Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium

University of Iowa

Status and phase: Completed; Phase 2

Conditions: Informed Consent

Treatments: Procedure: Audio-visual telemedicine; Procedure: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT02541799

201504742

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Telemedicine

Experimental group

Description:

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.

Treatment:

Procedure: Audio-visual telemedicine

Standard Care

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard care