Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium

Phase 2

Completed

• Conditions: Informed Consent
• Interventions: Procedure: Audio-visual telemedicine; Procedure: Standard care

• Registration Number: NCT02541799
• Lead Sponsor: University of Iowa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-03
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine	Audio-visual telemedicine	Participants allocated to this arm will be approached the using a telemedicine medium to discuss study participation. The consent form will be administered while the investigator is on a telemedicine link.
Standard Care	Standard care	Participants allocated to this arm will be approached in standard fashion where the investigator approaches the patient face to face. The consent form will be administered while the investigator is in the participant's room.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Consent rate	Immediately	Rate of consenting for a low-risk clinical trial in the emergency department, depending on how research participation was solicited.

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States