Agent-Enhanced Document Explanation
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2015 |
| End Date: | September 2016 |
| Contact: | Lori Henault, MPH |
| Email: | lori.henault@bmc.org |
| Phone: | 617-414-6935 |
Research Ethics and Safety Promoted by Embodied Conversational Technology
Both the main and sub-studies 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.
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.
The main study in this protocol is a 3 arm (HUMAN vs. ECA vs. ECA + HUMAN), randomized,
between-subjects experimental design.
There is one sub-study, the Images study, also included in this protocol. Subjects who are
eligible for the main study can choose if they would like to participate in this sub-study.
This is a within-subjects design, where subjects will be randomized to different conditions
within the system.
One additional sub-study, called Stance, also a within-subjects design, where subjects will
be randomized to different conditions within the system, was also included in the original
protocol,but has since been closed to enrollment. Data collection for this sub-study was the
same as for the current sub study (Images), and the main study (Consent Advocate).
Eligible subjects will be given the option to participate in the sub-study in addition to
the main study. Subjects may opt out of this sub-study, but not the main study (as in, a
subject cannot do the sub-study and NOT do the main study, unless there is some legitimate
reason to stop after the sub-study). Due to the nature of the content, the order of the
studies must be:
Images (sub) Consent Advocate (main) In these studies, baseline data is collected by the RA
verbally administering the instruments to the subjects. Then, the subject will sit in front
of a touch-screen monitor to interact with the character on the screen. A member of the
research team will be available at all times to assist with any technical issues, or if the
subject needs to take a break. Once the on-screen interaction(s) are complete, the RA will
administer any post-system data collection instruments.
Due to the amount of time required for data collection and completion of study protocol
(each study takes approximately 60-120 minutes), the subject can choose to complete the 2
studies in 1 or 2 study visits, depending on study subject and staff scheduling needs.
Main Study: Consent Advocate In this study, the participant will be randomized to one of
three arms: 1) a sham research informed consent form will be explained by a research
assistant; 2) a sham research informed consent form will be explained by an ECA, or 3) a
sham research informed consent form will be explained by an ECA and then questions will be
answered by a research assistant.
Baseline Data Collection:
1. Sociodemographics
2. Need for Cognition
3. Patient Activation
4. Trust in Medical System
5. REALM
Post Data Collection:
1. BICEP (primary outcome measure)
2. Trust in Agent
3. Instructor Evaluation Permission to audiotape the interaction will be obtained prior to
conducting this portion of the sub-study. The audio recording will be used to analyze
what questions the participant asks. If assigned to the ECA and RA condition, the audio
recording will be used by the research assistant prior to conducting the live consent
process. A knowledge test will be conducted after the consent process to ascertain what
was understood.
This study should take approximately 60 minutes to complete.
Sub-study:
1. Images. The ECA will explain a consent form but will use images to represent potential
risk as opposed to descriptive language only. Understanding will be measured by a knowledge
questionnaire. (n=50)
Baseline Data Collection:
Sociodemographics Need for Cognition
Post Data Collection:
Instructor Evaluation Informed Consent Scales Knowledge (of sham consent form) This study
should take approximately 60-90 minutes to complete. If a subject participates in the
sub-study that requires the same data collection forms (i.e. sociodemographics, need for
cognition, etc), these forms will only be completed once for each subject, not for each
study they participate in.
between-subjects experimental design.
There is one sub-study, the Images study, also included in this protocol. Subjects who are
eligible for the main study can choose if they would like to participate in this sub-study.
This is a within-subjects design, where subjects will be randomized to different conditions
within the system.
One additional sub-study, called Stance, also a within-subjects design, where subjects will
be randomized to different conditions within the system, was also included in the original
protocol,but has since been closed to enrollment. Data collection for this sub-study was the
same as for the current sub study (Images), and the main study (Consent Advocate).
Eligible subjects will be given the option to participate in the sub-study in addition to
the main study. Subjects may opt out of this sub-study, but not the main study (as in, a
subject cannot do the sub-study and NOT do the main study, unless there is some legitimate
reason to stop after the sub-study). Due to the nature of the content, the order of the
studies must be:
Images (sub) Consent Advocate (main) In these studies, baseline data is collected by the RA
verbally administering the instruments to the subjects. Then, the subject will sit in front
of a touch-screen monitor to interact with the character on the screen. A member of the
research team will be available at all times to assist with any technical issues, or if the
subject needs to take a break. Once the on-screen interaction(s) are complete, the RA will
administer any post-system data collection instruments.
Due to the amount of time required for data collection and completion of study protocol
(each study takes approximately 60-120 minutes), the subject can choose to complete the 2
studies in 1 or 2 study visits, depending on study subject and staff scheduling needs.
Main Study: Consent Advocate In this study, the participant will be randomized to one of
three arms: 1) a sham research informed consent form will be explained by a research
assistant; 2) a sham research informed consent form will be explained by an ECA, or 3) a
sham research informed consent form will be explained by an ECA and then questions will be
answered by a research assistant.
Baseline Data Collection:
1. Sociodemographics
2. Need for Cognition
3. Patient Activation
4. Trust in Medical System
5. REALM
Post Data Collection:
1. BICEP (primary outcome measure)
2. Trust in Agent
3. Instructor Evaluation Permission to audiotape the interaction will be obtained prior to
conducting this portion of the sub-study. The audio recording will be used to analyze
what questions the participant asks. If assigned to the ECA and RA condition, the audio
recording will be used by the research assistant prior to conducting the live consent
process. A knowledge test will be conducted after the consent process to ascertain what
was understood.
This study should take approximately 60 minutes to complete.
Sub-study:
1. Images. The ECA will explain a consent form but will use images to represent potential
risk as opposed to descriptive language only. Understanding will be measured by a knowledge
questionnaire. (n=50)
Baseline Data Collection:
Sociodemographics Need for Cognition
Post Data Collection:
Instructor Evaluation Informed Consent Scales Knowledge (of sham consent form) This study
should take approximately 60-90 minutes to complete. If a subject participates in the
sub-study that requires the same data collection forms (i.e. sociodemographics, need for
cognition, etc), these forms will only be completed once for each subject, not for each
study they participate in.
Inclusion Criteria:
1. understand spoken and written English (assessed by verbally asking candidates if they
"understand spoken and written English")
2. Must be an established patient in the Boston Medical Center clinics.
Exclusion Criteria:
- An issue determined by the patient's physician that would make this study
inappropriate.
We found this trial at
1
site
Click here to add this to my saved trials
