DEFENS - Drug Exposure Feedback and Education for Nurses' Safety: study protocol for a randomized controlled trial.
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
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.


BACKGROUND
Clinicaltrials.gov NCT02283164 , registered 31 October 2014.
University of Michigan School of Nursing, 400 North Ingalls, #4162, Ann Arbor, MI, USA. cfriese@umich.edu.
Christopher R
CR
Friese
University of Michigan School of Nursing, 400 North Ingalls, #4162, Ann Arbor, MI, USA. karimend@umich.edu.
Kari
K
Mendelsohn-Victor
University of Michigan College of Pharmacy, Pharmacokinetics Core, Ann Arbor, MI, USA. wenb@umich.edu.
Bo
B
Wen
University of Michigan College of Pharmacy, Pharmacokinetics Core, Ann Arbor, MI, USA. duxins@umich.edu.
Duxin
D
Sun
Johns Hopkins University Carey School of Business and School of Medicine, Baltimore, MD, USA. ksutcliffe@jhu.edu.
Kathleen
K
Sutcliffe
University of Michigan School of Nursing, 400 North Ingalls, #4162, Ann Arbor, MI, USA. jjyang@umich.edu.
James J
JJ
Yang
University of Michigan School of Nursing, 400 North Ingalls, #4162, Ann Arbor, MI, USA. dronis@umich.edu.
David L
DL
Ronis
University of Michigan School of Nursing, 400 North Ingalls, #4162, Ann Arbor, MI, USA. mcculla@umich.edu.
Marjorie C
MC
McCullagh
D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001291:Attitude of Health Personnel; D004509:Education, Nursing, Continuing / Q000379:methods*; D030141:Feedback, Psychological; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007263:Infusions, Parenteral; D007318:Inservice Training / Q000379:methods*; D007587:Job Description; D009741:Nursing Staff, Hospital / Q000193:education*; D016273:Occupational Exposure / Q000009:adverse effects*; D016272:Occupational Health / Q000193:education*; D009859:Oncology Nursing / Q000193:education*; D000067393:Personal Protective Equipment; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D014481:United States; D016526:Workload; D017132:Workplace
D000970:Antineoplastic Agents