Informed Consent Clinical Trial
Official title:
Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium
The investigators hypothesis is that patient comprehension of telemedicine-enabled research
informed consent is not inferior to standard face-to-face research informed consent.
The procotol will involve a prospective, randomized control trial to test the effectiveness
of a telemedicine medium in obtaining research informed consent. Within a single emergency
department, the investigators will conduct a simple, low risk randomized trial (single does
of oral chlorhexideine to prevent hospital acquired pneumonia among adult patients with
expected hospital admission). Prior to being approached for informed consent, potential
participants will be randomized in a 1:1 allocation ratio to standard face-to-face consent
vs. consent provided by audio-visual telemedicine. After standard clinical care, potential
participants will be approached according to their allocation. Comprehension of research
informed consent will be the primary outcome, and will be measured using the modified
Quality of Informed Consent (QuIC) instrument.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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