Clinical trial NCT01994447: The Train Study: Parental Understanding of Informed Consent
Official title: "Traditional Research Nurses Versus an Innovative Undergraduate Research Assistant Program: Parental Understanding of Informed Consent " (the TRAIN Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parental Comprehension of Informed Consent
Keywords: Informed Consent
Instructional Films and Video
Consent Comprehension
Multimedia Consent
Parent
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 12
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Parental understanding of informed consent process using a standardized measurement tool, the Deaconess Informed Consent Comprehension Test (DICCT)
timeFrame: 1 day ED visit
Secondary outcomes:
measure: Duration of consent process
timeFrame: 1 day ED visit
measure: Length of stay of the patient in the department
timeFrame: 1 day ED visit
Other outcomes:
measure: consent rate
timeFrame: 1 day ED visit
Locations:
city: Calgary
country: Canada
facility: University of Calgary, Alberta Children's Hospital Emergency Department
state: Alberta
Study officials:
affiliation: Department of Pediatrics, University of Calgary
name: Antonia S Stang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.