ECA vs E-Document Explanation

NCT03381911 | Completed

• 2 other identifiers: H-37101R01CA158219-05
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate how consent forms and other health care documents are explained to patients. The findings will be used to create a computer program that can successfully explain consent and other health-related forms to individuals who have difficulty reading and understanding consent forms on their own as a supplement to the normal consent process done in research settings. In a prior study, the investigators delivered a similar protocol, where subjects were first consented and then given a mock consent form (administered in 1 of 3 arms: RA, ECA, or ECA + RA). Subjects in this protocol struggled with the concept of a "mock" consent process, especially after they had just completed a consent process for the study itself. The current protocol, using deception research methods, aims to provide a more pure assessment of ECA consent vs the standard (here, E-consent) by waiving consent and delivering the sham consent as if it were reality. In the context of a protocol that employs deception methods, participants in the current study would be invited as healthy volunteers, and be randomized to 1 of 2 different consent processes to evaluate the relative benefits of different approaches for informed consent. After the knowledge tests have been completed, subjects will undergo a debriefing where they are made fully aware of the deception and its purpose. At that time, subjects will also be given the opportunity to "opt out" and not have their data included in the study results.

Conditions

Literacy; Information Disclosure

Outcome Measures

Primary Outcomes (1)

• Knowledge of informed consent document

  A knowledge test will be given to assess the subjects' level of comprehension of the informed consent form

  immediately following the study interview

Secondary Outcomes (2)

• Survey of level of satisfaction with the ECA

  immediately following the study interview

• Amount of time spent on consent process

  immediately following the study interview

Study Arms (2)

E-Consent

NO INTERVENTION

This arm is the standard of care, where the consent form is presented to the subject on a computer screen and he/she can scroll ahead and back as needed. There is also an option to have each screen read aloud.

ECA Consent

EXPERIMENTAL

In this arm an Embodied Conversational Agent (ECA) which is a computer generated character reads the consent form aloud to the subject, and also describes each section using a pre-loaded script. In addition, the character performs "teach-back", where she asks the subject a question about the section that was just described, and then repeats the section if the question is answered incorrectly.

Other: Embodied Conversational Agent

Interventions

Embodied Conversational Agent OTHER

The Embodied Conversational Agent (ECA) is a computer generated character that can interact with study subjects through a touch screen computer. The ECA is programmed to respond with relevant speech and body language to a subject's responses.

ECA Consent

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• able to come in for a single study visit

You may not qualify if:

• Deaf
• Blind

Sponsors & Collaborators

• Boston Medical Center: lead
• Northeastern University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Michael Paasche-Orlow, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dept General Internal Medicine, BUSM

Model Details: There are 2 study arms: ECA and E-Consent. In the ECA group subjects will have the consent form reviewed with them by the Embodied Conversational Agent character. In the E-Consent group (the standard of care), subjects will review the consent form on a computer screen with the option to have it read to them verbatim.

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 22, 2017
• Study Start: January 4, 2018
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)