Empowering Conversations for Postpartum Care

(DECORUM Trial)

Overseen By Samuel DeMaria Jr, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Anticoagulants

Disqualifiers: Severe labor pain, Coagulopathy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Labor and delivery period

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve trust and understanding of anesthesia care for pregnant women from underserved minority groups. It shares important information to help them make informed decisions during labor and delivery. The trial includes two groups: one engages in a guided conversation about these disparities (Disparities Conversation), and the other does not. Women who are at least 37 weeks pregnant, in labor at Mount Sinai Hospital, and planning to receive an epidural may be suitable candidates. As an unphased trial, participants contribute to important research that may enhance care for future mothers.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulation medications, you may not be eligible for the labor epidural.

What prior data suggests that this protocol is safe for postpartum care?

Research has shown that discussing differences in healthcare, particularly in maternal care, is important but can be complex. These discussions aim to address the different treatment many minority groups experience during pregnancy and childbirth. No evidence suggests that these conversations are unsafe. Since the goal is to improve understanding and trust, they pose no physical risk.

The study includes a planned conversation designed to share information and empower patients. This approach is safe because it does not involve any medical procedures. It focuses on communication and information sharing, which is generally safe and well-received. While specific data on negative effects from these conversations is lacking, their purpose is to educate and support, not to involve medical procedures or drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Disparities Conversation" approach for postpartum care because it focuses on enhancing communication between healthcare providers and new mothers. Unlike traditional care, which often emphasizes medical and physical health aspects, this method aims to address disparities by engaging in scripted, meaningful conversations. This could help identify and tackle specific social and emotional challenges faced by different groups of new mothers, potentially leading to more personalized and effective postpartum support.

What evidence suggests that this conversation method is effective for improving postpartum care?

Research has shown that social support after childbirth greatly benefits new mothers. Consistent support helps protect against mood and anxiety issues during this time. This trial will compare two approaches: one group will participate in a scripted "Disparities Conversation," while the other group will not. Studies also highlight that focusing on maternity care, especially for Black mothers, leads to better health outcomes. Discussing differences in care empowers patients, enhances understanding, and increases satisfaction. This approach aims to align patient beliefs with safe anesthetic care, ultimately improving overall care quality. ^{6 7 8 9 10}

Who Is on the Research Team?

Samuel DeMaria Jr., MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Allen Ninh, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Daniel Katz, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for pregnant individuals, 18 or older, with a single baby at least 37 weeks along and in the first stage of labor. They must be admitted to The Mount Sinai Hospital's labor unit and agree to an epidural. It excludes those in severe pain, having a cesarean after trying labor, with blood clotting issues or on certain medications.

Inclusion Criteria

Parturient patients being admitted to the labor and delivery unit at The Mount Sinai Hospital

Patients in the first stage of labor and who have consented for placement of a labor epidural

I am 18 or older, pregnant with one baby at least 37 weeks along, and in labor or about to be induced.

Exclusion Criteria

I cannot have an epidural due to a bleeding disorder or because I'm on blood thinners.

Patients who do not consent to labor epidural placement, or if they are on a mid-wife service

Patients who are in severe labor pain following verbal informed consent prohibiting them from participating in the discussion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive routine care with or without a disparities discussion following epidural placement

Labor and delivery period

Follow-up

Participants are monitored for outcomes and patient satisfaction using an 18-point questionnaire

1 day postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Disparities Conversation

Trial Overview The study aims to improve understanding and trust in obstetric anesthesia care among underserved minorities by sharing information about disparities. It seeks to empower these patients through education during their admission for childbirth.

How Is the Trial Designed?

Group I: Conversation Experimental Treatment 1 Intervention

Scripted interaction

Group II: No Conversation Active Control 1 Intervention

Control Group

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

Since the murder of George Floyd and the COVID-19 pandemic, there has been a significant increase in recognition of the importance of effective communication in perinatal care for Black patients, with a notable rise in relevant literature (P=0.012).

The review highlights that addressing the limitations of standardized communication methods (P=0.002) and improving health communication strategies can help reduce racial disparities in maternal and infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

America's Racial Reckoning Within Perinatal Communication: A Rapid Review Using Sociotechnical Systems Theory to Compare Publications Before and After 2020. Henderson, MSG., JaKa, MM., Dinh, JM., et al.[2023]

The postpartum period is crucial for improving maternal health, but many individuals face barriers to effective care, leading to poor health outcomes; patient navigation is a promising intervention to help overcome these obstacles.

A comprehensive training guide for postpartum patient navigators was developed, emphasizing six core elements essential for effective navigation, which can be adapted for various healthcare settings to enhance postpartum care access and quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the postpartum gap: best practices for training of obstetrical patient navigators. Yee, LM., Williams, B., Green, HM., et al.[2023]

A successful recruitment strategy for a postpartum survey included multilingual materials and outreach methods, resulting in a diverse sample of 120 participants, with over 80% identifying as Black or Hispanic and more than 30% having a language preference other than English.

Key strategies for effective recruitment included adjusting approaches based on ongoing assessments, utilizing pediatrics-based outreach, and offering multiple ways for participants to complete the survey, which helped engage individuals who might not attend scheduled postpartum visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for Recruiting a Diverse Postpartum Survey Sample. Murray Horwitz, ME., Saradjha Brédy, G., Schemm, JA., et al.[2023]

In a postpartum patient navigation program, women who engaged in more frequent text message communication with navigators were significantly more likely to complete follow-up care, with an adjusted odds ratio of 2.89 for those exchanging six or more messages.

The study identified that messages focusing on rapport-building and maternal health, as well as the use of emoticons, positively influenced the likelihood of follow-up, highlighting the importance of supportive communication in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the use of text message communication in a postpartum patient navigation program for publicly insured women. Strohbach, A., Hu, F., Martinez, NG., et al.[2020]

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]

Black birthing people experience higher rates of maternal morbidity and mortality, influenced by factors such as healthcare quality, structural racism, and implicit bias in clinician interactions.

Improving perinatal care for Black patients may hinge on enhancing mutual respect, effective communication, and shared decision-making between patients and clinicians, suggesting a need for targeted clinician education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative Review of Black Birthing People's Interactions With Clinicians During the Perinatal Period. Salahshurian, E., Moore, TA.[2023]

The implementation of a standardized pain management order set reduced overall opioid use after cesarean sections but did not eliminate racial and ethnic disparities in pain evaluation and management among patients, particularly affecting non-Hispanic Black patients who reported higher rates of severe pain.

Despite changes in pain management processes, such as fewer assessments and increased use of nonopioid analgesics, inequities in treatment remained largely unchanged, indicating a need for further interventions focused on racial equity in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized Order Sets Do Not Eliminate Racial or Ethnic Inequities in Postpartum Pain Management. Green, CA., Johnson, JD., McKenzie, C., et al.[2023]

A significant majority (84.1%) of postpartum women surveyed had access to the Internet, with notable differences in usage and confidence based on race/ethnicity and income, favoring White/Anglo women and those with higher incomes.

Interest in health information varied by income level, with lower-income women preferring parenting advice by mail, while higher-income women showed a greater interest in receiving weight loss and parenting information online.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication technologies and maternal interest in health-promotion information about postpartum weight and parenting practices. Walker, LO., Im, EO., Vaughan, MW.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3518627/

Social support during the postpartum period: Mothers ... The objective of this study was to explore postpartum women's views and experiences with social support following childbirth.

2. journals.copmadrid.org journals.copmadrid.org/pi/art/pi2025a12

Mom Supporting Mom: Effective Peer Support Intervention ... Our study provides evidence that integrating mental health care with maternity care for postpartum women can be effective, even in a country ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10400812/

Postpartum Depression and Maternal Care: Exploring the ... This review article aims to explore the complex effects of PPD on mothers and infants, focusing on maternal care.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1049386722000056

The Relationship between Social Support and Postnatal ... This study suggests that consistent social support serves as a robust protective factor against postpartum symptoms of PMADs.

5. apa.org apa.org/monitor/2022/10/better-care-black-mothers

Focusing on maternity and postpartum care for Black ... Focusing on maternity and postpartum care for Black mothers leads to better outcomes. Psychologists are working to reduce maternal mortality ...

6. mha.org mha.org/newsroom/addressing-disparities-in-maternal-care-a-conversation-during-black-maternal-health-week/

Addressing Disparities in Maternal Care: A Conversation ... Conversations about disparities in care are difficult and nuanced. ... Data shows that racial disparities in care are systemic, so we must ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8724640/

Improving Postpartum Care: Identifying Opportunities to ... This study describes the postpartum experiences of publicly-insured women of color with the objective of identifying areas for intervention to reduce ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0266613825000853

Exploring the perspectives of healthcare professionals on ... This qualitative study uniquely aims to explore healthcare professionals' perceptions of health disparities affecting pregnant and postpartum women's care, ...

9. aha.org aha.org/bhmb/issue-brief

Better Health for Mothers and Babies Toolkit: Issue Brief DISPARATE TREATMENTS: Data shows that minority populations report disparate or poor treatment during their pregnancy and deliveries: 1 in 3 Black, Hispanic, and ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11138136/

Disparities in Utilization and Delivery Outcomes for Women ... In this paper, we provide an overview of the disparities in utilization and delivery outcomes for individuals with perinatal mood and anxiety disorders in the ...