Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium

Study Overview
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Brief Summary
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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.

Official Title
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Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium

Conditions
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Informed Consent

Intervention / Treatment
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* Procedure: Audio-visual telemedicine
* Procedure: Standard care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine<br>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<br>* 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<br>|
| Active Comparator: Standard Care<br>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<br>* Participants in an emergency department will have their care delivered in person, then they will be approached by a study investigator face-to-face.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consent rate | Rate of consenting for a low-risk clinical trial in the emergency department, depending on how research participation was solicited. | Immediately | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, informed consent, research methods