Parental Comprehension of Informed ConsentTRAINNCT01994447
The Train Study: Parental Understanding of Informed Consent
A study testing Student Enrollment in people with Parental Comprehension of Informed Consent, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Parental Comprehension of Informed Consent
- What is being tested?
- Student Enrollment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Previous participant in the TRAIN study
- Parental language barrier
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Calgary, Alberta Children's Hospital Emergency Department
Calgary, Alberta, T3B 6A8
About this study
Official title: "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.
- Being tested
- Student Enrollment
- Keywords
- Informed Consent, Instructional Films and Video, Consent Comprehension, Multimedia Consent, Parent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Student EnrollmentOther
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 group | Role | What they receive |
|---|---|---|
| Traditional Nurse Enrollment | No intervention | Research nurses will obtain verbal consent from patient/caregiver. |
| Student Enrollment | Experimental | Trained research students will use digital video discs (DVD's) of primary investigators explaining study information to obtain informed consent Receives: Other: Student Enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day ED visit
Secondary outcomes (2)
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).
Measured: 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.
Measured: 1 day ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Change in study consent process at study site so that study had to be terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Parental Comprehension of Informed ConsentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Stang, University of Calgary
- Investigators
- Antonia S Stang, MD, Principal investigator, Department of Pediatrics, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994447
- Sponsor's protocol ID
- ACHF-001
- Acronym
- TRAIN
- Status last verified
- Oct 2016
- First submitted
- 19 Nov 2013
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.jemermed.2004.07.012.
PubMed 15657015Hollander 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.
PubMed 11825839Miller 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.
PubMed 8888082Tait 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.
PubMed 12606901Segal 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.
PubMed 2383337Ryan 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.
PubMed 18254029Flory 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.
PubMed 15467062
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Traditional Research Nurses Versus an Innovative Undergraduate Research Assistant Program: Parental Understanding of Informed Consent " (the TRAIN Study)
- ClinicalTrials.gov ID
- NCT01994447
- Acronym / sponsor ID
- TRAIN / ACHF-001
- Keywords
- Informed Consent, Instructional Films and Video, Consent Comprehension, Multimedia Consent, Parent
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in study consent process at study site so that study had to be terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Nurse Enrollment | No intervention | –Research nurses will obtain verbal consent from patient/caregiver. |
| Student Enrollment | Experimental | Other: Student EnrollmentTrained research students will use digital video discs (DVD's) of primary investigators explaining study information to obtain informed consent |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Previous participant in the TRAIN study
- Parental language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Student EnrollmentThe 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. | Other | Student Enrollment |
Primary outcome
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).
2 secondary outcomes
Duration of consent process
Time frame: 1 day ED visit
Length of stay of the patient in the department
Time frame: 1 day ED visit
Results and safety
The study was stopped early (reason given: Change in study consent process at study site so that study had to be terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Background: PubMed 15657015Davis 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.
- Background: PubMed 11825839Hollander 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.
- Background: PubMed 8888082Miller 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.
- Background: PubMed 12606901Tait 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.
- Background: PubMed 2383337Segal 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.
- Background: PubMed 18254029Ryan 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.
- Background: PubMed 15467062Flory 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia S Stang, MD principal investigator
Department of Pediatrics, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Student Enrollment in people with Parental Comprehension of Informed Consent, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in study consent process at study site so that study had to be terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental understanding of informed consent process using a standardized measurement tool, the Deaconess Informed Consent Comprehension Test (DICCT) (time frame: 1 day ED visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01994447, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.