The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 主要终点
- The Nkem Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Verbal+Anatomic Model (Behavioral)
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.
干预措施: Verbal+Video (Behavioral)
结局指标
主要结局
The Nkem Test
时间窗: 20 minutes
Comprehension based examination of an informed consent discussion
次要结局
- Patient Satisfaction Survey(5 minutes)
研究者
Nkemakolam Egekeze
Orthopedic Surgery Researcher
University of Missouri, Kansas City