Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium

Informed Consent Clinical Trial

Official title:

Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541799
• Other study ID #: 201504742
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2015
• Last updated: October 3, 2015
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: University of Iowa
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Informed Consent

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehension of research informed consent	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.	Immediately	Yes
Secondary	Consent rate	Rate of consenting for a low-risk clinical trial in the emergency department, depending on how research participation was solicited.	Immediately	No