ECA vs E-Document Explanation

Embodied Conversational Agent as Consent Advocate Compared to E-Consent Administration

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.

Study Overview

• Status: Completed
• Conditions: Information Disclosure; Literacy
• Intervention / Treatment: Other: Embodied Conversational Agent

Detailed Description

Participants who call in response to the clinic flyers will first confirm eligibility criteria of age (≥21) and language (able to complete a study visit in English). Once eligibility is confirmed, participants will be scheduled to come to BMC for a single study visit that will take approximately 60-90 minutes. Randomization to one study arm or the other will occur when subject arrives for appointment.

The following activities will occur at a single study visit:

1. administer sham consent (via e-consent or ECA per randomization result)
2. knowledge test

3. data collection

   1. socio-demographics
   2. health literacy assessment (REALM)
   3. ECA satisfaction (for ECA arm subjects only)
   4. Emotional connection (adapted PROMIS) (for ECA arm subjects only)

4. Debriefing

   1. Describe true study aims
   2. Opt out option (subject can request that their data not be used)

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Deaf
• Blind

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: E-Consent; 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.
Experimental: ECA Consent; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey of level of satisfaction with the ECA	For subjects in the ECA study arm, satisfaction with the agent will be assessed	immediately following the study interview
Amount of time spent on consent process	The amount of time that the subject spent with the consent form, assessed in both arms	immediately following the study interview

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Cancer Institute (NCI); Northeastern University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2018
• Primary Completion (Actual): April 18, 2018
• Study Completion (Actual): April 18, 2018

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: H-37101; R01CA158219-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No