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

Trial Summary

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 data supports the effectiveness of the treatment MOMs Chat and Care Study?

Research shows that telehealth strategies, like those used in the MOMs Chat and Care Study, can improve maternal health outcomes by making healthcare more accessible and empowering patients. In low-resource areas, similar telehealth and education programs have successfully reduced barriers to prenatal care, leading to better maternal health. ^{1 2 3 4 5}

Is telehealth and remote monitoring safe for maternal health?

Telehealth and remote monitoring for maternal health, especially for conditions like postpartum hypertension (high blood pressure after childbirth), have been found to be feasible and acceptable among women and healthcare providers, with early studies suggesting improved outcomes and patient satisfaction. ^{1 6 7 8 9}

How does the MOMs Chat and Care Study treatment differ from other treatments for maternal morbidity?

The MOMs Chat and Care Study treatment is unique because it uses telehealth and digital tools to provide maternal care, which can extend the reach of healthcare services to women in their everyday lives, especially in areas with limited access to traditional healthcare facilities. This approach leverages technology to improve maternal health outcomes by offering remote monitoring and communication, which is not typically available in standard maternal care. ^{1 4 5 10 11}

What is the purpose of this trial?

The purpose of this pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care for high-risk Black and Hispanic/Latina birthing people and reduce risk for severe maternal morbidity (SMM). Eligible Black and Hispanic/Latina birthing people (n = 674) will be recruited and randomized to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). The two study arms will be compared on incidence of SMM at labor and delivery (Aim 1), incidence rate of SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and initiation of treatment (Aim 2), change in perceived social support domains (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will also be used to examine facilitators and barriers to implementation (Aim 5). Findings from this study will help to determine how to feasibly implement an effective and sustainable integrated care approach to address SMM disparities.

Research Team

Stephanie L Fitzpatrick, PhD

Principal Investigator

Northwell Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 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; 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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

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

Overcoming the Maternal Care Crisis: How Can Lessons Learnt in Global Health Informatics Address US Maternal Health Outcomes? [2019]

3. United States 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. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Delivering Perinatal Health Information via a Voice Interactive App (SMILE): Mixed Methods Feasibility Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Experience of a telehealth and education program with maternal and perinatal outcomes in a low-resource region in Colombia. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Patient perceptions, opinions and satisfaction of telehealth with remote blood pressure monitoring postpartum. [2022]

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

Establishing Better Evidence on Remote Monitoring for Postpartum Hypertension: A Silver Lining of the Coronavirus Pandemic. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Feasibility of establishing a Canadian Obstetric Survey System (CanOSS) for severe maternal morbidity: a study protocol. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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

10. Switzerland 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. [2023]

11. United States 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. [2023]