The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent
NCT ID: NCT02416505
Last Updated: 2016-10-04
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
67 participants
INTERVENTIONAL
2014-09-30
Brief Summary
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In this study, the investigators aim to evaluate the impact of a visual aid on patient comprehension an orthopedic informed consent discussion in low socioeconomic populations.
The primary outcome is patient comprehension measured by a Validated Knowledge-Based Multiple Choice Questionnaire.
The secondary outcomes include: Patient satisfaction and Time efficiency.
The investigators hypothesize that using an Anatomic Model Visual Aid during an orthopedic informed consent discussion will improve patient comprehension, satisfaction and time-efficiency of orthopedic care.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Verbal Discussion: Control Group
In this group, participants will receive a 10 minute Verbal Only Knee Osteoarthritis Steroid Injection Informed Consent discussion.
This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection.
No interventions assigned to this group
Verbal+Anatomic Model
This intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Knee Model.
This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection.
Verbal+Anatomic Model
Verbal+Video Presentation
This intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Video.
This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection.
Verbal+Video
Interventions
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Verbal+Anatomic Model
Verbal+Video
Eligibility Criteria
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Inclusion Criteria
* Patients who express lack of knowledge regarding knee osteoarthritis (causes, diagnosis, treatment, anatomy)
* English speaking
* Patients that meet the Federal Poverty Guideline for Healthcare (i.e. Medicaid)
Exclusion Criteria
* College graduates
* Non-English speaking
* Patient without the capacity to give consent
* Patients with a tactile, mental, visual or auditory disability
18 Years
ALL
No
Sponsors
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University of Missouri, Kansas City
OTHER
Responsible Party
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Nkemakolam Egekeze
Orthopedic Surgery Researcher
Principal Investigators
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Mark Bernhardt, MD
Role: STUDY_CHAIR
UMKC Department of Orthopaedic Surgery
Johnathan Dubin, MD
Role: STUDY_DIRECTOR
UMKC Department of Orthopaedic Surgery
Karen Williams, PhD
Role: STUDY_DIRECTOR
UMKC Dept of Bioinformatics
Nkem Egekeze, MD
Role: PRINCIPAL_INVESTIGATOR
UMKC Dept of Orthopaedic Surgery
Other Identifiers
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14-334
Identifier Type: -
Identifier Source: org_study_id
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