Asthma, Consent Forms
Conditions
Keywords
Informed consent
Brief summary
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
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.
Interventions
BEHAVIORALOriginal consent form
Participants will review the full-length, original consent form for the clinical trial.
BEHAVIORALShortened 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.
BEHAVIORALReordered, 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).
BEHAVIORALShortened consent form with a highlights box
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.
BEHAVIORALInteractive, shortened consent form
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.
Sponsors
ICON plc
Carnegie Mellon University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score for high impact questions | through study completion, an average of 30 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of investigator transparency | through study completion, an average of 30 minutes | Likert measure of participants belief that the investigator is trying to communicate information about the trial accurately |
| Score for low impact questions | through study completion, an average of 30 minutes | 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. |
| Total score for all questions | through study completion, an average of 30 minutes | Sum of correct answers (T/F) on full knowledge test. |
| Interaction effect of format and importance on likelihood of correct answer | through study completion, an average of 30 minutes | Interaction effect in a logistic regression predicting a correct answer, based on the format of the consent form and the importance of the answer. |
| Scores for different information categories | through study completion, an average of 30 minutes | Sum of correct answers (T/F) for each of the 20 information categories |
| Decision to enroll | through study completion, an average of 30 minutes | Likert measure of participants hypothetical decision to enroll in the study |
| Confidence in enrollment decision | through study completion, an average of 30 minutes | Likert measure of participants confidence in hypothetical decision to enroll in the study |
| Satisfaction with consent structure | through study completion, an average of 30 minutes | Likert measure of participants satisfaction with the consent form |
| Perception of investigator concern for well being | through study completion, an average of 30 minutes | Likert measure of participants belief in the investigator's concerns for the participant's well-being |
| Participant's probability estimate of the likelihood that the treatment would help control their asthma | through study completion, an average of 30 minutes | 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%. |
| Effect of location on score | through study completion, an average of 30 minutes | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant's free-response text describing what was learned from reading the informed consent document | through study completion, an average of 30 minutes | 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. |
Countries
United States
Outcome results
None listed