Back to resultsThe Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Verbal+Anatomic Model
Verbal+Video
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients newly diagnosed with Knee Osteoarthritis managed with steroid injections
- 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:
- Patients under the age of 18
- College graduates
- Non-English speaking
- Patient without the capacity to give consent
- Patients with a tactile, mental, visual or auditory disability
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Verbal Discussion: Control Group
Verbal+Anatomic Model
Verbal+Video Presentation
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
The Nkem Test
Comprehension based examination of an informed consent discussion
Secondary Outcome Measures
Patient Satisfaction Survey
Full Information
NCT ID
NCT02416505
First Posted
April 6, 2015
Last Updated
October 2, 2016
Sponsor
University of Missouri, Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT02416505
Brief Title
The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri, Kansas City
4. Oversight
5. Study Description
Brief Summary
This study is a Non-funded, Single Center, Multi-Arm, Parallel Group Randomize Control Trial.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Verbal Discussion: Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Verbal+Anatomic Model
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Verbal+Video Presentation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Verbal+Anatomic Model
Intervention Type
Behavioral
Intervention Name(s)
Verbal+Video
Primary Outcome Measure Information:
Title
The Nkem Test
Description
Comprehension based examination of an informed consent discussion
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Patient Satisfaction Survey
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients newly diagnosed with Knee Osteoarthritis managed with steroid injections
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:
Patients under the age of 18
College graduates
Non-English speaking
Patient without the capacity to give consent
Patients with a tactile, mental, visual or auditory disability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Bernhardt, MD
Organizational Affiliation
UMKC Department of Orthopaedic Surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johnathan Dubin, MD
Organizational Affiliation
UMKC Department of Orthopaedic Surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karen Williams, PhD
Organizational Affiliation
UMKC Dept of Bioinformatics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nkem Egekeze, MD
Organizational Affiliation
UMKC Dept of Orthopaedic Surgery
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent
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