The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：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. |
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|
有源比较器：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. |
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有源比较器：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Nkem Test
大体时间：20 minutes
|
Comprehension based examination of an informed consent discussion
|
20 minutes
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Patient Satisfaction Survey
大体时间：5 minutes
|
5 minutes
|
合作者和调查者
调查人员
- 首席研究员：Nkem Egekeze, MD、UMKC DEPT OF ORTHOPAEDIC SURGERY
- 研究主任：Karen Williams, PhD、UMKC DEPT OF BIOINFORMATICS
- 学习椅：Mark Bernhardt, MD、UMKC Department of Orthopaedic Surgery
- 研究主任：Johnathan Dubin, MD、UMKC Department of Orthopaedic Surgery
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
膝骨性关节炎的临床试验
Verbal+Anatomic Model的临床试验
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The Second Hospital of Shandong University完全的
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University of MichiganNational Heart, Lung, and Blood Institute (NHLBI); Pixel Velocity, Inc. / Epsilon Imaging完全的