The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent in a Private Practice
NCT ID: NCT02694237
Last Updated: 2016-05-02
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
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COMPLETED
NA
66 participants
INTERVENTIONAL
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Verbal
This group will only receive a verbal discussion based on the same script used for all three groups. This is the control group.
Verbal
Each participant will receive a verbal informed consent discussion without a visual aid.
Verbal + Model
This group will receive a verbal discussion aided with an anatomic model intervention that group participants will be able to touch throughout the discussion.
Model
Each participant will receive an informed consent discussion with the aid of an anatomic knee model.
Verbal + Video
This group will receive a verbal discussion aided with a knee anatomy video intervention that will be played on silent an orated by an interviewer.
Knee Anatomy Video
Each participant will hear a scripted informed consent discussion while they watch a knee anatomy video orated by an interviewer.
Interventions
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Model
Each participant will receive an informed consent discussion with the aid of an anatomic knee model.
Knee Anatomy Video
Each participant will hear a scripted informed consent discussion while they watch a knee anatomy video orated by an interviewer.
Verbal
Each participant will receive a verbal informed consent discussion without a visual aid.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with a visual, auditory, psychological or tactile impairment requiring the assistance of another person.
18 Years
ALL
No
Sponsors
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University of Missouri, Kansas City
OTHER
Responsible Party
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Nkemakolam Egekeze
UMKC Orthopaedic Research Fellow
Principal Investigators
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Nkem Egekeze, MD
Role: PRINCIPAL_INVESTIGATOR
UMKC Department of Orthopaedic Surgery
Karen Williams, PhD
Role: STUDY_DIRECTOR
UMKC Department of Health Insight and Research
Luv Singh, MD
Role: STUDY_DIRECTOR
UMKC Department of Orthopaedic Surgery
Dan Gurba, MD
Role: STUDY_DIRECTOR
Dickson-Diveley Orthopaedic Clinic
Charles Rhoades, MD
Role: STUDY_DIRECTOR
UMKC Department of Orthopaedic Surgery
Mark Bernhardt, MD
Role: STUDY_CHAIR
UMKC Dept of Orthopaedic Surgery
Locations
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Truman Medical Center and Dickson-Diveley Orthopaedic Clinic
Kansas City, Missouri, United States
Countries
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Other Identifiers
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OrthoInfo
Identifier Type: -
Identifier Source: org_study_id
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