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NCT Number: NCT05260242

Delivering Empowering Conversations About Obstetric Regional Anesthesia for Underserved Minorities

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Mount Sinai Hospital

New York, 10029, United States

Location status: Recruiting

Location contact

Allen Ninh, MD

CONTACT

[email protected]

Daniel Katz, MD

CONTACT

[email protected]

Samuel DeMaria Jr.

PRINCIPAL_INVESTIGATOR

About this study

Patients admitted to Labor and Delivery Unit at MSH will self-identify race/ethnicity as part of the standard admission process (Documented in EPIC). Patients who elect for epidural placement for labor epidural analgesia will be approached by an Anesthesia Team Member to be enrolled in a minimal risk study. Participants who self-identify as a racial/ethnic underserved group (as defined by the NIH) will be randomized to receive routine care with a disparities discussion or routine care alone (in a Block Randomization format). Self-identified white participants will receive routine care and serve as a secondary comparison group. The disparities discussion will be performed following epidural placement when the patient is comfortable. During the postpartum period at patient follow-up (within 24hrs postpartum), an 18-point questionnaire evaluating outcomes and patient satisfaction will be administered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parturient patients being admitted to the labor and delivery unit at The Mount Sinai Hospital.
  • Patients of age 18 or greater with a singleton fetus of at least 37 weeks of gestation that present in spontaneous labor, for induction of labor, or augmentation of labor.
  • Patients in the first stage of labor and who have consented for placement of a labor epidural.

Exclusion criteria

  • Patients who are in severe labor pain following verbal informed consent prohibiting them from participating in the discussion,
  • Patients who present with a coagulopathy or on anticoagulation medications that exclude them from receiving labor epidural analgesia,
  • Patients who do not consent to labor epidural placement, or if they are on a mid-wife service.
  • Patients that are converted to a cesarean delivery following trial of labor

Treatment and study plan

Disparities Conversation

Other

The study intervention will be a scripted interaction delivered by an anesthesia healthcare provider to an individual patient admitted to the labor/delivery unit for labor epidural placement and obstetric care. The discussion will highlight current data relating to healthcare disparities in obstetric anesthesia care within underserved groups and will explain various aspects of obstetric anesthesia care in a culturally-sensitive manner.

Primary outcomes

  1. DECORUM Questionnaire

    Time frame: postpartum Day 1

    DECORUM Questionnaire is split into 2 subscales, scored separately: The first subscale are built from the Obstetric-Quality of Recovery-10 Questionnaire scored from 0-100, with higher score indicating better health outcomes. The second subscale built from the Maryland Cultural Competency Questionnaire scored from 8 - 80, with higher score indicating better health outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel DeMaria Jr, MD

CONTACT

[email protected]

212-241-7473

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Acronym: DECORUM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2022
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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