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Completed

NCT Number: NCT03416907

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.

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Key information

Conditions

Consent Forms Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Original consent form

Behavioral

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

Shortened consent form

Behavioral

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.

Reordered, shortened consent form

Behavioral

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).

Shortened consent form with a highlights box

Behavioral

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.

Interactive, shortened consent form

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Carnegie Mellon University

Other

Collaborators

  • ICON plc

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 31, 2018
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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