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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02541799
Other study ID # 201504742
Secondary ID
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


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
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