Informed Consent Formats by Information Preference and Priority

Carnegie Mellon University

Status: Completed

Conditions: Asthma; Consent Forms

Treatments: Behavioral: Interactive, shortened consent form; Behavioral: Shortened consent form; Behavioral: Reordered, shortened consent form; Behavioral: Shortened consent form with a highlights box; Behavioral: Original consent form

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03416907

STUDY2017_00000268

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 5 patient groups

Original

Active Comparator group

Description:

Participants will review the full-length, original consent form for the clinical trial.

Treatment:

Behavioral: Original consent form

Shortened

Experimental group

Description:

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.

Treatment:

Behavioral: Shortened consent form

Reordered

Experimental group

Description:

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).

Treatment:

Behavioral: Reordered, shortened consent form

Highlighted

Experimental group

Description:

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.

Treatment:

Behavioral: Shortened consent form with a highlights box

Interactive

Experimental group

Description:

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.

Treatment:

Behavioral: Interactive, shortened consent form