Clinical trial NCT02489682: Clinical Informed Consent Format Evaluation
Official title: Clinical Informed Consent Format Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Consent Forms
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: ICON plc
First posted: 2015-07-03
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
measure: Hypothetical trial enrollment as assessed by a likelihood of enrollment question
timeFrame: immediately after intervention
measure: Engagement as assessed by a likert scale engagement question
timeFrame: immediately after intervention
measure: Trust in physician as assessed by a composite of likert scale questions measuring trust
timeFrame: immediately after intervention
measure: Trial Knowledge as assessed by a composite of 12 true/false questions
timeFrame: immediately after intervention
measure: Perceived Risk and Benefit as assessed by a series of judgment questions
timeFrame: immediately after intervention
Secondary outcomes:
measure: Change in hypothetical trial enrollment as assessed by a likelihood of enrollment question at 1 week from intervention
timeFrame: 1-week follow-up
measure: Change in trust in physician as assessed by a composite of likert scale questions measuring trust at 1 week from intervention
timeFrame: 1-week follow-up
measure: Change in hypothetical trial trial knowledge as assessed by a composite of 12 true/false questions at 1 week from intervention
timeFrame: 1-week follow-up
measure: Change in Perceived Risk and Benefit as assessed by a series of judgment questions at 1 week from intervention
timeFrame: 1-week follow-up
Other outcomes:
Locations:
Study officials:
References: