Race and Preference for Knee Replacement: A Patient-Centered Intervention (REPAIR)
A randomized, controlled design will be utilized to examine and compare the effectiveness of the proposed educational intervention, which includes a combination of an educational decision aid and motivational interviewing with attention control on select key patient-centered and process of care outcomes. The study sample will consist of approximately 450 African-American patients with osteoarthritis of the knee. Patients will be recruited from the University of Pennsylvania Health System and the Philadelphia VA Medical Center and will be randomized to one of the two study arms.
The immediate goal of this randomized controlled trial is to assess the effect of a high-quality, evidence-based, patient-centered educational intervention supplemented with targeted counseling (motivational interviewing) on African American patient preferences, expectations, and the likelihood of achieving a referral for surgical evaluation. The long-term goal of this research is to widely implement a patient-centered educational intervention targeting African Americans who are potential candidates for joint replacement, in a national effort to reduce and ultimately eliminate racial disparities in the utilization of this effective treatment option.
Study Aim:To examine the effect of the knee osteoarthritis Decision Aid (DA)/Motivational Interviewing (MI) intervention on orthopedic surgery referral rates for African American (AA) patients. Hypothesis: Compared to attention control, the DA/MI intervention will lead to higher orthopedic surgery referral rates for AA patients.
Secondary aim: To examine the effect of the DA/MI intervention on the rate of knee replacement receipt among AA patients. Hypothesis: AA patients randomized to receive the intervention will have higher rates of knee replacement compared to those in the attention control group.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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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:
- African American primary care patients
- Age 50 or older
- Chronic, frequent knee pain based on the NHANES questions
- Moderate to sever knee osteoarthritis based on WOMAC index score greater than or equal to 39 or positive answer to knee treatment questions
- Radiographic evidence of knee osteoarthritis
Exclusion Criteria:
- Prior history of any major joint replacement
- Terminal illness (e.g. end stage cancer)
- Physician-diagnosed inflammatory arthritis (i.e., rheumatoid arthritis, connective tissue disease, ankylosing spondylitis, or other seronegative sypondylarthoplasty.)
- Contra-indications to replacement surgery (e.g., lower extremity paralysis as a result of stroke.)
- Prosthetic leg
- Cognitive impairment (e.g., dementia)
- No home telephone service
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:DA/MI Intervention
Patients randomized to the DA/MI intervention arm will be shown a decision aid video entitled, Treatment Choices for Knee Osteoarthritis.
Following the viewing of the decision aid video, the participant will be engaged in a motivational interview by the research study interventionist.
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Patients randomized to the DA/MI intervention arm will be shown a decision aid video entitled, Treatment Choices for Knee Osteoarthritis.
Following the viewing of the decision aid video, the participant will be engaged in a motivational interview by the research study interventionist.
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有源比较器:Attention Control
Patients randomized to the attention control arm will receive an educational program (an NIH-developed booklet) that summarizes how to live with knee OA but does not specifically mention joint replacement.
This booklet provides examples of exercises one could do to improve pain and reduce stiffness from knee OA.
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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 |
|---|---|---|
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Referral to knee joint replacement
大体时间:12-months post-intervention
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Referral to knee joint replacement will be assessed for all patients 12 months post-intervention initially through telephone survey and then validated by medical record review
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12-months post-intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Receipt of knee joint replacement
大体时间:12-months post-intervention
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Receipt of knee joint replacement will be assessed for all patients 12-months post-intervention initially through telephone survey and then validated by medical record review
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12-months post-intervention
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合作者和调查者
调查人员
- 首席研究员:Said A Ibrahim, MD, MPH、University of Pennsylvania
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
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