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

Study Design

This study is designed to be a prospective, single-blinded, randomized controlled trial at
Oregon Health and Science University (OHSU) in Portland, Oregon. The investigators will
enroll Hispanic and non-Hispanic parturients in equal numbers on the labor and delivery floor
to receive both an educational pamphlet and video in their primary language or no educational
intervention. All parturients will receive standard of practice consent for general/regional
anesthesia by an anesthesiology resident or attending.

Study Population

A total of 176 participants will be enrolled in the study. Within the 176 participants there
will be four groups of patients: (1) Hispanic subjects that receive additional epidural
education [44 patients], (2) Hispanic subjects that receive standard of care [44 patients],
(3) non-Hispanic subjects that receive additional epidural education [44 patients], and (4)
non-Hispanic subjects that receive standard of care [44 patients].

Over the past year 421 Hispanic and 215 non-Hispanic patients with Medicaid insurance
delivered at OHSU. The rate-limiting step in the study will be enrolling enough non-Hispanic
subjects on Medicaid and so study timeline calculations are based upon expected enrollment of
those subjects. Assuming 15% of patients approached decline study participation and the
research team misses another 35% of patients the investigators believe they can enroll the
necessary 88 subjects in 300 days or approximately 10 months (during which time 177
non-Hispanic Medicaid deliveries would occur).

Patients appropriate for inclusion in the study will be identified at OHSU after they have
been admitted to the labor and delivery unit. A cursory review of the labor and delivery unit
census on EPIC will be used to identify qualifying patients (ASA I-III category patients of
18 years of age on Medicaid with that are either in labor or committed to labor via
induction). All patients who pass this initial screen with have a more thorough review of
their record with particular attention paid to ethnicity and medical conditions that would
affect the decision to offer neuraxial analgesia.

Setting

Informed consent, Initial Encounter survey, and Epidural Pre-Test Questionnaire will be
administered in the OHSU Labor and Delivery Unit. The Epidural Post-Test Questionnaire will
be administered in the patient's recovery room 1-2 days after giving birth.

Recruitment Methods

Patients that appear to meet inclusion criteria will be identified at OHSU after they have
been admitted to the labor and delivery unit. A cursory review of EPIC on the work computers
of the researchers or labor and delivery unit computers will be used to identify patients
that warrant a deeper chart review (ASA I-III category patients of at least 18 years on
Medicaid that are either in labor or committed to labor via induction). All patients that
pass this initial screen will have a more thorough review of their medical record with
particular attention paid to ethnicity, whether they are an MD or midwife patient, and
medical conditions that may affect the decision to offer neuraxial anesthesia. All patients
that pass this EPIC screen will be approached by the research team and allowed to participate
in the study. There will be no fliers, advertisements, videos, or webpages set up to recruit
patients. There will be no monetary awards or free services offered to study participants.

Consent Process

A member of the research team will perform subject recruitment and obtain written informed
consent in the OHSU Labor and Delivery Unit in order to minimize the possibility of coercion.

Patients will be provided the Consent and Authorization form in their preferred language
(English or Spanish) and will have an opportunity to ask questions of the research team
member after the study protocol is explained. An interpreter/translator will be available via
telephone for Spanish speaking women during this time.

Procedures

Subject allocation will occur in the labor room after informed consent has occurred.
Allocation will occur when the research assistant opens one of a series of sequentially
numbered opaque envelopes containing group assignment (by a computer generated random number
sequence [Excel, Redmond WA]. A researcher not involved in either subject enrollment or
subject assignment will generate the random number sequence. The anesthesia and obstetric
team caring for the subject will remain blinded on whether the subject received additional
educational materials; however, due to the type of study it is impossible to blind the
subject. Subjects will be allocated to either an epidural-focused educational intervention or
no intervention by ethnicity stratified block randomization.

Subjects that agree to participate in the study will have demographic data collected from
EPIC (age, race, gravida, parity, gestational age, BMI, birth history) and will be given a
subject questionnaire in their primary language that will ask about potential confounders
that may affect epidural usage (highest education achieved, length of time the subject's
family has lived in the U.S., past personal and family experience with epidurals, needle
phobia, etc.). At the conclusion of the study some additional information will be taken from
EPIC (length of labor, type of delivery, APGAR scores, and whether an epidural was used for
labor analgesia).

All subjects enrolled in the study will be given a survey in their primary language seeking
to identify potential barriers to neuraxial anesthesia utilization. Included in this survey
will be a yes/no checklist for the subject to complete that includes some previously
published reasons that patients commonly give for not wanting neuraxial anesthesia. This
survey will be given again in the postpartum period to all women enrolled in the study. The
postpartum survey will serve as a post-test to evaluate the effectiveness of the educational
intervention in those women that received additional education materials. The post-test will
also be given to women in the control group to determine if the process of delivering a baby
either with or without an epidural affects subject views on neuraxial anesthesia. The
completion of the posttest will mark the end of each parturient's time of participation in
the study.

All women allocated to receive additional educational materials 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.

Women who elect to receive neuraxial anesthesia will be administered the procedure by an
anesthesiology resident with supervision by an attending anesthesiologist. A lumbar epidural
catheter will be placed and after initial bolus (spinal or epidural) all subjects will be
started on a patient-controlled epidural analgesia (PCEA) protocol with a solution of 0.055%
bupivacaine with 1 mcg/mL sufentanil. The initial PCEA settings for all subjects will be the
following: maintenance infusion rate of 10 ml/hr, bolus of 5 ml, lockout of 15 minutes, with
a maximum of 4 boluses an hour. The maintenance infusion rate, bolus volume, and lockout
interval will be allowed to be adjusted as deemed necessary by the obstetric anesthesiology
team. Subjects with pain refractory to the initial PCEA settings will be allowed to get
additional epidural boluses of medication by the anesthesiology resident or attending. The
PCEA will be continued until delivery or slightly thereafter depending upon subject need. The
PCEA will be allowed to be turned off or down to help with stage two pushing or to avoid
maternal hypotension. Other more rare complications involving neuraxial anesthesia will be
dealt with according to standard of care practice.

Data Analysis

Sample size calculations are based upon the abstract presented at the Society for
Maternal-Fetal Medicine. In that study, only 40% of women assigned to additional prenatal
epidural education classes attended the prescribed intervention. With 40% attendance the
authors of the study found a 14% difference in epidural utilization rates. Subjects in this
study will be randomized on labor and delivery after hospital admission. The investigators
estimate that 90% of women will get the assigned educational intervention. Assuming epidural
education has the same effect in this study as that seen in the abstract by Kanter et al. the
investigators expect to see a 31% increase in epidural utilization. Based upon data at OHSU
from June 2013 to May 2014 the current epidural rate at OHSU for Hispanics is 45.3% and the
current epidural rate for non-Hispanics is 55.8%. Assuming a 31% difference in epidural usage
in the Hispanic population after implementation of the study protocol, with an alpha of 0.05
and a power of 80%, 44 subjects would need to be randomized to each of four groups.

The investigators will compare the intervention to control group within both the Hispanic and
non-Hispanic populations on the primary outcome of neuraxial anesthesia utilization using the
chi-squared statistic. Pre and post delivery scores from the Neuraxial Anesthesia Survey will
be compared using the Wilcoxon signed-rank test. Subject characteristics between study arms
will be compared to one another with the chi-squared statistic or Fisher's Exact Test for
categorical outcomes and the student t test, or a non-parametric equivalent, for continuous
variables. A p < 0.05 will be required to reject the null hypothesis that no difference
between epidural utilization rates exists between those that received the educational
intervention and those that did not.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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