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.

Study Overview

• Status: Completed
• Conditions: Consent Forms
• Intervention / Treatment: Other: Short-form written Informed consent information; Other: Long-form written Informed consent information; Other: Video Informed consent information

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Informed Consent Format - short written; Intervention to be administered: - Short-form written informed consent information, followed immediately by outcomes questionnaire	Other: Short-form written Informed consent information
Experimental: Informed Consent Format - long written; Intervention to be administered: - Long-form written informed consent information, followed immediately by outcomes questionnaire	Other: Long-form written Informed consent information
Experimental: Informed Consent Format - video; Intervention to be administered: - Video informed consent information, followed immediately by outcomes questionnaire	Other: Video Informed consent information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hypothetical trial enrollment as assessed by a likelihood of enrollment question	immediately after intervention
Engagement as assessed by a likert scale engagement question	immediately after intervention
Trust in physician as assessed by a composite of likert scale questions measuring trust	immediately after intervention
Trial Knowledge as assessed by a composite of 12 true/false questions	immediately after intervention
Perceived Risk and Benefit as assessed by a series of judgment questions	immediately after intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in hypothetical trial enrollment as assessed by a likelihood of enrollment question at 1 week from intervention	1-week follow-up
Change in trust in physician as assessed by a composite of likert scale questions measuring trust at 1 week from intervention	1-week follow-up
Change in hypothetical trial trial knowledge as assessed by a composite of 12 true/false questions at 1 week from intervention	1-week follow-up
Change in Perceived Risk and Benefit as assessed by a series of judgment questions at 1 week from intervention	1-week follow-up

Collaborators and Investigators

• Sponsor: Carnegie Mellon University
• Collaborators: ICON plc

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimated): July 3, 2015

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: A016520