A Technology-enabled Decision Aid for Patients With Hip and Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Knee Osteoarthritis Decision Quality Instrument
研究概览
简要总结
This study evaluates a technology-enabled decision aid that provides evidence-based education (i.e. on understanding the condition, treatment options and comparisons, patient values and question & answer quiz) and personalized, quantifiable benefit-risk ratio alongside the level of potential benefit in relation to joint stiffness, joint pain and quality of life. The study will be performed in the setting of an integrated care system providing patient-centered care for hip and knee osteoarthritis over the full cycle of care. The impact of a technology-enabled decision aid incorporating predictive analytics with machine learning capabilities on decision quality, activation, experience & limitations of patients in this setting is relatively unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with a presumptive diagnosis of knee OA aged between 45 and 89 (in-line with the decision aid algorithm)
- •Radiographic evidence of moderate to severe osteoarthritis (Kellgren and Lawrence grade 3-4)
- •KOOS Jr scores between 0-85 (in-line with the decision-aid algorithm)
- •Participant able to give informed consent for participation in the study
排除标准
- •Kellgren and Lawrence scale for classification of osteoarthritis grade 0-2
- •Patients with a prior experience of total joint replacement
- •Patient with experience with the pilot form of the decision aid
- •Patients undergoing consideration for revision joint replacement
- •Patients seeking care for trauma condition or psoriatic/rheumatoid arthritis
- •Non-English or Non-Spanish speakers
- •Patients with BMI below 20 or above 46 (in-line with the decision-aid algorithm)
研究组 & 干预措施
Experimental
Full decision aid, consisting of education on osteoarthritis and treatment options, preferences and values elicitation, and personalized risk/benefit estimates based on patient's response to patient-reported outcome measures.
干预措施: OM1 Dell Shared Decision Making Tool (Other)
Control
Education component of the decision aid only.
干预措施: Education material from OM1 Dell Shared Decision Making Tool (Other)
结局指标
主要结局
Knee Osteoarthritis Decision Quality Instrument
时间窗: Day 1
Decision process subscore. Participants receive 1 point for a response of "yes" or "a lot/some." The total points are summed and then divided by the total number of items to result in scores from 0-100%, with higher scores indicated a more shared decision making process.
次要结局
- Undergoing joint replacement surgery or not(Day 1)
- Average time of patient visit and average time spent with provider(Day 1)
- CollaboRATE(Day 1)
- Numeric rating scale-satisfaction(Day 1)
- Knee injury and osteoarthritis outcome score, joint replacement (KOOS JR)(6 months after baseline visit)
研究者
Kevin Bozic
Professor of Surgery
University of Texas at Austin