Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium

Completed · Phase 2

Conditions studied: Informed Consent

In brief

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.

Key facts

Study ID

NCT02541799

Run by

University of Iowa

People needed

130

Starts

2015-06-01

Expected to finish

2015-09-01

Last updated by the study team

2015-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• any adult patient presenting to the emergency department, and expected to be admitted to the hospital.

You may not qualify if…

• prisoners
• pregnant patients
• non-English speaking patients
• unable to provide informed consent based on mental status.

Where it is running

• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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