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OpenTrials
Completed

NCT Number: NCT02541799

Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium

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.

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Key information

Conditions

Informed Consent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Comprehension of research informed consent

    Time frame: 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 outcomes

  1. Consent rate

    Time frame: Immediately

    Rate of consenting for a low-risk clinical trial in the emergency department, depending on how research participation was solicited.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2015
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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