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Worldwide, nurses have been reporting high levels of burnout. Given the high prevalence of nurse burnout, measurements of burnout need to be carefully considered for their validity and reliability. Our research team used a relatively new instrument to measure burnout among nurses: the Copenhagen Burnout Inventory (CBI). This 19-item instrument measures burnout in three dimensions: Personal, Work-related, and Client-related Burnout. However, the psychometric properties of the CBI have not been examined in nurses. Thus, the purpose of this study was to determine the psychometric properties of the CBI in a state-wide survey of inpatient staff nurses. A total of 928 registered nurses working in Alabama-area hospitals (N = 42 hospitals) participated in this study. Confirmatory factor analysis resulted in an adequate fit to the data and supported construct validity. As evidence of convergent validity, the CBI was moderately to highly correlated with measures of the overall work environment, job satisfaction, and intent to leave, in the anticipated directions. The Cronbach's alphas for Personal Burnout, Work-related Burnout, and Client-related Burnout were 0.91, 0.89, and 0.92, respectively, demonstrating excellent internal consistency reliability for the subscales. Based on our data, the CBI demonstrates adequate validity and reliability for measuring burnout among frontline nurses. As nurses provide care to the most vulnerable patients in healthcare systems, their psychological well-being is important due to the impact on quality of care on patient outcomes. The availability of the CBI on its website allows nurses, nurse managers, and researchers to evaluate burnout in a variety of nursing populations with no licensing costs.

Introduction Oncologists have increasingly been proponents of shared decision making (SDM) to enhance patient outcomes and reduce unnecessary health care spending. However, its effect on patient out-of-pocket costs is unknown. This study investigated the relationship between patient preferences for SDM and financial toxicity (FT) in patients with metastatic breast cancer (MBC). Patients and Methods This cross-sectional study utilized surveys of women aged ≥ 18 with MBC who received care at two academic hospitals in Alabama from 2017 to 2019. Patients self-reported their SDM preference (Control Preferences Scale) and FT (Comprehensive Score for Financial Toxicity [COST] tool; 11-item scale, with lower scores indicating worse FT). Effect sizes were calculated using the proportion of variance explained (R2) or Cramer’s V. Differences in FT by SDM preference were estimated using mixed models clustered by site and treating medical oncologist. Results In 95 women with MBC, 44% preferred SDM, 29% preferred provider-driven decision making, and 27% preferred patient-driven decision making. Patients preferring SDM were more often college educated (53% vs. 39%; V = 0.12) with an income greater than $40,000/y (55% vs. 43%; V = 0.18). Overall median COST was 22 (interquartile range, 16-29). After adjusting for patient demographic and clinical characteristics, patients preferring patient-driven decision making trended toward worse FT (COST 17: 95% confidence interval, 12-22) compared to those preferring SDM (COST 19: 95% confidence interval, 15-23) and those preferring provider-driven decision making (COST 22: 95% confidence interval, 17-27). Conclusion Patients preferring more patient-driven decision making reported worse FT, although differences did not reach statistical significance. Further research is needed to understand this relationship.

BACKGROUND: There are multiple issues that arise when researchers focus on and only report “statistical significance” of study findings. An important element that is often not included in reports is a discussion of clinical relevance. OBJECTIVES: The authors address issues related to significance, the use of effect sizes, confidence or credible intervals, and the inclusion of clinical relevance in reports of research findings. METHODS: Measures of magnitude, precision, and relevance such as effect sizes, confidence intervals (CIs), and clinically relevant effects are described in detail. Additionally, recommendations for reporting and evaluating effect sizes and CIs are included. Example scenarios are presented to illustrate the interplay of statistical significance and clinical relevance. RESULTS: there are several issues that may arise when significance is the focus of clinical research reporting. One issue is the lack of attention to nonsignificant findings in published works even though findings demonstrate clinical relevance. Another issue is that significance is interpreted as clinical relevance. As well, clinically relevant results from small sample studies are often not considered for publication, and, thus, findings might not be available for meta-analysis. DISCUSSION: Findings in research reports should address effect sizes and clinical relevance and significance. Failure to publish clinically relevant effects and CIs may preclude the inclusion of clinically relevant studies in systematic reviews and meta-analyses thereby limiting the advancement of evidence-based practice. Several accessible resources for researchers to generate, report, and evaluate measures of magnitude, precision, and relevance are included in this article.

PURPOSE Sequential drug treatments in metastatic breast cancer (MBC) are disparate. Clinical trial data includes limited reporting of treatment context, primarily including the number of prior therapies. This study evaluates the relationship between prior treatment time, prior lines of treatment, and survival using a novel visualization technique coupled with statistical analyses. PATIENTS AND METHODS This retrospective cohort study used a nationwide, de-identified electronic health record–derived database to identify women with hormone receptor–positive, human epidermal growth factor receptor 2–negative MBC diagnosed in 2014 who subsequently received paclitaxel. Images were created, with individual patients represented on the y-axis and time, on the x-axis. Specific treatments were represented by colored bars, with Kaplan-Meier curves overlaying the image. Separate images assessed progression-free survival and overall survival (OS). Hazard ratios (HRs) and 95% CIs from Cox proportional hazards models evaluated the association between prior treatment time and OS. RESULTS Of 234 patients, median survival from first paclitaxel administration was 20 months (interquartile range, 8-53 months). An inverse relationship was observed between OS after paclitaxel and timing of administration. In adjusted models, each year on treatment prior to paclitaxel was associated with a 16% increased hazard of death after paclitaxel (HR, 1.16; 95% CI, 1.05 to 1.29). CONCLUSION OS after a specific treatment is dependent on when a drug is given in the disease context, highlighting the potential for an overall OS benefit to be observed on the basis of treatment timing. Prior time on treatment should be considered as a stratifying factor in randomized trials and a confounding factor when examining survival in observational data.

PURPOSE Treatment sequencing of metastatic breast cancer (MBC) is heterogeneous. The primary objective of this study was to develop a visualization technique to understand population-level treatment sequencing for MBC. Secondary outcomes were to describe the heterogeneity of MBC treatment sequencing, as measured by the proportion of patients with a rare sequence, and to generate hypotheses about the impact of sequencing on overall survival. METHODS This retrospective review evaluated treatment sequencing for patients with MBC in the SEER–Medicare database. Patients with either de novo MBC or International Classification of Diseases, Ninth Revision, diagnosis codes for secondary metastasis (197.XX-198.XX) on two separate dates, excluding breast (198.81, 198.82, 198.2) and lymph nodes (196.XX), were included. Complete Medicare Parts A, B, and D coverage was required. A treatment sequence that fewer than 11 patients received was considered rare. A graphic was created with each nonrare treatment-sequence grouping on the y-axis and time on the x-axis. Bars representing time on hormonal therapy, chemotherapy, human epidermal growth factor receptor 2–targeted therapy, and other targeted therapies were color coded. Kaplan-Meier–like curves were overlaid on treatment maps, using estimated median survival for each sequence. RESULTS Of 6,639 patients with MBC, 56% received a treatment sequence that fewer than 11 other patients received, with 2,985 other unique, rare sequences were identified. Sequence visualization demonstrated differential survival, with longer median survival for those initially receiving hormonal therapy. The median time receiving initial treatment was similar for patients receiving first-line chemotherapy. CONCLUSION Treatment-sequence visualization can enhance the capacity to effectively conceptualize treatment patterns and patient outcomes.

Lifestyle changes associated with end-stage renal disease may be a factor in depression and quality of life (QOL) for patients receiving hemodialysis. This cross-sectional study examined the relationship between nutritional status, QOL, and depression in 124 hemodialysis patients. Nutritional markers included serum albumin, normalized protein catabolic rate (nPCR), body mass index (BMI), body fat percentage, and daily protein intake. Physical and Mental dimension scores of the Kidney Disease QOL-Short Form (KDQOL-SF), and the Center for Epidemiological Studies of Depression (CESD) survey were used to measure QOL and depression, respectively. Data were analyzed using regression analyses. Measures of effect size were used for interpretation. Nutritional status indicators explained a moderate amount of the variability of the Physical dimension of QOL (crude R2 = .14, covariate-adjusted ΔR2 = .06) but had weak explanatory ability for the Mental dimension of QOL (crude R2 = .05, covariate-adjusted ΔR2 = .02) and CESD (crude R2 = .02, covariate-adjusted ΔR2 = .005). Additional findings suggested the presence of non-linear relationships between protein intake and both the Physical and Mental QOL dimension scores. Longer dialysis vintage was also correlated with lower psychosocial patient outcomes. While nutritional status is an important element in predicting hemodialysis patient outcomes, its relationship to depression and QOL, in this sample, demonstrated only moderate explanatory ability. However, dialysis vintage and level of education had a significant relationship with depression and QOL. These findings suggest that patients with longer dialysis vintage and limited health literacy require unique plans of care. Future studies aimed at understanding the interrelationships between non-modifiable patient characteristics and psychosocial outcomes are imperative.

Background Burdens related to time spent receiving cancer care may be substantial for patients with incurable, life‐limiting cancers such as metastatic breast cancer (MBC). Estimates of time spent on health care are needed to inform treatment‐related decision‐making. Methods Estimates of time spent receiving cancer‐related health care in the initial 3 months of treatment for patients with MBC were calculated using the following data sources: (a) direct observations from a time‐in‐motion quality improvement evaluation (process mapping); (b) cross‐sectional patient surveys; and (c) administrative claims. Average ambulatory, inpatient, and total health care time were calculated for specific treatments which differed by antineoplastic type and administration method, including fulvestrant (injection, hormonal), letrozole (oral, hormonal), capecitabine (oral, chemotherapy), and paclitaxel (infusion, chemotherapy). Results Average total time spent on health care ranged from 7% to 10% of all days included within the initial 3 months of treatment, depending on treatment. The greatest time contributions were time spent traveling for care and on inpatient services. Time with providers contributed modestly to total care time. Patients receiving infusion/injection treatments, compared with those receiving oral therapy, spent more time in ambulatory care. Health care time was higher for patients receiving chemotherapeutic agents compared to those receiving hormonal agents. Conclusion Time spent traveling and receiving inpatient care represented a substantial burden to patients with MBC, with variation in time by treatment type and administration method., In patients with metastatic breast cancer, time spent on health care ranged from 7% to 10% of all days included within the initial 3 months of treatment, depending on type of treatment received and its administration method. The greatest time contributions were time spent traveling for care and on inpatient services, and health care time was higher for patients receiving chemotherapeutic agents compared to those receiving hormonal agents.

Women living with HIV (WLWH) have lower employment rates and more difficulty finding and keeping employment compared with their counterparts without HIV. These disparities affect physical, psychological, and socioeconomic outcomes, and they may compound the disadvantages associated with living with HIV. Although historical literature has emphasized the impact of clinical factors on employment, current evidence suggests that socioeconomic and psychosocial factors associated with HIV should be included for a more comprehensive view. Based on this broader inclusion, a conceptual framework is presented describing how socioeconomic and psychosocial characteristics influence employment acquisition and maintenance among WLWH. The framework posits that there is a reciprocal relationship between employment acquisition and occupational productivity, and psychological health, physical health, social support, and empowerment. Implications for future research and interventions include (a) an extended conceptualization of vocational rehabilitation and (b) the use of peer support groups to increase social capital, empowerment, knowledge, and resources among WLWH.

Background Every one out of 10 nurses reported suffering from high levels of burnout worldwide. It is unclear if burnout affects job performance, and in turn, impairs patient safety, including medication safety. The purpose of this study is to determine whether nurse burnout predicts self-reported medication administration errors (MAEs). Methods A cross-sectional study using electronic surveys was conducted from July 2018 through January 2019, using the Copenhagen Burnout Inventory. Staff registered nurses (N = 928) in acute care Alabama hospitals (N = 42) were included in this study. Descriptive statistics, correlational, and multilevel mixed-modeling analyses were examined. Results All burnout dimensions (Personal, Work-related, and Client-related Burnout) were significantly correlated with age (r = -0.17 to -0.21), years in nursing (r = -0.10 to -0.17), years of hospital work (r = -0.07 to -0.10), and work environment (r = -0.24 to -0.57). The average number of self-reported MAEs in the last 3 months was 2.13. Each burnout dimension was a statistically significant predictor of self-reported MAEs (p Conclusions Nurse burnout is a significant factor in predicting MAEs. This study provides important baseline data for actionable interventions to improve nursing care delivery, and ultimately health care, for Alabamians.

PURPOSE: In patients with metastatic breast cancer (MBC), low health insurance literacy may be associated with adverse material conditions, psychological response, and coping behaviors because of financial hardship (FH). This study explored the relationship between health insurance literacy and FH in women with MBC. METHODS: This cross-sectional study used data collected from 84 women receiving MBC treatment at 2 southeastern cancer centers. Low health insurance literacy was defined as not knowing premium or deductible costs. FH was defined by lifestyle changes as a result of medical expenses, financial toxicity, and medical care modifications attributable to cost. Mean differences were calculated using Cramer’s V. Associations between health insurance literacy and FH were estimated with adjusted linear models. RESULTS: Half of the surveyed patients had low health insurance literacy, 26% were underinsured, 45% had private insurance, 39% had Medicare, and 15% had Medicaid. Patients with low health insurance literacy more often reported borrowing money (19% v 4%; V = 0.35); an inability to pay for basic necessities like food, heat, or rent (10% v 4%; V = 0.18); and skipping a procedure (8% v 1%; V = 0.21), medical test (7% v 0%; V = 0.30), or treatment (4% v 0%; V = 0.20) compared with patients with high health insurance literacy. Median Comprehensive Score for Financial Toxicity was 23 (interquartile range, 17-29). In adjusted models, health insurance literacy was not associated with financial toxicity. CONCLUSION: Low health insurance literacy was common in women receiving MBC treatment. Additional research to increase health insurance literacy could lessen undesirable material FH and unnecessary behavioral FH associated with cancer-related care.

Background: Sequential therapeutic options in metastatic breast cancer (MBC) are disparate. However, clinical trial data on treatments received pre- or post-trial are limited to number of prior therapies and not the prior sequence or duration of treatment. The lack of contextual data on prior treatment history in clinical trials may contribute to challenges evaluating efficacy. This study sought to understand the relationship between sequential order of treatments, prior treatment time, and survival using a novel visualization technique and conventional statistics. Methods: This retrospective cohort study utilized the nationwide, de-identified electronic health record (EHR)-derived Flatiron Health database to identify women with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) -negative MBC diagnosed in 2014 who subsequently received paclitaxel. Visualizations were created with individual patients represented on the Y-axis and time on the X-axis to qualitatively evaluate treatment patterns and survival. Time 0 was defined as initiation of paclitaxel in the metastatic setting. Specific treatments were represented by a color-coded treatment bar, with post-metastatic paclitaxel in black, hormonal therapy in shades of red, chemotherapy in shades of blue, HER2-targeted therapy in shades of green, and other targeted therapies in shades of orange. Treatment gaps were represented by white space. A Kaplan-Meier curve was generated as a function of time from paclitaxel to death or censoring and was superimposed on the visualization. Separate visualizations assessed progression-free and overall survival (PFS, OS). Hazard ratios (HR) and 95% confidence intervals (CI) from Cox proportional hazard models evaluated the association between prior treatment time and post-paclitaxel OS. Results: Of 877 ER+/HER2- MBC patients diagnosed in 2014, 234 received paclitaxel. Qualitatively, the visualization graphic sorted by OS demonstrated that patients who received treatments for longer durations prior to paclitaxel had worse survival compared to those who received paclitaxel earlier in their treatment course (i.e., shorter time on treatment prior to receiving paclitaxel). Quantitatively, median survival from paclitaxel initiation was 20 months (IQR 8-53). When dividing the sample into quartiles based on overall survival after paclitaxel, median time on treatment prior to paclitaxel was 2 months (IQR 0.3-7), 8 months (1-31 IQR), 10 (1-28) months (IQR), and 11 months (IQR 3-32; Table 2). In adjusted models, every year increase on treatment prior to paclitaxel initiation was associated with a 16% increased yearly hazard of death (HR 1.16, 95% CI 1.05-1.29). Conclusion: Visualizing paclitaxel in the context of disease course demonstrates an association between length of time on prior therapy and remaining OS, highlighting the potential for an overall OS benefit to be observed merely based on early vs. late receipt of treatment. This approach to graphically visualizing treatment sequences can aid in better understanding treatment patterns and their impact on survival outcomes through the power of patient-level data. This study should promote future evaluation of treatment sequencing and duration of prior therapies when studying the impact of new treatments, which will be perpetually important as new FDA-approved medications are incorporated into existing MBC treatment paradigms. Citation Format: Gabrielle Rocque, Aidan Gilbert, Courtney P Williams, Arie Nakhmani, Pravinkumar G Kandhare, Andres Azuero, Smita Bhatia, Kelly M Kenzik, Mark E Burkard. Visualization of the relationship between survival and sequential treatments in metastatic breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-15-05.

