Factors Associated With Job Satisfaction in Medical Oncology Practices: Results From a Multisite Survey.

OBJECTIVE: The aim of this study was to examine the factors influencing job satisfaction of nurses, physicians, and advanced practice providers in ambulatory oncology settings. BACKGROUND: Job satisfaction is essential to clinician well-being and quality of care. METHODS: In 2017, clinicians from 29 ambulatory medical oncology practices completed anonymous paper questionnaires that examined job satisfaction, clinician-to-clinician communication, and perceptions of patient safety. Linear regression, adjusted for clustered observations, examined the relationship between job satisfaction, clinician communication, and patient safety perceptions. RESULTS: Of 280 respondents (response rate of 68%), 85% reported that they were satisfied or very satisfied with their current position. Patient safety and accuracy of clinician communication were positively and significantly associated with job satisfaction. CONCLUSIONS: Although most surveyed clinicians were satisfied, 15% were dissatisfied and reported communication and safety concerns. Leadership efforts to strengthen clinician communication actions and develop positive safety cultures are promising strategies to promote clinician well-being and high-quality cancer care.

Application of an innovative high-throughput liquid chromatography-tandem mass spectrometry method for simultaneous analysis of 18 hazardous drugs to rule out accidental acute chemotherapy exposures in health care workers.

OBJECTIVES: Despite safe handling guidelines published by several groups, health care worker exposure to hazardous drugs continues to occur due to suboptimal engineering controls and low use of protective equipment. Simple, multi-target and specific analytical methods are needed so that acute exposures to these drugs in the workplace can be assessed rapidly. Our aim was to develop an analytical method for simultaneous detection and quantification of widely used cancer drugs to rule out accidental acute chemotherapy exposures in health care workers. METHODS: We examined the feasibility of alternate high-performance liquid chromatographic-tandem mass spectrometry methods to simultaneously detect eighteen chemotherapy analytes in plasma and urine. The linear concentration ranges tested during assay development were 0.1-50 ng/mL. After development of a multi-analyte assay protocol, plasma samples (n = 743) from a multi-center cluster-randomized clinical trial (n = 12 sites) of an hazardous drug educational intervention were assayed. Confirmatory assays were performed based on the individual acute-spill case-histories. RESULTS: An innovative HPLC-multiple reaction monitoring-information dependent acquisition-enhanced production ion (MRM-IDA-EPI) analytical method was developed to simultaneously detect: cytarabine, gemcitabine, dacarbazine, methotrexate, topotecan, mitomycin, pemetrexed, irinotecan, doxorubicin, vincristine, vinblastine, ifosamide, cyclophosphamide, vinorelbine, bendamustine, etoposide, docetaxel, and paclitaxel. The retention times ranged from 4 min to 13 min for the analytical run. The limit of detection (MRM-IDA-EPI) and limit of quantitation (MRM) was 0.25 ng/mL and 0.1 ng/mL, respectively for most analytes. No detectable plasma concentrations were measured at baseline, post-intervention and in cases of documented acute spills. Use of a secondary tandem mass spectrometry approach was able to successfully rule out false positive results. CONCLUSIONS: Development of a sensitive high-throughput multi-analyte cancer chemotherapy assay is feasible using an MRM-IDA-EPI method. This method can be used to rapidly rule out systemic exposure to accidental acute chemotherapy spills in health care workers.

Disparities in genetic services utilization in a random sample of young breast cancer survivors.

PURPOSE: Increasing use of genetic services (counseling/testing) among young breast cancer survivors (YBCS) can help decrease breast cancer incidence and mortality. The study examined use of genetic services between Black and White/Other YBCS, attitudes and knowledge of breast cancer risk factors, and reasons for disparities in using genetic services. METHODS: We used baseline data from a randomized control trial including a population-based, stratified random sample of 3000 potentially eligible YBCS, with oversampling of Black YBCS. RESULTS: Among 883 YBCS (353 Black, 530 White/Other) were significant disparities between the two racial groups. More White/Other YBCS had received genetic counseling and had genetic testing than Blacks. Although White/Other YBCS resided farther away from board-certified genetic counseling centers, they had fewer barriers to access these services. Black race, high out-of-pocket costs, older age, and more years since diagnosis were negatively associated with use of genetic services. Black YBCS had lower knowledge of breast cancer risk factors. Higher education and genetic counseling were associated with higher genetic knowledge. CONCLUSION: Racial inequalities of cost-related access to care and education create disparities in genetic services utilization. System-based interventions that reduce socioeconomic disparities and empower YBCS with genetic knowledge, as well as physician referrals, can increase access to genetic services.

Surveillance for cancer recurrence in long-term young breast cancer survivors randomly selected from a statewide cancer registry.

PURPOSE: This study examined clinical breast exam (CBE) and mammography surveillance in long-term young breast cancer survivors (YBCS) and identified barriers and facilitators to cancer surveillance practices. METHODS: Data collected with a self-administered survey from a statewide, randomly selected sample of YBCS diagnosed with invasive breast cancer or ductal carcinoma in situ younger than 45 years old, stratified by race (Black vs. White/Other). Multivariate logistic regression models identified predictors of annual CBEs and mammograms. RESULTS: Among 859 YBCS (n = 340 Black; n = 519 White/Other; mean age = 51.0 ± 5.9; diagnosed 11.0 ± 4.0 years ago), the majority (> 85%) reported an annual CBE and a mammogram. Black YBCS in the study were more likely to report lower rates of annual mammography and more barriers accessing care compared to White/Other YBCS. Having a routine source of care, confidence to use healthcare services, perceived expectations from family members and healthcare providers to engage in cancer surveillance, and motivation to comply with these expectations were significant predictors of having annual CBEs and annual mammograms. Cost-related lack of access to care was a significant barrier to annual mammograms. CONCLUSIONS: Routine source of post-treatment care facilitated breast cancer surveillance above national average rates. Persistent disparities regarding access to mammography surveillance were identified for Black YBCS, primarily due to lack of access to routine source of care and high out-of-pocket costs. IMPLICATIONS: Public health action targeting cancer surveillance in YBCS should ensure routine source of post-treatment care and address cost-related barriers. Clinical Trials Registration Number: NCT01612338.

Recruiting families at risk for hereditary breast and ovarian cancer from a statewide cancer registry: a methodological study.

PURPOSE: Cancer genetic services (counseling/testing) are recommended for women diagnosed with breast cancer younger than 45 years old (young breast cancer survivors-YBCS) and at-risk relatives. We present recruitment of YBCS, identification and recruitment of at-risk relatives, and YBCS willingness to contact their cancer-free, female relatives. METHODS: A random sample of 3,000 YBCS, stratified by race (Black vs. White/Other), was identified through a population-based cancer registry and recruited in a randomized trial designed to increase use of cancer genetic services. Baseline demographic, clinical, and family characteristics, and variables associated with the Theory of Planned Behavior (TPB) were assessed as predictors of YBCS' willingness to contact at-risk relatives. RESULTS: The 883 YBCS (33.2% response rate; 40% Black) who returned a survey had 1,875 at-risk relatives and were willing to contact 1,360 (72.5%). From 853 invited at-risk relatives (up to two relatives per YBCS), 442 responded (51.6% response rate). YBCS with larger families, with a previous diagnosis of depression, and motivated to comply with recommendations from family members were likely to contact a greater number of relatives. Black YBCS were more likely to contact younger relatives and those living further than 50 miles compared to White/Other YBCS. CONCLUSION: It is feasible to recruit diverse families at risk for hereditary cancer from a population-based cancer registry. This recruitment approach can be used as a paradigm for harmonizing processes and increasing internal and external validity of large-scale public health genomic initiatives in the era of precision medicine.

Lessons Learned From a Practice-Based, Multisite Intervention Study With Nurse Participants.

PURPOSE: To identify challenges and solutions to the efficient conduct of a multisite, practice-based randomized controlled trial to improve nurses' adherence to personal protective equipment use in ambulatory oncology settings. DESIGN: The Drug Exposure Feedback and Education for Nurses' Safety (DEFENS) study is a clustered, randomized, controlled trial. Participating sites are randomized to Web-based feedback on hazardous drug exposures in the sites plus tailored messages to address barriers versus a control intervention of a Web-based continuing education video. APPROACH: The study principal investigator, the study coordinator, and two site leaders identified challenges to study implementation and potential solutions, plus potential methods to prevent logistical challenges in future studies. FINDINGS: Noteworthy challenges included variation in human subjects' protection policies, grants and contracts budgeting, infrastructure for nursing-led research, and information technology variation. Successful strategies included scheduled Web conferences, site-based study champions, site visits by the principal investigator, and centrally based document preparation. Strategies to improve efficiency in future studies include early and continued engagement with contract personnel in sites, and proposed changes to the common rule concerning human subjects. The DEFENS study successfully recruited 393 nurses across 12 sites. To date, 369 have completed surveys and 174 nurses have viewed educational materials. CONCLUSIONS: Multisite studies of nursing personnel are rare and challenging to the existing infrastructure. These barriers can be overcome with strong engagement and planning. CLINICAL RELEVANCE: Leadership engagement, onsite staff support, and continuous communication can facilitate successful recruitment to a workplace-based randomized, controlled behavioral trial.

Patient-reported outcomes collected in ambulatory oncology practices: Feasibility, patterns, and correlates.

OBJECTIVE: To examine the feasibility of soliciting outcomes from adults who received chemotherapy treatment for cancer and describe the patterns and correlates of patient-reported toxicities. DATA SOURCES: Patient survey data from 29 Michigan ambulatory oncology practices collected in 2017. STUDY DESIGN: Secondary analysis of patient survey data. Descriptive statistics were generated at the patient and practice levels. Thematic analysis of open-text comments identified clusters of frequently reported toxicities. DATA COLLECTION METHODS: Patients completed 11 items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. Using a 5-point Likert scale, patients rated the frequency of nausea, vomiting, diarrhea, and pain; the severity of nausea, vomiting, constipation, numbness/tingling, and pain; and how much numbness/tingling and pain interfered with usual or daily activities. Patients could also report two toxicities in open-text comments. Finally, patients reported unplanned health care service for toxicity or side effect management. PRINCIPAL FINDINGS: Of 3565 eligible patients, 2245 participated (63%) and 457 (20%) rated at least one toxicity as severe/very severe. Across practices, the proportion of patients who reported at least one severe/very severe toxicity ranged from 8% to 50%. Troubling toxicities included pain frequency (mean 2.3, SD 1.3), pain severity (2.1, 1.1), and diarrhea frequency (1.9, 1.0). From completed assessments, 1653 (74%) reported at least one toxicity in open-text comments; fatigue (n = 182), stomach discomfort (n = 53), and skin/nail changes (n = 41) were most frequently reported. Regarding consequences, 156 patients (7%) reported unplanned health care service use: 41 (26%) visited an emergency department and 32 (21%) were admitted to a hospital. CONCLUSIONS: Querying patients on chemotherapy treatment experiences and toxicities was feasible. Toxicity rates varied across practices, which informed quality improvement. Toxicity severity and service use incidence exceed previously published trial data, particularly for pain, fatigue, and gastrointestinal issues. Open-text questions enabled exploration with newer treatment regimens.

Facilitators and Barriers to Recruiting Ambulatory Oncology Practices Into a Large Multisite Study: Mixed Methods Study.

