Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery: A Factorial Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,220
- 试验地点
- 3
- 主要终点
- Patients Knowledge
研究概览
简要总结
This study is a 2X2 factorial randomized trial that will the examine the comparative effectiveness of two patient decision aids for hip and knee osteoarthritis (OA) as well as the impact of a surgeon-focused intervention.
详细描述
This study is a 2X2 factorial randomized trial that will examine the comparative effectiveness of different decision support strategies for patients making treatment decisions about hip or knee osteoarthritis (OA). Eligible patient subjects will be randomly assigned to receive one of two decision aids before their upcoming clinic visit with a participating orthopedic specialist. Participating providers are randomly assigned to either usual care or an intervention (a report that includes patients' goals and treatment preferences). Patient participants will complete three surveys at different time points: before their orthopedic visit, one week after the clinic visit, and 12 months later. Providers will complete a short survey for a subset of patient participants. The study is titled the DECIDE-OA study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of either hip or knee osteoarthritis
- •Scheduled visit with participating orthopedic surgeon
排除标准
- •prior partial or total knee or hip joint replacement within last 5 years
- •hip fracture or asceptic necrosis (AVN) in last 12 months
- •Rheumatoid arthritis
- •Psoriatic arthritis
- •Unable to read English or Spanish
- •Unable to consent for self due to cognitive or medical issue
- •Hip or knee decision aid provided by Partners Healthcare clinician within 12 months
研究组 & 干预措施
Interactive Decision Aid and Usual Care
Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.
干预措施: Interactive decision aid (Behavioral)
Video decision aid and usual care
Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.
干预措施: Video decision aid (Behavioral)
Interactive Decision Aid and Provider Report
Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.
干预措施: Interactive decision aid (Behavioral)
Interactive Decision Aid and Provider Report
Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.
干预措施: Provider Report (Behavioral)
Video decision aid and Provider report
Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.
干预措施: Interactive decision aid (Behavioral)
Video decision aid and Provider report
Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.
干预措施: Provider Report (Behavioral)
结局指标
主要结局
Patients Knowledge
时间窗: before orthopedic visit
Knowledge sub-score generated from responses to the Hip or Knee Decision Quality Instrument (DQI). Scores range from 0-100%, with higher score meaning higher knowledge.
Percentage of Patients Who Received Preferred Treatment
时间窗: 1 week after visit with orthopedic surgeon
Patient preferred treatment item from the Hip or Knee Decision Quality Instrument will be compared with the treatment received to determine percentage of patients who received treatment that matched their preferences.
次要结局
- Percentage of Participants Who Used the Decision Aid(before orthopedic visit)
- Change in Quality of Life(before orthopedic visit; 12 months from date of orthopedic visit)
- Surgical Rates(6 months after the initial visit)
研究者
Karen Sepucha
Director, Health Decision Sciences Center
Massachusetts General Hospital