The Train Study: Parental Understanding of Informed Consent

Study Overview
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Brief Summary
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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.

Official Title
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Traditional Research Nurses Versus an Innovative Undergraduate Research Assistant Program: Parental Understanding of Informed Consent  (the TRAIN Study)

Conditions
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Parental Comprehension of Informed Consent

Intervention / Treatment
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* Other: Student Enrollment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional Nurse Enrollment<br>Research nurses will obtain verbal consent from patient/caregiver. | |
| Experimental: Student Enrollment<br>Trained research students will use digital video discs (DVD's) of primary investigators explaining study information to obtain informed consent | Other: Student Enrollment<br>* The standard informed consent process is for research nurses to provide verbal explanations of studies. In the intervention arm trained research students will use DVD's made by the studies principal investigator to explain study information in the informed consent process.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental understanding of informed consent process using a standardized measurement tool, the Deaconess Informed Consent Comprehension Test (DICCT) | 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). | 1 day ED visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of consent process | Duration of consent process from initial approach to time consent form is obtained or consent refused will be reported for all enrolled patients (median, IQR) as well as for patients in the intervention (student enrollment) and control group (traditional nurse enrollment). | 1 day ED visit | 
| Length of stay of the patient in the department | Length of stay in the ED for all patients enrolled in the study, for patients in the intervention group (student enrollment) and in the control group (traditional nurse enrollment), presented as medians with IQR. | 1 day ED visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Informed Consent, Instructional Films and Video, Consent Comprehension, Multimedia Consent, Parent