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Clinical Trials/NCT02283164
NCT02283164
Completed
Not Applicable

Randomized Controlled Trial to Improve Oncology Nurses' Protective Equipment Use

University of Michigan0 sites396 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Occupational Health
Sponsor
University of Michigan
Enrollment
396
Primary Endpoint
Usage of PPE
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
June 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christopher R. Friese

Elizabeth Tone Hosmer Professor of Nursing

University of Michigan

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Treatment with an antineoplastic agent in the past year.

Outcomes

Primary Outcomes

Usage of PPE

Time Frame: 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.

Secondary Outcomes

  • 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))

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