Purpose and justification:
Wider access to digital technologies, familiarity with apps, and the Coronavirus disease
2019 (COVID-19) pandemic increased the demand for virtual care, prompting the need for
electronic documentation of consent for research as families no longer attend in-person
clinics. The investigators previously developed an app to consent patients for donating
research study data in addition to traditional paper-based consent. This study aims to
understand how well app-based consent performs compared to paper-based consent when
recruiting families for a clinical research project.
The investigators aim to demonstrate that app-based consent is as effective as
traditional methods measured by questionnaires assessing the family's comprehension and
preference. If successful, this study will provide evidence for using app-based consent
to enable future researchers to use similar approaches or help us further improve our
app. Supporting a diverse array of consenting methods that are equivalent in promoting
comprehension and participant preferences can improve research recruitment rates and
increase research participant satisfaction.
Hypotheses: App-augmented consent is not inferior to traditional paper-based consent in
ensuring comprehension.
Research Design:
This project will be integrated into an anesthesia study (evaluating bubble blowing as a
method of distraction during IV insertions in young children, known as the BubblesRCT) by
adding app-based consent and its evaluation into the regular consent flow so that
families experience either app-based or traditional paper-based consent. The questions
used are drawn from an established consent comprehension questionnaire and were modified
to suit the requirements of our anesthesia study. Participants will also be asked a
series of questions to measure characteristics like participant trust and the ease of the
consenting process.
This consent modality trial will have a separate allocation schedule. Any family, who may
participate in BubblesRCT, and who can be approached for consent will be allocated either
to this trial's intervention (Consent modality app) or control (Consent modality paper),
whereby the allocation will be switched after four participants; this is for operational
feasibility purposes as randomization before approaching the parent would delay
recruitment. As blinding is impossible, there will be no attempt to conceal consent
modality allocation from the clinical or study teams.
Data collection:
The research assistant (RA) will thoroughly explain the BubblesRCT study, answer any
preliminary questions, and leave the family with either a detailed paper consent
form to review (Consent modality control group) or an iPad containing the consent
app for review (Consent modality intervention group).
The family will get 15 minutes to review the consent information privately.
After the family have read the paper or the app-based consent form, an RA will
answer any questions about the study that the family might have and invite them to
consent to the BubblesRCT study. The parents will provide consent to the study
either on paper or within the app (using the REDCap Electronic Informed Consent
[eConsent] framework).
All participants who have been approached, whether the family agree to participate
in the Bubbles RCT or not, will be asked to complete a comprehension questionnaire
with multiple-choice questions based on a modified form of the Deaconess Informed
Consent Comprehension Test (DICCT) and with a selected a set of comprehension
questions with known correct answer(s) that can be used to determine accuracy.
Statistical Analysis:
The block-randomized controlled trial for non-inferiority of consent modality will
tabulate results and use Wilcoxon rank sum tests for the composite comprehension
correctness score. Groups will also be compared element-wise for the Likert scales using
Wilcoxon rank sum tests; results may also be interpreted qualitatively.