African American Preference for Knee Replacement: A Patient-Centered Intervention (ACTION)
Behavioral & Social Science Research on Understanding and Reducing Health Disparities
A randomized, controlled design will be utilized to examine and compare the effectiveness of the proposed educational intervention, which includes an educational decision aid with attention control on select key patient-centered and process of care outcomes. The study sample will consist of approximately 300 African-American patients with osteoarthritis (OA) of the knee. Patients will be recruited from Pennsylvania Presbyterian Medical Center 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 on African American patient preferences, expectations, and the likelihood of receiving a recommendation for knee joint replacement surgery when clinically indicated. The long-term goal of this research is to implement effective strategies to improve minority patients' access to joint replacement and ultimately eliminate racial disparities in the utilization of this effective treatment for knee OA.
Study Aim: To examine the effect of the decision aid (DA) intervention on the likelihood of receiving a recommendation for knee joint replacement when clinically indicated. Hypothesis: The DA intervention will lead to higher rate of treatment recommendation within 6 months.
Secondary Aim: To examine the effect of the DA intervention on the rate of knee replacement receipt within 12 months. Hypothesis: Patients randomized to receive the intervention will undergo knee replacement within 12 months at a higher rate than 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 patient referred to orthopedic doctor
- Age 50 or older
- Presence of knee OA by American College of Rheumatology as evidenced by:
- Chronic, frequent knee pain based on the NHANES questions.
- Moderate to severe knee OA based on WOMAC index score 39.
- Radiographic evidence of knee OA.
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 Spondyloarthropathy.)
- Contra-indications to replacement surgery (e.g., lower extremity paralysis as 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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无干预:Attention control
Subjects 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 information about OA, examples of exercises one could do to improve pain and reduce stiffness, types of non-drug pain relief such as massage, and information about various medications.
The interventionist will give the participant the booklet and describe what can be found inside.
They are also encouraged to ask their doctor any questions they may have about the information in the booklet or questions they may have about their OA.
The purpose of this educational program is to provide a tangible clinical incentive to the control group for participating in this additional component of the study.
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实验性的:Decision Aid (DA) Intervention
Patients randomized to the DA Intervention will watch a Knee OA Decision Aid (DA) developed by the Foundation for Informed Medical Decision Making and then receive a brief counseling session called "AskMe3."
The DA is a video that provides viewers with information about OA, treatment choices such as lifestyle changes, non-drug treatments, medication, injections, complementary therapies, and surgery, as well as the pros and cons of each type of treatment.
The AskMe3 is a communication, skill-building intervention, which instructs patients to ask 3 questions to the doctor: 1) What is my main problem? 2) What do I need to do? 3) Why is it important for me to do this?
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Patients randomized to the DA Intervention will watch a Knee OA Decision Aid (DA) developed by the Foundation for Informed Medical Decision Making and then receive a brief counseling session called "AskMe3."
The DA is a video that provides viewers with information about OA, treatment choices such as lifestyle changes, non-drug treatments, medication, injections, complementary therapies, and surgery, as well as the pros and cons of each type of treatment.
The AskMe3 is a communication, skill-building intervention, which instructs patients to ask 3 questions to the doctor: 1) What is my main problem? 2) What do I need to do? 3) Why is it important for me to do this?
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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 |
---|---|---|
Recommendation of knee joint replacement
大体时间:6 months after intervention
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Recommendation of knee joint replacement 6 months after intervention will be assessed for all patients by chart abstraction.
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6 months after intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Receipt of knee joint replacement
大体时间:assessed for all patients 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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assessed for all patients 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
- 首席研究员:Gwo-Chin Lee, MD、University of Pennsylvania
出版物和有用的链接
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 (实际的)
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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