Stepped Wedge Cluster Randomized Controlled Trial for the Evaluation of Effectiveness of a Accidental Falls Care Bundle Implementation in Elderly Hospital Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,000
- 主要终点
- Falls Incidence rate
研究概览
简要总结
Accidental falls represents an elderly very important health problem, both in the community and within the hospital. The aim of this research project is to evaluate the effectiveness of accidental falls prevention care bundle in geriatrics, internal medicine, post acute, and rehabilitation wards, in terms of incidence and outcome reduction. It will be also investigated the cost effectiveness ratio, in terms of falls avoided, care bundle implementation costs, and falls related healthcare costs. The study will permit to evaluate the implementation feasibleness in time, considering the study will last for 20 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ≥ 75 years of age with or without documented fall risk and patients with < 75 years of age, but ≥ 18, only at documented fall risk, admitted at participant wards. The risk assessment will be performed with Conley scale and/or on the base of some specific fall risk characteristics (previous falls, cognitive impairment, neuropsychological damage, increased need to go to the bathroom for increased evacuative needs, neuroleptic or cardiovascular drugs assumption);
- •Patients (or legal guardian for those incapable of giving their consent) that give their consent to the study participation .
排除标准
- •Patients or legal guardian that don't give their consent to study participation.
结局指标
主要结局
Falls Incidence rate
时间窗: 5 months
Number of accidental falls respect number of hospital days of stay in elderly hospital patients at the end of a 5 months step.
次要结局
- Falls outcome(5 monts)
- Cost-effectiveness(20 months)
研究者
Daniela Mosci
Registered Nurse
IRCCS Azienda Ospedaliero-Universitaria di Bologna