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

Trial Summary

What is the purpose of this trial?

Racial and ethnic disparities in obstetric anesthesia care remains persistent despite studies documenting its existence and calling for action. The goal of this study is to share disparity data with underserved minority groups being admitted to the labor and delivery unit for obstetric care, to reduce mistrust and misconceptions regarding obstetric anesthesia care, and to bridge the cultural gap between patient beliefs and safe anesthetic care and to empower patients through transparency and provide them with the information necessary to make informed decisions about their care, to improve health literacy, and to ultimately improve patient outcomes and satisfaction.

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 data supports the effectiveness of the treatment Disparities Conversation for postpartum care?

Research suggests that improving communication between healthcare providers and Black patients during the perinatal period can enhance care quality and outcomes. Effective communication, mutual respect, and shared decision-making are key factors that can be addressed through clinician education to improve perinatal care for Black individuals. ^{1 2 3 4 5}

How does the treatment in the 'Empowering Conversations for Postpartum Care' trial differ from other postpartum care treatments?

The 'Empowering Conversations for Postpartum Care' treatment is unique because it focuses on improving communication between healthcare providers and postpartum women, particularly addressing racial disparities and enhancing patient experience. Unlike traditional treatments that may focus solely on medical interventions, this approach emphasizes the importance of effective communication and support to improve health outcomes for postpartum women. ^{1 3 6 7 8}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

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

Bridging the postpartum gap: best practices for training of obstetrical patient navigators. [2023]

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

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

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

Integrative Review of Black Birthing People's Interactions With Clinicians During the Perinatal Period. [2023]

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

Standardized Order Sets Do Not Eliminate Racial or Ethnic Inequities in Postpartum Pain Management. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Evaluating the use of text message communication in a postpartum patient navigation program for publicly insured women. [2020]

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

Communication technologies and maternal interest in health-promotion information about postpartum weight and parenting practices. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Strategies for Recruiting a Diverse Postpartum Survey Sample. [2023]