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

• ClinicalTrials.gov Identifier: NCT01994447
• Recruitment Status: Terminated
• First Posted: November 25, 2013
• Last Update Posted: October 26, 2016
• Sponsor: University of Calgary
• Information provided by (Responsible Party): Antonia Stang, University of Calgary

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parental Comprehension of Informed Consent	Other: Student Enrollment	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Official Title: "Traditional Research Nurses Versus an Innovative Undergraduate Research Assistant Program: Parental Understanding of Informed Consent " (the TRAIN Study)
• Study Start Date: November 2013
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Parental understanding of informed consent process using a standardized measurement tool, the Deaconess Informed Consent Comprehension Test (DICCT) [ Time Frame: 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 :

1. Duration of consent process [ Time Frame: 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).
2. Length of stay of the patient in the department [ Time Frame: 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.

Other Outcome Measures:

1. consent rate [ Time Frame: 1 day ED visit ]
   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.

Eligibility Criteria

• Ages Eligible for Study: up to 14 Years (Child)
• Sexes Eligible for Study: All
• 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

Locations

Canada, Alberta

University of Calgary, Alberta Children's Hospital Emergency Department

Calgary, Alberta, Canada, T3B 6A8

Sponsors and Collaborators

University of Calgary

Investigators

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

More Information

Publications:

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.

Hollander JE, Singer AJ. An innovative strategy for conducting clinical research: the academic associate program. Acad Emerg Med. 2002 Feb;9(2):134-7.

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.

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.

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. Review. Update in: Cochrane Database Syst Rev. 2014;5:CD003717.

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. Review.

• Responsible Party: Antonia Stang, Assistant Professor, University of Calgary
• ClinicalTrials.gov Identifier: NCT01994447
• Other Study ID Numbers: ACHF-001
• First Posted: November 25, 2013
• Last Update Posted: October 26, 2016
• Last Verified: October 2016

Keywords provided by Antonia Stang, University of Calgary:

Informed Consent; Instructional Films and Video; Consent Comprehension; Multimedia Consent; Parent