Testing the Effectiveness of a Falls Prevention System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 521
- 试验地点
- 1
- 主要终点
- High Risk Fall Rate
研究概览
简要总结
The purpose of this single arm intervention study is to determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the PUP™ [Patient is UP Falls Prevention System] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain & Spine Hospital.
详细描述
The purpose of this single arm intervention study is to determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the PUP™ [Patient is UP Falls Prevention System] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain & Spine Hospital. All Brain and Spine Hospital patients will be evaluated as to fall risk using the current fall risk assessment tool employed by OSU Medical Center and administered in the usual and customary fashion upon evaluation on the floor and Pod. Patients who are determined to be at a high fall risk will be approached to participate. Those patients who consent to participate in the study will remain in the study until a nurse removes the patient from high risk fall status or the participant has been discharged from the hospital. Any patient fall will to be reported and evaluated following current processes and procedures developed by the OSU Brain and Spine Institute as maintained with IHIS; the PUP™ as the intervention for this study will be an adjunct to those fall prevention processes already in place.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 years of age or older;
- •All high-risk fall patients, eighteen years of age or older, who are admitted to the OSU Brain and Spine Hospital on Floors 8 South, 9 South, 10 South, 8 East, 9 East or 10 East. Patients will undergo a pre-assessment as per OSUWMC procedure to determine if they are a high-fall risk.
排除标准
- •Patients whose medical condition as assessed by the PI prohibits their participation in the program, which would include among others the following: patients who lack the capacity to consent, patients with an anatomy or wound issue on their feet or around their calves that would bar them from wearing socks on either foot, and/or patients for whom the sock would impede medical treatment.
研究组 & 干预措施
Palarum Fall Prevention System
The Study site, the OSU Wexner Center Brain and Spine Hospital, is located on three contiguous floors with each floor being made up of two units or Pods designated East and South. Following commencement of the study, and throughout its duration, Pods assigned to the Study will only utilize the Palarum Fall Prevention System and a monitored PUP™ sock, i.e., (Patient is Up) System as the standard of care intervention for fall prevention in accordance with its operating instructions and procedures.
干预措施: PUP™ sock (Device)
结局指标
主要结局
High Risk Fall Rate
时间窗: hospital stay (on average 5 days)
To determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the intervention (Patient is UP fall prevention technology \[PUP™ \]) when compared to historical NDNQI data for the prior 12 months ("Benchmark Data") from nursing units where the intervention is being undertaken.
次要结局
未报告次要终点
研究者
Tammy Moore
Director of Nursing, Neurological Institute
Ohio State University