An interventional study of Original consent form and Shortened consent form in Consent Forms and Asthma, sponsored by Carnegie Mellon University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by Carnegie Mellon University · Not applicable, Interventional, and Basic science
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.
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.
Exclusion Criteria:
Participants will review the full-length, original consent form for the clinical trial.
Behavioral: Original consent form
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
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
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
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
Participants will review the full-length, original consent form for the clinical trial.
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.
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).
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.
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.
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.
Time frame: through study completion, an average of 30 minutes
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.
Time frame: through study completion, an average of 30 minutes
Total score for all questions
Sum of correct answers (T/F) on full knowledge test.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: through study completion, an average of 30 minutes
Decision to enroll
Likert measure of participants hypothetical decision to enroll in the study
Time frame: 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
Time frame: through study completion, an average of 30 minutes
Satisfaction with consent structure
Likert measure of participants satisfaction with the consent form
Time frame: 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
Time frame: 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
Time frame: 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%.
Time frame: through study completion, an average of 30 minutes
Participant's free-response text describing what was learned from reading the informed consent document
Survey question of the following form: "What are some of the key things you learned from reading the informed consent document?" Participants are then provided with an free-response text box where they are allowed to enter whatever text they want, as long as they enter some text. These responses will be coded by two independent coders, blinded to the treatment arms, using an emergent coding system to identify different topics that participants may raise.
Time frame: through study completion, an average of 30 minutes
Plan to share: Undecided — Intend to share deidentified participant data, but we want to review the received data to ensure that there is no information that could potentially reveal individual identity that we may not initially anticipate. As such, a clear delineation of what data will be disclosed is not yet available.
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Carnegie Mellon University