Interactive Tool for Informed Consent

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Interactive Tool for Informed Consent: A Randomized Controlled Trial

Conditions
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Informed Consent

Intervention / Treatment
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* Behavioral: Intervention A: Questionnaire accuracy
* Behavioral: Intervention B: Questionnaire speed of completion
* Behavioral: Intervention C: Questionnaire Completion rate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital informed consent<br>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<br>* Participants will be tested by questionnaire to measure how well consent is understood<br>Behavioral: Intervention B: Questionnaire speed of completion<br>* Time to complete questionnaire from time of presentation<br>Behavioral: Intervention C: Questionnaire Completion rate<br>* Number of participants who complete the questionnaire<br>|
| Experimental: Multi-media informed consent<br>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<br>* Participants will be tested by questionnaire to measure how well consent is understood<br>Behavioral: Intervention B: Questionnaire speed of completion<br>* Time to complete questionnaire from time of presentation<br>Behavioral: Intervention C: Questionnaire Completion rate<br>* Number of participants who complete the questionnaire<br>|
| Experimental: Test to train informed consent<br>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<br>* Participants will be tested by questionnaire to measure how well consent is understood<br>Behavioral: Intervention B: Questionnaire speed of completion<br>* Time to complete questionnaire from time of presentation<br>Behavioral: Intervention C: Questionnaire Completion rate<br>* Number of participants who complete the questionnaire<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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informed consent, public led trials, shared decision making,