"Traditional Research Nurses Versus an Innovative Undergraduate Research Assistant Program: Parental Understanding of Informed Consent " (the TRAIN Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Parental understanding of informed consent process using a standardized measurement tool, the Deaconess Informed Consent Comprehension Test (DICCT)
研究概览
简要总结
Project Summary: One of the challenges facing pediatric researchers is the need to balance decreasing funding with the time and human resource costs associated with enrolling children. In order to address this, the Emergency Department (ED) research team developed an innovative model for subject enrollment and consent using highly trained and supervised undergraduate students. From a human resources perspective, utilizing students is more cost effective than the traditional research nurse model. However, a concern with this method is the adequacy of parental understanding of study information for informed consent. The aim of this project is to determine if the use of students is at least as good as the more costly "gold standard" of experienced research nurses. The validation of this innovative student model will enable child health investigators to better meet parent's needs and increase the efficiency of pediatric research.
The primary objective of this study is to measure parental comprehension of informed consent information using an innovative undergraduate research assistant program compared to consent using the traditional research nurse model. We hypothesize that parental comprehension of the informed consent information process when approached by undergraduate students will be comparable (or not worse) than when consent is obtained by a research nurse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent's child must be eligible for an interventional study in the Alberta Children's Hospital Emergency Department
- •Parent or accompanying adult must be the legal guardian
- •One independent trained research student and one research nurse must be available for randomization
- •Parent must be exposed to entire informed consent process
排除标准
- •Previous participant in the TRAIN study
- •Parental language barrier
研究组 & 干预措施
Traditional Nurse Enrollment
Research nurses will obtain verbal consent from patient/caregiver.
Student Enrollment
Trained research students will use digital video discs (DVD's) of primary investigators explaining study information to obtain informed consent
干预措施: Student Enrollment (Other)
结局指标
主要结局
Parental understanding of informed consent process using a standardized measurement tool, the Deaconess Informed Consent Comprehension Test (DICCT)
时间窗: 1 day ED visit
The DICCT is a validated and reliable tool that was developed to assess comprehension of informed consent information among adult study subjects and adapted to measure parental understanding of consent. Parental understanding of the consent process will be measured using a modified Deaconess Informed Consent Comprehension Test (mDICCT), which has previously been used in a pediatric setting. The score on the DICCT will be presented as a mean or median (depending on distribution) with 95% Confidence Intervals (CI's). The appropriate parametric (t-test) or non-parametric test will be used to compare the score on the DICCT between the intervention (student enrollment) and the control group (traditional nurse enrollment).
次要结局
- Length of stay of the patient in the department(1 day ED visit)
- Duration of consent process(1 day ED visit)
研究者
Antonia Stang
Assistant Professor
University of Calgary