Details:

Alternative Title:
Trials
Publisher's site:
http://dx.doi.org/10.1186/s13063-015-0674-5
Personal Author:
Friese, Christopher R ; Mendelsohn-Victor, Kari ; Wen, Bo ; Sun, Duxin ; Sutcliffe, Kathleen ; ... More +
Friese, Christopher R ; Mendelsohn-Victor, Kari ; Wen, Bo ; Sun, Duxin ; Sutcliffe, Kathleen ; Yang, James J ; Ronis, David L ; McCullagh, Marjorie C Less -
Corporate Authors:
For the DEFENS Study Investigators
Description:
Background

Three decades of research findings have documented the health effects of handling hazardous drugs. Oncology nurses are vulnerable due to frequent administration of antineoplastics, low adherence to equipment use, reported barriers to use, and perceived low risk of health effects. No interventions have been tested in a controlled, multi-site trial to increase nurses’ use of protective equipment when handling hazardous drugs. The Drug Exposure Feedback and Education for Nurses’ Safety (DEFENS) study will compare the efficacy of education (control) versus an audit and feedback intervention (treatment) on nurses’ self-reported use of personal protective equipment when handling hazardous drugs. The treatment intervention will include tailored messages based on nurses’ reported barriers to protective equipment use.

Methods/Design

The DEFENS Study is a cluster randomized controlled trial. We are enrolling cancer centers and will recruit nurse participants in April 2015. Eligible cancer centers employ at least 20 eligible registered nurses in the chemotherapy infusion setting and have on-site phlebotomy resources. Eligible participants are nurses who work at least 0.40 full-time equivalent hours in the chemotherapy infusion setting and have not received an antineoplastic drug for a health problem in the past year. An encrypted, user-authenticated website will administer surveys and deliver control and treatment interventions. The primary endpoint is the change in score on nurses’ reports of the Revised Hazardous Drug Handling Questionnaire between baseline and approximately 18 months later. A baseline survey is completed after informed consent and is repeated 18 months later. Nurses in all sites who experience a drug spill will also report incidents as they occur; these reports inform the treatment intervention. Plasma will be obtained at baseline, approximately 18 months later (the primary endpoint), and with drug spill occurrences to measure hazardous drugs levels and to inform the treatment intervention. Potential mediators include knowledge of hazardous drug handling and perceived risk of drug exposure. We will examine whether personal factors and organizational factors moderate the intervention effects.

Trial registration

Clinicaltrials.gov NCT02283164, registered 31 October 2014.

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-015-0674-5) contains supplementary material, which is available to authorized users.


Subject:
[+]
Antineoplastic Drugs
Cluster Randomized Trials
Occupational Safety And Health
Oncologic Nursing
Study Protocol
Web-based Interventions

Source:
Trials. 16.
Pubmed ID:
25928792
Pubmed Central ID:
PMC4411718
Document Type:
Journal Article
Funding:
1 R01 OH 010582-01/OH/NIOSH CDC HHS/United States ; R01 OH010582/OH/NIOSH CDC HHS/United States ; UL1 TR000433/TR/NCATS NIH HHS/United States
1 R01 OH 010582-01/OH/NIOSH CDC HHS/United States ; R01 OH010582/OH/NIOSH CDC HHS/United States ; UL1 TR000433/TR/NCATS NIH HHS/United States Less -
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:60c775da907346e14e735c86caccc20b98cc30e7b28ee4ab9aff6c72f67082ab
File Type:

Supporting Files

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  	13063_2015_674_Fig1_HTML.jpg	jpeg
  	13063_2015_674_MOESM1_ESM.docx	docx
  	13063_2015_Article_674.nxml	txt
  	license.txt	txt

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