Addressing risk of financial toxicity in an ambulatory oncology practice: Our institutional experience with the ASCO Quality Training Program.

2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 114-114
Author(s):  
Thomas A. Hensing ◽  
Tyler Bauer ◽  
Anna Palafox ◽  
Margaret Whalen ◽  
George W. Carro

114 Background: Due to escalating cost of cancer care, patients (PTs) with cancer are at increased risk for financial toxicity (FTOX) that can exacerbate disparities in care and lead to clinically relevant adverse PT outcomes; including quality of life; symptom burden; adherence; and survival. A review of our informed consent (IC) process demonstrated that PTs were not routinely informed of financial risks of high-cost (HC) cancer therapies at the time of IC. Methods: A multidisciplinary team was formed to conduct a rapid-cycle quality improvement project with the aim of reducing FTOX through improvement in patient education at the time of IC. Because of HC and increased utilization, the initial pilot focused on treatment with immune checkpoint inhibitors (ICI). A cause and effect diagram identified the potential causes that FTOX was not addressed during the IC process. Diagnostic data were obtained through staff surveys and querying our EMR from June to August, 2016. A Pareto chart identified lack of educational (ED) tools at the time of IC and a poorly understood prior authorization (PA) process as the most common causes for not addressing risk of FTOX during IC. Plan-do-study-act (PDSA) #1 began with development of a PT ED tool to be used during IC. The tool was approved by the Patient Advisory Board. Staff from clinical teams utilizing ICI for approved indication completed training on its use and a pilot study was initiated. PDSA#2 focused on optimizing the PA process and PDSA#3 focused on PT distress and FTOX monitoring through the NCCN distress and a validated patient-reported-outcome tools (COST), respectively. Results: The utilization of the PT ED tool reached the project aim (administer to > 65% of pts during IC) during initial phase of PDSA#1, although accrual is ongoing. A revised PA process (PDSA#2) was developed, staff were educated and the updated PA process was initiated. Work on PDSA#3 is ongoing. Conclusions: This QI project suggests that it is feasible to address FTOX through PT ED during IC for HC cancer therapies. However, the impact of this intervention on PT distress, overall FTOX and treatment disparities will need to be monitored closely.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23160-e23160
Author(s):  
James Dickerson ◽  
Evan Thomas Hall ◽  
Surbhi Singhal ◽  
Brooke Peterson Gabster ◽  
Lidia Schapira

e23160 Background: Immune checkpoint inhibitors (ICIs) have been met with a wave of excitement due to their novel mechanism. We hypothesized that this may impact how patients (via PROs) report treatment tolerability in comparison to traditional therapies. We sought to examine if there was a notable difference in PROs in blinded vs unblinded trials of ICIs. Methods: We systematically searched PubMed, CINAHL, Embase, Web of Science, and Scopus in August 2018 for publications with quantitative PRO data comparing ICIs to cytotoxic chemotherapy. Case series, narrative reviews, and publications lacking original data were excluded. Eligible publications were reviewed to assess if patients were blinded to the agent received, and a comparison for common PRO metrics was performed. Results: Of the 1,450 unique references identified, eight met inclusion criteria: 1 double blinded placebo-controlled trial and 7 trials where patients were aware of the assigned arm. The blinded trial had quantitative PRO data in the form of the European Organisation for Research and Treatment of Cancer (EORTC) global health status (GHS) score and patient reported symptom burden at week 12. Most (6 of 7; 86%) unblinded trials reported the GHS at either week 12 or 15, and patient symptom burden at these time points as well (5 of 7; 71%). For the EORTC GHS, the blinded trial showed no inter-arm difference at week 12. 4 of 6 (67%) open label trials noted statistically significant differences in GHS favoring the ICI arm. For symptom burden at week 12 or 15, there was no difference found in the blinded study. In unblinded trials, there were domains where patients receiving ICIs reported a statistically significant lower symptom burden than those receiving chemotherapy: fatigue (4 of 5 trials favoring ICIs; 80%), dyspnea (2 of 5; 40%), insomnia (1 of 4; 25%), appetite loss (1 of 4; 25%), and diarrhea (1 of 5; 20%). There were no differences in pain (n = 5), nausea/vomit (n = 5), and constipation (n = 5). Conclusions: We found a trend towards more favorable reporting on common symptoms in unblinded studies of patients receiving ICIs. Our analysis is limited by the lack of available comparisons in the published literature.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 246-246
Author(s):  
Melanie Lynn Powis ◽  
Alyssa Macedo ◽  
Monika K. Krzyzanowska ◽  
Vishal Kukreti ◽  
Lucy Xiaolu Ma ◽  
...  

246 Background: Prior to COVID we undertook a QI project with the aim improving the documentation of a best possible medication history (BPMH) or medication reconciliation (MedRec) for patients initiating systemic therapy (ST) in ambulatory oncology, where care spans multiple providers and patients may be at increased risk of adverse drug events. While initial improvements were realized (16.7% and 3.9% increases for BPMH and MedRec, respectively), completion rates returned to baseline following the start of the COVID pandemic. Methods: Guided by the four-phase Quality Implementation Framework we sought to recover implementation of MedRec. We initially undertook a purposeful re-examination of the MedRec process (Phase 1) to identify barriers to conducting MedRec during COVID. This guided the tailored selection of Expert Recommendations for Implementing Change (ERIC) implementation strategies utilized during the successive phase of the project. During each phase the proportion of patients with documented BPMH or MedRec within 30 days of initiating ST out of those eligible was calculated. Results: Major barriers to conducting MedRec during COVID included reduced resources (time, human resources and physical resources), loss of dedicated staff, and change in workflow/ clinical models brought on by the introduction of virtual care. This informed our strategy to improve capacity to conduct MedRec (Phase 2) through the development and distribution of educational materials, revisions of professional roles, and creation of a new dedicated clinical team consisting of existing modified duty nurses to conduct MedRec. To support ongoing implementation (Phase 3), additional implementation strategies included the staged implementation scale-up, conduct of educational meetings/ outreach visits, facilitation, and provision of clinical supervision. The impact of each phase of implementation on BPMH and MedRec completion rates is summarized in Table. Conclusions: Recovery of a quality improvement intervention during COVID was realized through the utilization of a structured, implementation process model approach to identify and address barriers to implementation. Future work will focus on improvement of MedRec completion rates by clinicians, and on embedding processes into practice (Phase 4) to support sustainability of the intervention.[Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11574-11574
Author(s):  
VIKAS GARG ◽  
Sameer Rastogi ◽  
Adarsh Barwad ◽  
Rambha Panday ◽  
Sandeep Kumar Bhoriwal ◽  
...  

11574 Background: Desmoid type fibromatosis (DTF) is a rare benign neoplasm with infiltrative growth and high local recurrences. Due to long disease course, unpredictable growth pattern, and low mortality, using only survival outcomes may be inappropriate. In this study we assessed the impact of DTF on health related quality of life (HRQoL). Methods: This was a cross-sectional study done in patients with DTF. The study participants were asked to fill the EORTC QLQ-C30, GAD-7 and PHQ- 9 q uestionnaires to assess HRQoL, anxiety and depression . Outcomes were also compared with healthy controls. Results: 204 subjects (102 DTF patients and 102 healthy controls) were recruited. Study parameters have been summarized in Table. Appendicular skeleton (limbs + girdle) was most commonly involved in 59 % patients and abdominal wall or mesentery was involved in 22.5 %. Patients have received median of 2 lines of therapy. 54 % patients were currently on sorafenib and 41 % were under active surveillance. Mean global health status in DTF patient 65.58 ± 22.64, was significantly lower than healthy controls. Similarly, DTF patients scored low on all functional scales except cognitive functioning. Symptom scale showed significantly higher symptom burden of fatigue, pain, insomnia and financial difficulties. Anxiety & depression was observed in 39.22 % and 50 % of DTF patients respectively. DTF patients had higher rates of mild, moderate and severe anxiety and depression compared to healthy controls. No difference was observed based on site of disease. Conclusions: DTF patients have significant symptom burden, poor functioning, and heightened anxiety and depression. Patient reported outcomes should be routinely used to assess treatment efficacy in DTF patients.[Table: see text]


2022 ◽  
Author(s):  
Abdul-Rahman Gomaa ◽  
Sharan Sambhwani ◽  
Jonathan Wilkinson

BACKGROUND Intravenous (IV) fluids are some of the most commonly prescribed day-to-day drugs. Evidence suggests that such prescriptions are rarely ever done correctly despite the presence of clear guidelines (NICE CG174). This is believed to be due to lack of knowledge and experience, which often breeds confusion and places patients at increased risk of harm. It also incurs avoidable costs to hospitals. OBJECTIVE This quality improvement project (QIP) aims to ensure that IV fluid prescriptions are: safe, appropriate and adhere to evidence-based NICE guidance. The project’s aims will be achieved through implementing multiple interventions that are categorised under: educational, changing prescribing habits and raising awareness. METHODS Review and improve the prescribing process of “IV fluid prescribing” via three simultaneous approaches.  Teaching sessions were delivered to all junior doctors in order to improve knowledge and awareness of appropriate IV fluid prescribing and promote familiarity with the current NICE IV fluid guidelines. This included a ‘feature session’ at our local hospital Grand Round. A point-of-care aide-memoire containing a summary of the information needed for correct prescription was designed and printed. This complimented the teaching sessions and supported good clinical practice. Using serial Plan-Do-Study-Act (PDSA) cycles, a novel “IV fluid bundle” was developed, fine-tuned and trialled on five wards, (three surgical, two medical). The aim of the bundle was to ensure that patients were clinically reviewed in order to assess their volaemic status in order that appropriate IV fluids could then be selected and prescribed safely. The impact of these interventions was assessed on the trial wards via a weekly point prevalence audit of the IV fluid bundles for the duration of the trial. Parameters looked at were: incidence of deranged U&E’s, incidence of AKI and the number of days between the latest U&E’s and the patient’s IV fluid prescription. RESULTS These interventions were assessed on trial wards via a weekly point prevalence audit of the new IV fluid prescription chart (bundle; IFB) for the duration of the trial. Parameters monitored were: incidence of deranged U&E’s, incidence of acute kidney injury (AKI) and the number of days between the latest U&E’s and the patient’s IV fluid prescription. Of all of the patients on the IV fluid bundle, 100% had a documented weight, review of both fluid status and balance. The incidence of deranged U&E’s decreased from 48% to 35%. Incidence of AKI decreased from 24% to 10%. The average number of days between the latest U&E’s and a fluid prescription decreased from 2.2 days to 0.6 day. CONCLUSIONS Prescribing IV fluids is a complex task that requires significant improvement both locally and nationally. With 85% uptake of the IFB, we were able to significantly improve all measured outcomes. Through carefully structured interventions geared towards tackling the confounding issues identified from previous audits and process mapping we have shown that prescribing IV fluids can be made safer.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Jarrin Penny ◽  
Fabio R Salerno ◽  
Lisa Hur ◽  
Christopher McIntyre

Abstract Background and Aims High flux dialysis membranes sufficiently remove smaller sized uremic toxins however, the accumulation and retention of larger middle molecular weight toxins, which are associated with chronic inflammation, cardiovascular disease and suboptimal outcomes are poorly cleared. The recent advent of medium-cut-off dialysis membranes, labelled “expanded dialysis” (HDx) are permeable to molecules of larger size responsible for poor clinical outcomes. However, it remains unclear if HDx can directly impact the symptoms associated with hemodialysis (HD). Symptom burden plays a significant role in quality of life (QOL) and mortality rates in the HD population. The London Evaluation of Illness (LEVIL), an application-based platform has been developed to measure patient reported outcomes (PROM). In comparison to cross-sectional PROM’s, LEVIL more accurately represents the fluctuations in daily symptoms and the impact of intervention. LEVIL evaluates general well-being, energy, sleep, appetite, pain and breathing, all of which are outcomes of interest on symptom burden in chronic kidney disease. Our aim was to determine if HDx therapy had any effect on symtoms/QOL domains using LEVIL. Method 28 patients from two dialysis centers in London Ontario were consented to participate. Patients were required to be over 18 years of age and on conventional thrice weekly maintenance HD for at least three months. 23 participants completed study and analyzed (five lost for various reasons). Baseline (BL) symptom characteristics were obtained while using high flux membrane for two weeks. Symptoms continued to be measured throughout the 12 weeks of HDx therapy two-three times weekly using LEVIL. Laboratory biomarkers including beta-2 microglobulin and free-light chains were collected at baseline and after 12 weeks of HDx therapy. Results Patients were stratified into tertiles (high/middle/low) using mean values of BL symptoms scores in each domain (wellbeing, energy, sleep, appetite, pain, breathing). Those in the high BL group were labeled as “control”. Low and middle BL measures were further stratified into responders vs. non-responders (responders were considered to have a 50% increase in any symptom domain by ≥50%). Of those domains which responded to HDx, 76% also had low BL scores with 27% having middle BL scores. General wellbeing, energy and sleep were domains with the greatest response reaching statistical significance after eight weeks of therapy. HDx had limited effect on appetite, pain and breathing. Although stratification was per domain, overall, 74% of the population studied did respond in at least one domain, with some responding in as many as five. Conclusion HDx using Theranova (Baxter) shows the most benefit in domains with low BL measures. Additionally, not everyone who had low BL scores responded after 12 weeks of therapy, leaving us to question whether HDx may have a latent effect in some individuals/populations. Those who had no response to therapy in certain domains also had greater baseline quality of life respectively. This information may assist in decision making/rationale for the utilization and implementation of such therapy. Although more work is required to further stratify symptoms in relation to demographic/biochemical finding and clinical outcomes. It is evident that HDx improves patient reported symptoms and QOL.


