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临床试验/NCT02996331
NCT02996331已完成不适用

Preventing Pressure Ulcers With Repositioning Frequency and Precipitating Factors

Duke University2 个研究点 分布在 1 个国家目标入组 2,113 人开始时间: 2017年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,113
试验地点
2
主要终点
Determine differences in PrU Incidence among NH in study arms.

研究概览

简要总结

The purpose of this study is to determine whether repositioning frequency can be extended for nursing home (NH) residents who are low, moderate, and high risk for pressure ulcer (PrU) development. The investigators will also determine how changes in medical severity interact with changes in risk level and repositioning schedule to predict PrU development. This study will advance knowledge about repositioning frequency and clinically assessed PrU risk-level in relation to medical severity. Outcomes of this research will contribute to future guidelines for more precise preventive nursing practices and refinement of PrU prevention guidelines.

详细描述

The purpose of this 9 nursing homes (NH) cluster randomized study is to determine whether repositioning frequency can be extended for NH residents who are low, moderate, and high risk for pressure ulcer (PrU) development and on visco-elastic (VE) high-density foam support-surfaces without compromising PrU incidence. The investigators will also determine how changes in medical severity interact with changes in risk level and repositioning schedule to predict PrU development. PrUs result primarily from pressure over bony prominences that occlude blood flow to tissues. Current PrU prevention protocols recommend repositioning moderate, high, and severe risk residents a minimum of every 2 hours. The investigators propose to include low risk residents because studies suggest they too develop PrUs. New pressure redistribution mattresses may make 2 hour repositioning unnecessary, but optimal time between repositioning remains unclear. Aims are 1) determine differences in incidence of new PrUs in NH residents (low, moderate, high risk level) using VE surfaces and repositioned at 2, 3, and 4 hour frequencies; and 2) determine how medical severity components (measured by a modified Comprehensive Severity Index), changes in clinically assessed risk-level (low, moderate, high as measured by Braden Scale), repositioning schedule, and their interactions are associated with PrU development; and an Exploratory Aim: Evaluate PrU prevention intervention approach between NH groups repositioned at 2, 3, or 4 hour by: 1) comparing the intervention resource costs (VE surfaces, Leaf service/sensor use, fixed and variable labor costs for training and repositioning) and incremental cost-effectiveness ratio of cost per % reduction in PrUs, and 2) exploring staff and resident satisfaction with intervention approach. The investigators will randomly assign each NH to one of 3 study arms (2, 3, 4 hour) while providing standard nursing care. Leaf Patient Monitoring System will be used with sensor worn continuously to monitor repositioning. Periodic safety and care checks will be performed to ensure skin integrity. Residents admitted to study NHs for at least 3 days during the 6 week intervention, without an existing PrU, not using a specialty support surface, and of low, moderate, or high risk for PrU development will be included in analysis based on intention to treat. The outcome, no difference in PrU incidence, will determine whether repositioning frequency can be extended for low, moderate, high risk residents. Medical severity components and clinically assessed risk level will be examined for assessment to assessment change in relation to PrU development, thus identifying severity components associated with new PrUs. Data will be monitored by investigators daily. Data analysis and management will be performed by HSIR. NH staff and resident satisfaction with the intervention approach will be explored using focus groups. This study will advance knowledge about repositioning frequency and clinically assessed PrU risk-level in relation to medical severity. Outcomes of this research will contribute to future guidelines for more precise preventive nursing practices and refinement of PrU prevention guidelines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • NH residents for a minimum of 3 days who use a VE-surface mattress, are without PrUs and are clinically assessed as low, moderate, or high risk for new PrU development will participate in their respective NH-wide repositioning frequency protocol.
  • Participants will include residents at the time of study initiation and any newly admitted residents during the 6-week study period.

排除标准

  • Newly admitted residents (less than 3 days)
  • resident has been diagnosed with pre-existing pressure ulcer
  • PrU Risk is severe (Braden score <= 9)
  • the resident is cared for on a specialty bed (such as a bariatric bed)
  • "do not turn" orders are present
  • Allergy to adhesive

结局指标

主要结局

Determine differences in PrU Incidence among NH in study arms.

时间窗: 4 weeks

Determine differences in the incidence of new PrUs in NH residents at low, moderate, and high risk using VE surfaces and repositioned at 2, 3, or 4 hour frequencies, in nine randomly assigned NHs over a 4-week period. We hypothesize that there will be no significant difference in PrU incidence between the 3 treatment arms in the study using three risk level groups: high risk (Braden Scale Score, 10-12), moderate risk (Braden Scale Score, 13-14), and low risk (Braden Scores \>14). The hypothesis of no group-difference will be tested by examining whether the 95% confidence intervals of the rates of PrU and the 2-hour repositioning overlap. If they do, the hypothesis for no group-difference will be confirmed. Cumulative Incidence rate = \[(# of residents with 1 or more new PrUs during intervention period) ÷ (# of residents participating in intervention for 3 or more days)\] x 100; calculated for the full 4-week intervention period.

次要结局

  • Determine how medical severity components, changes in clinically assessed risk level, repositioning schedule, and their interactions are associated with development of PrUs.(4 weeks)
  • Evaluate cost-effectiveness of PrU prevention intervention approach between NH groups repositioned at 2, 3, or 4 hour intervals.(4 weeks)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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