The Effect of a Culturally Sensitive Educational Intervention on Acceptance of Neuraxial Anesthesia

NCT02672397 | Completed

• 1 other identifier: IRB00010975
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if an educational intervention provided to pregnant women in early labor has an effect on their decision to use epidural anesthesia for relief of labor pain. The study will also investigate differences between Hispanic and non-Hispanic white women in their attitudes and beliefs regarding epidurals in labor. Previous studies have shown that Hispanic women receive epidural anesthesia in labor much less frequently than their non-Hispanic white counterparts. The investigators hypothesize that the rate of epidural use will be higher in subjects who receive the educational intervention than in those who do not. Women who have been admitted to the OHSU labor and delivery unit will be screened for study eligibility. In order to minimize the influence of socioeconomic factors, only women receiving Medicaid will be enrolled. Other inclusion criteria include age of at least 18 years, having a fetus of at least 24 weeks gestational age, and being categorized as American Society of Anesthesiologist category 1 to 3. Exclusion criteria include any condition that either excludes or mandates neuraxial anesthesia. Midwife patients are also excluded from this study. Those who meet study criteria will be approached by a member of the study team and informed consent will be obtained. Subjects will be randomly assigned to receive an educational intervention about epidurals or no educational intervention. Hispanic and non-Hispanic subjects will be randomized separately, yielding four study groups (Hispanic - intervention; Hispanic - control; non-Hispanic - intervention, non-Hispanic - control). The investigators expect to enroll approximately 176 women, 44 in each group. All subjects will complete a survey in early labor and again 1 to 2 days postpartum that asks about common beliefs and misconceptions regarding epidurals. Subjects in the intervention group will receive an educational pamphlet and watch a video in their native language (spanish or english) about epidurals, and have an opportunity to ask questions. Study staff will collect limited information about the subject's labor and delivery from the electronic medical record.

Conditions

Labor Pain

Keywords

Epidural; Ethnicity; Education; Labor; obstetrical analgesia

Outcome Measures

Primary Outcomes (1)

• Epidural usage rate

  The primary aim of this study is to determine if women that receive focused education on epidural labor pain management in the form of a pamphlet and video are more likely to decide to use an epidural. The investigators will also compare the effect of the intervention on hispanic women to the effect of the intervention on non-hispanic women.

  1 year

Secondary Outcomes (1)

• Pre and post intervention Beliefs about Epidurals Questionnaire

  1 year

Study Arms (4)

Hispanic Intervention

EXPERIMENTAL

Hispanic subjects that receive additional epidural education \[44 patients\]

Behavioral: Additional Epidural Education

Hispanic Control

NO INTERVENTION

Hispanic subjects that receive standard of care \[44 patients\]

Non-Hispanic Intervention

EXPERIMENTAL

Non-Hispanic subjects that receive additional epidural education \[44 patients\]

Behavioral: Additional Epidural Education

Non-Hispanic Control

NO INTERVENTION

Non-Hispanic subjects that receive standard of care \[44 patients\].

Interventions

Additional Epidural Education BEHAVIORAL

All women allocated to receive additional epidural educational will be given a language appropriate pamphlet and video on neuraxial anesthesia. The video and pamphlet will be in the subject's primary language. After the subject watches the educational video they will be given an opportunity to go through the pamphlet with the research assistant and ask any questions they may have. For Spanish-speaking subjects this will occur through a telephone interpreter. The obstetric anesthesia providers and obstetricians caring for the subject will be absent for the educational video and post-video conversation.

Hispanic Intervention; Non-Hispanic Intervention

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Pregnant with a fetus \> 24 weeks gestation
• Medicaid insurance
• ASA class 1 to 3
• Arriving at OHSU in spontaneous labor, requiring induction, or receiving augmentation of labor

You may not qualify if:

• Patients having scheduled cesarean sections
• Patients with conditions that are contraindications for epidural labor analgesia
• Patients in whom epidural analgesia is mandated by the medical team
• Patients delivering with a midwife

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

OHSU Labor and Delivery; Oregon Health and Science University Hospital

Portland, Oregon, 97239, United States

Location

Related Publications (3)

• Rust G, Nembhard WN, Nichols M, Omole F, Minor P, Barosso G, Mayberry R. Racial and ethnic disparities in the provision of epidural analgesia to Georgia Medicaid beneficiaries during labor and delivery. Am J Obstet Gynecol. 2004 Aug;191(2):456-62. doi: 10.1016/j.ajog.2004.03.005.

  PMID: 15343221 BACKGROUND

• Glance LG, Wissler R, Glantz C, Osler TM, Mukamel DB, Dick AW. Racial differences in the use of epidural analgesia for labor. Anesthesiology. 2007 Jan;106(1):19-25; discussion 6-8. doi: 10.1097/00000542-200701000-00008.

  PMID: 17197841 BACKGROUND

• Toledo P, Sun J, Grobman WA, Wong CA, Feinglass J, Hasnain-Wynia R. Racial and ethnic disparities in neuraxial labor analgesia. Anesth Analg. 2012 Jan;114(1):172-8. doi: 10.1213/ANE.0b013e318239dc7c. Epub 2011 Nov 10.

  PMID: 22075013 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brandon M Togioka, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2016
• First Posted: February 3, 2016
• Study Start: February 10, 2015
• Primary Completion: February 25, 2017
• Study Completion: December 31, 2017
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)