2019 ◽  
Vol 21 (Supplement_M) ◽  
pp. M44-M49 ◽  
Author(s):  
Mohsen Habibian ◽  
Alexander R Lyon

Abstract A growing number of effective cancer therapies is associated with cardiovascular (CV) toxicities including myocardial injury or dysfunction, leading to reduced ventricular function, and increased risk of heart failure. As the timing of administration of cancer treatment is known, the potential for risk stratification pre-treatment, and appropriate surveillance and monitoring during treatment, and intervention with cardio-protective treatment strategies in patients exhibiting early evidence of CV toxicity is an appealing clinical strategy. The field of cardio-oncology has developed, and the application of monitoring strategies using CV biomarkers and CV imaging has been to focus of many studies and is now implemented in dedicated cardio-oncology services supporting oncology centres. In this article, we review the background and rationale for monitoring, the different options and their strengths, weaknesses and where they are helpful in specific cardiotoxic cancer therapies, and the impact in cardio-oncology care.


2020 ◽  
pp. 089719002097077
Author(s):  
Daniel Park ◽  
Sweta Patel ◽  
Kendra Yum ◽  
Cardinale B. Smith ◽  
Che-Kai Tsao ◽  
...  

Introduction: Although pharmacist-driven patient education has been shown to increase adherence, reduce medication errors, and lower 30-day readmission rates, the data in the ambulatory oncology setting is limited. This pilot quality initiative study was conducted from June 1, 2018, to November 15, 2018, in the ambulatory cancer center affiliated with The Mount Sinai Hospital in New York, NY, to determine the impact of pharmacist counseling on chemotherapy regimens. Methods and Materials: English-speaking patients with gastrointestinal malignancies who were newly started on chemotherapy were selected for this study. They received a pharmacist-led education session regarding their medications, potential side effects, and how to manage them at home. After each session, they completed a 5-question survey on a 5-point Likert-scale about how they felt before and after speaking with a pharmacist. Survey results were analyzed by median scores and Wilcoxon signed-rank test. Results: Of the 96 patients who were counseled, 71 patients were included in this analysis. The median score increased from 3 to 5 for the understanding of their chemotherapy regimen and side effects (questions 1 and 2), 3 to 4.5 for knowledge about interactions with their oral chemotherapy (question 3), 4 to 5 for overall experience in the cancer center (question 5). The median score for anxiety level was unchanged at 3 (question 4). Conclusion: This survey-based study demonstrated the benefit of a pharmacist-led counseling session. An interdisciplinary approach involving the integration of oncology pharmacists in patient education can greatly impact the quality of care for oncology patients.


2007 ◽  
Vol 25 (32) ◽  
pp. 5087-5093 ◽  
Author(s):  
Kathleen Gondek ◽  
Pierre-Philippe Sagnier ◽  
Kim Gilchrist ◽  
J. Michael Woolley

Assessing patient-reported outcomes (PROs) in clinical trials is of interest to clinicians, patients, regulators, and industry. The use and impact of PROs is a growing area of methodologic research, particularly as they relate to tumor types, biomarkers, and various patient populations and cultures. Both the US Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products in recent guidance have acknowledged the need to account for treatment-related impact on patient symptoms and/or health-related quality of life (HRQOL). Clinical research likely reflects the informative value of PROs. A search of www.clinicaltrials.gov , the FDA Web site, and product package inserts was conducted to assess the inclusion of symptom assessment and HRQOL within industry-sponsored clinical trials in cancer and approved cancer therapies and their respective product labels. Overall, there were 2,704 industry-sponsored oncology trials, of which 322 (12%) included a PRO measure. Of the 70 FDA new or revised labels, only six package inserts include PRO data. Symptoms were assessed uniformly across the phases of clinical trials, whereas HRQOL assessment increased in the later phases of clinical trials. Collecting PRO data can enhance our understanding of cancer burden and the impact of interventions on patients' lives.


