"Traditional Research Nurses Versus an Innovative Undergraduate Research Assistant Program: Parental Understanding of Informed Consent " (the TRAIN Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Calgary
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Parental understanding of informed consent process using a standardized measurement tool, the Deaconess Informed Consent Comprehension Test (DICCT)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Previous participant in the TRAIN study
- •Parental language barrier
Arms & Interventions
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
Intervention: Student Enrollment (Other)
Outcomes
Primary Outcomes
Parental understanding of informed consent process using a standardized measurement tool, the Deaconess Informed Consent Comprehension Test (DICCT)
Time Frame: 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).
Secondary Outcomes
- Length of stay of the patient in the department(1 day ED visit)
- Duration of consent process(1 day ED visit)
Investigators
Antonia Stang
Assistant Professor
University of Calgary