Clinical trial NCT03416907: Informed Consent Formats by Information Preference and Priority
Official title: Informed Consent Formats by Information Preference and Priority
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Consent Forms
Asthma
Keywords: Informed consent
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: ICON plc
First posted: 2018-01-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Score for high impact questions
timeFrame: through study completion, an average of 30 minutes
Secondary outcomes:
measure: Score for low impact questions
timeFrame: through study completion, an average of 30 minutes
measure: Total score for all questions
timeFrame: through study completion, an average of 30 minutes
measure: Interaction effect of format and importance on likelihood of correct answer
timeFrame: through study completion, an average of 30 minutes
measure: Scores for different information categories
timeFrame: through study completion, an average of 30 minutes
measure: Effect of location on score
timeFrame: through study completion, an average of 30 minutes
measure: Decision to enroll
timeFrame: through study completion, an average of 30 minutes
measure: Confidence in enrollment decision
timeFrame: through study completion, an average of 30 minutes
measure: Satisfaction with consent structure
timeFrame: through study completion, an average of 30 minutes
measure: Perception of investigator concern for well being
timeFrame: through study completion, an average of 30 minutes
measure: Perception of investigator transparency
timeFrame: through study completion, an average of 30 minutes
measure: Participant's probability estimate of the likelihood that the treatment would help control their asthma
timeFrame: through study completion, an average of 30 minutes
Other outcomes:
measure: Participant's free-response text describing what was learned from reading the informed consent document
timeFrame: through study completion, an average of 30 minutes
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
References: