PURPOSE The Hematology Oncology Pharmacist Association Oral Chemotherapy Collaborative (HOPA OCC) developed practice-based tools to use in program development and improvement for the management of patients receiving oral anticancer agents (OAAs). METHODS These tools include a baseline OAA program assessment, clinical OAA adherence tool, and OAA dashboard. HOPA OCC distributed these tools to teams participating in the 6-month HOPA ASCO Quality Training Programs (QTPs). Barriers in the delivery of OAA services across practice sites were determined through the use of baseline assessments, and the following domains were evaluated: (1) side-effect monitoring, (2) adherence monitoring, (3) use of patient-reported outcomes, (4) social determinants of health, and (5) collaborative practice agreements for oncology pharmacists. The OAA adherence tool offers clinical patient adherence questions and guidance for supporting adherence in practice. Finally, the dashboard includes multiple metrics that may be helpful for practices to measure their program outcomes. HOPA OCC used the Consolidated Framework for Implementation Research to assess tool usefulness by the QTP participants. RESULTS Barriers to implementation include deficits in information technology, resources, and competing priorities. CONCLUSION Standardized OAA tools can inform and support quality improvement initiatives and improve the care of patients receiving OAAs.
Introduction Critical care, emergency medicine, and surgical trainees frequently perform surgical and Seldinger-technique tube thoracostomy, thoracentesis, and thoracic ultrasound. However, approaches to teaching these skills are highly heterogeneous. Over 10 years, we have developed a standardized, multidisciplinary curriculum to teach these procedures. Methods Emergency medicine residents, surgical residents, and critical care fellows, all in the first year of their respective programs, underwent training in surgical and Seldinger chest tube placement and securement, thoracentesis, and thoracic ultrasound. The curriculum included preworkshop instructional videos and 45-minute in-person practice stations (3.5 hours total). Sessions were co-led by faculty from emergency medicine, thoracic surgery, and pulmonary/critical care who performed real-time formative assessment with standardized procedural steps. Postcourse surveys assessed learners’ confidence before versus after the workshop in each procedure, learners’ evaluations of faculty by station and specialty, and the workshop overall. Results One hundred twenty-three trainees completed course evaluations, demonstrating stable and positive responses from learners of different backgrounds taught by a multidisciplinary group of instructors, as well as statistically significant improvement in learner confidence in each procedure. Over time, we have made incremental changes to our curriculum based on feedback from instructors and learners. Discussion We have developed a unique curriculum designed, revised, and taught by a multidisciplinary faculty over many years to teach a unified approach to the performance of common chest procedures to surgical, emergency medicine, and critical care trainees. Our curriculum can be readily adapted to the needs of institutions that desire a standardized, multidisciplinary approach to thoracic procedural education.
Allogeneic hematopoietic cell transplantation (allo-HCT) represents an important and potentially curative treatment option for adult patients with acute lymphoblastic leukemia. Relapse continues to remain the most important factor influencing overall survival post allo-HCT. We discuss early identification, clinical manifestations, and management of relapsed disease. Routine evaluation of measurable residual disease (MRD) and change in donor chimerism play a crucial role in early detection. Pivotal clinical trials have led to FDA approval of multiple novel agents like blinatumomab and inotuzumab. Combining targeted therapy with cellular immunotherapy serves as the backbone for prolonging overall survival in these patients. Donor lymphocyte infusions have traditionally been used in relapsed disease with suboptimal outcomes. This review provides insight into use of cellular therapy in MRD positivity and decreasing donor chimerism. It also discusses various modalities of combining cellular therapy with novel agents and discussing the impact of chimeric antigen receptor T-cell therapy in the setting of post allo-HCT relapse both as consolidative therapy and as a bridge to second transplant.
377 Background: Pharmacists have a recognized role in optimizing medication management and enhancing patient quality of care. The Hematology/Oncology Pharmacy Association (HOPA) partnered with American Society of Clinical Oncology (ASCO) Quality Training Program (QTP) to provide 1-day HOPA sponsored HOPA-ASCO QTP Workshops for HOPA members to enhance knowledge and skills related to oncology quality improvement (QI). The Workshop has been given annually from 2019-2022. Methods: The 1-day Workshop is a condensed overview of foundational quality improvement principles and methodologies consistent with ASCO’s QTP 6-month curriculum. These Workshops were tailored for HOPA members with examples specific to challenges routinely met by oncology pharmacists and leveraged prior HOPA-workshop participants to moderate breakout sessions. Surveys were formulated to assess knowledge pre- and post-participation as well as actionable efforts participants made given knowledge gained from the workshop. Results: A total of 124 HOPA members from 83 different oncology institutions have participated in the four workshops. With a 83% post-participation survey response rate, measures of knowledge and competency increased after participation. Knowledge increased an average of 3.3 points from 3.99 to 7.31 (1-10 scale) and competence increased an average of 3.1 points from 3.82 to 6.91. Ninety-nine percent of respondents were extremely or very likely to recommend someone to participate in the workshop, and 99% were extremely or very likely to continue using the skills gained in their practice. In the 3-month follow-up survey (41% response rate), 84% of respondents indicated they used the skills gained from the program somewhat, very or extremely often and 80% had or were planning to develop a QI project. Top reasons for participation were: content focused on cancer care, ASCO’s reputation, and the comprehensive training in the science of quality improvement. Seven participants completed the ASCO QTP 6-month course after participating in the Workshop. Conclusions: Consistent positive feedback from participants and aligned organizational priorities in improving the quality of care of cancer patients facilitates this continued organizational collaboration. Future workshops will consider feedback from participants to optimize the learning environment and program outcomes. This Workshop is the only quality improvement training program focused specifically on oncology pharmacists providing excellent training and education to HOPA members.
Introduction In-hospital cardiac arrest in patients with COVID-19 presents significant challenges to health care teams. Airborne precautions can delay patient care, place providers at high risk of virus exposure, and exacerbate an already stressful environment. Within the constraints of an ongoing pandemic, an efficient educational program is required to prepare health care teams for airborne isolation code blue. Methods This simulation was conducted in a room on the target unit using a CPR manikin to represent the patient. A “talk-through walk-through” scripted simulation directed learners (internal medicine residents, unit nurses, and other code blue responders) through a resuscitation using an airborne isolation code blue protocol. Key scripted events prompted role identification, communication, and item transfer. Learners self-assessed their airborne isolation code blue knowledge and skills and their confidence in providing quality care while maintaining safety using a pre-/posttraining 5-point Likert-scale survey. Results We trained 100 participants over a 5-month period, with 65 participants surveyed (43 respondents; 16 residents, 22 nurses). Following training, participants had a statistically significant (p < .001) increase in percentage selecting agree/strongly agree for all statements related to knowledge and skills specific to airborne isolation code blue protocol, as well as confidence in providing care while keeping themselves and their colleagues safe. Discussion Our simulation program allowed a small number of educators to feasibly train a large number of learners, let learners practice required skills, and improved learners’ self-assessed knowledge, skills, and confidence regarding quality and safety of care.
Variant acute promyelocytic leukemia (vAPL) is a rare leukemia characterized by rearrangement between RARα and a non-PML partner gene. This type of leukemia can be difficult to recognize by histomorphologic evaluation, particularly in patients with few or no Auer rods, and by flow cytometry, but it can be identified by distinct cytogenetic features. Herein, we report on a patient with vAPL with t(11;17)(q23;q21) who presented an initial diagnostic challenge. Detailed flow cytometry findings are presented for this rare entity. Our case study also presents novel treatment (chemotherapy in combination with venetoclax) chosen based on mechanistic data from preclinical studies.
PURPOSE OF REVIEW:Measurable residual disease (MRD) is an important monitoring parameter that can help predict survival outcomes in acute lymphoblastic leukemia (ALL). Identifying patients with MRD has the potential to decrease the risk of relapse with the initiation of early salvage therapy and to help guide decision making regarding allogeneic hematopoietic cell transplantation. In this review, we discuss MRD in ALL, focusing on advantages and limitations between MRD testing techniques and how to monitor MRD in specific patient populations.RECENT FINDINGS:MRD has traditionally been measured through bone marrow samples, but more data for evaluation of MRD via peripheral blood is emerging. Current and developmental testing strategies for MRD include multiparametric flow cytometry (MFC), next-generation sequencing (NGS), quantitative polymerase chain reaction (qPCR), and ClonoSeq. Novel therapies are incorporating MRD as an outcome measure to demonstrate efficacy, including blinatumomab, inotuzumab ozogamicin, and chimeric antigen receptor T (CAR-T) cell therapy. Understanding how to incorporate MRD testing into the management of ALL could improve patient outcomes and predict efficacy of new therapy options.
50 Background: Educating staff on new anticancer medications is imperative for patient safety. Infusion nurses at Dana Farber Cancer Institute (DFCI) satellite infusion centers were surveyed on their comfort level administering newer oncology drugs. Results revealed only 57% of nurses were “extremely comfortable or somewhat comfortable,” while 32% of nurses were “somewhat uncomfortable or very uncomfortable.” This project aimed to increase percentage of nurses at the satellites indicating they are “extremely comfortable” or “somewhat comfortable” from baseline of 57% to ≥75%. Methods: An interdisciplinary team including pharmacy, medical oncology, and nursing was formed to analyze workflows around new drug onboarding, staff education, and satellite communication. The team utilized Plan-Do-Study-Act (PDSA) cycle methodology. Tools included process maps and fishbone to identify areas of improvement. Intervention development tools included a Pareto chart and a priority matrix. Results were analyzed using statistical process control charts. Results: PDSA cycle 1 consisted of making the pharmacy driven education sheet, At-A-Glance (AAG), more accessible for new drugs. AAGs for drugs approved by the FDA in the previous 18 months were posted on the DFCI pharmacy intranet page. Nurses were educated on how to access AAG weekly. For PDSA cycle 2, the survey was modified to target individual nurses administering new drugs rather than all nurses. A “Nursing consideration” section was added to the AAG template and workflow developed; Navigation and review of AAG was added to nursing competency. Monthly nursing/pharmacy huddles were established to optimize communication. These interventions increased the percentage of nurses indicating they are “extremely comfortable” or “somewhat comfortable” to ≥75% which was sustainable through PDSA cycle 2 (see Table). Conclusions: Making an easy-to-use nursing education resource accessible improved nursing comfort level. There were challenges with nursing survey due to COVID-19 surge and staff shortages. Routine huddles are essential for sustainability.[Table: see text]
e19016 Background: The standard remission induction regimen for medically fit patients with AML consists of a backbone of cytarabine & an anthracycline (“7+3” therapy). However, the choice & dose of the anthracycline varies between institutions & practitioner preference, particularly in patients with favorable risk cytogenetics. Gemtuzumab ozogamicin (GO) may improve outcomes in this patient population but is associated with increased toxicities. Methods: We performed a retrospective analysis on medically fit patients ≥ 18 yo with favorable risk AML from 2015-2020 treated with 7+3 at the University of Virginia. Patients were stratified based on standard dose (45 or 60 mg/m2 daunorubicin) (SD) vs higher dose (90 mg/m2 daunorubicin or 12 mg/m2 idarubicin) (HD) of anthracycline vs the addition of GO. Measures included rates of remission, EFS, RFS, and OS as well as rates of treatment-related complications. Results: In total, 58 patients were identified, of which 33 received induction with SD, 19 received HD, & 6 received GO. The majority (75%) of patients were < 60 years old & 93% had de novo AML. The rates of complete remission in the SD, HD & GO groups were 90.9%, 89.5% & 100%, respectively (p = 0.57). EFS at 2-years was 43.9%, 36.7%, & 66.7%, respectively (p = 0.85). RFS at 2-years was 53.0%, 39.0%, & 100%, respectively (p = 0.18). OS at 2-years was similar between all groups (58.9%, 56.9%, & 66.7%, p = 0.92). The rate & duration of cytopenias after induction were similar among all groups (median duration 29 days), however cytopenias were more common in the GO group following consolidation. The rates of major bleeding, admission to the intensive care unit (ICU), and new onset cardiomyopathy (EF < 50%) were higher in the GO group (major bleeding: 0% in SD, 5.3% in HD, 33.3% in GO; ICU admission: 12.1% in SD, 21.1% in HD, 33.3% in GO; cardiomyopathy: 12.1% in SD, 26.3% in HD, 33.3% in GO). The rate of infection, liver dysfunction, & acute renal injury were similar among all groups. No patients developed veno-occlusive disease. Conclusions: Patients receiving GO had a trend toward improved EFS & RFS, however with a similar OS at the expense of higher rates of cytopenias, major bleeding, ICU admission, & cardiotoxicity. Patients receiving HD had a trend toward worse outcomes than those who received SD. A major limitation of our study is the small sample size & single institution experience, however multi-institutional analysis is ongoing for further investigation.[Table: see text]
INTRODUCTION:Cardiac point-of-care ultrasound (c-POCUS) is an increasingly implemented diagnostic tool with the potential to guide clinical management. We sought to characterize and analyze the existing c-POCUS literature with a focus on the temporal trends and differences across specialties.METHODS:A literature search for c-POCUS and related terms was conducted using Ovid (MEDLINE and Embase) and Web of Science databases through 2020. Eligible publications were classified by publication type and topic, author specialty, geographical region of senior author, and journal specialty.RESULTS:The initial search produced 1761 potential publications. A strict definition of c-POCUS yielded a final total of 574 cardiac POCUS manuscripts. A yearly increase in c-POCUS publications was observed. Nearly half of publications were original research (48.8%) followed by case report or series (22.8%). Most publications had an emergency medicine senior author (38.5%), followed by cardiology (20.8%), anesthesiology (12.5%), and critical care (12.5%). The proportion authored by emergency medicine and cardiologists has decreased over time while those by anesthesiology and critical care has generally increased, particularly over the last decade. First authorship demonstrated a similar trend. Articles were published in emergency medicine (24.4%) and cardiology journals (20.5%) with comparable frequency.CONCLUSION:The annual number of c-POCUS publications has steadily increased over time, reflecting the increased recognition and utilization of c-POCUS. This study can help inform clinicians of the current state of c-POCUS and augment the discussion surrounding barriers to continued adoption across all specialties.
e19015 Background: The prognosis of adult patients with acute lymphoblastic leukemia (ALL) has improved with the adoption of pediatric-inspired chemotherapy regimens. PEGylated asparaginase (PEG-Asp) is essential to these regimens. Although PEG-Asp is associated with an increased risk of coagulopathy, venous thromboembolism, and depletion of antithrombin III (AT3), there is limited data evaluating the risk of thrombosis and bleeding and optimal antithrombotic interventions in these patients are unknown. Methods: We performed a single-center retrospective study of patients ≥ 18 years-old who received PEG-Asp for B- or T-ALL at the University of Virginia between 2015 and 2020. The primary outcomes were the incidence of thrombosis and bleeding events. All patients received prophylactic AT3 repletion for activity level <60% & cryoprecipitate for fibrinogen <100mg/dL. None received prophylactic anticoagulation. All received prednisone during induction at a median daily dose of 1 mg/kg. Results: We identified 57 patients who received PEG-Asp for ALL. Median age was 32 years (range 18-63). Five patients (8.8%) had a thrombotic event during induction versus five (16%) during post-induction. Four patients (7%) had a bleeding event during induction versus five (10%) during post-induction. The most common type of thrombosis was deep venous thrombosis, with the majority being catheter-associated. Pulmonary embolism and CNS thrombosis were less common. During induction, the median time to thrombotic event was 18 days after last PEG-Asp administration. 60% and 80% of patients received AT3 and cryoprecipitate, respectively. During post-induction, the median time to thrombotic event was 58 days after last PEG-Asp administration. 38% and 63% of the patients received AT3 and cryoprecipitate, respectively. There was one episode of major bleeding during induction and six during post-induction. Conclusions: Though the increase in thrombotic risk in adult patients receiving PEG-Asp is well-characterized, rates of reported thromboses vary widely. Studies examining bleeding risk associated with PEG-Asp regimens are even scarcer and with variable outcomes. There was a significant occurrence of both thrombotic and bleeding events associated with administration of PEG-Asp. More investigation into the relative thrombotic and bleeding risks associated with PEG-Asp is needed to determine optimal antithrombotic interventions in adult patients with ALL.[Table: see text]
Escape Rooms are gaining prominence as education modalities; the use of principles of game design have been shown to augment knowledge acquisition in a fun, team-based learning experience ("edutainment"). In this report, we outline some of the medical literature and then provide our step-by-step approach and lessons learned when building what was, to our knowledge, the first continuing medical education Escape Room at a national scientific meeting. We then comment on how this innovative educational offering was reimagined the following year for remote (virtual) learning because of the COVID-19 pandemic.
Purpose of Review The incorporation of pegaspargase in chemotherapy regimens has significantly improved the prognosis of ALL in adults. However, pegaspargase use poses many challenges due to its unique toxicity profile. Here, we review pegaspargase's most clinically significant toxicities, and provide guidance for their prevention and management in order to avoid unnecessary drug discontinuation and achieve maximum clinical benefit. Recent Findings Clinically significant toxicities of pegaspargase include thrombosis, hypersensitivity and inactivation, hepatotoxicity, pancreatitis, and hypertriglyceridemia. The majority of these toxicities are temporary, nonfatal, and can be managed supportively without permanent pegaspargase discontinuation. Special attention should be paid to inactivation, which can lead to treatment failure, as well as pancreatitis, which necessitates complete cessation of asparaginase therapy. The question of how to best proceed in patients who cannot tolerate pegaspargase remains unanswered, and is an important area of future investigation. Pegaspargase is an essential component of the pediatric-inspired regimens that have improved survival in adult ALL. Although pegaspargase's toxicity profile is unique, it is also highly manageable and should not be a barrier to achieving maximum clinical benefit using this drug.
257 Background: For patients receiving high dose cytarabine (HiDAC) at University of Virginia (UVA) Health between 10/2019 and 10/2020, median length of stay (LOS) from time of clinic appointment to hospital discharge was 119.35 hours. Standard treatment time should be 112 hours from premedication to end of chemotherapy. There are no national standards for duration of inpatient stay for planned chemotherapy, but only 50% of these patients were discharged after noon (over 3 hours post-chemotherapy completion). LOS that extends beyond the standard treatment time results in increased cost, overutilization of hospital resources, delayed admissions for future patients, and patient dissatisfaction. Methods: A multidisciplinary team comprised of licensed providers, pharmacists, and nurses was formed. The team focused on percentage of patients discharged by noon as a surrogate marker for LOS due to inconsistency of admission times; the aim was to increase patients discharged by noon to 65%. Reviewing the baseline data revealed an unstable process with a 3-sigma X-bar statistical process control chart. The team developed current and ideal process state maps, a Pareto chart, and a priority matrix to determine an action plan. The most common identified causes for delay in discharge included: lack of standardized discharge checklist, discharge order placed after 10 am, medications dispensed from the outpatient pharmacy after 11 am, licensed providers not prioritizing discharge patients, and medication reconciliation not completed prior to day of discharge. Results: From 10/2020 to 5/2021, the first PDSA cycle focused on standardizing the discharge process to correct the instability in the process. A discharge checklist was created based on the ideal process map, which allowed the providers to have a consistent process at discharge. 3-sigma Xbar chart demonstrated a now stable process and an increase of patients discharged by noon to 58%. During the second PDSA cycle starting in 6/2021, providers completed medication reconciliation the day before discharge, prioritized HiDAC discharges first during rounds, and ensured discharge orders were placed by completion of the last chemotherapy bag. Data collection is ongoing, and will be analyzed by August 2021. Future tests of change are planned to focus on the pharmacy medication delivery service. Hospital LOS has also decreased after the first PDSA cycle. Conclusions: Using quality improvement methodology, a multidisciplinary team developed an action plan for patients receiving HiDAC which to date has increased the percentage of patients discharging by noon and decreased length of stay. This outcome may lead to reduce hospitalization costs and increase bed availability for other oncology patients. Further PDSA cycles are scheduled and continuous evaluation of the process is ongoing.
