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

500 Participants Needed

Trial Summary

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 data supports the effectiveness of the Her Health Program treatment for postpartum care?

The Her Health Program treatment is supported by data showing that similar programs, like the one in New York City, improved timely postpartum visits for high-risk mothers, increasing the visit rate from 56% to 67%. This suggests that coordinated care and payment redesign can enhance postpartum care access and outcomes. ^{1 2 3 4 5}

Is the Her Health Program for Postpartum Care safe for humans?

The available research does not provide specific safety data for the Her Health Program for Postpartum Care, but it focuses on improving postpartum care and reducing health disparities, which suggests a focus on patient safety and well-being. ^{4 6 7 8 9}

How is the Her Health Program treatment different from other postpartum care treatments?

The Her Health Program is unique because it offers a comprehensive, multidisciplinary approach to postpartum care, addressing both physical and mental health needs through community support, home visits, and specialized clinics, unlike traditional care models that often lack continuity and comprehensive support. ^{10 11 12 13 14}

What is the purpose of this trial?

The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby. The main question\[s\] the study aims to answer are: * Can the Her Health program increase access to healthcare in the first year postpartum? * Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system? Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum. Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby.

Research Team

Elizabeth Sutton, PhD

Principal Investigator

Woman's Hospital, Louisiana

Eligibility Criteria

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

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

I am 16 years old or older.

Gave birth within 7 days before randomization

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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 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]

References

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

Elevating mothers' voices: recommendations for improved patient-centered postpartum. [2019]

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

Implementation of postpartum navigation for low-income individuals at an urban academic medical center. [2023]

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

A competency based approach to comprehensive pregnancy care. [2019]

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

Delivery and Payment Redesign to Reduce Disparities in High Risk Postpartum Care. [2018]

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

Timely Postpartum Visits for Low-Income Women: A Health System and Medicaid Payer Partnership. [2020]

6. Denmark pubmed.ncbi.nlm.nih.gov

[Adverse events management. Methods and results of a development project]. [2006]

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

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

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

Under-reporting of maternal and perinatal adverse events in New Zealand. [2022]

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

Changes in care associated with the introduction of a postpartum hemorrhage patient safety program. [2019]

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

The Broken Thread of Health Promotion and Disease Prevention for Women During the Postpartum Period. [2020]

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

Postpartum Care Utilization Among Women with Medicaid-Funded Live Births in Oregon. [2022]

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

Redesigning Care for the Management of Postpartum Hypertension: How Can Ob-Gyns and Primary Care Physicians Partner in Caring for Patients after a Hypertensive Pregnancy? [2023]

13. England pubmed.ncbi.nlm.nih.gov

Going home with baby: innovative and comprehensive support for new mothers. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Women's Postpartum Sexual Health Program: A Collaborative and Integrated Approach to Restoring Sexual Health in the Postpartum Period. [2022]