BACKGROUND: Practice-based research is essential to generate the data necessary to understand outcomes in ambulatory oncology care. Although there is an increased interest in studying ambulatory oncology care, given the rising patient volumes and complexity in those settings, little guidance is available on how best to recruit ambulatory oncology practices for research. OBJECTIVE: This paper aimed to describe the facilitators and barriers to recruiting ambulatory oncology practices into a large multisite study. METHODS: Using a mixed methods design, we sought to recruit 52 ambulatory oncology practices that have participated in a state-wide quality improvement collaborative for the quantitative phase. We used 4 domains of the Consolidated Framework for Implementation Research (CFIR) to describe facilitators and barriers to recruitment. RESULTS: We successfully recruited 28 of the 52 collaborative-affiliated practices, collecting survey data from 2223 patients and 297 clinicians. Intervention attributes included multimodal outreach and training activities to assure high fidelity to the data collection protocol. The implementation process was enhanced through interactive training and practice-assigned champions responsible for data collection. External context attributes that facilitated practice recruitment included partnership with a quality improvement collaborative and the inclusion of a staff member from the collaborative in our team. Key opinion leaders within each practice who could identify challenges to participation and propose flexible solutions represented internal context attributes. We also reported lessons learned during the recruitment process, which included navigating diverse approaches to human subjects protection policies and understanding that recruitment could be a negotiated process that took longer than anticipated, among others. CONCLUSIONS: Our experience provides other researchers with challenges to anticipate and possible solutions for common issues. Using the CFIR as a guide, we identified numerous recruitment barriers and facilitators and devised strategies to enhance recruitment efforts. In conclusion, researchers and clinicians can partner effectively to design and implement research protocols that ultimately benefit patients who are increasingly seeking care in ambulatory practices.

Hazardous Drug Exposure: Case Report Analysis From a Prospective, Multisite Study of Oncology Nurses' Exposure in Ambulatory Settings.

BACKGROUND: Hazardous drug exposure is an occupational health hazard to oncology nurses. Sparse data are available regarding the frequency and characteristics of hazardous drug spills. OBJECTIVES: This article aims to describe nurses' hazardous drug exposures and use of personal protective equipment during drug spills. METHODS: The Drug Exposure Feedback and Education for Nurses' Safety study launched in March 2015. When drug spills occurred, consented RNs administering chemotherapy in ambulatory infusion settings completed brief questionnaires. Descriptive statistics were used to summarize equipment use and spill events. FINDINGS: Spills were common, despite the use of closed-system transfer devices. Over two years, 51 nurses from 12 participating academic infusion centers reported 61 unique spills. Spills commonly involved highly toxic drugs. Personal protective equipment use during drug spills was suboptimal. These foundational data reveal gaps in clinical practice.

Genetic Testing and Surveillance of Young Breast Cancer Survivors and Blood Relatives: A Cluster Randomized Trial.

We compared a tailored and a targeted intervention designed to increase genetic testing, clinical breast exam (CBE), and mammography in young breast cancer survivors (YBCS) (diagnosed <45 years old) and their blood relatives. A two-arm cluster randomized trial recruited a random sample of YBCS from the Michigan cancer registry and up to two of their blood relatives. Participants were stratified according to race and randomly assigned as family units to the tailored (n = 637) or the targeted (n = 595) intervention. Approximately 40% of participants were Black. Based on intention-to-treat analyses, YBCS in the tailored arm reported higher self-efficacy for genetic services (p = 0.0205) at 8-months follow-up. Genetic testing increased approximately 5% for YBCS in the tailored and the targeted arm (p ≤ 0.001; p < 0.001) and for Black and White/Other YBCS (p < 0.001; p < 0.001). CBEs and mammograms increased significantly in both arms, 5% for YBCS and 10% for relatives and were similar for Blacks and White/Others. YBCS and relatives needing less support from providers reported significantly higher self-efficacy and intention for genetic testing and surveillance. Black participants reported significantly higher satisfaction and acceptability. Effects of these two low-resource interventions were comparable to previous studies. Materials are suitable for Black women at risk for hereditary breast/ovarian cancer (HBOC).

