Telehealth and Monitoring for Maternal Morbidity

(MOMs-CC Trial)

Overseen By Patti Ephraim, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Cognitive, psychiatric impairment

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

Compensation: Varies

Number of Visits: 12

674 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test two levels of telehealth support to determine their effectiveness in reducing severe maternal morbidity (serious childbirth-related complications). Participants will receive either a high-touch approach with frequent health monitoring and support or a low-touch approach with less frequent interactions. The MOMs Chat and Care Study seeks Black and Hispanic pregnant individuals who have a history of pre-eclampsia or other risk factors and are less than 17 weeks pregnant. To determine if this trial is suitable, visit the trial's website for more information. As an unphased trial, this study offers a unique opportunity to contribute to important research that could improve maternal health outcomes.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this integrated care model is safe for maternal morbidity?

Research has shown that integrated care models, like the one used in the MOMs Chat and Care Study, are generally safe and well-received. The study includes two methods: MOMs High-Touch (MOMs-HT) and MOMs Low-Touch (MOMs-LT). Both methods involve regular check-ins and support through telehealth, using tools like chatbots and Fitbits.

These methods have been used in other settings without major safety issues. They focus on monitoring and support, rather than medication or medical procedures, making them less likely to cause side effects. Participants receive guidance and support, which helps manage health issues effectively.

In past studies on similar care models, unwanted effects were rare. Most people found the extra monitoring and support helpful. This suggests that the MOMs program is a safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MOMs Chat and Care treatments because they offer a fresh approach to managing maternal morbidity through enhanced telehealth and digital support. Unlike traditional care, which often relies on in-person visits and standard monitoring, MOMs-HT provides intensive support with weekly chatbot check-ins and comprehensive telehealth sessions, along with tools like a blood pressure monitor and Fitbit to track health metrics. MOMs-LT, while less intensive, still offers regular digital communication and activity tracking, ensuring continuous support. This combination of advanced technology and personalized care has the potential to improve outcomes by making health monitoring and support more accessible and responsive to individual needs throughout pregnancy and postpartum.

What evidence suggests that this trial's treatments could be effective for reducing maternal morbidity?

Research has shown that the MOMs High-Touch (MOMs-HT) approach, a treatment arm in this trial, reduces serious health problems in mothers. An early study with 2,500 participants significantly lowered hospital visits for these issues. This approach includes weekly chats and online doctor visits to monitor health and connect patients with necessary services. It also provides tools like home blood pressure monitors and fitness trackers. These steps aim to offer timely care and support for pregnant women at higher risk. ^{1 2 3 4 6}

Who Is on the Research Team?

Stephanie L Fitzpatrick, PhD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for high-risk Black birthing individuals to test care models aimed at reducing severe maternal morbidity (SMM). Participants will be randomly assigned to a 'High-Touch' or 'Low-Touch' group, receiving different levels of care intensity.

Inclusion Criteria

OB-CMI risk score ≥ 3 and/or history of preeclampsia

Self-identify as Black/African American (includes Black + another race; Black Hispanic/Latina, African, and Black Caribbean [West Indian])

Receive care at Northwell Health Physician Partners obstetrics practice site

Exclusion Criteria

Birthing people who are not able to provide informed consent due to cognitive or psychiatric impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Treatment

Participants receive clinical and behavioral health monitoring via chatbot technology and telehealth visits. MOMs-HT includes 12 bi-weekly self-management support telehealth visits during the prenatal period.

Up to 9 months

12 bi-weekly telehealth visits

Postpartum Follow-up

Participants continue to receive bi-weekly telehealth visits with navigation to clinical, behavioral, and social services up to 6 weeks postpartum.

6 weeks

Bi-weekly telehealth visits

Extended Follow-up

Participants are monitored for severe maternal morbidity and other outcomes up to 1 year postpartum.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• MOMs Chat and Care Study

Trial Overview The study compares two approaches: MOMs High-Touch with more frequent support and MOMs Low-Touch with less. It includes chats, telehealth visits, home blood pressure monitoring, and Fitbit use to track health outcomes.

How Is the Trial Designed?

Group I: MOMs High Touch (MOMs-HT) Experimental Treatment 5 Interventions

Participants randomized to the MOMs-HT arm will receive close clinical and behavioral health monitoring via weekly chats (text or email) using chatbot technology and navigation to timely clinical, behavioral health, and/or social care services by the MOMs team throughout the prenatal and postpartum periods; 12 bi-weekly self-management support telehealth visits with a MOMs care management coordinator (CMC) or registered nurse (RN) during the prenatal period; home blood pressure monitor to measure their blood pressure regularly; Fitbit to track physical activity; and 5 bi-weekly telehealth visits with navigation to clinical, behavioral, and social services as needed by the MOMs team up to 6 weeks postpartum.

Group II: MOMs Low Touch (MOMs-LT) Active Control 3 Interventions

Participants randomized to the MOMs-LT arm will receive close clinical and behavioral health monitoring via weekly chats (text or email) using chatbot technology and navigation to timely clinical, behavioral health, and/or social care services by the MOMs team throughout the prenatal and postpartum periods; 5 bi-weekly telehealth visits with navigation to clinical, behavioral, and social services as needed by the MOMs team up to 6 weeks postpartum; and a Fitbit to track physical activity.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

This review analyzed maternal risks associated with pregnancy and childbirth, focusing on both short- and long-term outcomes, using data from large cohort studies involving 54,000 births to create an educational tool for better understanding maternal morbidity and mortality.

Key risk factors for increased maternal morbidity include advanced maternal age (over 45 years), pre-existing health conditions like hypertension or cardiac issues, and complications during pregnancy such as gestational hypertension and postpartum hemorrhage, highlighting the need for personalized pre-conception education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Real Maternal Risks in a Pregnancy: A Structured Review to Enhance Maternal Understanding and Education. Wilson, RD.[2021]

The study assessed the quality of care for women experiencing severe maternal morbidity across 27 hospitals, revealing that 17 provided adequate care while 10 did not, with a nearly twofold increase in maternal mortality in the latter group.

Key factors linked to inadequate care included geographic access issues, delays in medical care quality, lack of blood products, communication difficulties between health services, and overall delays in the care process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying the maternal near miss approach for the evaluation of quality of obstetric care: a worked example from a Multicenter Surveillance Study. Haddad, SM., Cecatti, JG., Souza, JP., et al.[2022]

The implementation of a telehealth and education model between two hospitals in southwestern Colombia led to a significant 29% reduction in perinatal mortality rates after the intervention, indicating improved maternal and perinatal care quality.

Additionally, the intervention resulted in fewer cases of postpartum hemorrhage requiring blood transfusions and a decrease in eclampsia rates, showcasing the effectiveness of telemedicine in enhancing obstetric emergency care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience of a telehealth and education program with maternal and perinatal outcomes in a low-resource region in Colombia. Escobar, MF., Echavarria, MP., Vasquez, H., et al.[2022]

A survey of postpartum women using telehealth for blood pressure monitoring showed that 95% preferred this remote care method, indicating high acceptability and satisfaction with the technology.

The majority of participants found the telehealth system easy to use and integrate into their lives, with minimal privacy concerns, suggesting it is a safe and effective option for managing postpartum hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perceptions, opinions and satisfaction of telehealth with remote blood pressure monitoring postpartum. Thomas, NA., Drewry, A., Racine Passmore, S., et al.[2022]

A study involving 19 pregnant women tested the feasibility of using voice technology to deliver perinatal health information through short podcasts, showing promise for improving maternal and infant health outcomes.

Participants highlighted the importance of customization, privacy, and convenience in voice interactions, suggesting that future interventions should focus on accurate, succinct content and allow for family engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Perinatal Health Information via a Voice Interactive App (SMILE): Mixed Methods Feasibility Study. Militello, L., Sezgin, E., Huang, Y., et al.[2021]

This study aims to assess the feasibility of collecting detailed data on severe maternal morbidity (SMM) from maternity units across Canada, which could help improve maternal health care by identifying specific causes and circumstances leading to SMM.

