NCT03416907

Informed Consent Formats by Information Preference and Priority

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Carnegie Mellon University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Consent Forms
• Asthma

Interventions

Type	Name	Description
BEHAVIORAL	Original consent form	Participants will review the full-length, original consent form for the clinical trial.
BEHAVIORAL	Shortened 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	Reordered, 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	Shortened 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.
BEHAVIORAL	Interactive, 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.

Timeline

• Start date: 2017-11-27
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2018-01-31
• Last updated: 2018-01-31

Locations

1 site across 1 country: United States