Randomized Controlled Trial of an Intervention to Improve Nurses' Hazardous Drug Handling

OBJECTIVES: To evaluate whether a web-based educational intervention improved personal protective equipment (PPE) use among oncology nurses who handle hazardous drugs. SAMPLE & SETTING: From 2015 to 2017, the authors partnered with 12 ambulatory oncology settings in the United States to enroll 396 nurses, 257 of whom completed baseline and primary endpoint surveys. METHODS & VARIABLES: In a cluster randomized controlled trial, 136 nurses in control settings received a one-hour educational module on PPE use with quarterly reminders, and 121 nurses in treatment settings received the control intervention plus tailored messages to address perceived barriers and quarterly data gathered on hazardous drug spills across all study settings. The primary outcome was nurse-reported PPE use. RESULTS: Control and intervention sites had suboptimal PPE use before and after the intervention. No significant differences were observed in PPE use knowledge or perceived barriers. Participants reported high satisfaction with the study experience. IMPLICATIONS FOR NURSING: Hazardous drug exposure confers notable health risks to healthcare workers. To improve hazardous drug handling, occupational healthcare workers, health systems, and professional organizations should consider coordinated efforts to implement policy and practice changes.

Clinician Perspectives on Electronic Health Records, Communication, and Patient Safety Across Diverse Medical Oncology Practices.

PURPOSE: We know little about how increased technological sophistication of clinical practices affects safety of chemotherapy delivery in the outpatient setting. This study investigated to what degree electronic health records (EHRs), satisfaction with technology, and quality of clinician-to-clinician communication enable a safety culture. METHODS: We measured actions consistent with a safety culture, satisfaction with practice technology, and quality of clinician communication using validated instruments among 297 oncology nurses and prescribers in a statewide collaborative. We constructed an index to reflect practice reliance on EHRs (1 = "all paper" to 5 = "all electronic"). Linear regression models (with robust SEs to account for clustering) examined relationships between independent variables of interest and safety. Models were adjusted for clinician age. RESULTS: The survey response rate was 68% (76% for nurses and 59% for prescribers). The mean (standard deviation) safety score was 5.3 (1.1), with a practice-level range of 4.9 to 5.4. Prescribers reported fewer safety actions than nurses. Higher satisfaction with technology and higher-quality clinician communication were significantly associated with increased safety actions, whereas increased reliance on EHRs was significantly associated with lower safety actions. CONCLUSION: Practices vary in their performance of patient safety actions. Supporting clinicians to integrate technology and strengthen communication are promising intervention targets. The inverse relationship between reliance on EHRs and safety suggests that technology may not facilitate clinicians' ability to attend to patient safety. Efforts to improve cancer care quality should focus on more seamless integration of EHRs into routine care delivery and emphasize increasing the capacity of all care clinicians to communicate effectively and coordinate efforts when administering high-risk treatments in ambulatory settings.

Development of a Web-based Family Intervention for BRCA Carriers and Their Biological Relatives: Acceptability, Feasibility, and Usability Study.

BACKGROUND: Carriers of breast cancer gene (BRCA) mutations are asked to communicate genetic test results to their biological relatives to increase awareness of cancer risk and promote use of genetic services. This process is highly variable from family to family. Interventions that support communication of genetic test results, coping, and offer decision support in families harboring a pathogenic variant may contribute to effective management of hereditary cancer. OBJECTIVE: The aim of this paper was to describe the development of the Family Gene Toolkit, a Web-based intervention targeting BRCA carriers and untested blood relatives, designed to enhance coping, family communication, and decision making. METHODS: We present findings from focus groups regarding intervention acceptability and participant satisfaction and from a pre-post pilot study with random allocation to a wait-listed control group regarding intervention feasibility and usability. RESULTS: The Family Gene Toolkit was developed by a multidisciplinary team as a psycho-educational and skills-building intervention. It includes two live webinar sessions and a follow-up phone call guided by a certified genetic counselor and a master's prepared oncology nurse. Each live webinar includes two modules (total four modules) presenting information about BRCA mutations, a decision aid for genetic testing, and two skill-building modules for effective coping and family communication. Participants in focus groups (n=11) were highly satisfied with the intervention, reporting it to be useful and describing clearly the important issues. From the 12 dyads recruited in the pre-post pilot study (response rate 12/52, 23%), completion rate was 71% (10/14) for intervention and 40% (4/10) for wait-listed control groups. CONCLUSIONS: Acceptability and satisfaction with the Family Gene Toolkit is high. On the basis of the findings from usability and feasibility testing, modifications on timing, delivery mode, and recruitment methods have been implemented. TRIAL REGISTRATION: ClinicalTrials.gov NCT02154633; https://clinicaltrials.gov/ct2/show/NCT02154633 (Archived by WebCite at http://www.webcitation.org/6yYNvLPjv).

Personal Protective Equipment Use and Hazardous Drug Spills Among Ambulatory Oncology Nurses

Purpose/Objectives: To examine patterns and organizational correlates of personal protective equipment (PPE) use and hazardous drug spills. Design: Cross-sectional mailed survey. Setting: Ambulatory practices in California, Georgia, and Michigan. Sample: 252 Oncology Nursing Society members who administer hazardous drugs. Methods: Bivariate and multivariable regression analyses. Main Research Variables: Outcomes were PPE use and hazardous drug spills. Covariates included nursing workloads, nurses' practice environments, and barriers to PPE use. Findings: Twenty-six percent reported a recent drug spill, and 90% wore only one pair of chemotherapy-tested gloves. Increased PPE use was associated with increased nurse participation in practice affairs, nonprivate ownership, increased nursing workloads, and fewer barriers to PPE use. Spills were associated with significantly less favorable manager leadership and support and higher workloads. Conclusions: Drug spills occur often in ambulatory settings. PPE use remains low, and barriers to PPE use persist. Higher workloads are associated with more drug spills. Implications for Practice: Managers should monitor and correct aberrant workloads and ensure that PPE is available and that staff are trained.

Toxicity-Related Factors Associated With Use of Services Among Community Oncology Patients.

PURPOSE: Community oncology practices frequently manage chemotherapy-associated toxicities, which may disrupt treatment, impair quality of life, and induce unplanned service use. We sought to understand the patterns and correlates of unplanned health care service use among patients receiving first-cycle chemotherapy at five community-based ambulatory oncology practices. PATIENTS AND METHODS: A survey study examined the dichotomous outcome of unplanned service use, defined as oncologist visits, emergency department visits, and hospitalizations, resulting from toxicity-related factors. Newly diagnosed patients with breast, lung, head and neck, or colorectal cancer or non-Hodgkin lymphoma were recruited during the first chemotherapy cycle. Before beginning the second cycle of chemotherapy, patients completed a questionnaire that measured unplanned service use and overall distress, plus severity of nausea, vomiting, diarrhea, constipation, mouth sores, intravenous catheter problems, pain, fever and chills, extremity edema, and dyspnea on a 5-point scale (1, did not experience; 5, disabling). Medical record reviews captured chemotherapy doses, comorbid conditions, and supportive care interventions. Mixed-effects logistic regression was used to identify factors associated with unplanned service use, with random effects specified for each clinic. RESULTS: Among 106 patients (white, 98%; female, 74.5%; mean age ± standard deviation, 60 ± 11 years), frequently reported toxicities were pain, nausea, diarrhea, and constipation. Thirty-six patients (34%) reported unplanned service use: 29% reported oncologist visits, 14% reported emergency department visits, and 8% reported hospitalizations. Factors significantly associated with unplanned service use were high patient-reported distress and receipt of colony-stimulating factor. CONCLUSION: Service use resulting from toxicity-related factors occurs frequently in community oncology settings. Monitoring toxicity patterns and outcomes can inform proactive symptom management approaches to reduce toxicity burden between scheduled visits.