The research will involve a cross-sectional survey and follow-up interviews with maternity unit leaders to understand their data-sharing capabilities and perceptions of SMM, ultimately aiming to establish a national obstetric survey system for better monitoring and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of establishing a Canadian Obstetric Survey System (CanOSS) for severe maternal morbidity: a study protocol. D'Souza, R., Seymour, RJ., Knight, M., et al.[2022]

Telehealth has emerged as a valuable tool for postpartum care, particularly for managing hypertension, with evidence suggesting it improves compliance and reduces disparities in follow-up care.

Remote blood pressure monitoring is feasible and acceptable for postpartum women, making it a promising strategy for enhancing maternal health outcomes during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing Better Evidence on Remote Monitoring for Postpartum Hypertension: A Silver Lining of the Coronavirus Pandemic. Sawyer, MR., Jaffe, EF., Naqvi, M., et al.[2020]

The Mobile WACh NEO mHealth system, which provides personalized SMS communication between pregnant women and healthcare workers, was used in a study involving 798 women in Kenya to improve maternal and neonatal health outcomes.

The study found that older maternal age was linked to a higher risk of stillbirth, but there were no significant predictors for neonatal death, indicating a need for better understanding of maternal messaging patterns and health concerns to enhance interventions during this critical period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for stillbirth and neonatal mortality among participants in Mobile WACh NEO pilot, a two-way SMS communication program in Kenya. Hedstrom, AB., Choo, EM., Ronen, K., 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]

A systematic review of six studies involving 7,886 participants found that mobile health (mHealth) interventions significantly increased the likelihood of pregnant women in low- and middle-income countries attending antenatal care check-ups, with a relative risk of 1.66.

The study highlights the potential of mHealth technologies to improve maternal and fetal health outcomes, suggesting that policymakers should integrate these interventions into healthcare services to enhance accessibility and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mHealth Interventions for Monitoring Antenatal Care among Pregnant Women in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis. Mishra, M., Parida, D., Murmu, J., et al.[2023]

Despite high spending on maternal healthcare in the US, outcomes have worsened, while many low and middle-income countries (LMIC) have seen improvements, suggesting that the US could learn from their successful strategies.

Innovations such as mobile health (mHealth) technologies, telehealth, and community health worker involvement have been effective in improving maternal care in LMICs and should be evaluated for potential adoption in the US healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming the Maternal Care Crisis: How Can Lessons Learnt in Global Health Informatics Address US Maternal Health Outcomes? Kasthurirathne, SN., Mamlin, BW., Purkayastha, S., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06335381

Study Details | NCT06335381 | MOMs Chat and Care Study The purpose of this study is to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39987957/

MOMs Chat & Care Study: Rationale and design of ... - PubMed A pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model to facilitate timely, appropriate care for high-risk ...

3. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/demonstration-projects/moms/

R01: Maternal OutcoMes Program: Testing Integrated ... The purpose of the MOMs Chat & Care Study is to test the effectiveness of the MOMs approach at 2 levels of intensity designed to facilitate timely, appropriate ...

4. dcricollab.dcri.duke.edu dcricollab.dcri.duke.edu/sites/NIHKR/KR/MOMs%20Chat%20and%20Care%20Study%20Snapshot.pdf

MOMs Chat and Care Study Snapshot. ... In a preliminary analysis of data from 2500 participants, the program significantly reduced the risk of severe maternal morbidity–related hospital admissions at ...

5. trialx.com trialx.com/clinical-trials/listings/292473/moms-chat-and-care-study/

MOMs Chat and Care Study This is a pragmatic, randomized clinical trial designed to compare the effectiveness of an integrated care approach at differing levels of ...

6. momschatandcare.com momschatandcare.com/

Northwell Health MOMs Chat & Care Study | Support During ... The MOMs Chat & Care Study is being conducted to understand the best way to support women during pregnancy and after delivery up to 1-year postpartum.