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Donabedian's framework offers a model to evaluate the relationship between patient outcomes, influenced by clinical care delivery structures and processes. Applying this model proposes that adequate and appropriate structures and processes within organizations are necessary to realize optimal outcomes; it is imperative that leadership focuses on those structures and processes to reduce the risk of burnout. Current research cannot determine whether burnout causes decreased quality or working in a setting with decreased quality causes burnout. The follow-up question is whether curtailing burnout will improve quality or whether improving quality of care will reduce provider burnout?

Nurses experience high levels of burnout, and this has become a major factor in recruitment and retention of nurses. Several factors have been associated with burnout, but it is not clear which factors are the most significant predictors. Understanding the most prevalent factors that are associated with burnout will allow for the development and implementation of interventions to ameliorate and/or reduce burnout in the nursing workforce.

Burnout syndrome has been defined as a state of chronic stress characterized by high levels of emotional exhaustion and depersonalization with low levels of professional efficacy. The effects of nurse burnout include poor job satisfaction and turnover. Nurses' physical and mental well-being are both essential to sustaining a healthy nursing workforce with factors such as an empowering work environment showing positive effects on reducing burnout. Formal and informal individual and organizational approaches to supporting novice nurses' transition and experienced nurses' sustained practice fulfillment are key to addressing burnout and fostering retention.

Burnout is a condition resulting from chronic workplace stress that has not been effectively managed, described in 3 dimensions: (a) feelings of energy depletion or exhaustion, (b) increased mental distance from one's job, and (c) reduced professional efficacy. Burnout is a widespread problem reaching concerning levels among health care professionals, with more than 50% of physicians and one-third as many as 80% of nurses reporting symptoms. The National Academy of Medicine (NAM) action collaborative on clinician well-being and resilience has prioritized exploring ways to enhance baseline understanding of clinician well-being and promotion of multidisciplinary solutions to burnout.

Oral anthelmintic niclosamide has potent in vitro antiviral activity against SARS-CoV-2. Repurposed niclosamide could be a safe and efficacious COVID-19 therapy.To investigate whether niclosamide decreased SARS-CoV-2 shedding and duration of symptoms among patients with mild to moderate COVID-19.This randomized, placebo-controlled clinical trial enrolled individuals testing positive for SARS-CoV-2 by polymerase chain reaction with mild to moderate symptoms of COVID. All trial participants, investigators, staff, and laboratory personnel were kept blind to participant assignments. Enrollment was among individuals reporting at Tufts Medical Center and Wellforce Network in Massachusetts for outpatient COVID-19 testing. The trial opened to accrual on October 1, 2020; the last participant enrolled on April 20, 2021. Trial exclusion criteria included hospitalization at time of enrollment or use of any experimental treatment for COVID-19, including vaccination. Enrollment was stopped before attaining the planned sample size when COVID-19 diagnoses decreased precipitously in Massachusetts. Data were analyzed from July through September 2021.In addition to receiving current standard of care, participants were randomly assigned on a 1:1 basis to receive niclosamide 2 g by mouth daily for 7 days or identically labeled placebo at the same dosing schedule.Oropharyngeal and fecal samples were self-collected for viral shedding measured by reverse-transcriptase-polymerase-chain-reaction on days 3, 7, 10, and 14, and an additional fecal sample was collected on day 21. A telehealth platform was developed to conduct remote study visits, monitor symptoms, and coordinate sample collection via couriers. The primary end point was the proportion of participants with viral clearance in respiratory samples at day 3 based on the intention-to-treat sample. Mean times to viral clearance and symptom resolution were calculated as restricted mean survival times and accounted for censored observations.Among 73 participants, 36 individuals were enrolled and randomized to niclosamide and 37 individuals to placebo. Participant characteristics were similar across treatment groups; among 34 patients receiving placebo and 33 patients receiving niclosamide in the intention-to-treat sample, mean (SD) age was 36.0 (13.3) years vs 36.8 (12.9) years and there were 21 (61.8%) men vs 20 (60.6%) men. The overall mean (SD) age was 36.4 (13.0) years. For the primary end point, 66.67% (95% CI, 50.74% to 81.81%) of participants receiving niclosamide and 55.88% (95% CI, 40.27% to 72.73%) of participants receiving placebo had oropharyngeal SARS-CoV-2 clearance at day 3 (P = .37). Among 63 participants with symptoms, niclosamide did not significantly shorten symptom duration, which was 12.01 (95% CI, 8.82 to 15.2) days in the niclosamide group vs 14.61 (95% CI, 11.25 to 17.96) days in the placebo group (mean difference, -2.6 [95% CI, -7.23 to 2.03] days). Niclosamide was well-tolerated; the most commonly reported adverse events in the placebo and niclosamide groups were headaches (11 patients [32.4%] vs 7 patients [21.2%]; P = .31) and cough (8 patients [23.5%] vs 7 patients [21.2%]; P = .82).In this randomized clinical trial, there was no significant difference in oropharyngeal clearance of SARS-CoV-2 at day 3 between placebo and niclosamide groups. Confirmation in larger studies is warranted.ClinicalTrials.gov Identifier: NCT04399356.

Cancer survivors face several challenges following the completion of active treatment, including uncertainty about late effects of treatment and confusion about coordination of follow-up care. The authors evaluated patient satisfaction with personalized survivorship care plans designed to clarify those issues. The authors enrolled 48 patients with breast cancer and 10 patients with colorectal cancer who had completed treatment in the previous two months from an urban academic medical center and a rural community hospital. Patient satisfaction with the care plan was assessed by telephone interview. Overall, about 80% of patients were very or completely satisfied with the care plan, and 90% or more agreed that it was useful, it was easy to understand, and the length was appropriate. Most patients reported that the care plan was very or critically important to understanding an array of survivorship issues. However, only about half felt that it helped them better understand the roles of primary care providers and oncologists in survivorship care. The results provide evidence that patients with cancer find high value in personalized survivorship care plans, but the plans do not eliminate confusion regarding the coordination of follow-up care. Future efforts to improve care plans should focus on better descriptions of how survivorship care will be coordinated.

Purpose There is growing interest to enhance symptom monitoring during routine cancer care using patient-reported outcomes, but evidence of impact on clinical outcomes is limited. Methods We randomly assigned patients receiving routine outpatient chemotherapy for advanced solid tumors at Memorial Sloan Kettering Cancer Center to report 12 common symptoms via tablet computers or to receive usual care consisting of symptom monitoring at the discretion of clinicians. Those with home computers received weekly e-mail prompts to report between visits. Treating physicians received symptom printouts at visits, and nurses received e-mail alerts when participants reported severe or worsening symptoms. The primary outcome was change in health-related quality of life (HRQL) at 6 months compared with baseline, measured by the EuroQol EQ-5D Index. Secondary endpoints included emergency room (ER) visits, hospitalizations, and survival. Results Among 766 patients allocated, HRQL improved among more participants in the intervention group than usual care (34% v 18%) and worsened among fewer (38% v 53%; P < .001). Overall, mean HRQL declined by less in the intervention group than usual care (1.4- v 7.1-point drop; P < .001). Patients receiving intervention were less frequently admitted to the ER (34% v 41%; P = .02) or hospitalized (45% v 49%; P = .08) and remained on chemotherapy longer (mean, 8.2 v 6.3 months; P = .002). Although 75% of the intervention group was alive at 1 year, 69% with usual care survived the year (P = .05), with differences also seen in quality-adjusted survival (mean of 8.7 v. 8.0 months; P = .004). Benefits were greater for participants lacking prior computer experience. Most patients receiving intervention (63%) reported severe symptoms during the study. Nurses frequently initiated clinical actions in response to e-mail alerts. Conclusion Clinical benefits were associated with symptom self-reporting during cancer care.

Although patient satisfaction has been used traditionally as a measure of excellence, research has suggested that the perception of being well cared for is likely a more promising indicator of quality than satisfaction alone. Expectations, physical environment, communication, participation and involvement, technical competence, and the influence of healthcare organizations are factors that may impair patients' ability to distinguish nursing care from their overall healthcare experience. This study evaluated the effect of a nurse practitioner audit and feedback intervention on hospitalized patients' perception of care.

