Randomized Controlled Trial to Improve Oncology Nurses' Protective Equipment Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 396
- Primary Endpoint
- Usage of PPE
Study 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:
- Evaluate the efficacy of an audit and feedback intervention to improve recommended use of PPE;
- Determine whether the intervention effects on PPE use are mediated by knowledge about PPE use and perceived risk of hazardous drug exposure, and;
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Treatment
Hazardous materials online education and study feedback
Intervention: Hazardous materials online education and study feedback (Behavioral)
Control then treatment
Hazardous materials online education and study feedback
Intervention: Hazardous materials online education and study feedback (Behavioral)
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))
Investigators
Christopher R. Friese
Elizabeth Tone Hosmer Professor of Nursing
University of Michigan