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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994447
Recruitment Status : Terminated (Change in study consent process at study site so that study had to be terminated)
First Posted : November 25, 2013
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Antonia Stang, University of Calgary

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 22, 2013)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Train Study: Parental Understanding of Informed Consent
Official Title  ICMJE "Traditional Research Nurses Versus an Innovative Undergraduate Research Assistant Program: Parental Understanding of Informed Consent " (the TRAIN Study)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE Parental Comprehension of Informed Consent
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Other: Student Enrollment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 24, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2013)
110
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994447
Other Study ID Numbers  ICMJE ACHF-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antonia Stang, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonia S Stang, MD Department of Pediatrics, University of Calgary
PRS Account University of Calgary
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP