Delivering Empowering Conversations About Obstetric Regional Anesthesia for Underserved Minorities

NCT05260242 | Recruiting

• 1 other identifier: STUDY-21-00270
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Recovery

Outcome Measures

Primary Outcomes (1)

• DECORUM Questionnaire

  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.

  postpartum Day 1

Study Arms (2)

Conversation

EXPERIMENTAL

Scripted interaction

Other: Disparities Conversation

No Conversation

NO INTERVENTION

Control Group

Interventions

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.

Conversation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

The Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Study Officials

• Samuel DeMaria Jr., MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Allen Ninh, MD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

• Daniel Katz, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

Central Study Contacts

Samuel DeMaria Jr, MD

CONTACT

212-241-7473; Samuel.Demariajr@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anesthesiology Perioperative and Pain Medicine

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 2, 2022
• Study Start: May 1, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)