Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium
NCT ID: NCT02541799
Last Updated: 2015-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2015-06-30
2015-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pilot Study of Video and Telephone Primary Care Visits
NCT04496713
Integrated Telemedicine Program Evaluation
NCT07042477
Project Resurgence Communication Trial
NCT04418947
Effect of Telemedicine on Physician-Patient Communication
NCT00057083
Comparison of Telemedicine Versus Traditional Practice in a University Health Center
NCT01787422
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Audio-visual telemedicine
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
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.
Standard care
Participants in an emergency department will have their care delivered in person, then they will be approached by a study investigator face-to-face.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Audio-visual telemedicine
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
Participants in an emergency department will have their care delivered in person, then they will be approached by a study investigator face-to-face.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* pregnant patients
* non-English speaking patients
* unable to provide informed consent based on mental status.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Iowa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohr, Nicholas M
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201504742
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.