Effectiveness of Early Intervention in the Diagnosis and Treatment of Hyponatremia in the Prevention of Hospitalized Patients Falls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls.
研究概览
简要总结
Cross ecological quasi-experimental study to assess effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls.
详细描述
Effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls.
Aims:
- To assess the effectiveness of corrective activity of hyponatremia in falls reducing incidence.
- To assess the cost-effectiveness ratio of the two proposed strategies: conventional treatment versus early intervention.
Cross ecological quasi-experimental study. The project will take place in Gregorio Marañón Hospital (Madrid, Spain) in the following inpatient adult Units: Neurology, Rehabilitation 1, Geriatrics, Internal Medicine (Group A), Cardiology, Rehabilitation 2, Gastroenterology, Neurosurgery and Oncology (Group B).
The estimated sample size for a confidence level of 95% (α = 0.05) and power of 90% (β = 0.010), taking into account a decrease in the incidence of falls of 20% restocking losses, is 124 patients per group (ie, the 124 patients receiving regular performance ** and 124 patients receiving the experimental intervention *, if necessary, by participant Unit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >65 years
- •Admitted to a participating study unit
- •Wish to participate in the study and signature of informed consent.
排除标准
- •Transfer of the patient to a unit not included in the study
- •Deterioration of the patient's condition to severe or extremely painful
研究组 & 干预措施
Early hyponatremia diagnosis and treatment
The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early.
干预措施: Early detection and treatment of hyponatremia (Other)
Early hyponatremia diagnosis and treatment
The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early.
干预措施: No Intervention (SOC) (Other)
No intervention
Usual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months.
结局指标
主要结局
To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls.
时间窗: 1 year
The effectiveness will be measured in terms of less incidence of falls
次要结局
- To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention.(1 year)
研究者
Mª del Carmen Lobo Rodríguez
Msc Nurse Research
Hospital General Universitario Gregorio Marañon