ECA vs E-Document Explanation

Not Applicable

Completed

• Conditions: Information Disclosure; Literacy

• Registration Number: NCT03381911
• Lead Sponsor: Boston Medical Center

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)

Study Timeline

• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-22
• Study Start: 2018-01-04
• Primary Completion: 2018-04-18
• Study Completion: 2018-04-18
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

Exclusion Criteria

• Deaf
• Blind

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knowledge of informed consent document	immediately following the study interview	A knowledge test will be given to assess the subjects' level of comprehension of the informed consent form

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States