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临床试验/NCT02283164
NCT02283164已完成不适用

Randomized Controlled Trial to Improve Oncology Nurses' Protective Equipment Use

University of Michigan0 个研究点目标入组 396 人开始时间: 2015年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
396
主要终点
Usage of PPE

研究概览

简要总结

The goal of this research is to evaluate the efficacy of an audit and feedback intervention to improve personal protective equipment (PPE) use by nurses who handle hazardous drugs in the ambulatory oncology setting.

详细描述

The overall objective of the proposed study is to investigate exposures to hazardous antineoplastic drugs among oncology nurses who handle them. The specific project objective is to evaluate the efficacy of an audit and feedback intervention to improve PPE use by nurses who handle hazardous drugs in the ambulatory oncology setting. This project will pursue three specific aims:

  1. Evaluate the efficacy of an audit and feedback intervention to improve recommended use of PPE;
  2. Determine whether the intervention effects on PPE use are mediated by knowledge about PPE use and perceived risk of hazardous drug exposure, and;
  3. Determine whether the intervention effects on PPE use are moderated by personal (experience, education, certification) and organizational factors (workloads, practice environments, safety organizing).

To achieve these aims, 382 nurses employed in 11 oncology centers will participate in a cluster randomized controlled trial. Sites will be randomized so participants will receive a one-hour web-based educational module on hazardous drug safe handling with quarterly email reminders about the educational content (control) or the web-based educational module plus quarterly feedback on hazardous drug spills and drug levels measured in the study population (treatment). The hypothesis is that nurses in sites who receive the treatment will report significantly higher PPE use compared to nurses in sites assigned to receive the control. Data will also identify organizational factors that can be targeted for future interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • registered nurses
  • employed 16 hours or more per week in the ambulatory chemotherapy infusion area

排除标准

  • Treatment with an antineoplastic agent in the past year.

研究组 & 干预措施

Treatment

Experimental

Hazardous materials online education and study feedback

干预措施: Hazardous materials online education and study feedback (Behavioral)

Control then treatment

Active Comparator

Hazardous materials online education and study feedback

干预措施: Hazardous materials online education and study feedback (Behavioral)

结局指标

主要结局

Usage of PPE

时间窗: Baseline (Year 1) and follow-up (Year 3)

Use of PPE is measured on a 6-point Likert scale (5=always, 4=76-99% of the time, 3=51-75%, 2=26-50%, 1=1-25%, and 0=never). A mean score is calculated for each participant across 5 items: use of chemotherapy gloves, double gloves, single-use disposable gowns, eye protection, and respirators. Higher scores reflect more frequent use of PPE elements.

次要结局

  • Potential Moderators--Organization(Baseline (Year 1) and follow-up (Year 3))
  • Potential Moderators--Personal(Baseline (Year 1) and follow-up (Year 3))
  • Potential Mediators(Baseline (Year 1) and follow-up (Year 3))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher R. Friese

Elizabeth Tone Hosmer Professor of Nursing

University of Michigan

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