App-based Consent for Pediatric Clinical Research

Study Overview
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Brief Summary
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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; this will be measured by questionnaires assessing the family's comprehension and preference.

Detailed Description
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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.

Official Title
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App-based Consent for Participation in Pediatric Clinical Research: a Feasibility Study

Conditions
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Consent

Intervention / Treatment
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* Device: Consent App
* Other: Traditional paper-based consent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between the ages of 2 to 5 years who need an IV insertion in the medical imaging department. Exclusion Criteria: Children who are nonverbal; Children with existing vascular access Families who choose not to have topical anesthetic placed on their child's hands Children receiving anxiolytic premedication Children planned to undergo mask induction of anesthesia before IV placement.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open Label Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App-based consent<br>Prototype consent app based on REDCap eConsent module | Device: Consent App<br>* Family will receive their study information and consent form in an app on a tablet<br>|
| Active Comparator: Traditional paper-based consent<br>Traditional paper-based consent | Other: Traditional paper-based consent<br>* Patient/family will receive their study information and consent on a traditional paper form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of app-based consent versus paper-based consent | To determine better or similar comprehension of study requirements, risks and benefits, as measured by a comprehension questionnaire, and better or similar family preference for this mode of consenting. Scored using a 5-item custom multiple-choice test, with higher scores being better. | Immediately after consent is given for the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trust in the research consent process when using app-based consent versus paper-based consent | To determine whether app-based consent increases trust in the research consent process using a single Likert scale question (range 1-5, higher is better) | Immediately after consent is given for the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Clinical research, App