Modeling passive data collected by smartphones, or digital phenotyping, may help detect the early signs of declines in daily health and lead to steps to prevent declines. Health-related outcomes have been typically acquired through self-report measures, however this broad approach has several limitations, such as recall and social desirability bias. A potential solution is digital phenotyping. Guided by the Arksey and O’Malley methodological framework, the aim of this scoping review was to identify studies that modeled passive smartphone-sensor data into behavioral markers that correlate or predict health-related outcomes. A literature search of peer-reviewed or conference studies in PubMed, Scopus, Compendex, and HTA yielded 3,170 articles. 40 studies met the inclusion criteria. Studies were organized and assessed for their: 1) data collection approaches (e.g., smartphone passive sensor data and questionnaire), 2) feature extraction (e.g., converting bedtime or wake time into sleep), 3) data analytics (e.g., identifying accelerometer data into sleep patterns using machine learning), 4) behavioral markers, which is observing the activity pattern for an extended period of time and then modeling the activities into appropriate behaviors, and 5) health-related outcomes. The findings of this study demonstrate how to transform passive smartphone-sensor data into behavioral markers that correlate or predict health-related outcomes, which could provide information for more grounded predictive use and successful implementation of digital phenotyping in future research.

110 Background: In Sudan, healthcare access may limit diagnostic workup for breast cancer. This study evaluates the relationship between geography and ethnicity and completeness of documentation of diagnostic workup (staging and receptor testing) in Sudan. Methods: This retrospective study used data abstracted from patients with breast cancer receiving cancer care at Sudan’s largest cancer center (Radiation and Isotopes Center Khartoum [RICK]) in 2017. The patient’s age at diagnosis, sex, breast cancer stage, ethnic subgroup (further categorized as Arab and non-Arab), regions of origin and residence (Central, Northeastern, Western, and Khartoum [where RICK is located]), and receptor status from pathology reports were abstracted from paper medical records. Complete diagnostic workup was defined as having both receptor testing and staging. Descriptive statistics were calculated using frequencies and percentages for categorical variables and median and interquartile range (IQR) for continuous variables. Odds ratios (OR) and 95% confidence intervals (CI) were estimated to evaluate complete diagnostic workup on ethnic group, origin, and residence using binomial logistic regression models (excluding non-Sudanese patients and those with missing demographics). Results: Of 240 patients included, 237 were female, median age was 53 (IQR 43-62). Most often patients were Arab (68%), originated from Northeastern and Khartoum regions (both 28%) and lived in the Khartoum region (53%). Overall, 49% patients were missing receptor testing and/or staging, with modest differences by geographic region and ethnicity (Table). In adjusted analyses, non-Arab patients had similar odds of having complete diagnostic workup when compared to Arab patients (OR 1.22; 95% CI 0.70-2.10). Patients originating from and residing in regions outside the Khartoum region had similar odds of complete diagnostic workup when compared to patients originating from and residing in the Khartoum region. Conclusions: Almost half of breast cancer patients had incomplete diagnostic workup, regardless of region of origin, region of residence, and ethnic group. This highlights a substantial systems-based quality gap in care delivery, warranting efforts to improve completeness in diagnostic workup for all patients with breast cancer in Sudan.[Table: see text]

351 Background: One key challenge of practice transformation activities, such as remote symptom monitoring (RSM) using electronic patient reported outcomes (ePROs), is identification of patients starting treatment. In real-world settings, reliance on referrals is likely to miss patients. We describe the difficulties encountered in patient identification and the subsequent changes implemented in protocol to remediate this. Methods: We conducted two PDSA cycles focused on identification and engagement of patients for RSM at the Mitchel Cancer Institute (MCI). Target patient capture was > 75%. Modifications to the patient identification process were documented. Schedules of physicians participating in the RSM program were reviewed from 6/2021 – 5/2022 to identify eligible patients. Patients were considered eligible if they were starting chemotherapy, targeted therapy, or immunotherapy. Patients seeking a second opinion were excluded. Patient demographics, cancer type, cancer stage, and PROs were abstracted from electronic health records and the PRO platform (Carevive). Initial clinic roll-out was conducted in gynecologic oncology, with expansion to breast and thoracic oncology in 10/2021 and 3/2022, respectively. The proportion of eligible patients approached per month was reported.Results: In the first PDSA cycle, the eligibility criteria was defined. Although clinical trials included advanced disease, non-clinical staff screening expressed concern about determining advanced vs. early-stage disease. Thus, inclusion criteria was broadened to include all patients starting treatments. From 6/2021 –8/2021, navigators identified patients by screening patients who presented for chemo-education visits. The navigation team approached 23 patients during this period. However, this process didn’t identify all eligible patients as not all patients beginning treatment received chemo-education visits. In PDSA Cycle 2, the process for new patient contact from initial call for appointment through treatment was reviewed. The implementation team screened all patients in a physician’s schedule a week prior to the office visit as well as on the day of visit. This updated process identified all eligible patients starting either intravenous or oral chemotherapy. The recruitment process was modified to screen the physician schedules rather than chemo educator visits. From 9/2022-5/22, the proportion of eligible patients identified and approached remained high at 100%. This methodological screening process helped the navigation team identify all eligible patients in an efficient manner and they reported comfort in expanding to additional disease teams. Conclusions: Systematic screening of physician schedules can be successfully leveraged for patient identification and reduce time spent manually screening for eligible patients by non-clinical navigators. Clinical trial information: NCT04809740.

272 Background: Despite evidence of clinical benefits, widespread implementation of remote symptom monitoring has been limited. We describe a process of adapting a remote symptom monitoring intervention developed in a research setting to a real-world clinical setting at two cancer centers. Methods: This formative evaluation assessed core components and adaptations to improve acceptability and fit of remote symptom monitoring using Stirman’s Framework for Modifications and Adaptations. Implementation outcomes were evaluated in pilot studies at the two cancer centers testing technology (Phase I) and workflow (Phase II and III) using electronic health data; qualitative evaluation with semi-structured interviews of clinical team members; and capture of field notes from clinical teams and administrators regarding barriers and recommended adaptations for future implementation. Results: Core components of remote symptom monitoring included electronic delivery of surveys with actionable symptoms, patient education on the intervention, a system to monitor survey compliance in real-time, the capacity to generate alerts, training nurses to manage alerts, and identification of personnel responsible for managing symptoms. In the pilot studies, while most patients completed > 50% of expected surveys, adaptations were identified to address barriers related to workflow challenges, patient and clinician access to technology, digital health literacy, survey fatigue, alert fatigue, and data visibility. Conclusions: Using an implementation science approach, we facilitated adaptation of remote symptom monitoring interventions from the research setting to clinical practice and identified key areas to promote effective uptake and sustainability.

341 Background: Remote symptom monitoring (RSM) using electronic patient reported outcomes (ePROs) allow for patients with cancer to communicate symptoms to their clinical team between clinic visits. Prior randomized control trials of RSM focused on advanced cancer, and less data are available for patient with early stage cancers. The University of Alabama at Birmingham (UAB) implemented RSM for early stage (I-III) and advanced stage (IV) patients on active treatment. This study evaluates nurses’ real-world response time to alerts by varying severity and by patients cancer stages. Methods: This study included women with stage I-IV breast cancer who received care at UAB from October 2020 through May 2022. The program was first implemented in the breast clinic allowing for larger patient numbers with early and advanced stage breast cancer. A composite score for symptom severity is automatically calculated in the Carevive® platform for moderate, severe, or worsening symptoms using patient responses for frequency, severity, and interference. The nurse receives an alert if a symptom is moderate or severe. Surveys with at least one severe alert were categorized as severe and response time was categorized as optimal if the survey was closed within 48 hours (goal time for phone message follow-up). Odds ratios (OR), predicted probabilities, and 95% confidence intervals (CI) were estimated using a patient nested logistic regression evaluating time to response comparing surveys with at least one severe alert notification to those with no severe, adjusting for age at enrollment, race, cancer stage, provider who closed the surveys, and quarter from study start and date. An interaction between severity and cancer stage was evaluated. Results: Of 137 patients included in this study, 64% were White; 86% were diagnosed with early-stage breast cancer. The median age at diagnosis was 54 (27-79). Of 802 surveys included, 38% reported at least one severe symptom and 70% had an optimal response time. Similar results were seen when stratified by early vs. advanced stage with 39% and 38% reporting at least one severe alert and 68% and 71% an optimal response time, respectively. In our adjusted analysis, when compared with surveys that had no severe alerts, surveys with at least one severe alert had similar odds of having an optimal response time (OR, 1.29; 95%CI, 0.88, 1.89). No significant interaction between severity and stage was observed on the odds of optimal response time. Conclusions: Response times to alerts were similar regardless of the severity of the alert and cancer stage, suggesting alert management is incorporated into routine workflows and not prioritized based on disease or alert severity. Additional research is needed to understand factors contributing to non-optimal response times.

421 Background: For successful remote symptom monitoring using patient-reported outcomes, nurses should respond to alerts in a timely fashion. Where clinical trials utilized research staff for alert management, the shift to standard-of-care delivery necessitates that this responsibility be added as a task to an already strained nursing workforce. Little is known about strategies to engage nurses to improve timeliness of alert management. Methods: In this quality improvement initiative, we aimed to improve timeliness of alert closures generated by moderate or severe symptoms within a remote symptom monitoring program. Optimal closure was defined as < 48 hours, which was consistent with institutional requirements for response to patient phone calls. A continuous quality improvement approach, with multiple Plan Do Study Act (PDSA) cycles was conducted. Data was captured from the electronic medical record and PRO platform (Carevive). Descriptive statistics included frequencies and percentages. The proportion of alerts closed each month < 48 hours, 48-72 hours, 3-7 days, and > 7 days were reported overall and by disease team (i.e., major cancer types). Surveys not closed were considered > 7 days. The timing of strategies to improve nursing engagement were documented and evaluated for impact on alert closure. Results: From June 1, 2021-May 31, 2022, 1121 moderate or severe alerts were generated from 234 patients. Disease teams had variable remote symptom monitoring start dates: breast, leukemia, and limited gynecologic (prior to 6/2021); myeloma and gastrointestinal (7/2021); genitourinary (10/2021); head and neck (12/2021); melanoma (2/2022); and Lymphoma (4/2022). In 6/2021, the overall alert closure at < 48 hours, 48-72 hours, 3-7 days, and > 7 days was 57%, 4%, 14%, and 25% respectively (n = 28). To improve alert closures, several key strategies were deployed to improve alert closure times including disease-specific reporting and meetings with nursing leadership (10/2021); identification of a nurse champion, creation of “cheat sheets” to remind nurses how to close alerts, and individualized calls with nurses with open alerts (1/2022), and inclusions of requirement to close alerts in nursing newsletters (2/2022). Overall, alert closure less than 48 hours improved to 61% by 12/2021 (n = 97) and to 69% by 5/2022 (n = 167). Disease group alert closure varied, with higher closure more commonly in teams with greater duration of use, such as breast cancer team with an alert closure of 85% < 48 hours in May 2022. Conclusions: Key nursing engagement strategies improve alert closure for remote symptom monitoring programs implemented in real-world settings.

268 Background: Remote symptom monitoring (RSM) using patient-reported outcomes has been shown to reduce symptom burden and hospitalizations in clinical trials. However, little is known about how willing patients are to participate in remote symptom monitoring in real-world settings, particularly for vulnerable patient populations. This study aims to compare characteristics of cancer patients enrolled vs. patients who declined enrollment into RSM. Methods: This prospective study used data that assessed the characteristics of patients who enrolled vs. patients who declined enrollment into RSM. Inclusion criteria included participants’ age ≥18 with cancer who received chemotherapy, targeted therapy, or immunotherapy at the University of Alabama at Birmingham. Race and ethnicity (Black or African American, White, Asian, other and unknown), sex, cancer type (breast, gastrointestinal [GI], genitourinary [GU], gynecological [GYNX], head and neck, leukemia, lymphoma, melanoma, myeloma and other), urban/rural residence, Area Deprivation Index (ADI), and insurance type (Medicaid, Medicare, none, other and private) were abstracted from electronic medical records (EMR) and PRO platform (Carevive). Descriptive statistics were calculated using frequencies and percentages for categorical variables and medians and interquartile ranges for continuous variables. Differences in enrollment status characteristics were calculated using measures of effect size such as Cramer’s V. Results: Of the 307 patients, two thirds of patients were female (71%); 25% were Black or African American and 66% were White patients; 15% lived in an area of higher disadvantage. For insurance, 46%, 26%, 10%, 8%, and 9% of patients had Private, Medicare, Medicaid, other insurance, and no insurance, respectively. The proportion of patients who declined enrollment was higher for males than females (22% vs. 10%), Black or African American than White (18% vs 13%); and having Medicare than private insurance (22% vs. 10%). Compared to those who enrolled, patients who declined enrollment were more often to be male (V:0.2), Black or African American (V:0.1); and have Medicare insurance (V:0.2). Patients enrolled vs. declined in RSM had similar ADI scores (V:0.01). Conclusions: This study demonstrates that potentially vulnerable patients, including Black patients and those with public insurance, have lower RSM engagement. Future analysis is needed to understand participation barriers and how to better engage diverse populations to ensure optimal healthcare delivery to all patients.

85 Background: Most patients with cancer experience multi-leveled barriers to clinical trial participation, potentially including financial concerns due to the complexity surrounding trial-related insurance coverage. Our study sought to understand the association between insurance status and cancer clinical trial eligibility, offer, and enrollment. Methods: This retrospective cohort study included patients with breast or ovarian cancer receiving a therapeutic cancer drug at the University of Alabama at Birmingham between January 2017 and February 2020. Available clinical trials and eligibility criteria were abstracted from OnCore and ClinicalTrials.gov. Patient trial eligibility, offer from provider, demographics, and clinical characteristics were abstracted from electronic medical records. Patient trial enrollment was determined via OnCore. Odds of clinical trial eligibility, offer, and enrollment by insurance status (private, public [Medicaid, Medicare]) were estimated using logistic regression models. Models estimating odds of trial offer and enrollment contained only eligible patients. Models were adjusted for patient age at diagnosis, race and ethnicity, rural-urban residence, Area Deprivation Index, cancer type, and cancer stage (early, late). Results: A total of 513 patients with breast (71%) or ovarian (29%) cancer were included in our analyses. Median age at diagnosis was 60 (interquartile range: 49-67) years; the majority were White (69%) and had early stage cancer (65%). Half of patients had private insurance (54%), and 46% of patients had public insurance (38% Medicare, 8% Medicaid). Patients with private insurance more often had early stage cancer compared to patients with public insurance (73% vs 57%). Almost two-thirds of patients (65%) were eligible for clinical trial enrollment. Of eligible patients (n = 333), 68% were offered a trial and 47% enrolled onto a trial. In adjusted analyses, patients with public vs private insurance had similar odds of clinical trial eligibility (odds ratio [OR] 0.95, 95% confidence intervals [CI] 0.61-1.48), being offered to participate (OR 1.23, 95% CI 0.71-2.14), and clinical trial enrollment (OR 1.13, 95% CI 0.68-1.89). Conclusions: Our results suggest oncologists do not assess trial eligibility or offering a trial based on insurance status, and patients do not differentially participate based on their insurance coverage. Further research is needed to understand implications of trial participation (e.g., out-of-pocket and time costs) for patients covered by differing insurance.

OBJECTIVES: To examine whether self-reported added sugar consumption is associated with an increased risk for prediabetes in U.S. adults. METHODS: A secondary data analysis was performed using National Health and Nutrition Examination Survey data collected between 2013–2018 in a subsample of adults (≥20 years) with prediabetes (HgbA1c 5.7% to 6.4%) and normoglycemia (HgbA1c 15% g/day) were associated with an increased odds of prediabetes. RESULTS: In the sample of 10,671 adults, 34% were identified as having prediabetes, consuming an estimated average of 49.4 g/day of added sugar. In unadjusted models, added sugar was not relevantly associated with an increased odds of prediabetes [total: (OR = 1.001, P = 0.625); tertiles (reference: 15% (OR = 1.057, P = 0.531)]. Similarly, in adjusted models that controlled for age, gender, race/ethnicity, total energy intake, physical activity status, smoking status, BMI, and socioeconomic covariates, added sugar was not relevantly associated with an increased odds of prediabetes [total: (OR = 1.001, P = 0.601); tertiles (reference: 15% (OR = 1.053, P = 0.665)]. CONCLUSIONS: Results indicate that self-reported added sugar consumption does not appear to relevantly increase the odds of prediabetes in adults. Because prediabetes is an early indicator of type 2 diabetes risk, it is possible that exposure to added sugar over time contributes to the significant associations observed in individuals with type 2 diabetes and not prediabetes. FUNDING SOURCES: University of Alabama at Birmingham Graduate School and School of Nursing.

Background Little is known about the prevalence of healthy lifestyle (HLS) discussions between providers and older cancer survivors. Methods We utilized cross‐sectional data from older cancer survivors (≥65 years) seen at 12 southeastern cancer centers during 2013‐2015. Data on demographics, time since diagnosis, weight, height, and healthy behaviors were collected. Respondents were asked if providers (oncologists, other physicians, and/or nurses) discussed exercise, healthy diet, weight management, and/or smoking cessation during clinical encounters. Descriptive statistics and bivariate associations between HLS topics and survivor characteristics were calculated. Results Among 1460 cancer survivors, mean age was 74 years (SD 6), most were white (81%), and >1 year postdiagnosis (84%). The majority (71%) reported discussing at least one of three HLS topics (exercise 49%, healthy diet 53%, vegetable consumption 28%); 17% received counseling on all three. Weight loss was recommended to 33% of overweight/obese survivors and smoking cessation to 85% of current smokers. Oncologists and nurses discussed HLS less frequently compared to other physicians. Younger survivors (65‐74 years) received recommendations for exercise, weight loss, and tobacco cessation more often than older survivors (≥75 years). Compared to white respondents, minorities reported discussions on all topics more often except for tobacco cessation. Excluding tobacco cessation, survivors with recent cancer diagnoses (1 year postdiagnosis. Conclusion Despite the American Cancer Society's recommendations, older survivors reported a low prevalence of HLS discussions with their providers, with some variation by demographic groups. Strategies are needed to promote these important discussions in this population., Provider's recommendations for weight management, healthy diet, physical activity, and smoking cessation are key in promoting healthy lifestyles (HLS) among older cancer survivors. However, we found that not all survivors discuss all relevant HLS with their providers, with some groups of survivors having these discussions less often than others. Additional studies and strategies are needed to promote HLS discussions and achieve the American Cancer Society's (ACS) recommended HLS goals especially for diet, weight, and physical activity among older cancer survivors in the Southeastern US healthcare system

Although CDC guidelines call for universal, "opt-out" HIV testing, barriers to testing continue to exist throughout the United States, with the rural South particularly vulnerable to both HIV infection and decreased awareness of status. Therefore, the objectives of this study were to evaluate uptake of "opt-out" HIV testing and barriers to testing within the primary care setting in the South. A concurrent triangulation design guided the collection of quantitative data from patients (N = 250) and qualitative data from providers (N = 10) across three primary health clinics in Alabama. We found that 30% of patients had never been tested for HIV, with the highest ranked barrier among patients being perceived costs, access to specialty care, and not feeling at risk. Significant differences existed in perceived barriers between patients and providers. Increased provider-patient engagement and the routine implementation of "opt-out" HIV testing would effectively reveal and mitigate barriers to testing, thus, increasing awareness of status.

Background: Improving family caregiver preparation for surrogate decision making is a critical priority. Objective: Determine a parsimonious set of intrapersonal factors associated with family caregivers' confidence in making future medical decisions for their relatives with cancer. Methods: Cross-sectional mail survey. Family caregivers of Medicare beneficiaries with pancreatic, lung, brain, ovarian, head and neck, hematologic, and stage IV cancers from communities of eight U.S. cancer centers. Participants completed validated measures of their social and mental health, self-care behaviors, coping styles, and surrogate decision-making confidence. Using linear modeling, the Bayesian information criterion was used to identify factors associated with decision-making confidence. A bootstrap approach was used to conduct penalized inference on the selected model coefficients. Model fit validation was assessed with a random forest ensemble. Results: Caregivers (n = 294) were on average 65.5 years old, mostly female (72.8%), and care recipients' spouse/partner (60.2%). The parsimonious set of factors associated with low caregiver decision-making confidence included less engagement in spiritual growth self-care, more use of avoidant coping, low emotional social support, and younger care recipient age (in-sample R(2) = 0.22). These factors were also identified by a random forest approach. After overfitting adjustment (shrunken R(2) = 0.09), the strongest associations with low surrogate decision-making confidence were low spiritual growth self-care (adjusted standardized B = 0.17, p = 0.005) and high use of avoidant coping (adjusted standardized B = −0.12, p = 0.049). Discussion: Identifying strategies to enhance spiritual growth and reduce avoidant coping may be promising targets for interventions to improve family caregivers' confidence in future surrogate decision making.

CONTEXT: Research priority guidelines highlight the need for examining the “dose” components of palliative care (PC) interventions, such as intervention adherence and completion rates, that contribute to optimal outcomes. OBJECTIVES: Examine the “dose” effect of PC intervention completion vs. non-completion on quality of life (QoL) and healthcare use in patients with advanced heart failure (HF) over 32 weeks. METHODS: Secondary analysis of the ENABLE CHF-PC intervention trial for patients with New York Heart Association (NYHA) Class III/IV HF. ‘Completers’ defined as completing a single, in-person outpatient palliative care consultation (OPCC) plus six weekly, PC nurse coach-led telehealth sessions. ‘Non-completers’ were defined as either not attending the OPCC or completing < 6 telehealth sessions. Outcome variables were QoL and healthcare resource use (hospital days; emergency department visits). Mixed models were used to model dose effects for ‘completers’ vs ‘non-completers’ over 32 weeks. RESULTS: Of 208 intervention group participants, 81 (38.9%) were classified as ‘completers’ with a mean age of 64.6 years; 72.8% were urban-dwelling; 92.5% had NYHA Class III HF. ‘Completers’ vs. ‘non-completers’ groups were well-balanced at baseline; however ‘non-completers’ did report higher anxiety (6.0 vs 7.0, p

Every one out of 10 nurses reported suffering from high levels of burnout worldwide. It is unclear if burnout affects job performance, and in turn, impairs patient safety, including medication safety. The purpose of this study is to determine whether nurse burnout predicts self-reported medication administration errors (MAEs).A cross-sectional study using electronic surveys was conducted from July 2018 through January 2019, using the Copenhagen Burnout Inventory. Staff registered nurses (N = 928) in acute care Alabama hospitals (N = 42) were included in this study. Descriptive statistics, correlational, and multilevel mixed-modeling analyses were examined.All burnout dimensions (Personal, Work-related, and Client-related Burnout) were significantly correlated with age (r = -0.17 to -0.21), years in nursing (r = -0.10 to -0.17), years of hospital work (r = -0.07 to -0.10), and work environment (r = -0.24 to -0.57). The average number of self-reported MAEs in the last 3 months was 2.13. Each burnout dimension was a statistically significant predictor of self-reported MAEs (p.05).Nurse burnout is a significant factor in predicting MAEs. This study provides important baseline data for actionable interventions to improve nursing care delivery, and ultimately health care, for Alabamians.

BACKGROUND Psychometric properties of the 38-item version of the Dutch Objective Burden Inventory (DOBI) have been evaluated primarily in older female caregivers, with no published studies that vary by a different gender and age distribution. OBJECTIVE The aim of this study was to test the construct validity and reliability of the DOBI in caregivers of individuals with heart failure from the United States and other countries. METHODS This secondary analysis from a cross-sectional study used an online survey. Factorial validity was tested with confirmatory factor analysis, item performance was examined with ordinal item response analysis, and convergent validity was tested correlating DOBI subscale scores with Bakas Caregiving Outcomes Scale scores. Internal consistency reliability was assessed with Cronbach α. RESULTS Item response analysis removed 14 items. Confirmatory factor analysis retained the original 4-factor solution. Original and reduced instruments demonstrated good internal consistency. Validity was supported by meaningful associations with the Bakas Caregiving Outcomes Scale. CONCLUSIONS Both the original 38-item DOBI and the reduced 24-item DOBI had support for their construct validity and internal consistency. The 24-item DOBI may be a useful alternative to the 38-item version, because it maintains psychometric properties of the original instrument while decreasing data collection burden. However, more research is needed to assess whether the shorter version is useful in assessing objective caregiving burden.

The healthy eating index-2015 (HEI-2015) reflects diet quality in reference to the 2015-2020 Dietary Guidelines for Americans (DGA). Little is known regarding its application in individuals with chronic spinal cord injury (SCI).To explore the relationship between diet quality as assessed by the HEI-2015 and cardiovascular risk factors among individuals with chronic SCI.This is a cross-sectional analysis of baseline data collected from August 2017 through November 2019 for an interventional study that evaluates the effects of a high-protein/low-carbohydrate diet on cardiovascular risk factors in individuals with chronic SCI at the University of Alabama at Birmingham.Twenty-four free-living adults with SCI (mean age, 45 ± 12 y; 8F/16M, level of injury: nine cervical, 15 thoracic; mean duration of injury: 20 ± 13 y) were included.Participants underwent a 2-hour oral glucose tolerance test (OGTT) and a dual-energy x-ray absorptiometry scan. Dietary intake was assessed by three, 24-hour multiple-pass dietary recalls to calculate the HEI-2015 using the simple HEI scoring algorithm method.Multiple linear regression analyses were performed to predict indices of lipid metabolism and glucose homeostasis and C-reactive protein (CRP) from the HEI-2015. Principal component analysis was used to reduce the number of covariates (level of injury, sex, and body fat percentage).On average, participants' diets were of low quality (HEI-2015, 47.2 ± 10.8). The regression models for fasting glucose (FG), cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and CRP had moderate to large effect sizes (adjusted RAmong participants with SCI, higher conformance to the 2015-2020 DGA was 1) moderately associated with better FG homeostasis; and 2) trivially associated with other cardiovascular risk factors. Because of the small sample size, these conclusions cannot be extrapolated beyond the study sample. Future larger studies are warranted to better understand the relationship between diet quality and cardiovascular disease risks in this population.

Women living with HIV (WLWH) have lower employment rates and more difficulty finding and keeping employment compared with their counterparts without HIV. These disparities affect physical, psychological, and socioeconomic outcomes, and they may compound the disadvantages associated with living with HIV. Although historical literature has emphasized the impact of clinical factors on employment, current evidence suggests that socioeconomic and psychosocial factors associated with HIV should be included for a more comprehensive view. Based on this broader inclusion, a conceptual framework is presented describing how socioeconomic and psychosocial characteristics influence employment acquisition and maintenance among WLWH. The framework posits that there is a reciprocal relationship between employment acquisition and occupational productivity, and psychological health, physical health, social support, and empowerment. Implications for future research and interventions include (a) an extended conceptualization of vocational rehabilitation and (b) the use of peer support groups to increase social capital, empowerment, knowledge, and resources among WLWH.

Importance National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations. Objective To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure. Design, Setting, and Participants A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals. Interventions The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks. Main Outcomes and Measures Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered “fairly good” quality of life; and the Functional Assessment of Chronic Illness Therapy–Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits). Results Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7;d = 0.07 [95% CI, −0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8;d = 0.12 [95% CI, −0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety,d = −0.02 [95% CI, –0.20 to 0.16]; HADS-depression,d = –0.09 [95% CI, –0.24 to 0.06]). Conclusions and Relevance This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement. Trial Registration ClinicalTrials.gov Identifier:NCT02505425

Women living with HIV are disproportionally affected by depression and mental healthcare access. A pilot feasibility trial using videoconferencing compared cognitive behavioral therapy for antiretroviral therapy adherence and depression ( N = 11) to supportive psychotherapy ( N = 11). Participants completed 10–12 weekly therapy sessions and 6-month follow-up. Retention at 6 months was 95 percent. Depression symptoms significantly decreased in both arms; antiretroviral therapy adherence remained high as measured via self-report and Wisepill. Satisfaction with intervention components was high; videoconferencing was highly acceptable and comparable to face-to-face counseling. This study demonstrates the feasibility of telemedicine-administered psychotherapy addressing mental health needs among women living with HIV.

PURPOSE: To compare two implementation telephone-based strategies of an evidence-based educational and support intervention to Rural Breast Cancer Survivor (RBCS) in which education was delivered early or after the support component. METHODS: Florida RBCS participated in a 12-month randomized clinical trial (RCT) with two arms: Early Education and Support (EE-S), and Support and Delayed Education (S-DE). Arms differed in the timing of 6 support and 3 education sessions. Main outcome was quality of life (QOL, SF-36 physical and mental composite scores [PCS, MCS]). Secondary outcomes were depressive symptoms (Centers for Epidemiologic Studies Depression Scale, CES-D), mood (Profile of Mood States, POMS), and social support (Medical Outcomes Study - Social Support Survey, MOS-SSS). Outcomes were analyzed longitudinally using repeated measures models fitted with linear mixed methods. RESULTS: Of 432 RBCS (mean 25.6 months from diagnosis), about 48% were 65+, 73% married/partnered, 28% with ≤high school education. There were no differences between EE-S and S-DE in demographics or outcomes at baseline (Mean (Standard deviation): SF-36 PCS: 44.88 (10.6) vs. 45.08 (10.6) ; MCS: 49.45 (11.1) vs. 48.1 (11.9); CES-D: 10.11 (9.8) vs. 10.86 (10.5) ; POMS-SF: 23.95 (38.6) vs. 26.35 (38.8); MOS-SSS: 79.2 (21.2) vs. 78.66 (21.2)) or over time. One exception was slightly worse mean scores at month 9 in MCS (Cohen’s d −0.22, 95% CI: −0.38, −0.06) and POMS (Cohen’s d 0.23, 95% CI: 0.07, 0.39) for EE-S vs. S-DE. CONCLUSIONS: The implementation strategies were equivalent. IMPLICATIONS FOR SURVIVORS: Enhancing support may be considered before delivering not-in-person interventions to RBCS.

Background Heart failure (HF) caregivers experience increased demands and burden. Social support and problem solving may influence the effect of these variables on caregiver outcomes. Objective The aim of this study was to examine whether social support and problem solving mediate relationships among caregiver demands and burden, self-care, depression, and life changes in heart failure caregivers. Methods Using a cross-sectional, exploratory design, heart failure caregivers (n = 530) completed online questionnaires on caregiver demands and burden, social support, problem solving, depression, self-care, and life changes. Path analysis examined a hypothesized mediating role of social support and problem solving in the relationships among caregiver demands and burden and caregiver outcomes. The analysis included (1) a model-development phase (n = 329) to make data-based decisions on measurement indicators and model structure and (2) a confirmatory phase (n = 201) to provide unbiased inference on the model structure resulting from the initial phase. Results Participants were 41.39 (±10.38) years old and primarily white (78.3%) men (50.9%) caring for a spouse (44.9%). Per the magnitudes of the estimated path coefficients, social support mediated the relationship between caregiver burden and depression but did not relevantly mediate the relationship between caregiver burden and self-care or caregiver life changes. In the presence of social support as a parallel mediator, problem solving was not a relevant mediator between caregiver burden and demands and caregiver outcomes. Conclusions Social support mediates the effects of caregiver burden on depression but has little effect on self-care or life changes. In the presence of social support, problem solving does not mediate the effects of caregiver demands and burden on caregiver outcomes.

Background Preterm birth is a risk factor for elevated blood pressure in childhood and the development of hypertension and cardiometabolic disease in adulthood; however, mechanisms for the development of both are poorly understood. Rapid weight gain early in childhood may serve as a driver directly and indirectly through cortisol levels found to be elevated in early childhood in individuals born preterm. Objectives The objective of this pilot study was to examine the effect sizes of the relationships between weight gain and blood pressure in toddlers born very preterm. A secondary aim was to note any mediating effect of cortisol on the relationships between weight gain and blood pressure. Methods A cross-sectional design with a convenience sample of 36 toddlers who were born very preterm was used to examine the relationships between postnatal weight gain, cortisol, and blood pressure at follow-up. Results Many of the participants experienced rapid weight gain in the first 12 months of life. Mean systolic and diastolic readings were 94 and 56.6, respectively. Diastolic blood pressure readings were obtained from 23 participants, and the majority were elevated. Weight gain was associated with diastolic blood pressure with a medium effect size. A mediating role with cortisol was not supported. Discussion Although findings need to be validated in a larger sample, the blood pressure elevations in this sample were alarming. If readings continue to amplify as these children age, the fact that elevations are already present during the toddler period could indicate more significant cardiovascular disease in adulthood for this population. Rapid weight gain in early life may be a driver for elevated blood pressure even during early childhood in individuals born preterm.

