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Delivering Empowering Conversations About Obstetric Regional Anesthesia for Underserved Minorities

Delivering Empowering Conversations About Obstetric Regional Anesthesia for Underserved Minorities

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05260242
Acronym
DECORUM
Enrollment
100
Registered
2022-03-02
Start date
2023-05-01
Completion date
2026-05-31
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Recovery

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.

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.

Interventions

OTHERDisparities 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.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
DECORUM Questionnairepostpartum Day 1DECORUM 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.

Countries

United States

Contacts

Primary ContactSamuel DeMaria Jr, MD
Samuel.Demariajr@mountsinai.org212-241-7473

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026