Clinical trial NCT02283164: Drug Exposure Feedback and Education for Nurses' Safety
Official title: Randomized Controlled Trial to Improve Oncology Nurses' Protective Equipment Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Health
Hazardous Material Handling
Keywords: Occupational health
Hazardous material handling
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2014-11-05
Enrollment: 396
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Usage of PPE
timeFrame: Baseline (Year 1) and follow-up (Year 3)
Secondary outcomes:
measure: Potential Mediators
timeFrame: Baseline (Year 1) and follow-up (Year 3)
measure: Potential Moderators--Organization
timeFrame: Baseline (Year 1) and follow-up (Year 3)
measure: Potential Moderators--Personal
timeFrame: Baseline (Year 1) and follow-up (Year 3)
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan School of Nursing
name: Christopher R Friese, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friese CR, Mendelsohn-Victor K, Wen B, Sun D, Sutcliffe K, Yang JJ, Ronis DL, McCullagh MC; DEFENS Study Investigators. DEFENS - Drug Exposure Feedback and Education for Nurses' Safety: study protocol for a randomized controlled trial. Trials. 2015 Apr 17;16:171. doi: 10.1186/s13063-015-0674-5.
citation: Friese CR, Yang J, Mendelsohn-Victor K, McCullagh M. Randomized Controlled Trial of an Intervention to Improve Nurses' Hazardous Drug Handling. Oncol Nurs Forum. 2019 Mar 1;46(2):248-256. doi: 10.1188/19.ONF.248-256.