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Completed

NCT Number: NCT02489682

Clinical Informed Consent Format Evaluation

This study evaluates the effectiveness of a patient-centered short written informed consent form and a patient-centered short video informed consent in a randomized controlled trial (control = traditional informed consent ). Primary outcome measures include critical knowledge acquisition, risk and benefit judgments, and desired enrollment in a hypothetical clinical trial. The investigators hypothesized that the patient-centered patient-designed consent forms (video and written format) would do as well as or outperform the traditional consent form on the primary outcomes.

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Key information

Conditions

Consent Forms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Traditional informed consent documents tend to be lengthy and technical, often too dense to facilitate proper patient-engagement. In this study, the investigators test the effectiveness of a previously developed patient-centered, short informed consent document and a patient-centered, short informed animated consent video as compared to a lengthy traditional informed consent document for the same clinical condition (i.e. severe asthma)

In this study, self-identified asthma patients, aged 18 or older, attending an experimental session in a university computer laboratory will be randomly assigned to read either the full informed consent document (control) or the short, patient-centered informed consent document or to view the short patient-centered informed consent video. Participants will also complete a follow-up survey at 1-week.

The main outcome measures are:

Engagement in the information (1=not at all engaged, 2=not very engaged, 3= somewhat engaged, 4=very engaged, 5=completely engaged).

Intention to enroll in the clinical trial

(1=definitely would not, 3=neutral, and 5=definitely would)

Trial knowledge (12 multiple choice questions, e.g. ""When can [the participants] withdraw from the trial?")

Trust in the clinical trial physician (Six questions beginning with, "If [the participant] decided to enroll in this study, how much would [the participant] trust Dr. Janet Taylor, the physician who is leading the study, to...")

Perceived risks and benefits of the trial (Four questions, e.g. "Imagine that [the participant] enrolled in the clinical trial, how likely do [the participants] think it is that the drug would be more effective in treating [the participant's] asthma symptoms than an average asthma drug on the market?")

The investigators hypothesize that the two experimental conditions will outperform the control condition on engagement and trial knowledge and would do as well as the control on the remaining outcome measures.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • at least 18 years of age
  • fluent in English
  • self-identifying as asthma patients

Exclusion criteria

Treatment and study plan

Long-form written Informed consent information

Other

Short-form written Informed consent information

Other

Video Informed consent information

Other

Primary outcomes

  1. Hypothetical trial enrollment as assessed by a likelihood of enrollment question

    Time frame: immediately after intervention

  2. Engagement as assessed by a likert scale engagement question

    Time frame: immediately after intervention

  3. Trust in physician as assessed by a composite of likert scale questions measuring trust

    Time frame: immediately after intervention

  4. Trial Knowledge as assessed by a composite of 12 true/false questions

    Time frame: immediately after intervention

  5. Perceived Risk and Benefit as assessed by a series of judgment questions

    Time frame: immediately after intervention

Secondary outcomes

  1. Change in hypothetical trial enrollment as assessed by a likelihood of enrollment question at 1 week from intervention

    Time frame: 1-week follow-up

  2. Change in trust in physician as assessed by a composite of likert scale questions measuring trust at 1 week from intervention

    Time frame: 1-week follow-up

  3. Change in hypothetical trial trial knowledge as assessed by a composite of 12 true/false questions at 1 week from intervention

    Time frame: 1-week follow-up

  4. Change in Perceived Risk and Benefit as assessed by a series of judgment questions at 1 week from intervention

    Time frame: 1-week follow-up

Sponsors and collaborators

Lead sponsor

Carnegie Mellon University

Other

Collaborators

  • ICON plc

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 3, 2015
Registry last updated
Feb 6, 2024

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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