The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent in a Private Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The Nkem Test
研究概览
简要总结
The aim of the study is determine which method of informed consent improves comprehension in college educated patients in a private practice setting.
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
- Quadruple (Participant, Care Provider, 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
- •Knee osteoarthritis patients over the age of 18 with a college education deemed appropriate for medical management with a knee injection.
排除标准
- •Patients without the capacity to provide consent
- •Patients with a visual, auditory, psychological or tactile impairment requiring the assistance of another person.
研究组 & 干预措施
Verbal
This group will only receive a verbal discussion based on the same script used for all three groups. This is the control group.
干预措施: Verbal (Behavioral)
Verbal + Model
This group will receive a verbal discussion aided with an anatomic model intervention that group participants will be able to touch throughout the discussion.
干预措施: Model (Behavioral)
Verbal + Video
This group will receive a verbal discussion aided with a knee anatomy video intervention that will be played on silent an orated by an interviewer.
干预措施: Knee Anatomy Video (Behavioral)
结局指标
主要结局
The Nkem Test
时间窗: baseline
This knowledge based questionnaire assesses patient comprehension of an informed consent discussion. The score of the test is known as "The Nkem Score".
次要结局
未报告次要终点
研究者
Nkemakolam Egekeze
UMKC Orthopaedic Research Fellow
University of Missouri, Kansas City