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Informed Consent Formats by Information Preference and Priority

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416907
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Consent Forms Asthma 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Informed Consent Formats by Information Preference and Priority
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

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.




Primary Outcome Measures :
  1. Score for high impact questions [ Time Frame: through 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 :
  1. Score for low impact questions [ Time Frame: through 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.

  2. Total score for all questions [ Time Frame: through study completion, an average of 30 minutes ]
    Sum of correct answers (T/F) on full knowledge test.

  3. Interaction effect of format and importance on likelihood of correct answer [ Time Frame: through 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.

  4. Scores for different information categories [ Time Frame: through study completion, an average of 30 minutes ]
    Sum of correct answers (T/F) for each of the 20 information categories

  5. Effect of location on score [ Time Frame: through 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.

  6. Decision to enroll [ Time Frame: through study completion, an average of 30 minutes ]
    Likert measure of participants hypothetical decision to enroll in the study

  7. Confidence in enrollment decision [ Time Frame: through study completion, an average of 30 minutes ]
    Likert measure of participants confidence in hypothetical decision to enroll in the study

  8. Satisfaction with consent structure [ Time Frame: through study completion, an average of 30 minutes ]
    Likert measure of participants satisfaction with the consent form

  9. Perception of investigator concern for well being [ Time Frame: through study completion, an average of 30 minutes ]
    Likert measure of participants belief in the investigator's concerns for the participant's well-being

  10. Perception of investigator transparency [ Time Frame: through study completion, an average of 30 minutes ]
    Likert measure of participants belief that the investigator is trying to communicate information about the trial accurately

  11. Participant's probability estimate of the likelihood that the treatment would help control their asthma [ Time Frame: through 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%.



Other Outcome Measures:
  1. Participant's free-response text describing what was learned from reading the informed consent document [ Time Frame: through study completion, an average of 30 minutes ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416907


Locations
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United States, Pennsylvania
Carnegie Mellon University
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Carnegie Mellon University
ICON plc
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Responsible Party: Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT03416907    
Other Study ID Numbers: STUDY2017_00000268
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carnegie Mellon University:
Informed consent