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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Calgary
Sponsor:
Information provided by (Responsible Party):
Antonia Stang, University of Calgary
ClinicalTrials.gov Identifier:
NCT01994447
First received: November 19, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Parental Comprehension of Informed Consent
Other: Student Enrollment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: "Traditional Research Nurses Versus an Innovative Undergraduate Research Assistant Program: Parental Understanding of Informed Consent " (the TRAIN Study)

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Parental understanding of informed consent process using a standardized measurement tool, the Deaconess Informed Consent Comprehension Test (DICCT) [ Time Frame: 1 day ED visit ] [ Designated as safety issue: No ]
    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:
  • Duration of consent process [ Time Frame: 1 day ED visit ] [ Designated as safety issue: No ]
    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).

  • Length of stay of the patient in the department [ Time Frame: 1 day ED visit ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • consent rate [ Time Frame: 1 day ED visit ] [ Designated as safety issue: No ]
    Proportion of patients/caregivers who consent in the intervention (student enrollment group) and in the control (traditional nurse enrollment) group reported as a proportion with 95% CI's.


Estimated Enrollment: 110
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Traditional Nurse Enrollment
Research nurses will obtain verbal consent from patient/caregiver.
Experimental: Student Enrollment
Trained research students will use digital video discs (DVD's) of primary investigators explaining study information to obtain informed consent
Other: Student Enrollment
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.

  Eligibility

Ages Eligible for Study:   up to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994447

Contacts
Contact: Darmyn DJ Ritchie, MSc 403-955-7762 darmyn.ritchie@albertahealthservices.ca
Contact: Antonia S Stang, MD 403-955-7493 antonia.stang@albertahealthservices.ca

Locations
Canada, Alberta
University of Calgary, Alberta Children's Hospital Emergency Department Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Darmyn DJ Ritchie, MSc    403-955-7762    darmyn.ritchie@albertahealthservices.ca   
Contact: Antonia S Stang, MD    403-955-7493    antonia.stang@albertahealthservices.ca   
Principal Investigator: Antonia S Stang, MD         
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Antonia S Stang, MD Department of Pediatrics, University of Calgary
  More Information

Publications:
Responsible Party: Antonia Stang, Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01994447     History of Changes
Other Study ID Numbers: ACHF-001
Study First Received: November 19, 2013
Last Updated: November 25, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Informed Consent
Instructional Films and Video
Consent Comprehension
Multimedia Consent
Parent

ClinicalTrials.gov processed this record on September 16, 2014