The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent

Study Overview
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Brief Summary
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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.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Verbal+Anatomic Model
* Behavioral: Verbal+Video


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Verbal Discussion: Control Group<br>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. | |
| Active Comparator: Verbal+Anatomic Model<br>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. | Behavioral: Verbal+Anatomic Model<br> <br> |
| Active Comparator: Verbal+Video Presentation<br>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. | Behavioral: Verbal+Video<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Nkem Test | Comprehension based examination of an informed consent discussion | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Survey |  | 5 minutes |