Clinical trial NCT05260242: Delivering Empowering Conversations About Obstetric Regional Anesthesia for Underserved Minorities
Official title: Delivering Empowering Conversations About Obstetric Regional Anesthesia for Underserved Minorities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Recovery
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: DECORUM Questionnaire
timeFrame: postpartum Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Samuel DeMaria Jr., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Allen Ninh, MD
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Daniel Katz, MD
role: STUDY_CHAIR
References: