The Train Study: Parental Understanding of Informed Consent

Not Applicable

Terminated

• Conditions: Parental Comprehension of Informed Consent
• Interventions: Other: Student Enrollment

• Registration Number: NCT01994447
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-25
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Student Enrollment	Student Enrollment	Trained research students will use digital video discs (DVD's) of primary investigators explaining study information to obtain informed consent

Primary Outcome Measures

Name	Time	Method
Parental understanding of informed consent process using a standardized measurement tool, the Deaconess Informed Consent Comprehension Test (DICCT)	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 Outcome Measures

Name	Time	Method
Length of stay of the patient in the department	1 day ED visit	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.
Duration of consent process	1 day ED visit	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).

Trial Locations

Locations (1)

University of Calgary, Alberta Children's Hospital Emergency Department; 🇨🇦 Calgary, Alberta, Canada