Clinical trial NCT03381911: ECA vs E-Document Explanation
Official title: Embodied Conversational Agent as Consent Advocate Compared to E-Consent Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Literacy
Information Disclosure
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Northeastern University
name: National Cancer Institute (NCI)
First posted: 2017-12-22
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Deaf
* Blind

Primary outcomes:
measure: Knowledge of informed consent document
timeFrame: immediately following the study interview
Secondary outcomes:
measure: Survey of level of satisfaction with the ECA
timeFrame: immediately following the study interview
measure: Amount of time spent on consent process
timeFrame: immediately following the study interview
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Michael Paasche-Orlow, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: