Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium

NCT02541799 | Completed Phase 2

• 1 other identifier: 201504742
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Informed Consent

Keywords

informed consent; telemedicine; research methods

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Consent rate

  Immediately

Study Arms (2)

Telemedicine

EXPERIMENTAL

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.

Procedure: Audio-visual telemedicine

Standard Care

ACTIVE COMPARATOR

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.

Procedure: Standard care

Interventions

Audio-visual telemedicine PROCEDURE

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

Telemedicine

Standard care PROCEDURE

Participants in an emergency department will have their care delivered in person, then they will be approached by a study investigator face-to-face.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 4, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

US (1)