Interactive Tool for Informed Consent (I-TIC)

Interactive Tool for Informed Consent: A Randomized Controlled Trial

Online trials require informed consent from participants. Massive online trials make face-to-face signed consent unrealistic and existing consent comprehension could be improved to increase participant safety and understanding.

This trial will compare understanding of traditional digital consent with multi-media consent and with consent that is multi-media and interactive and uses a test and train model.

The computer will assign participants to 1 of 3 methods to present online consent to participants

Study Overview

• Status: Withdrawn
• Conditions: Informed Consent
• Intervention / Treatment: Behavioral: Intervention A: Questionnaire accuracy; Behavioral: Intervention B: Questionnaire speed of completion; Behavioral: Intervention C: Questionnaire Completion rate

Detailed Description

Online trials require informed consent from participants. Massive online trials make face-to-face signed consent unrealistic and existing consent comprehension could be improved to increase participant safety.

Without accurate knowledge decision-making is not informed. Informed consent for participation in research is part of this process. In online trials the opportunity for face-to-face signed consent with researchers is not an option.

Consent acts as a safeguard that full disclosure occurred. Adequate documentation is evidence against false reports of coercion.

Informed consent inclusive of signed participant information sheets provide a record between researcher and participant of the roles and agreements they share.

According to existing research, only 6% of consents and participant information sheets are written below an eighth grade level of comprehension; 54% of participants with an 8th grade level education partially understood the consent with figures rising to 72% for participants with greater than 8th grade educations, however no participant fully understood the consent materials. The deficits ranged from misunderstandings about risk, side effects, adverse effects reporting, a participants right to withdraw, confidentiality and even the purpose of the trial.

This trial will compare understanding of traditional digital consent with multi-media consent and with consent that is multi-media and interactive and uses a test and train model.

The computer will assign participants to 1 of 3 methods to present online consent to participants

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• pre-screened as eligible for a ThinkWell PLOT trial
• 18 years of age
• No personal email address

Exclusion Criteria:

• not pre-screened or eligible for an existing ThinkWell PLOT trial
• people without internet access
• People who cannot read
• People without the ability to understand the website and informed consent documents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital informed consent; Traditional digitally signed text based informed consent Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate	Behavioral: Intervention A: Questionnaire accuracy; Participants will be tested by questionnaire to measure how well consent is understood; Behavioral: Intervention B: Questionnaire speed of completion; Time to complete questionnaire from time of presentation; Behavioral: Intervention C: Questionnaire Completion rate; Number of participants who complete the questionnaire
Experimental: Multi-media informed consent; Informed consent with images, text and auditory presentation Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate	Behavioral: Intervention A: Questionnaire accuracy; Participants will be tested by questionnaire to measure how well consent is understood; Behavioral: Intervention B: Questionnaire speed of completion; Time to complete questionnaire from time of presentation; Behavioral: Intervention C: Questionnaire Completion rate; Number of participants who complete the questionnaire
Experimental: Test to train informed consent; Informed consent with images, text, auditory presentation and test to train feature where participants get feedback on comprehension responses throughout the consent and can change them Intervention A: questionnaire accuracy Intervention B: Questionnaire speed of completion Intervention C: Questionnaire completion rate	Behavioral: Intervention A: Questionnaire accuracy; Participants will be tested by questionnaire to measure how well consent is understood; Behavioral: Intervention B: Questionnaire speed of completion; Time to complete questionnaire from time of presentation; Behavioral: Intervention C: Questionnaire Completion rate; Number of participants who complete the questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of consent comprehension	assessed by accuracy on scored questionnaire	immediately following intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete consent	Time between presentation of consent materials and signing of consent	immediately following intervention
Compliance	number of participants who complete consent questionnaire	immediately following intervention

Collaborators and Investigators

• Sponsor: ThinkWell

Publications and helpful links

General Publications

• 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.
• Gillies K, Huang W, Skea Z, Brehaut J, Cotton S. Patient information leaflets (PILs) for UK randomised controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation. Trials. 2014 Feb 18;15:62. doi: 10.1186/1745-6215-15-62.
• Antoniou EE, Draper H, Reed K, Burls A, Southwood TR, Zeegers MP. An empirical study on the preferred size of the participant information sheet in research. J Med Ethics. 2011 Sep;37(9):557-62. doi: 10.1136/jme.2010.041871. Epub 2011 Apr 8.
• Rowbotham MC, Astin J, Greene K, Cummings SR. Interactive informed consent: randomized comparison with paper consents. PLoS One. 2013;8(3):e58603. doi: 10.1371/journal.pone.0058603. Epub 2013 Mar 6.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: January 4, 2015
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: informed consent, public led trials, shared decision making,
• Other Study ID Numbers: ThinkWell PLOT-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No