Clinical Informed Consent Format Evaluation

NCT ID: NCT02489682

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-05-31

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.

Conditions

Consent Forms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Informed Consent Format - short written

Intervention to be administered:

• Short-form written informed consent information, followed immediately by outcomes questionnaire

Group Type: EXPERIMENTAL

Short-form written Informed consent information

Intervention Type: OTHER

Informed Consent Format - long written

Intervention to be administered:

• Long-form written informed consent information, followed immediately by outcomes questionnaire

Group Type: EXPERIMENTAL

Long-form written Informed consent information

Intervention Type: OTHER

Informed Consent Format - video

Intervention to be administered:

• Video informed consent information, followed immediately by outcomes questionnaire

Group Type: EXPERIMENTAL

Video Informed consent information

Intervention Type: OTHER

Interventions

Long-form written Informed consent information

Intervention Type: OTHER

Short-form written Informed consent information

Intervention Type: OTHER

Video Informed consent information

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ICON plc

INDUSTRY

Sponsor Role: collaborator

Carnegie Mellon University

OTHER

Sponsor Role: lead

Responsible Party

Tamar Krishnamurti

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

A016520

Identifier Type: -

Identifier Source: org_study_id