BACKGROUND The impact of National Comprehensive Cancer Network (NCCN) treatment guideline concordance on costs, health care utilization, and mortality for patients with breast cancer and secondary metastases is unknown. METHODS From 2007 to 2013, women with early-stage breast cancer who received treatment for secondary metastases (n = 5651) were evaluated for first recorded systemic therapy concordance with NCCN guidelines within the Surveillance, Epidemiology, and End Results Program-Medicare linked database. Generalized linear and mixed effects models evaluated factors associated with nonconcordance and the relation between concordance status and health care utilization and costs. Mortality risk was estimated with Cox regression. RESULTS Eighteen percent of the patients received nonconcordant therapy, with the most common being single-agent, human epidermal growth factor receptor 2 (HER2)-targeted therapy (36%), therapy mismatched with the estrogen receptor/HER2 status (11%), unapproved bevacizumab regimens (10%), and adjuvant regimens in a metastatic setting (6%). A younger age, a hormone receptor-negative status, and a HER2-positive status were associated with nonconcordance (P < .05). Nonconcordance was associated with 22% and 21% increased rates of emergency department visits and hospitalizations, respectively, and $1765 higher average monthly Medicare costs. Differences in adjusted mortality risk were noted by the category of nonconcordance; single-agent, HER2-targeted therapy was associated with decreased mortality risk (hazard ratio [HR], 0.66; 95% confidence limit [CL], 0.57-0.76), and increased mortality risk was observed with unapproved bevacizumab use (HR, 1.40; 95% CL, 1.13-1.74). CONCLUSIONS Most patients (82%) received treatment consistent with NCCN guidelines. Nonconcordant treatment was associated with higher health care utilization and costs, with mortality differences observed by the type of guideline deviation. Consideration of both patient and financial outcomes will be important as health systems increase the emphasis on guideline-based care.

To determine the effects of gamification on student education, researchers implemented "Kaizen," a software-based knowledge competition, among a first-year class of undergraduate nursing students. Multiple-choice questions were released weekly or biweekly during two rounds of play. Participation was voluntary, and students could play the game using any Web-enabled device. Analyses of data generated from the game included (1) descriptive, (2) logistic regression modeling of factors associated with user attrition, (3) generalized linear mixed model for retention of knowledge, and (4) analysis of variance of final examination performance by play styles. Researchers found a statistically significant increase in the odds of a correct response (odds ratio, 1.8; 95% confidence interval, 1.0-3.4) for a round 1 question repeated in round 2, suggesting retention of knowledge. They also found statistically significant differences in final examination performance among different play styles.To maximize the benefits of gamification, researchers must use the resulting data both to power educational analytics and to inform nurse educators how to enhance student engagement, knowledge retention, and academic performance.

Background National Comprehensive Cancer Network (NCCN) guideline-based treatment is a marker of high-quality care. The impact of guideline discordance on cost and health care utilization is unclear. Materials and Methods This retrospective cohort study of Medicare claims data from 2012 to 2015 included women age ≥65 with stage I–III breast cancer receiving care within the University of Alabama at Birmingham Cancer Community Network. Concordance with NCCN guidelines was assessed for treatment regimens. Costs to Medicare and health care utilization were identified from start of cancer treatment until death or available follow-up. Adjusted monthly cost and utilization rates were estimated using linear mixed effect and generalized linear models. Results Of 1,177 patients, 16% received guideline-discordant treatment, which was associated with nonwhite race, estrogen receptor/progesterone receptor negative, human epidermal growth receptor 2 (HER2) positive, and later-stage cancer. Discordant therapy was primarily related to reduced-intensity treatments (single-agent chemotherapy, HER2-targeted therapy without chemotherapy, bevacizumab without chemotherapy, platinum combinations without anthracyclines). In adjusted models, average monthly costs for guideline-discordant patients were $936 higher compared with concordant (95% confidence limits $611, $1,260). For guideline-discordant patients, adjusted rates of emergency department visits and hospitalizations per thousand observations were 25% higher (49.9 vs. 39.9) and 19% higher (24.0 vs. 20.1) per month than concordant patients, respectively. Conclusion One in six patients with early-stage breast cancer received guideline-discordant care, predominantly related to undertreatment, which was associated with higher costs and rates of health care utilization. Additional randomized trials are needed to test lower-toxicity regimens and guide clinicians in treatment for older breast cancer patients. Implications for Practice Previous studies lack details about types of deviations from chemotherapy guidelines that occur in older early-stage breast cancer patients. Understanding the patterns of guideline discordance and its impact on patient outcomes will be particularly important for these patients. This study found 16% received guideline-discordant care, predominantly related to reduced intensity treatment and associated with higher costs and rates of health care utilization. Increasing older adult participation in clinical trials should be a priority in order to fill the knowledge gap about how to treat older, less fit patients with breast cancer.

Background Palliative care is specialized medical care for people with serious illness that is focused on providing relief from symptoms and stress and improving the quality of life (QOL) for patients and their families. To help the 6.5 million U.S. adults and families affected by heart failure manage the high symptom burden, complex decision-making, and risk of exacerbation and death, the early integration of palliative care is critical and has been recommended by numerous professional organizations. However, few trials have tested early outpatient community-based models of palliative care for patients diagnosed with advanced heart failure and their caregivers. To address this gap, through a series of formative evaluation trials, we translated an oncology early palliative care telehealth intervention for heart failure to create ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends, Comprehensive Heartcare for Patients and Caregivers). Methods/Design The primary objective of this multisite pragmatic randomized controlled trial is to test the efficacy of ENABLE CHF-PC plus usual heart failure care compared to usual care alone. Community-dwelling persons who are ≥50 years of age with New York Heart Association class III/IV or American Heart Association/American College of Cardiology stage C/D heart failure and their primary caregiver (if present) are being randomized to one of two study arms. The ENABLE CHF-PC intervention group receives usual heart failure care plus an in-person palliative care assessment by a board-certified palliative care provider (caregivers are invited to attend), a series of nurse coach-led, weekly psychoeducational 20 to 60 min phone sessions using a guidebook called Charting Your Course (patients: 6 sessions and caregivers: 4 sessions), and monthly check-in calls. Charting Your Course topical content includes problem-solving, coping, self-care and symptom management, communication, decision-making, advance care planning, and life review (patients only). Primary outcomes include patient QOL and mood (depressive symptoms/anxiety) and caregiver QOL, mood, and burden at 8 and 16 weeks after baseline. Outcomes will be examined using an intention-to-treat approach and mixed effects modeling for repeated measures. Discussion This trial will determine whether the ENABLE CHF-PC model of concurrent heart failure palliative care is superior to usual heart failure care alone in achieving higher patient and caregiver QOL, improving mood, and lowering burden. Trial registration ClinicalTrials.gov, NCT02505425. Registered on 22 July 2015. Electronic supplementary material The online version of this article (10.1186/s13063-018-2770-9) contains supplementary material, which is available to authorized users.

Objectives The purpose of this study was to test the efficacy of MOUTh (Managing Oral Hygiene Using Threat Reduction), a nonpharmacologic, relationship-based intervention vs. control on 2 primary outcomes for nursing home (NH) residents with dementia who resisted mouth care: (i) reduction in the occurrence and intensity of care-resistant behaviours (CRBs) and (ii) improvement in oral health. Two secondary outcomes were also examined: (i) the duration of mouth care and (ii) the completion of oral hygiene activities. Background Persons with dementia who exhibit CRBs are at risk for inadequate mouth care and subsequent systemic illnesses. Materials and methods The study used a randomised repeated measures design. Recruitment occurred in 9 nursing homes that varied in size, ownership, reimbursement patterns and location. One hundred and one nursing home residents with dementia were randomised at the individual level to experimental (n = 55) or control groups (n = 46). One hundred participants provided data for the analyses. Results Compared to the control group, persons in the experimental group had twice the odds of allowing mouth care and completing oral hygiene activities; they also allowed longer duration of mouth care (d = 0.56), but showed only small reductions in the intensity of CRBs (d = 0.16) and small differential improvements in oral health (d = 0.18). Conclusion The data suggest that this intervention facilitates mouth care among persons with dementia. The management of refusal behaviour may be a clinically more realistic approach than reducing or eradicating refusals.

Context There is a scarcity of early palliative care interventions to support family caregivers of persons with advanced cancer living in the rural Southern U.S. Objective The objective of this study was to adapt the content, format, and delivery of a six session, palliative care, telehealth intervention with monthly follow-up for rural family caregivers to enhance their own self-care and caregiving skills. Methods Qualitative formative evaluation consisting of one-on-one, semistructured interviews with rural-dwelling persons with metastatic cancer (n = 18), their primary family caregiver (n = 20), and lay patient navigators (n = 26) were conducted to elicit feedback on a family caregiver intervention outline based on published evidence-based interventions. Transcribed interviews were analyzed using a thematic analysis approach. Coinvestigators reviewed and refined preliminary themes. Results Participants recommended that intervention topical content be flexible and has an adaptable format based on continuous needs assessment. Sessions should be 20 minutes long at minimum, and additional sessions should be offered if requested. Faith and spirituality is essential to address but should not be an overarching intervention theme. Content needs to be communicated in simple language. Intervention delivery via telephone is acceptable, but face-to-face contact is desired to establish relationships. Other Internet-based technologies (e.g., video-conferencing) could be helpful, but many rural dwellers may not be technology savvy or have Internet access. Most lay navigators believed they could lead the intervention with additional training, protocols for professional referral, and supervision by specialty-trained palliative care clinicians. Conclusions A potentially scalable palliative care intervention is being adapted for family caregivers of rural-dwelling persons with advanced cancer and will undergo piloting in a small-scale randomized controlled trial.

Purpose: The Oncology Care Model (OCM) is a highly controversial specialty care model developed by the Centers for Medicare & Medicaid aimed to provide higher-quality care at lower cost. Because oncologists will be increasingly held accountable for spending as well as quality within new value-based health care models like the OCM, they need to understand the drivers of total spending for their patients. Methods: This retrospective cohort study included patients ≥ 65 years of age with primary fee-for-service Medicare insurance who received antineoplastic therapy at 12 cancer centers in the Southeast from 2012 to 2014. Medicare administrative claims data were used to identify health care spending during the prechemotherapy period (from cancer diagnosis to antineoplastic therapy initiation) and during the OCM episodes of care triggered by antineoplastic treatment. Total health care spending per episode includes all types of services received by a patient, including nononcology services. Spending was further characterized by type of service. Results: Average total health care spending in the three OCM episodes of care was $33,838 (n = 3,427), $23,811 (n = 1,207), and $19,241 (n = 678). Antineoplastic drugs accounted for 27%, 32%, and 36% of total health care spending in the first, second, and third episodes. Ten drugs, used by 31% of patients, contributed 61% to drug spending ($18.8 million) in the first episode. Inpatient spending also substantially contributed to total costs, representing 17% to 20% ($30.5 million) of total health care spending. Conclusion: Health care spending was heavily driven by both antineoplastic drugs and hospital use. Oncologists’ ability to affect these types of spending will determine their success under alternative payment models.

This abstract was withdrawn by the authors.

Background: Symptom burden has a negative impact on Health-Related Quality of Life (HRQoL). Identifying symptom burden and sources utilized for symptom management at different points in the cancer trajectory may guide development of supportive care services for older patients with breast cancer. Methods: This was secondary analysis of survey data from the University of Alabama at Birmingham Health System Cancer Community Network, which includes 12 hospitals across the Southeast. Female Medicare beneficiaries with breast cancer were surveyed from 2013-2015 via telephone. Demographic information, treatment status, HRQoL (Short Form Health Survey, SF-12), symptom burden (MD Anderson Symptom Inventory, MDASI), and sources used for symptom management (e.g. doctors, nurses) were collected. Descriptive statistics were computed for all variables of interest. HRQoL, overall symptom burden, and individual symptom scores by treatment status were compared using standardized mean differences (Cohen's d) and Student's t-tests. Simple linear regression was used to determine the association between symptom burden and HRQoL scores. A 10% False-Discovery-Rate was used to adjust for multiple inference. Results: 321 women age 65 years and older with breast cancer were included in the survey sample; 141 (45%) were on treatment with chemotherapy (9%), radiation (1%), recurrence treatment (6%), or other planned cancer treatment (29%). Similar HRQoL scores were observed for participants on and off treatment, with SF-12 physical scores of 39.2 (SD 11.5) vs. 41.4 (SD 11.9, d=.19) and SF-12 mental scores of 52.5 (SD 9.7) vs. 53.2 (SD 9.4, d=.07). Symptom burden was also similar, with overall MDASI severity scores of 2.5 (SD 1.9) and 2.2 (SD 1.7, d=.17). For participants on treatment, fatigue and disturbed sleep were the most severe symptoms with average scores of 4.4 (SD 3.0) and 3.6 (SD 3.2), respectively. For participants off treatment, the most severe symptoms were fatigue and memory problems with average scores of 3.8 (SD 3.1) and 3.1 (SD 2.7). A small difference in disturbed sleep was observed, with participants on treatment reporting more symptom severity (3.6 [SD 3.2] vs 2.7 [SD 2.9], d=.3, p=.01). Minor differences were observed for the severity of other specific symptoms between the groups. For patients both on and off treatment, MDASI scores were strongly and significantly associated with decreased SF-12 physical (on: β=-3.0 [SE 0.4], R2=.21, p Conclusion: Quality of life and overall symptom burden were similar for patients on and off treatment, with only a small difference in disturbed sleep. Overall symptom burden was strongly associated with decreased HRQoL among older females with breast cancer. Nurses were the most common source utilized for symptom management, suggesting the importance of systematic trainings, particularly for nurses, on symptom management and supportive care services for patients on and beyond treatment. Citation Format: Halilova KI, Williams CP, Azuero A, Kvale EA, Yagnik SK, Goertz H-P, Pizu M, Rocque GB. Health-related quality of life, symptom burden and management in older women with breast cancer across the illness trajectory [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-12.

Nearly 50% of adults with HIV have some form of HIV-associated neurocognitive disorder (HAND), ranging from subtle to symptoms that interfere with everyday functioning and quality of life. HAND is diagnosed when a person performs more than 1 standard deviation below his or her normative mean on standardized measures in two or more cognitive domains (e.g., attention, speed of processing, verbal memory, executive functioning). As adults age with HIV, they are more likely to develop comorbidities such as cardiovascular disease, hypertension, and insulin resistance that may further contribute to poorer cognitive functioning and HAND. Certain computerized cognitive training programs may be able to improve specific cognitive domains in those with HIV. Such programs may be effective in changing the diagnosis of HAND in cognitively vulnerable adults. In this article, we describe the design and methods of TOPS-the Training On Purpose Study. In this on-going experimental study, 146 older adults (50+) with HAND are randomized to either: (i) an Individualized-Targeted Cognitive Training group, or (ii) a no-contact control group. This study targets those cognitive domains in which participants experience a deficit and trains participants with the corresponding computerized cognitive training program for that domain. An Individualized Targeted Cognitive Training approach using cognitive-domain-specific cognitive training programs may offer symptom relief to those individuals diagnosed with HAND, which may actually reverse this diagnosis. Given that these cognitive training programs are commercially available, this approach represents a potential paradigm shift in how HAND is considered and treated.

Background As the population of older adults with cancer continues to grow, the most important factors contributing to their health-related quality of life (HRQOL) remain unclear. Methods A total of 1457 older adults (aged ≥65 years) with cancer participated in a telephone survey. Outcomes were measured using the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the 12-Item Short Form Survey (SF-12) from the Medical Outcomes Study (version 2). Statistical techniques used to identify factors in 4 domains (physical, psychological, social, and spiritual) most strongly associated with HRQOL included linear models, recursive partitioning, and random forests. Models were developed in a training data set (920 respondents) and performance was assessed in a validation data set (537 respondents). Results Respondents were a median of 19 months from diagnosis, and 28.1% were receiving active treatment. The most relevant factors found to be associated with PCS were symptom severity, comorbidity scores, leisure-time physical activity, and having physical support needs. The most relevant factors for MCS were having emotional support needs, symptom severity score, and the number of financial hardship events. Results were consistent across modeling techniques. Symptoms found to be strongly associated with PCS included fatigue (adjusted proportion of summary score's variance [R2 ] = 0.34), pain (adjusted R2 = 0.32), disturbed sleep (adjusted R2 = 0.16), and drowsiness (adjusted R2 = 0.16). Symptoms found to be strongly associated with MCS included fatigue (adjusted R2 = 0.23), problems remembering things (adjusted R2 = 0.17), disturbed sleep (adjusted R2 = 0.16), and lack of appetite (adjusted R2 = 0.16). Conclusions The findings of the current study support the importance of addressing persistent symptoms, managing comorbidities, promoting leisure-time physical activity, and addressing financial challenges. A long-term comprehensive approach is needed to ensure the well-being of older adults with cancer. Cancer 2018;124:596-605. © 2017 American Cancer Society.

75 Background: Many patient population groups are not proportionally represented in clinical trials, including patients of color, at age extremes, or with comorbidities. It is unclear how treatment outcomes may differ for these patients compared to those well represented in trials. Methods: This retrospective cohort study included women diagnosed with early-stage (I-III) breast cancer (EBC) between 2005-2015 in the CancerLinQ Discovery electronic medical record-based dataset. Patients with comorbidities or concurrent cancer were considered unrepresented in clinical trials. Non-White patients and/or those aged