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

Christopher R Friese, Kari Mendelsohn-Victor, Bo Wen, Duxin Sun, Kathleen Sutcliffe, James J Yang, David L Ronis, Marjorie C McCullagh, DEFENS Study Investigators, Christopher R Friese, Kari Mendelsohn-Victor, Bo Wen, Duxin Sun, Kathleen Sutcliffe, James J Yang, David L Ronis, Marjorie C McCullagh, DEFENS Study Investigators

Abstract

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.

Figures

Figure 1
Figure 1
Conceptual framework. NIOSH: National Institute for Occupational Safety and Health. ONS: Oncology Nursing Society.

References

    1. Stellman JM, Aufiero BM, Taub RN. Assessment of potential exposure to antineoplastic agents in the health care setting. Prev Med. 1984;13:245–55. doi: 10.1016/0091-7435(84)90082-3.
    1. Connor TH, McDiarmid MA. Preventing occupational exposures to antineoplastic drugs in health care settings. CA Cancer J Clin. 2006;56:354–65. doi: 10.3322/canjclin.56.6.354.
    1. Fransman W, Roeleveld N, Peelen S, de Kort W, Kromhout H, Heederik D. Nurses with dermal exposure to antineoplastic drugs: reproductive outcomes. Epidemiology. 2007;18:112–9. doi: 10.1097/01.ede.0000246827.44093.c1.
    1. Valanis B, Vollmer WM, Steele P. Occupational exposure to antineoplastic agents: self-reported miscarriages and stillbirths among nurses and pharmacists. J Occup Environ Med. 1999;41:632–8. doi: 10.1097/00043764-199908000-00004.
    1. Fransman W, Peelen S, Hilhorst S, Roeleveld N, Heederik D, Kromhout H. A pooled analysis to study trends in exposure to antineoplastic drugs among nurses. Ann Occup Hyg. 2007;51:231–9. doi: 10.1093/annhyg/mel081.
    1. Burroughs GE, Connor TH, McDiarmid MA, Mead KR, Power LA, Reed LD. Preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: National Institute for Occupational Safety and Health, NIOSH publication number 2004–165; 2004.
    1. Polovich M. Safe handling of hazardous drugs. 2. Pittsburgh, PA: Oncology Nursing Press; 2011.
    1. American Society of Health-System Pharmacists ASHP guidelines on handling hazardous drugs. Am J Health Syst Pharm. 2006;63:1172–93. doi: 10.2146/ajhp050529.
    1. Neuss MN, Polovich M, McNiff K, Esper P, Gilmore TR, LeFebvre KB, et al. 2013 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards Including Standards for the Safe Administration and Management of Oral Chemotherapy. J Oncol Pract. 2013;9(2s):5s–13. doi: 10.1200/JOP.2013.000874.
    1. Polovich M, Martin S. Nurses’ use of hazardous drug-handling precautions and awareness of national safety guidelines. Oncol Nurs Forum. 2011;38:718–26. doi: 10.1188/11.ONF.718-726.
    1. Friese CR, Himes-Ferris L, Frasier MN, McCullagh MC, Griggs JJ. Structures and processes of care in ambulatory oncology settings and nurse-reported exposure to chemotherapy. BMJ Qual Saf. 2012;21:753–9. doi: 10.1136/bmjqs-2011-000178.
    1. Centers for Disease Control and Prevention. National Ambulatory Medical Care Survey: 2010 summary tables. . Accessed April 4, 2015.
    1. Grol R, Grimshaw J. From best evidence to best practice: effective implementation of change in patients’ care. Lancet. 2003;362(9391):1225–30. doi: 10.1016/S0140-6736(03)14546-1.
    1. Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, O’Brien MA, et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012;6:CD000259.
    1. Keat CH, Sooaid NS, Yun CY, Sriraman M. Improving safety-related knowledge, attitude, and practices of nurses handling cytotoxic anticancer drug(s): pharmacists’ experience in a general hospital, Malaysia. Asian Pac J Cancer Prev. 2013;14(1):69–73. doi: 10.7314/APJCP.2013.14.1.69.
    1. Kamimura A, Schneider K, Lee CS, Crawford SD, Friese CR. Practice environments of nurses in ambulatory oncology settings: a thematic analysis. Cancer Nurs. 2012;35(1):E1–7. doi: 10.1097/NCC.0b013e31820b6efa.
    1. Vogus T, Sutcliffe K, Weick K. Doing no harm: enabling, enacting, and elaborating a culture of safety in health care. Acad Manag Perspect. 2010;24:60–77.
    1. McCullagh M, Lusk SL, Ronis DL. Factors influencing use of hearing protection among farmers: a test of the Pender Health Promotion Model. Nurs Res. 2002;51(1):33–9. doi: 10.1097/00006199-200201000-00006.
    1. Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A. Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care. 2005;14(1):26–33. doi: 10.1136/qshc.2004.011155.
    1. Martin S, Larson E. Chemotherapy-handling practices of outpatient and office-based oncology nurses. Oncol Nurs Forum. 2003;30(4):575–81. doi: 10.1188/03.ONF.575-581.
    1. Geer LA, Anna D, Curbow B, Diener-West M, van Wendel de Joode B, Mitchell C, et al. Survey assessment of worker dermal exposure and underlying behavioral determinants. J Occup Environ Hyg. 2007;4(11):809–20. doi: 10.1080/15459620701612722.
    1. Vogus TJ, Sutcliffe KM. The safety organizing scale: development and validation of a behavioral measure of safety culture in hospital nursing units. Med Care. 2007;45(1):46–54. doi: 10.1097/01.mlr.0000244635.61178.7a.
    1. Connor TH, DeBord DG, Pretty JR, Oliver MS, Roth TS, Lees PS, et al. Evaluation of antineoplastic drug exposure of health care workers at three university-based US cancer centers. J Occup Environ Med. 2010;52(10):1019–27. doi: 10.1097/JOM.0b013e3181f72b63.
    1. Dillman DA. Mail and internet surveys: the tailored design method. 2. New York: Wiley and Sons; 2007.
    1. Cato J. User-centered web design. Boston: Addison Wesley Longman; 2001.
    1. NIOSH. Hazardous drug exposures in health care. . Accessed April 4, 2015
    1. Polovich M, Clark PC. Factors influencing oncology nurses’ use of hazardous drug safe-handling precautions. Oncol Nurs Forum. 2012;39(3):E299–309. doi: 10.1188/12.ONF.E299-E309.
    1. Kalisch BJ, Friese CR, Choi SH, Rochman M. Hospital nurse staffing: choice of measure matters. Med Care. 2011;49(8):775–9. doi: 10.1097/MLR.0b013e318222a6df.
    1. Friese CR, Lake ET, Aiken LH, Silber JH, Sochalski J. Hospital nurse practice environments and outcomes for surgical oncology patients. Health Serv Res. 2008;43(4):1145–63. doi: 10.1111/j.1475-6773.2007.00825.x.
    1. Clarke S. Organizational climate, staffing, and safety equipment as predictors of needlestick injuries and near-misses in hospital nurses. Am J Infect Control. 2002;30(4):207–16. doi: 10.1067/mic.2002.123392.
    1. Lake ET. The nursing practice environment: measurement and evidence. Med Care Res Rev. 2007;64(2 Suppl):104S–22. doi: 10.1177/1077558707299253.
    1. Friese CR. Practice environments of nurses employed in ambulatory oncology settings: measure refinement. Oncol Nurs Forum. 2012;39(2):166–72. doi: 10.1188/12.ONF.166-172.
    1. Guitton J, Cohen S, Tranchand B, Vignal B, Droz J-P, Guillaumont M, et al. Quantification of docetaxel and its main metabolites in human plasma by liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom. 2005;19(17):2419–26. doi: 10.1002/rcm.2072.
    1. U.S. Department of Health and Human Services. Guidance for the industry: bioanalytical method validation. . Accessed April 4, 2015.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) - a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81. doi: 10.1016/j.jbi.2008.08.010.
    1. Li Y, Baron J. Behavioral research data analysis with R. New York: Springer; 2011.
    1. Brown H, Prescott R. Applied mixed models in medicine. 2. West Sussex: Wiley; 2006.
    1. Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986;51(6):1173–82. doi: 10.1037/0022-3514.51.6.1173.
    1. Spybrook J, Bloom H, Congdon R, Hill C, Martinez A, Raudenbush S. Optimal design plus empirical evidence: documentation of the 'Optimal Design' software. . Accessed April 4, 2015.
    1. Cohen J. Statistical power analysis for the behavioral sciences. 2. Hillsdale: Lawrence Erlbaum Associates; 1988.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться