Clinical Informed Consent Format Evaluation

Consent Forms Clinical Trial

Official title:

Clinical Informed Consent Format Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489682
• Other study ID #: A016520
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: May 2015

Study information

• Verified date: February 2024
• Source: Carnegie Mellon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 18 years of age

• fluent in English

• self-identifying as asthma patients

Exclusion Criteria:

Related Conditions & MeSH terms

• Consent Forms

Intervention

Other:
• Long-form written Informed consent information

• Short-form written Informed consent information

• Video Informed consent information

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Carnegie Mellon University	ICON plc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypothetical trial enrollment as assessed by a likelihood of enrollment question		immediately after intervention
Primary	Engagement as assessed by a likert scale engagement question		immediately after intervention
Primary	Trust in physician as assessed by a composite of likert scale questions measuring trust		immediately after intervention
Primary	Trial Knowledge as assessed by a composite of 12 true/false questions		immediately after intervention
Primary	Perceived Risk and Benefit as assessed by a series of judgment questions		immediately after intervention
Secondary	Change in hypothetical trial enrollment as assessed by a likelihood of enrollment question at 1 week from intervention		1-week follow-up
Secondary	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
Secondary	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
Secondary	Change in Perceived Risk and Benefit as assessed by a series of judgment questions at 1 week from intervention		1-week follow-up