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Informed Consent Formats by Information Preference and Priority

Not Applicable
Completed
Conditions
Asthma
Consent Forms
Registration Number
NCT03416907
Lead Sponsor
Carnegie Mellon University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
500
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Score for high impact questionsthrough 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 Outcome Measures
NameTimeMethod
Perception of investigator transparencythrough study completion, an average of 30 minutes

Likert measure of participants belief that the investigator is trying to communicate information about the trial accurately

Interaction effect of format and importance on likelihood of correct answerthrough 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 categoriesthrough study completion, an average of 30 minutes

Sum of correct answers (T/F) for each of the 20 information categories

Effect of location on scorethrough 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.

Decision to enrollthrough study completion, an average of 30 minutes

Likert measure of participants hypothetical decision to enroll in the study

Confidence in enrollment decisionthrough study completion, an average of 30 minutes

Likert measure of participants confidence in hypothetical decision to enroll in the study

Satisfaction with consent structurethrough study completion, an average of 30 minutes

Likert measure of participants satisfaction with the consent form

Score for low impact questionsthrough 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 questionsthrough study completion, an average of 30 minutes

Sum of correct answers (T/F) on full knowledge test.

Perception of investigator concern for well beingthrough 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 asthmathrough 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%.

Trial Locations

Locations (1)

Carnegie Mellon University

🇺🇸

Pittsburgh, Pennsylvania, United States

Carnegie Mellon University
🇺🇸Pittsburgh, Pennsylvania, United States

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