Informed Consent Formats by Information Preference and Priority

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Consent Forms
• Intervention / Treatment: Behavioral: Original consent form; Behavioral: Shortened consent form; Behavioral: Reordered, shortened consent form; Behavioral: Shortened consent form with a highlights box; Behavioral: Interactive, shortened consent form

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Carnegie Mellon University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Original; Participants will review the full-length, original consent form for the clinical trial.	Behavioral: Original consent form; Participants will review the full-length, original consent form for the clinical trial.
Experimental: Shortened; 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: 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.
Experimental: Reordered; 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: 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).
Experimental: Highlighted; 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: 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.
Experimental: Interactive; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score for high impact questions	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.	through study completion, an average of 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score for low impact questions	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.	through study completion, an average of 30 minutes
Total score for all questions	Sum of correct answers (T/F) on full knowledge test.	through study completion, an average of 30 minutes
Interaction effect of format and importance on likelihood of correct answer	Interaction effect in a logistic regression predicting a correct answer, based on the format of the consent form and the importance of the answer.	through study completion, an average of 30 minutes
Scores for different information categories	Sum of correct answers (T/F) for each of the 20 information categories	through study completion, an average of 30 minutes
Effect of location on score	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.	through study completion, an average of 30 minutes
Decision to enroll	Likert measure of participants hypothetical decision to enroll in the study	through study completion, an average of 30 minutes
Confidence in enrollment decision	Likert measure of participants confidence in hypothetical decision to enroll in the study	through study completion, an average of 30 minutes
Satisfaction with consent structure	Likert measure of participants satisfaction with the consent form	through study completion, an average of 30 minutes
Perception of investigator concern for well being	Likert measure of participants belief in the investigator's concerns for the participant's well-being	through study completion, an average of 30 minutes
Perception of investigator transparency	Likert measure of participants belief that the investigator is trying to communicate information about the trial accurately	through study completion, an average of 30 minutes
Participant's probability estimate of the likelihood that the treatment would help control their asthma	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%.	through study completion, an average of 30 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant's free-response text describing what was learned from reading the informed consent document	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.	through study completion, an average of 30 minutes

Collaborators and Investigators

• Sponsor: Carnegie Mellon University
• Collaborators: ICON plc

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Informed consent
• Other Study ID Numbers: STUDY2017_00000268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Intend to share deidentified participant data, but we want to review the received data to ensure that there is no information that could potentially reveal individual identity that we may not initially anticipate. As such, a clear delineation of what data will be disclosed is not yet available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No