ECA vs E-Document Explanation

Boston Medical Center (BMC)

Status: Completed

Conditions: Literacy; Information Disclosure

Treatments: Other: Embodied Conversational Agent

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03381911

H-37101

R01CA158219-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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)

Enrollment: 35 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Deaf
• Blind

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

E-Consent

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Embodied Conversational Agent