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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA158219-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Northeastern University | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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:
administer sham consent (via e-consent or ECA per randomization result)
knowledge test
data collection
Debriefing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Paasche-Orlow, MD, MPH | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D000067010 | Literacy |
| ID | Term |
|---|---|
| D003142 | Communication |
| D001519 | Behavior |
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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.
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The amount of time that the subject spent with the consent form, assessed in both arms
| immediately following the study interview |