Her Health Program for Postpartum Care

(Her Health Trial)

Overseen By Renada Deschamp, MPA

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Elizabeth F Sutton, PhD

Disqualifiers: Private insurance, Non-English, Moving, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Her Health Program can improve healthcare for new moms in their first year postpartum. The program features a dedicated healthcare team member who provides regular guidance and support. Researchers seek to understand if this program enhances women's access to healthcare and improves their perceptions of the healthcare system. Women who recently gave birth, are on Medicaid, and live in disadvantaged areas may be suitable candidates for this study. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative healthcare solutions for new mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on healthcare access and support rather than medication changes.

What prior data suggests that the Her Health Program is safe for postpartum care?

Research shows that the Her Health Program lacks specific safety data. However, this program is not a new drug or medical procedure. Instead, it adds a community health navigator to guide and support new mothers during their first year postpartum. This navigator provides information and helps mothers access healthcare.

Since the program emphasizes extra support and education, it is considered safe. The navigator collaborates with the healthcare team and the mother to encourage regular check-ins and offer culturally respectful advice. This approach aims to help mothers feel more confident and informed about their healthcare choices.

Overall, the Her Health Program is designed as a supportive addition to regular postpartum care, with no known risks associated with having assistance in navigating the healthcare system. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Her Health Program because it offers a fresh approach to postpartum care that emphasizes personalized support and education. Unlike standard care, where new mothers typically see doctors at routine intervals, this program involves community health workers who provide ongoing navigation and culturally competent education throughout the first postpartum year. This method aims to boost mothers' confidence and empower them to effectively engage with the healthcare system, potentially improving their overall postpartum experience and outcomes.

What evidence suggests that the Her Health Program is effective for postpartum care?

Research has shown that postpartum care programs, such as the Her Health Program, can enhance new mothers' understanding of their health and improve access to healthcare. In this trial, participants may receive the Her Health Program, which includes community health navigators who offer support and education, boosting mothers' confidence in managing their health. Studies have found that these programs improve mothers' understanding of their health needs, leading to better healthcare experiences and outcomes. Previous studies also indicate that similar programs can increase participation in essential health check-ups and appointments. Overall, these programs aim to simplify and enhance access to necessary care for mothers after childbirth. ^{1 2 6 7 8}

Who Is on the Research Team?

Elizabeth Sutton, PhD

Principal Investigator

Woman's Hospital, Louisiana

Are You a Good Fit for This Trial?

This trial is for women who have recently given birth, to see if the Her Health Program can improve their access to healthcare and knowledge about health during the first year postpartum. The details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Gave birth within 7 days before randomization

Medicaid enrolled

Address of residence within a disadvantaged area (ADI>5)

Exclusion Criteria

Use of private health insurance exclusively

Plans to move out of state during the study time period

Unwilling to provide permission to link study records, medical records, and Medicaid and Vital Records Database records

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Enrollment

Participants are enrolled and assigned to either the Her Health Program group or the Usual Care group

1 visit

1 visit (in-person)

Intervention

Participants in the Her Health Program group receive usual care plus additional support from a community health navigator for a year postpartum

12 months

Weekly and monthly check-ins

Follow-up

Participants are monitored for healthcare access, knowledge, and feelings toward the healthcare system

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Her Health Program

Trial Overview

The study is testing the effectiveness of Woman's Hospital's Her Health Program versus usual care. Participants will be randomly assigned to either receive additional support from a community health navigator along with their standard care, or just continue with standard postpartum care.

How Is the Trial Designed?

Group I: Her Health Program Experimental Treatment 1 Intervention

Her Health is a patient navigation intervention delivered by community health workers across the first postpartum year. Her Health has two interspersed components: Navigation and Education. Her Health Navigation is delivered through weekly and monthly check-ins between participant and navigator. Her Health navigators will deliver historically informed and culturally competent education designed to promote self-efficacy and self-advocacy within the healthcare system.

Group II: Usual Care Active Control 1 Intervention

Subjects will see doctors as normal during first year postpartum with no assistance.

Who Is Running the Clinical Trial?

Elizabeth F Sutton, PhD

Lead Sponsor

Trials

1

Recruited

500+

Donaghue Medical Research Foundation

Collaborator

Trials

24

Recruited

578,000+

Published Research Related to This Trial

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 a postpartum hemorrhage (PPH) safety program at a maternity hospital led to an increased use of effective treatments, such as more frequent administration of prostaglandin F2α and multiple types of uterotonics, indicating a quicker response to PPH cases.

Despite the improved treatment protocols, the overall rates of blood transfusions, hysterectomies, and ICU admissions remained unchanged, suggesting that while the program enhanced immediate care, it did not significantly alter severe outcome rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in care associated with the introduction of a postpartum hemorrhage patient safety program. Lappen, JR., Seidman, D., Burke, C., et al.[2019]

The innovative postpartum care program aims to improve health outcomes for high-risk women by coordinating delivery and payment systems, with a goal to enroll 510 participants.

The program includes a social work component and financial incentives for clinicians, focusing on timely postpartum visits and addressing health disparities among minority women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery and Payment Redesign to Reduce Disparities in High Risk Postpartum Care. Howell, EA., Padrón, NA., Beane, SJ., et al.[2018]

The Healthy & Home postpartum community nursing program effectively supports new mothers and their families through home visits and various resources, helping to bridge the gap between hospital discharge and community care.

This program, which includes services like breastfeeding support and mental health resources, has evolved over 25 years and demonstrates the importance of comprehensive follow-up care to prevent hospital readmissions and promote maternal and infant wellbeing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Going home with baby: innovative and comprehensive support for new mothers. Olson, T., Bowen, A., Smith-Fehr, J., et al.[2023]

Only 58 maternal and perinatal serious adverse events (SAEs) were identified in the Health Quality and Safety Commission (HQSC) reports from 2009 to 2012, and only 50 of these matched the definitions used by the Perinatal and Maternal Mortality Review Committee (PMMRC), indicating a significant underreporting issue.

The PMMRC identified 536 potentially avoidable maternal and perinatal mortalities and morbidities during the same period, suggesting that fewer than 9% of these cases were captured by the HQSC, raising concerns about the reliability of HQSC reports for monitoring and improving maternity care quality in New Zealand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Under-reporting of maternal and perinatal adverse events in New Zealand. Farquhar, C., Armstrong, S., Kim, B., et al.[2022]

The implementation of a postpartum patient navigation program at an urban academic medical center showed high patient needs, particularly in the first three months postpartum, indicating that such programs can effectively address critical gaps in postpartum care.

Despite initial challenges like clinician unfamiliarity and the complexity of the navigation process, the program's adaptability and the navigators' increased self-efficacy over time suggest that patient navigation can enhance care coordination and support for postpartum patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of postpartum navigation for low-income individuals at an urban academic medical center. Green, HM., Carmona-Barrera, V., Diaz, L., et al.[2023]

The Copenhagen Hospital Corporation successfully implemented a reporting system for adverse events, resulting in 6011 reported incidents over three years, indicating a strong safety culture among staff.

The organization conducted 92 root cause analyses during this period, focusing on both optional and mandatory reports, which highlights their commitment to understanding and preventing future adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events management. Methods and results of a development project]. Rabøl, LI., Jensen, EB., Hellebek, AH., et al.[2006]

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Postpartum Visit Attendance in the United States

Most estimates indicate that a substantial proportion of women do not attend at least one postpartum visit, potentially contributing to maternal morbidity.

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ahrq.gov

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Toolkit for Improving Perinatal Safety

The toolkit helps L&D units improve patient safety, team communication, and quality of care for mothers and their newborns.