Drug Exposure Feedback and Education for Nurses' Safety
DEFENS
Randomized Controlled Trial to Improve Oncology Nurses' Protective Equipment Use
1 other identifier
interventional
396
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2014
CompletedFirst Posted
Study publicly available on registry
November 5, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedSeptember 4, 2019
August 1, 2019
2.1 years
October 31, 2014
August 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Usage of PPE
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.
Baseline (Year 1) and follow-up (Year 3)
Secondary Outcomes (3)
Potential Mediators
Baseline (Year 1) and follow-up (Year 3)
Potential Moderators--Organization
Baseline (Year 1) and follow-up (Year 3)
Potential Moderators--Personal
Baseline (Year 1) and follow-up (Year 3)
Study Arms (2)
Treatment
EXPERIMENTALHazardous materials online education and study feedback
Control then treatment
ACTIVE COMPARATORHazardous materials online education and study feedback
Interventions
Participants will receive a 45-minute educational webinar on hazardous materials handing best practices at the beginning of the intervention period. Subsequently they will receive quarterly feedback of interim study results.
Eligibility Criteria
You may qualify if:
- registered nurses
- employed 16 hours or more per week in the ambulatory chemotherapy infusion area
You may not qualify if:
- Treatment with an antineoplastic agent in the past year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 25928792BACKGROUNDFriese 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.
PMID: 30767961BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher R Friese, PhD
University of Michigan School of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Elizabeth Tone Hosmer Professor of Nursing
Study Record Dates
First Submitted
October 31, 2014
First Posted
November 5, 2014
Study Start
March 1, 2015
Primary Completion
April 1, 2017
Study Completion
June 30, 2019
Last Updated
September 4, 2019
Record last verified: 2019-08