The Train Study: Parental Understanding of Informed Consent (TRAIN)

University of Calgary

Status: Terminated

Conditions: Parental Comprehension of Informed Consent

Treatments: Other: Student Enrollment

Study type: Interventional

Funder types: Other

Identifiers

NCT01994447

ACHF-001

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: Under 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

12 participants in 2 patient groups

Traditional Nurse Enrollment

No Intervention group

Description:

Research nurses will obtain verbal consent from patient/caregiver.

Student Enrollment

Experimental group

Description:

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

Treatment:

Other: Student Enrollment