Telemedicine for Postpartum Complications

(IMPACT Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by David B Nelson, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Non-English/Spanish speakers, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Enhanced Virtual Care, Telehealth, Remote Care, Virtual Health Services, Intensive Education, Problem-Solving Education, Postpartum Education for postpartum complications?

Research shows that telemedicine, including remote monitoring and education, can improve health outcomes and access to care. For example, telehealth has been effective in managing postpartum hypertension and diabetes, reducing hospital visits, and increasing patient satisfaction. Additionally, educational programs have been shown to enhance healthcare practices and patient care. ^{1 2 3 4 5}

Is telemedicine safe for postpartum care?

Research shows that telemedicine for postpartum care is generally safe, with no increase in hospital visits or readmissions compared to in-person care. However, it is important to ensure that depression screening is effectively integrated into telemedicine visits. ^{3 6 7 8 9}

How is the treatment 'Enhanced Virtual Care, Intensive Education' for postpartum complications different from other treatments?

This treatment is unique because it uses telemedicine (remote healthcare services) to provide enhanced virtual care and intensive education for postpartum complications, allowing for personalized and timely support without the need for in-person visits, which is particularly beneficial during times like the COVID-19 pandemic. ^{1 10 11 12 13}

Research Team

Elaine Duryea, MD

Principal Investigator

UT Southwestern Medical Center

David B Nelson, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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

I am a woman over 18 and can give informed consent.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Enhanced Virtual Care (Behavioural Intervention)
• Intensive Education (Behavioural Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Nakela L. Cook

Patient-Centered Outcomes Research Institute

Chief Executive Officer since 2020

MD, MPH

Harv Feldman

Patient-Centered Outcomes Research Institute

Chief Medical Officer

MD, MSCE

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Utilizing Telehealth in a Multidisciplinary Postpartum Hypertension Clinic. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of an education program on perinatal care practices. [2004]

3. United States 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Postpartum remote home blood pressure monitoring: the new frontier. [2023]

5. England 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. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Improving Postpartum Education About Warning Signs Of Maternal Morbidity and Mortality. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Postpartum Care in the Time of COVID-19: The Use of Telemedicine for Postpartum Care. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Telehealth Strategies for the Delivery of Maternal Health Care : A Rapid Review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

An Initiative to Improve Postpartum Discharge Education. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Communication Between Postdelivery Mothers in the PACU and Newborns in Israel. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Implementing the individualized postpartum care with telemedicine during the COVID-19 pandemic at tertiary hospital in Thailand. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

The impact on postpartum care by telehealth: a retrospective cohort study. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Telemedicine in critical care: problems in design, implementation, and assessment. [2019]