Informed Consent
Conditions
Keywords
informed consent, telemedicine, research methods
Brief 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.
Interventions
PROCEDUREAudio-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
PROCEDUREStandard 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.
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* any adult patient presenting to the emergency department, and expected to be admitted to the hospital.
Exclusion criteria
* prisoners * pregnant patients * non-English speaking patients * unable to provide informed consent based on mental status.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehension of research informed consent | Immediately | Comprehension of research informed consent will be assessed within 30 minutes of approaching participants for study inclusion. The QuIC will be used to assess comprehension of the elements of research informed consent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consent rate | Immediately | Rate of consenting for a low-risk clinical trial in the emergency department, depending on how research participation was solicited. |
Countries
United States
Outcome results
None listed