Impact of Regional Implementation of a Clinical Pathway for ELderly Patients With pelVIc Fragility fraCtures (PELVIC); a Multicenter, Stepped-wedge Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 393
- 试验地点
- 16
- 主要终点
- Mobility, using the Parker mobility score (PMS)
研究概览
简要总结
Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence of these injuries, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practice. New insights in treatment strategies, such as early diagnosis and minimal invasive operative treatment of these fragile patient population, has led to the development of several clinical pathways in recent literature. The aim of this study is to implement an evidence and experience-based treatment clinical pathway to improve the outcomes in this fragile patient population that currently has multifactorial risks for poor outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Pelvic fragility fracture caused by low energetic trauma
- •Patients presented at the emergency room or out-patient clinic of a participating hospital
排除标准
- •Patients with high suspicion of a pelvic fracture due to a malignant tumor
- •Patients who are unable to follow instructions due to severe cognitive decline (for example due to dementia or Alzheimer's disease)
- •Patients who pre-trauma received palliative or terminal care
- •Patients who pre-trauma were wheelchair bound or bedridden
- •Patients who suffer from complications from previous pelvic ring fixation
- •Patients with insufficient comprehension of the Dutch language to be able to carry out the physiotherapy instructions for early mobilization
结局指标
主要结局
Mobility, using the Parker mobility score (PMS)
时间窗: Change from baseline PMS at 2 weeks, 3 months, 6 months, and 1 year
Since there is no validated tool to measure mobility specifically after a pelvic fracture, the investigators choose to use The Parker mobility score as a primary outcome measurement. The Parker mobility score is a valid and reliable score measuring mobility in hip fracture patients. The Parker Mobility Score answers three questions, each valued 0-3 points, and is commonly used in clinical practice to monitor the mobility of geriatric patients. A score of 0-3 is considered low, 4-6 moderate, and 7-9 reflects good mobility. Furthermore, the Parker Mobility Score is a validated assessment tool for mortality in patients with reduced mobility after hip surgery.
次要结局
- Functional performance, using the Katz Index of Independence in Activities of Daily Living (KATZ ADL)(Change from baseline KATZ ADL at 3 months and 1 year)
- Number of falls after treatment, resulting in additional injury or without injury(At 6 weeks and 3 months)
- 2-year mortality(At 2 year)
- Descriptive name and dosage of analgesic medications used(Baseline, 2 weeks, 6 weeks, 3 months, and 1 year)
- Quality of life, using the EuroQol (EQ-5D-5L) score(Change from baseline EQ-5D-5L at 1 year)
- Level of pain, using the Numerical Pain Rating Scale (NRS)(Baseline, one day post-operative (if patient underwent surgery), at 2 weeks, 6 weeks, 3 months and 1 year)
- Number of participants with (fracture related) complications(At 2 weeks, 3 months, 6 months, and 1 year)
- 1-year mortality(At 1 year)
- Mobility, using the Elderly mobility scale (EMS)(At 2 weeks, 3 months, and 1 year)
- Return to home rate(Change from baseline place of residency at 6 weeks, 3 months, 6 months and 1 year)
研究者
Dr. Daphne van Embden
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)