Informed Consent Formats by Information Preference and Priority

Study Overview
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Brief Summary
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This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials. The study will be primarily run through an online survey.

Detailed Description
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The goal of this study is to investigate whether the same information can be communicated in different formats of an informed consent document in ways that improve participant understanding and confidence. Participants will review one of several different versions of the same informed consent document, and will be asked to complete a survey after reading the documents. The survey will ask participants their willingness to enroll in the clinical trial discussed in the document and their confidence in their decision. The survey will also test participants recollection of information from the informed consent document. Researchers will look at this data to see if there are ways to improve knowledge about the clinical trial and confidence in decisions without necessarily changing enrollment preferences.

Official Title
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Informed Consent Formats by Information Preference and Priority

Conditions
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Consent Forms, Asthma

Intervention / Treatment
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* Behavioral: Original consent form
* Behavioral: Shortened consent form
* Behavioral: Reordered, shortened consent form
* Behavioral: Shortened consent form with a highlights box
* Behavioral: Interactive, shortened consent form


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 Years Old or Older Read and agreed to informed consent Indicated desire to participate Diagnosed with asthma US resident Exclusion Criteria: Participants from whom we receive multiple responses will be dropped from analysis (but will be compensated for participation)

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Original<br>Participants will review the full-length, original consent form for the clinical trial. | Behavioral: Original consent form<br>* Participants will review the full-length, original consent form for the clinical trial.<br>|
| Experimental: Shortened<br>Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study. | Behavioral: Shortened consent form<br>* Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study.<br>|
| Experimental: Reordered<br>Participants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section). | Behavioral: Reordered, shortened consent form<br>* Participants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section).<br>|
| Experimental: Highlighted<br>Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study. | Behavioral: Shortened consent form with a highlights box<br>* Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study.<br>|
| Experimental: Interactive<br>Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section. | Behavioral: Interactive, shortened consent form<br>* Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score for high impact questions | Sum of correct answers (T/F) for any item relating to material that was rated as 50 or higher on impact on willingness to enroll in a previous study. | through study completion, an average of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score for low impact questions | Sum of correct answers (T/F) for any item relating to material that was rated as 49 or lower on impact on willingness to enroll in a previous study. | through study completion, an average of 30 minutes | 
| Total score for all questions | Sum of correct answers (T/F) on full knowledge test. | through study completion, an average of 30 minutes | 
| Interaction effect of format and importance on likelihood of correct answer | Interaction effect in a logistic regression predicting a correct answer, based on the format of the consent form and the importance of the answer. | through study completion, an average of 30 minutes | 
| Scores for different information categories | Sum of correct answers (T/F) for each of the 20 information categories | through study completion, an average of 30 minutes | 
| Effect of location on score | Logistic regression coefficient of likelihood of predicting a correct answer, based upon the location on which the sentence appeared--uses only the shortened, and the reordered conditions. Note that sentences appearing in the introduction (which is the first section of all treatments) must be dropped, as there will be no variation in location. | through study completion, an average of 30 minutes | 
| Decision to enroll | Likert measure of participants hypothetical decision to enroll in the study | through study completion, an average of 30 minutes | 
| Confidence in enrollment decision | Likert measure of participants confidence in hypothetical decision to enroll in the study | through study completion, an average of 30 minutes | 
| Satisfaction with consent structure | Likert measure of participants satisfaction with the consent form | through study completion, an average of 30 minutes | 
| Perception of investigator concern for well being | Likert measure of participants belief in the investigator's concerns for the participant's well-being | through study completion, an average of 30 minutes | 
| Perception of investigator transparency | Likert measure of participants belief that the investigator is trying to communicate information about the trial accurately | through study completion, an average of 30 minutes | 
| Participant's probability estimate of the likelihood that the treatment would help control their asthma | Survey question of the following form: 'If you enrolled in the trial described in the consent form, what is the probability that the treatment could help control your asthma better, where 0% means no chance at all of helping and 100% means would definitely help?' Participants provided with drop-down menu including values from 0% to 100% in increments of 1%. | through study completion, an average of 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Informed consent