2021 ◽  
Vol 12 ◽  
Author(s):  
Mahdi Abdoli Shadbad ◽  
Zahra Asadzadeh ◽  
Negar Hosseinkhani ◽  
Afshin Derakhshani ◽  
Nazila Alizadeh ◽  
...  

Based on preclinical findings, programmed death-ligand 1 (PD-L1) can substantially attenuate CD8+ T-cell-mediated anti-tumoral immune responses. However, clinical studies have reported controversial results regarding the significance of the tumor-infiltrating CD8+ T-cells/PD-L1 axis on the clinical picture and the response rate of patients with high-grade glial tumors to anti-cancer therapies. Herein, we conducted a systematic review according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statements to clarify the clinical significance of the tumor-infiltrating CD8+ T-cells/PD-L1 axis and elucidate the impact of this axis on the response rate of affected patients to anti-cancer therapies. Indeed, a better understanding of the impact of this axis on the response rate of affected patients to anti-cancer therapies can provide valuable insights to address the futile response rate of immune checkpoint inhibitors in patients with high-grade glial tumors. For this purpose, we systematically searched Scopus, Web of Science, Embase, and PubMed to obtain peer-reviewed studies published before 1 January 2021. We have observed that PD-L1 overexpression can be associated with the inferior prognosis of glioblastoma patients who have not been exposed to chemo-radiotherapy. Besides, exposure to anti-cancer therapies, e.g., chemo-radiotherapy, can up-regulate inhibitory immune checkpoint molecules in tumor-infiltrating CD8+ T-cells. Therefore, unlike unexposed patients, increased tumor-infiltrating CD8+ T-cells in anti-cancer therapy-exposed tumoral tissues can be associated with the inferior prognosis of affected patients. Because various inhibitory immune checkpoints can regulate anti-tumoral immune responses, the single-cell sequencing of the cells residing in the tumor microenvironment can provide valuable insights into the expression patterns of inhibitory immune checkpoints in the tumor micromovement. Thus, administrating immune checkpoint inhibitors based on the data from the single-cell sequencing of these cells can increase patients’ response rates, decrease the risk of immune-related adverse events development, prevent immune-resistance development, and reduce the risk of tumor recurrence.


2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 87-87
Author(s):  
Jessica Ruth Bauman ◽  
Areej El-Jawahri ◽  
Karen Quinn ◽  
Lisa Arcikowski ◽  
Gina Chan ◽  
...  

87 Background: HNC caused by HPV has become an epidemic. Treatment for HNC results in a tremendous symptom burden. The impact of HPV-status on quality of life (QOL) and how this effects illness perception and mood has not been described. We sought to explore differences in PROs in patients with HPV + vs. - HNC. Methods: This is a secondary analysis of data from a prospective, longitudinal intervention study of 60 patients with newly diagnosed HNC undergoing concurrent chemoradiation. 30 control patients received standard care followed by 30 intervention patients who received an educational intervention. Satisfaction (information satisfaction questionnaire (ISQ)), mood (Hospital Anxiety and Depression Scale (HADS)), illness perception (Brief Illness Perception Questionnaire (IPQ)), and QOL (MD Anderson Symptom Inventory- Head and Neck (MDASI-HN)) were evaluated at baseline and 3 weeks. Data were analyzed using linear regression models controlling for the effect of the intervention to assess the association between HPV status and changes in PROs. Results: From 8/2014 to 10/2015, we enrolled 60 patients (2 excluded for hospitalization or care elsewhere). 29/58 (50%) had HPV + HNC. 40 (69%) were men. 54 (93%) had stage III/IV disease. Compared to patients with HPV - HNC, patients with HPV + HNC reported an increase in symptom burden, symptom interference, and depressive symptoms, as well as a more threatening illness perception from baseline to 3 weeks. There were no differences in anxiety or satisfaction. Table 1 details the regression models. Conclusions: Patients with HPV + HNC have a larger decrement in QOL during treatment than patients with HPV - HNC, which corresponds to a more threatening illness perception and more depressive symptoms. Interventions tailored to symptom management and mood should be developed for this unique population. [Table: see text]


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