Purpose Tracking symptoms related to treatment toxicity is standard practice in routine care and during clinical trials. Currently, clinicians collect symptom information via complex and often inefficient mechanisms, but there is growing interest in collecting outcome information directly from patients. Patients and Methods The National Cancer Institute Common Terminology Criteria for Adverse Events schema for seven common symptoms was adapted into a Web-based patient-reporting system, accessible from desktop computers in outpatient clinics and from home computers. Eighty patients with gynecologic malignancies beginning standard chemotherapy regimens were enrolled between April and September 2004. During an 8-week observation period, participants were encouraged to log in and report symptoms at each follow-up visit, or alternatively, to access the system from home. Results All patients completed an initial log in. At each subsequent appointment, most enrollees (80% to 85%) reported symptoms using the online system, with a mean of three follow-up visits per patient during the observation period (range, one to six). Sixty of 80 patients (75%) logged in at least once from home. Use was significantly associated with prior Internet experience. Forty-two severe toxicities (grade 3 to 4) entered from home prompted seven clinician interventions. Most patients (96%) found the system useful and would recommend it to others. Conclusion Patients are capable of reporting symptoms experienced during chemotherapy using a Web-based interface. Assessment in the clinical trial setting and comparison of direct patient- versus clinician-based approaches for reporting symptoms and their severity are warranted.

LBA2 Background: We previously reported significant benefits in quality of life, patient satisfaction, and emergency room utilization outcomes from a large single-center randomized controlled trial comparing web-based symptom monitoring with patient-reported outcomes (PROs) vs. usual care in patients receiving chemotherapy for metastatic solid tumors (Clinicaltrials.gov: NCT00578006). We now present overall survival results from this trial. Methods: Patients receiving routine outpatient chemotherapy for metastatic solid tumors at Memorial Sloan Kettering Cancer Center were randomly assigned to self-report 12 common symptoms via tablet computers (“PRO intervention”), or to usual care. Treating physicians received symptom printouts at visits and nurses received email alerts when participants reported severe or worsening symptoms. Overall survival was tabulated based on medical records and Social Security Death Index data, estimated using the Kaplan-Meier method, and compared between arms using a log-rank test and Cox proportional hazards regression adjusting for age, sex, race, education level, and cancer type. Results: Between September 2007 and January 2011, 766 patients were randomized, with median age 61 (range 26-91), 86% white, 58% female, and 22% with less than high school education. Cancer types included genitourinary (32% of patients), gynecologic (23%), breast (19%), and lung cancer (26%). Survival results were assessed in June 2016 after a median follow up of 7 years and 517/766 (67%) of participants had died. Median overall survival in the PRO intervention arm was 5 months longer than the control arm (31.2 vs. 26.0 months, p = 0.03). In the multivariable model, results remained statistically significant with a hazard ratio of 0.832 (p = 0.04; 95% CI; 0.696, 0.995). Conclusions: Systematic symptom monitoring during outpatient chemotherapy using web-based patient-reported outcomes confers overall survival benefits. These single-center results are being further evaluated in a national multicenter implementation trial. Clinical trial information: NCT00578006.

Objective: Survivorship care plans (SCP), which describe a cancer survivor’s diagnosis, treatment and follow-up, are recommended. The study objective was to evaluate primary care providers’ (PCP) responses to SCPs developed for breast and colorectal cancer survivors in their practice and to determine whether PCP response to the SCPs varied according to characteristics of the practitioner and their practice. Method: SCPs were created using the Journey Forward® Care Plan for breast and colorectal cancer patients in rural and urban settings. The SCP and a survey were sent to PCPs. Participants: Primary care physicians. Main Measures: Attitudes regarding survivorship care plans. Results: Thirty-nine (70.9% response rate) surveys were completed. Most felt the SCP was useful (90%), that it enhanced understanding (75%) and that detail was sufficient (>80%). However, 15% disagreed that the care plan helped them understand their role, a perception especially prevalent among PCPs in the rural setting. Among PCPs with ≤ 18 years in practice, 95% agreed that the SCP would improve communication with patients, contrasted with 60% of those with >21 years in practice. The most common barrier to providing follow-up care was limited access to survivors. Conclusions: While SCPs appear to improve PCPs understanding of a cancer diagnosis and treatment, clear delineation of each provider’s role in follow-up care is needed. Additional detail on which tests are needed and education on late and long term effects of cancer may improve coordination of care.

To evaluate the process of survivorship care plan (SCP) completion and to survey oncology staff and primary care physicians (PCPs) regarding challenges of implementing SCPs.Descriptive pilot study.Two facilities in Vermont, an urban academic medical center and a rural community academic cancer center.17 oncology clinical staff created SCPs, 39 PCPs completed surveys, and 58 patients (breast or colorectal cancer) participated in a telephone survey.Using Journey Forward tools, SCPs were created and presented to patients. PCPs received the SCP with a survey assessing its usefulness and barriers to delivery. Oncology staff were interviewed to assess perceived challenges and benefits of SCPs. Qualitative and quantitative data were used to identify challenges to the development and implementation process as well as patient perceptions of the SCP visit.SCP, healthcare provider perception of barriers to completion and implementation, and patient perception of SCP visit.Oncology staff cited the time required to obtain information for SCPs as a challenge. Completing SCPs 3-6 months after treatment ended was optimal. All participants felt advanced practice professionals should complete and review SCPs with patients. The most common challenge for PCPs to implement SCP recommendations was insufficient knowledge of cancer survivor issues. Most patients found the care plan visit very useful, particularly within six months of diagnosis.Creation time may be a barrier to widespread SCP implementation. Cancer survivors find SCPs useful, but PCPs feel insufficient knowledge of cancer survivor issues is a barrier to providing best follow-up care. Incorporating SCPs in electronic medical records may facilitate patient identification, appropriate staff scheduling, and timely SCP creation.Oncology nurse practitioners are well positioned to create and deliver SCPs, transitioning patients from oncology care to a PCP in a shared-care model of optimal wellness. Institution support for the time needed for SCP creation and review is imperative for sustaining this initiative.Accessing complete medical records is an obstacle for completing SCPs. A 3-6 month window to develop and deliver SCPs may be ideal. PCPs perceive insufficient knowledge of cancer survivor issues as a barrier to providing appropriate follow-up care.

Objective: To evaluate the efficacy of a self-collected vaginal introital specimen, obtained by women using only an instruction booklet as a guide, for the detection of Chlamydia trachomatis using polymerase chain reaction (PCR). Methods: Comparison analysis in an Urban hospital clinic, using a convenience sample of 101 women undergoing screening or treatment for C trachomatis infection. Subjects were given an illustrated instruction booklet and were asked to collect a single specimen from the vaginal introitus using the Amplicor collection kit. Cervical and introital specimens then were obtained by clinicians. The presence of C trachomatis in patient-collected versus clinician-collected samples was determined by PCR. Discordant specimens were retested by PCR, using primer pairs to the C trachomatis major outer membrane protein gene, and were screened for the presence of PCR assay inhibitors. Results: Ninety-nine subjects completed the self-collection. Sixty-two percent were adolescents and 17% spoke English as their second language. Forty-three percent had never used tampons, and 36% had never looked at their own genitals. Twenty-eight cervical specimens (28%), 32 clinician-collected introital specimens (32%), and 33 self-collected introital specimens (33%) were positive for C trachomatis infection. All clinician-collected introital specimens that were positive for C trachomatis and all cervical specimens that were positive for C trachomatis were positive on self-test. Compared with clinician-collected introital specimens, self-collected specimens had a sensitivity of 100% and a specificity of 98.5%. Compared with cervical specimens, self-collected specimens had a sensitivity of 100% and a specificity of 93.4%. After discrepant analysis, self-test had a sensitivity of 100% and a specificity of 94.6% for detection of C trachomatis cervical infection. Conclusion: Self-collection of introital samples is both sensitive and specific in screening for C trachomatis.

