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

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

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 Overview

• Status: Terminated
• Conditions: Parental Comprehension of Informed Consent
• Intervention / Treatment: Other: Student Enrollment

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • University of Calgary, Alberta Children's Hospital Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
consent rate	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.	1 day ED visit

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Antonia S Stang, MD, Department of Pediatrics, University of Calgary

Publications and helpful links

General Publications

• Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004 Oct 6;292(13):1593-601. doi: 10.1001/jama.292.13.1593.
• Davis DP, Poste JC, Kelly D. The UCSD Research Associate Program: a recipe for successfully integrating undergraduates with emergency medicine research. J Emerg Med. 2005 Jan;28(1):89-93. doi: 10.1016/j.jemermed.2004.07.012.
• Hollander JE, Singer AJ. An innovative strategy for conducting clinical research: the academic associate program. Acad Emerg Med. 2002 Feb;9(2):134-7. doi: 10.1111/j.1553-2712.2002.tb00230.x.
• Miller CK, O'Donnell DC, Searight HR, Barbarash RA. The Deaconess Informed Consent Comprehension Test: an assessment tool for clinical research subjects. Pharmacotherapy. 1996 Sep-Oct;16(5):872-8.
• Tait AR, Voepel-Lewis T, Malviya S. Do they understand? (part I): parental consent for children participating in clinical anesthesia and surgery research. Anesthesiology. 2003 Mar;98(3):603-8. doi: 10.1097/00000542-200303000-00005.
• Segal S, Lloyd T, Houts PS, Stillman PL, Jungas RL, Greer RB 3rd. The association between students' research involvement in medical school and their postgraduate medical activities. Acad Med. 1990 Aug;65(8):530-3. doi: 10.1097/00001888-199008000-00010.
• Ryan RE, Prictor MJ, McLaughlin KJ, Hill SJ. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD003717. doi: 10.1002/14651858.CD003717.pub2.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (ESTIMATE): November 25, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Parent; Informed Consent; Instructional Films and Video; Consent Comprehension; Multimedia Consent
• Other Study ID Numbers: ACHF-001