Cost-effectiveness of Routine Follow-up at One Year After Total Hip and Knee Arthroplasty Compared to Check-up on Demand: a Multicenter Hybrid Stepped-wedge Cluster De-implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 9
- 主要终点
- PROMIS Physical Function
研究概览
简要总结
After undergoing total hip or total knee arthroplasty, current guidelines recommend routine follow-up with an X-ray within 3 months and again at 1 year. Follow-up at 5 years (for hip arthroplasties) or every 5 years (for knee arthroplasties) is also considered worthwhile according to the guideline. However, these follow-up appointments require considerable time from patients, caregivers, and healthcare professionals, and it is unclear whether they are truly beneficial. It is possible that a single follow-up within 3 months is sufficient. This could potentially prevent over 100,000 unnecessary hospital visits per year, resulting in significant cost savings. If patients or healthcare providers have concerns, they can always request an additional follow-up.
The HAKA trial consists of three different work packages (WPs). This trial (WP1) investigates the 1-year follow-up, WP2 examines the 10-year follow-up, and WP3 is a qualitative study exploring the experiences and perceptions of patients and healthcare professionals. The aim of the HAKA trial is to safely reduce routine follow-up appointments after total hip or knee arthroplasty and to revise current clinical guidelines accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Painful and disabled hip or knee joint resulting from osteoarthritis
- •Scheduled for primary THA or TKA surgery
- •Age 50 years or older at the time of THA or TKA
- •Capable and willing to complete questionnaires
- •Proficient in Dutch or English
- •Willing to provide informed consent
排除标准
- •Other indication for surgery than osteoarthritis
- •Scheduled for hip or knee revision arthroplasty, except a conversion from unicompartmental knee arthroplasty to TKA or from hip hemiarthroplasty/resurfacing to THA
- •Already participating in this study due to a previous hip or knee surgery
研究组 & 干预措施
Routine Follow-Up (RFU)
X-ray and clinical visit within 3 months and at 1 year after surgery.
干预措施: Routine Follow-Up (RFU) (Other)
Check-Up on Demand (COD)
X-ray and clinical visit within 3 months and only at 1 year when requested by the patient or healthcare provider.
干预措施: Check-Up on Demand (COD) (Other)
结局指标
主要结局
PROMIS Physical Function
时间窗: Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.
Patient-reported physical functioning will be assessed using the PROMIS® Physical Function Version 1.0, Short Form 10a. The short form consists of 10 items and is expressed by raw summed score ranging from 10 to 50, which can be converted to a T-score and SE. The T-score is a standardized score with a mean of 50 and a SD of 10. Higher T-scores indicate better physical functioning.
Number of clinical visits and X-rays
时间窗: From surgery until 24 months after surgery.
Assesses healthcare consumption based on the number of postoperative outpatient clinical visits and X-ray assessments.
次要结局
- Type of Surgical Interventions(From surgery until 24 months after surgery)
- Number of complications(From surgery until 24 months after surgery.)
- Type of Complications(From surgery until 24 months after surgery.)
- Number of surgical interventions(From surgery until 24 months after surgery.)
- Costs related to THA or TKA follow-up(Assessed at 15, 18, and 24 months after surgery.)
- Numeric Pain Rating Scale (NPRS)(Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.)
- EQ-5D-5L(Assessed before surgery and at 3, 12, 15, 18, and 24 months after surgery.)