, maternal mortality, postpartum complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Emory University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Education | Active comparator | Other: Intensive EducationWomen 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. |
| Enhanced Virtual Care | Active comparator | Other: Enhanced Virtual CareWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive EducationIntervention will consist of virtual education and communication through scheduled push notifications | Other | Intensive Education |
| Enhanced Virtual CareIntervention will utilize a telehealth model consisting of "pull" approach of patient engagement. | Other | Enhanced Virtual Care |
Primary outcome
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.
17 secondary outcomes
Edinburgh Postnatal Depression Scale
Time frame: 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
Number of patients requiring emergency room visits, % preventable
Time frame: Up to one year postpartum
Number of patients requiring hospital admissions, % preventable
Time frame: 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
PROMIS-29 questionnaire v 2.1
Time frame: 6 weeks and 1 year postpartum
Healthy People 2030 questionnaire
Time frame: 6 weeks and 1 year postpartum
PRAPARE questionnaire
Time frame: 6 weeks and 1 year postpartum
Short Assessment of Patient Satisfaction (SAPS)
Time frame: 6 weeks and 1 year postpartum
Provider Satisfaction Survey (Quantitative)
Time frame: Every 6 months throughout the study period
Systolic Blood Pressure
Time frame: 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
Social Determinants of Health - Healthy People 2030 and PRAPARE questionnaire
Time frame: 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
Long-term disease control - hypertension - serum creatinine
Time frame: 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
Long-term disease control - anemia - hemoglobin and hematocrit
Time frame: enrollment, 6 weeks, 3 months, and 1 year postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 40090665Zhang R, Boulet SL, Nelson DB, Goedken P, Catchings J, McIntire D, Platner M, Martin RB, Spong CY, Duryea EL. Improving Maternal Postpartum Access to Care through Telemedicine (IMPACT): A multi-center randomized controlled trial of postpartum interventions to improve access and outcome. Contemp Clin Trials. 2025 May;152:107882. doi: 10.1016/j.cct.2025.107882. Epub 2025 Mar 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elaine Duryea, MD principal investigator
University of Texas Southwestern Medical Center
David B Nelson, MD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Education and Enhanced Virtual Care in people with Postpartum Complication, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Catchings, PhD (214-648-7413, jacqueline.catchings@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge (time frame: Up to one year postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06218355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.