Use of Cancer Genetics Services in African-American Young Breast Cancer Survivors.

INTRODUCTION: African-American women have higher rates of early-onset breast cancer compared with their Caucasian counterparts; yet, when diagnosed with breast cancer at a young age, they underuse genetic counseling and testing to manage their risk of developing future cancers. METHODS: Self-reported baseline data were collected between September 2012 and January 2013 and analyzed in 2014 from a subpopulation of 340 African-American young breast cancer survivors (YBCSs) enrolled in an RCT. YBCSs were diagnosed with invasive breast cancer or ductal carcinoma in situ between ages 20 and 45 years and were randomly selected from a statewide cancer registry. Logistic regression examined predictors of using cancer genetics services. RESULTS: Overall, 28% of the sample reported having genetic counseling and 21% reported having genetic testing, which were significantly lower (p≤0.005) compared with white/other YBCSs participating in the parent study. In a multivariate analysis, income was positively associated with counseling (B=0.254, p≤0.01) and testing (B=0.297, p≤0.01), whereas higher education levels (B=-0.328, p≤0.05) and lack of access to healthcare services owing to cost (B=-1.10, p≤0.03) were negatively associated with genetic counseling. Lower income and lack of care because of high out-of-pocket costs were commonly reported barriers. CONCLUSIONS: Despite national recommendations for genetic evaluation among women with early-onset breast cancer, few African-American YBCSs reported undergoing genetic counseling and testing. Most reported that their healthcare provider did not recommend these services. Interventions addressing patient, provider, and structural healthcare system barriers to using genetic counseling and testing in this population are needed.

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/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.

Markers of inflammation and coagulation after long-term exposure to coarse particulate matter: a cross-sectional analysis from the multi-ethnic study of atherosclerosis.

BACKGROUND: Toxicological research suggests that coarse particles (PM10-2.5) are inflammatory, but responses are complex and may be best summarized by multiple inflammatory markers. Few human studies have investigated associations with PM10-2.5 and, of those, none have explored long-term exposures. Here we examine long-term associations with inflammation and coagulation in the Multi-Ethnic Study of Atherosclerosis. METHODS: Participants included 3,295 adults (45-84 years of age) from three metropolitan areas. Site-specific spatial models were used to estimate 5-year concentrations of PM10-2.5 mass and copper, zinc, phosphorus, silicon, and endotoxin found in PM10-2.5. Outcomes included interleukin-6, C-reactive protein, fibrinogen, total homocysteine, D-dimer, factor VIII, plasmin-antiplasmin complex, and inflammation and coagulation scores. We used multivariable regression with multiply imputed data to estimate associations while controlling for potential confounders, including co-pollutants such as fine particulate matter. RESULTS: Some limited evidence was found of relationships between inflammation and coagulation and PM10-2.5. Endotoxin was the PM10-2.5 component most strongly associated with inflammation, with an interquartile range (IQR) increase (0.08 EU/m3) associated with 0.15 (95% CI: 0.01, 0.28; p = 0.03) and 0.08 (95% CI: -0.07, 0.23; p = 0.28) higher inflammation scores before and after control for city, respectively. Copper was the component with the strongest association with coagulation, with a 4-ng/m3 increase associated with 0.19 (95% CI: 0.08, 0.30; p = 0.0008) and 0.12 (95% CI: -0.05, 0.30; p = 0.16) unit higher coagulation scores before and after city adjustment, respectively. CONCLUSIONS: Our cross-sectional analysis provided some evidence that long-term PM10-2.5 exposure was associated with inflammation and coagulation, but associations were modest and depended on particle composition.