225 Background: Between June and December 2019, hematology-oncology patients admitted for elective chemotherapy at Memorial Regional Hospital had a median delay of 10 hours to initiate chemotherapy infusion from time of admission. This contributes to increased cost to the healthcare system and patient dissatisfaction. By September 2020, elective inpatient median time from admission to chemotherapy initiation at Memorial Regional Hospital will be reduced by 20%. Methods: Multidisciplinary team formed to evaluate the time from admission to initiation of chemotherapy for patients who are electively admitted for chemotherapy in 8 Central based on time stamps available in the electronic health records. Patients electively admitted by a non MCI oncologist were excluded. Data collections included time stamp between each process from admission to administration of 1st chemotherapy. Longest time lapse between each process was counted as an occurrence/contributor to delay. Top 80% contributors identified from Pareto chart allowed team to identify countermeasures. Priority Matrix of implementation in PDSA cycle based on highest impact and ease of implementation. Statistical process control chart was developed. Results: (see table). Conclusions: PDSA Cycle 1, obtaining labs 24-48 hours prior to admission, resulted in a 10% reduction in chemotherapy initiation time. PDSA Cycle 2, enhancing “ok to treat” communication, resulted in a further reduction of time to treatment. The combination of PDSA Cycle 1 & 2 resulted in a 40% reduction in time to chemotherapy initiation, exceeding the planned aim of 20%. Balance measures reflected no reduction in the mean number of overnight stays between baseline and PDSA Cycle 2 (4 nights) that could contribute to a decreased cost. Results and recommendations to adopt at all inpatient oncology departments within the healthcare system will be presented to leadership for support. Data automation through collaborative efforts with information technology is in process to assist with continuous monitoring. Future state, the quality improvement tools gained from ASCO QTP will be utilized to evaluate and improve workflow issues in the outpatient oncology setting. Nationally recognized organizations are encouraged to propose a benchmark for admission time to first chemotherapy administration based on the evaluation of current available data. Additional studies are needed to evaluate chemotherapy treatment delays in other settings.[Table: see text]
Bispecific antibodies (BsAbs) are an emerging class of novel immunotherapy agents that have led to major breakthroughs in the treatment of hematologic malignancies. By targeting two separate antigens at the same time, BsAbs can bridge tumor cells to cytotoxic immune cells and bypass several limitations of conventional monoclonal antibody treatment (Wang et al., 2019).
BACKGROUND & AIMS: In celiac disease (CeD), gluten induces immune activation, leading to enteropathy. TAK-101, gluten protein (gliadin) encapsulated in negatively charged poly(DL-lactide-co-glycolic acid) nanoparticles, is designed to induce gluten-specific tolerance. METHODS: TAK-101 was evaluated in phase 1 dose escalation safety and phase 2a double-blind, randomized, placebo-controlled studies. Primary endpoints included pharmacokinetics, safety, and tolerability of TAK-101 (phase 1) and change from baseline in circulating gliadin-specific interferon-gamma-producing cells at day 6 of gluten challenge, in patients with CeD (phase 2a). Secondary endpoints in the phase 2a study included changes from baseline in enteropathy (villus height to crypt depth ratio [Vh:Cd]), and frequency of intestinal intraepithelial lymphocytes and peripheral gut-homing T cells. RESULTS: In phase 2a, 33 randomized patients completed the 14-day gluten challenge. TAK-101 induced an 88% reduction in change from baseline in interferon-gamma spot-forming units vs placebo (2.01 vs 17.58, P = .006). Vh:Cd deteriorated in the placebo group (-0.63, P = .002), but not in the TAK-101 group (-0.18, P = 110), although the inter-group change from baseline was not significant (P = .08). Intraepithelial lymphocyte numbers remained equal. TAK-101 reduced changes in circulating alpha 4 beta 7(+)CD4(+) (0.26 vs 1.05, P = .032), alpha E beta 7(+)CD8(+) (0.69 vs 3.64, P = .003), and gamma delta (0.15 vs 1.59, P = .010) effector memory T cells. TAK-101 (up to 8 mg/kg) induced no clinically meaningful changes in vital signs or routine clinical laboratory evaluations. No serious adverse events occurred. CONCLUSIONS: TAK-101 was well tolerated and prevented gluten-induced immune activation in CeD. The findings from the present clinical trial suggest that antigen-specific tolerance was induced and represent a novel approach translatable to other immune-mediated diseases.