Purpose: Despite the availability of clinical practice guidelines (CPGs) for cancer pain, consistent integration of these principles into practice has not been achieved. The optimal method for implementing CPGs and the impact of guidelines on healthcare outcomes remain uncertain. This study evaluated the effect of an audit and feedback (A/F) intervention on nurse practitioner (NP) implementation of cancer pain CPGs and on hospitalized patients' self-report of pain and satisfaction with pain relief. Data sources: Eight NPs and two groups of 96 patients were the sources of data. Eligible patients in both groups completed the Brief Pain Inventory-Short Form (BPI-SF) within 24 h of admission and every 48 h until discharge. During A/F, NPs received weekly feedback on pain scores and guideline adherence. Conclusions: Nurse practitioner adherence to CPGs increased during A/F. Pain intensity did not significantly differ between groups. Intervention group patients reported significantly less overall pain interference (p < .0001), interference with general activity (p = .0003), and sleep (p = .006). Satisfaction with pain relief increased from 68.4% to 95.1% during A/F (p < .0001). Implications for practice: A/F is an effective strategy to promote CPG use. Improved functional status in the absence of decreased pain severity underscores the need to consider symptom clusters when studying pain.

7602 Background: SCLC relies on the Hh developmental pathway for tumor initiation and progression. Pharmacologic blockade with Hh inhibitors blocks these processes. We performed a phase I study to ...

250 Background: Electronic health records have potential to enhance health care safety and quality by enabling effective communication, Clinical Decision Support technology, and generation of structured data for analysis. Despite the fact that EHRs have been shown to improve health care processes, the rapid growth of technology used to support medical care has resulted in the creation of enormous volumes of data used to assess and manage healthcare delivery. Valuable data is often siloed in multiple IT systems or captured in free-text clinical notes and non-searchable documents (unstructured data) making it impossible to quickly develop and act on real-time longitudinal data. Methods: Flatiron (FI) operates a "big data" software platform that aggregates, cleans and structures deep clinical oncology data thus facilitating understanding of operational, clinical and financial analytics related to cancer care. The platform proposes to solve these fundamental data challenges, enabling a range of real-time quality measures. It is best understood as three related components: the first is the technical integration between FI and providers' IT and data systems. That integration serves as the plumbing through which data flows securely from the provider to FI. The second is FI’s structured database, which transforms raw clinical, operational, and billing data into clean, structured, longitudinal, real-time patient data. The third is the FI user interface portal, which is a web-based analytics tool that facilitates access to the continually updated structured database. Results: Over 10 institutions have partnered with FI to deploy the platform. The full integration of an institution can be achieved in 12 to 16 weeks with daily updates to the analytics after the initial phase. Over 15,000 patients are expected to be fully integrated in the next 3-6 months. Initial QOPI and other quality measures have been included and customizable dashboards linking charge databases with clinical outcomes have been created. Dashboards with quality metrics will be presented in the conference. Conclusions: Implementation of EMRs alone does not improve healthcare delivery. Data on colorectal cancer patients will be presented at the meeting.

188 Background: Survivorship care represents a distinct phase of the cancer care and addresses surveillance, the physical and psychosocial sequelae of the cancer and treatment, and health promotion. Survivorship care plans (SCP) were recommended in the 2005 IOM From Cancer Patient to Cancer Survivor as a tool to address these issues and will be required by the Commission on Cancer in 2015. As part of two studies implementing SCP using the JourneyForward (JF-SCP) template, we evaluated primary care providers (PCP) perspective on their use. Methods: JF-SCP were developed and delivered to patients and PCP at the end of treatment. We collected information about usability, comprehension, barriers to use, and respondent demographics. Results: Of the 61 PCP who responded: 86% were physicians, 60% were women, had an average of 20 years in practice. PCP strongly agreed/agreed that SCP were easy to understand (95.7%), the right length (73.9%), addressed the right topics (95.7%), would be useful in talking with patients about survivorship plans (91.3%), would improve communication with oncologists (74.4%) and with patients (74.4%). Significant barriers interfering with the PCP providing follow-up care included: limited access to survivors as they stay with oncologists (59.5%), insufficient knowledge of issues (53.4%), inadequate recommendations from the oncologist (43.9%), lack of survivor care guidelines (42%), lack of time (38%), and poor reimbursement (16.6%). Specific suggestions about the JF-SCP included making it shorter and being clear about which provider was responsible for obtaining recommended testing. PCP commented on the importance of ongoing primary care provided throughout the cancer continuum. Conclusions: PCP reported ease of SCP use but did identify areas for improvement. Many PCP were frequently not included or did not stay involved with the cancer patient when being seen by oncologists. The SCP was viewed as a tool to facilitate communication with oncologists and patients.