Parental Comprehension of Informed Consent Clinical Trial
— TRAINOfficial title:
"Traditional Research Nurses Versus an Innovative Undergraduate Research Assistant Program: Parental Understanding of Informed Consent " (the TRAIN Study)
| Verified date | October 2016 |
| Source | University of Calgary |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 12 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A to 14 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Calgary, Alberta Children's Hospital Emergency Department | Calgary | Alberta |
| Lead Sponsor | Collaborator |
|---|---|
| University of Calgary |
Canada,
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. — View 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. Review. — View 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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2014;5:CD003717. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | No |
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |