NCT02541799

Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Informed Consent

Interventions

Type	Name	Description
PROCEDURE	Audio-visual telemedicine	Participants in an emergency department will have their care delivered using telemedicine, then they will be approached for a study by a study investigator using the same telemedicine link
PROCEDURE	Standard care	Participants in an emergency department will have their care delivered in person, then they will be approached by a study investigator face-to-face.

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-09-04
• Last updated: 2015-10-06

Locations

1 site across 1 country: United States