DECORUM: Delivering Empowering Conversations About Obstetric Regional Anesthesia for Underserved Minorities

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Recruiting
CT.gov ID
NCT05260242
Collaborator
(none)
500
1
2
15.1
33.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Disparities Conversation
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Delivering Empowering Conversations About Obstetric Regional Anesthesia for Underserved Minorities
Actual Study Start Date :
Mar 28, 2022
Anticipated Primary Completion Date :
Feb 14, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Conversation

Scripted interaction

Other: Disparities Conversation
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.

No Intervention: No Conversation

Control Group

Outcome Measures

Primary Outcome Measures

  1. DECORUM Questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Mount Sinai Hospital New York New York United States 10029

Sponsors and Collaborators

  • Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Samuel DeMaria Jr., MD, Icahn School of Medicine at Mount Sinai
  • Study Director: Allen Ninh, MD, Icahn School of Medicine at Mount Sinai
  • Study Chair: Daniel Katz, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samuel Demaria Jr, Professor, Anesthesiology Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT05260242
Other Study ID Numbers:
  • STUDY-21-00270
First Posted:
Mar 2, 2022
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Apr 4, 2022