Use of a Multimedia Presentation to Enhance the Informed Consent for Ketamine Sedation in a Pediatric Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Parents' satisfaction with the informed consent process
研究概览
简要总结
This is a prospective cohort study in which the standard verbal informed consent process for ketamine sedation is compared to a multimedia informed consent process. The goals include determining if parents prefer a multimedia consent process and evaluating the effectiveness of multimedia consent process.
详细描述
BACKGROUND: Informed consent (IC) is an ethical process for ensuring patient autonomy. Multimedia presentations (MMP) often aid the IC process for research studies. Thus, it follows that MMP would improve IC in clinical settings.
OBJECTIVE
To determine if MMP for the IC process for ketamine sedation improves parental satisfaction and comprehension as compared to standard practice.
DESIGN/METHODS: This two phase study compared two methods of IC for ketamine sedation of pediatric patients. Phase one was a randomized, prospective study that compared the standard verbal consent to a MMP. Phase two implemented the MMP into daily work flow. Parents completed a survey evaluating their satisfaction of the IC process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the IC process and knowledge of ketamine sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving ketamine sedation for fracture reduction
- •Less than 18 years of age
- •English as primary language
排除标准
- •patients who received medications in addition to ketamine for sedation
- •Families where English was not the primary language
结局指标
主要结局
Parents' satisfaction with the informed consent process
时间窗: Within 1 hour of consent
Parents are given a survey with a 5-point Likert scale to evaluated their satisfaction with the informed consent process
The parent's knowledge of ketamine sedation.
时间窗: Within one hour of consent
The parents are give a multiple choice quiz on the information present on ketamine sedation
次要结局
- Satisfaction within each domain(Within one hour of consent)
- Comparison of satisfaction and knowledge with demographics(Within one hour of consent)
- Provider Satisfaction(Time 0 and 6 months later)
研究者
Sandra Spencer
Assistant Professor of Clinical Pediatrics
Nationwide Children's Hospital