Telemedicine for Postpartum Complications

(IMPACT Trial)

Recruiting at 1 trial location

Overseen By Lisa Moseley, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Non-English/Spanish speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether virtual care or intensive education better assists new mothers facing health issues after childbirth. One group will participate in telehealth visits, sharing health readings with doctors from home. The other group will receive both in-person and online education about their health, along with reminders to monitor and report their vital signs. Women who have given birth at Parkland Hospital or Grady Health and receive postpartum care at specific clinics are well-suited for this study. As an unphased trial, participants have the opportunity to contribute to innovative postpartum care solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these postpartum interventions are safe?

Research has shown that telehealth, used in the Enhanced Virtual Care model, is generally safe and easy to use. Studies indicate that remote monitoring for postpartum care, such as checking blood pressure, can improve health outcomes without major safety concerns. Many people feel comfortable with virtual visits because they can be done from home and allow for regular check-ins with healthcare providers.

For the Intensive Education model, research has shown that educational programs for new mothers are safe. These programs aim to improve health by teaching important information about recognizing warning signs and managing health after childbirth. Women who receive this education often feel more confident about their health and safety.

Both approaches focus on improving care without introducing new medical procedures or medications, making them relatively low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these approaches for postpartum complications because they leverage technology in innovative ways to improve care. The Enhanced Virtual Care model allows new moms to have telehealth visits on their preferred platform, either video or audio-only, where they can share vital signs directly with their healthcare provider during the call. This "pull" approach to gathering health data contrasts with traditional methods. Meanwhile, the Intensive Education model offers a blend of in-person and virtual education, sending timely "push" notifications through a Care Companion to remind women to check and report their vital signs. Both methods aim to make monitoring and education more accessible and engaging, potentially enhancing outcomes for postpartum women.

What evidence suggests that this trial's treatments could be effective for postpartum complications?

This trial will compare Enhanced Virtual Care with Intensive Education for postpartum complications. Research has shown that Enhanced Virtual Care, one of the treatment arms, can improve postpartum care by providing regular follow-ups and support through online health services. One study highlighted how this approach increases access to care and education for mothers with limited resources, potentially reducing health issues. Another study found that this method helps manage conditions like high blood pressure, which can lead to hospital readmissions after childbirth.

Intensive Education, another treatment arm, has also shown promise. Studies suggest that thorough education and reminders help mothers better understand and manage their postpartum care. This approach aims to equip mothers with the knowledge and support needed to prevent complications. Both treatments in this trial focus on improving maternal health in meaningful ways. ^{1 6 7 8 9}

Who Is on the Research Team?

Elaine Duryea, MD

Principal Investigator

University of Texas Southwestern Medical Center

David B Nelson, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for postpartum women who gave birth to a live infant at Parkland Hospital or Grady Health and are getting care at certain community clinics. They must be 18 or older and able to give informed consent. Women who didn't deliver at these hospitals or don't speak English or Spanish can't join.

Inclusion Criteria

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

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

My primary language is not English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 - Baseline Data Collection

Collection of baseline data and ensuring patient input into the final study design

Not specified

Phase 2 - Randomization and Intervention

Participants are randomized into either the enhanced virtual care model or the intensive education care model

6 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of mental health, emergency room visits, and long-term disease control

1 year

Regular follow-up visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Virtual Care
• Intensive Education

Trial Overview

The study compares two programs designed to help new moms after giving birth, especially those with lower incomes: one provides intensive education on postpartum care, while the other offers enhanced support through virtual visits and online resources.

How Is the Trial Designed?

Group I: Enhanced Virtual Care Active Control 1 Intervention

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.

Group II: Intensive Education Active Control 1 Intervention

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.

Enhanced Virtual Care is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Enhanced Virtual Care for:

• Postpartum care
• Maternal health services

Approved in European Union as Telemedicine Services for:

• General healthcare services
• Remote monitoring

Approved in Canada as Virtual Health Services for:

• Primary care
• Specialty care

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

The Tele-Lactation Pilot Project successfully provided breastfeeding education and support to 35 low-income mothers through 134 videoconferencing sessions with a lactation consultant, demonstrating the feasibility of remote support in healthcare.

Participants reported that the tele-lactation sessions not only increased their confidence in breastfeeding but also reduced anxiety related to childbirth and hospital experiences, highlighting the emotional benefits of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Videoconferencing Technology to Provide Breastfeeding Support to Low-Income Women: Connecting Hospital-Based Lactation Consultants with Clients Receiving Care at a Community Health Center. Friesen, CA., Hormuth, LJ., Petersen, D., et al.[2019]

A study involving 29 mothers showed that using video conferencing technology significantly helps postcesarean section mothers connect with their newborns, fulfilling their primary need for communication and bonding right after birth.

Qualitative feedback from 10 mothers highlighted that seeing their baby through video conferencing provided emotional benefits, such as a calming effect and increased confidence, indicating that this method can enhance postpartum well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication Between Postdelivery Mothers in the PACU and Newborns in Israel. Qoussine, S., Benbenishty, J., Penso, S., et al.[2018]

A multidisciplinary postpartum hypertension clinic utilizing telehealth was successfully implemented, with 80% of scheduled patients attending their visits, demonstrating that virtual care can effectively reach women at high risk for elevated postpartum blood pressure.

The study found that virtual visits were particularly beneficial for women living farther from the clinic, ensuring equitable access to care across different racial and socioeconomic groups, without compromising attendance rates compared to in-person visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Utilizing Telehealth in a Multidisciplinary Postpartum Hypertension Clinic. Countouris, M., Jaramillo Restrepo, V., Bidani, S., et al.[2023]

A media-based, self-instructional education program for health professionals was developed and tested in Michigan, showing significant improvements in knowledge and patient care practices among physicians and nurses.

The study demonstrates that targeted educational interventions can effectively enhance perinatal care, indicating a successful approach to improving healthcare delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an education program on perinatal care practices. Harlan, WR., Hess, GE., Borer, RC., et al.[2004]

The implementation of telemedicine clinics and online education for children with diabetes significantly reduced the average time between medical visits from 149 days to 89 days over two years, improving access to care.

Hospitalizations decreased from an average of 13 per year to 3.5, and emergency department visits dropped from 8 to 2.5, demonstrating that this approach not only improved health outcomes but also saved approximately $27,860 annually.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved access to subspecialist diabetes care by telemedicine: cost savings and care measures in the first two years of the FITE diabetes project. Malasanos, TH., Burlingame, JB., Youngblade, L., et al.[2007]

Telemedicine consultations using interactive television significantly improved clinical and educational outcomes for ICU patients compared to traditional telephone consultations, with 1548 visits made to 395 patients over 18 months.

While the technology was reliable and user-friendly, the high cost of equipment and the need for further research indicate that the full potential of telemedicine in critical care has yet to be realized.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine in critical care: problems in design, implementation, and assessment. Grundy, BL., Jones, PK., Lovitt, A.[2019]

Maternal morbidity and mortality rates in the U.S. are concerningly high, particularly with rising postpartum deaths, highlighting the need for better education on potential complications.

The project aims to enhance postpartum discharge education provided by nurses, ensuring that women receive consistent and evidence-based information to recognize and respond to warning signs after childbirth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Postpartum Education About Warning Signs Of Maternal Morbidity and Mortality. Suplee, PD., Kleppel, L., Santa-Donato, A., et al.[2019]

The implementation of telehealth during the COVID-19 pandemic significantly increased attendance at postpartum visits, with a 90% higher likelihood of attendance compared to the pre-telehealth period (82.9% vs 72.4%).

Telehealth also led to a higher rate of postpartum depression screening (86.3% vs 65.1%), but it was associated with a decrease in the selection of long-acting reversible contraception or permanent sterilization options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact on postpartum care by telehealth: a retrospective cohort study. Arias, MP., Wang, E., Leitner, K., et al.[2023]

Telemedicine use for postpartum care surged from 1% pre-COVID to 60% during peak COVID, showing its rapid adoption, but attendance rates for postpartum visits remained similar across different periods, indicating comparable effectiveness to in-person visits.

Despite the successful implementation of telemedicine, there was a significant drop in postpartum depression screening rates during the pandemic, highlighting the need for improved integration of mental health assessments in telehealth services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum Care in the Time of COVID-19: The Use of Telemedicine for Postpartum Care. Adams, AM., Wu, H., Zhang, FR., et al.[2023]

A review of 28 randomized controlled trials and 14 observational studies involving 44,894 participants found that telehealth strategies for maternal care generally resulted in similar or better clinical outcomes and patient satisfaction compared to traditional in-person care.

Telehealth interventions, particularly for mental health and diabetes management during pregnancy, were effective in supplementing in-person care, but the impact on health equity and potential harms remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Strategies for the Delivery of Maternal Health Care : A Rapid Review. Cantor, AG., Jungbauer, RM., Totten, AM., et al.[2022]

Hypertensive disorders of pregnancy are a major cause of maternal morbidity and mortality, particularly in the postpartum period, highlighting the need for effective monitoring and care during this time.

Implementing remote blood pressure monitoring programs can improve care for postpartum patients, enhance blood pressure control, and reduce racial disparities in healthcare access, while being well-received by both patients and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum remote home blood pressure monitoring: the new frontier. Corlin, T., Raghuraman, N., Rampersad, RM., et al.[2023]

Implementing individualized postpartum care with telemedicine during the COVID-19 pandemic significantly increased postpartum contact from 48.0% to 64.6%, indicating improved access to care for new mothers.

While contraceptive use rose dramatically from 49.7% to 84.7% post-intervention, there was a concerning decline in exclusive breastfeeding rates from 75.1% to 46.6%, suggesting a need for enhanced telehealth support in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing the individualized postpartum care with telemedicine during the COVID-19 pandemic at tertiary hospital in Thailand. Sothornwit, J., Kaewrudee, S., Somboonporn, W., et al.[2023]

The online POST-BIRTH Warning Signs (PBWS) educational program led to an 11% increase in knowledge among 2,363 registered nurses, enhancing their ability to teach postpartum patients about potential complications.

After the course, nurses reported a 59% increase in confidence regarding their teaching, indicating that the program effectively prepared them to implement standardized education protocols for postpartum care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Initiative to Improve Postpartum Discharge Education. Suplee, PD., D'Oria, R., Larson, K., et al.[2023]

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