The Effect of a Culturally Sensitive Educational Intervention on Acceptance of Neuraxial Anesthesia in Hispanic and Caucasian Parturients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Epidural usage rate
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Epidural usage rate
时间窗: 1 year
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.
次要结局
- Pre and post intervention Beliefs about Epidurals Questionnaire(1 year)
研究者
Brandon Togioka
Assistant Professor
Oregon Health and Science University