scholarly journals Navigating uncharted waters: Developing a standardized approach for evaluating and implementing biosimilar products at a comprehensive cancer center

2020 ◽  
Author(s):  
Mara N Villanueva ◽  
Jennifer E Davis ◽  
Stacey M Sobocinski
Keyword(s):  
Transition Period ◽  
Treatment Protocol ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Specific Product ◽  
Team Members ◽  
Research Protocols ◽  
Institutional Review ◽  
Multiple Challenges ◽  
Coordinate Changes

Abstract Purpose The processes for formulary implementation and electronic health record (EHR) integration of biosimilar products at a comprehensive cancer center are described. Implications for research protocols are also discussed. Summary The existing literature focuses on practical considerations for formulary addition of biosimilar products, but there is a lack of guidance on how to implement the change, particularly within the EHR. Before building the ordering tools for biosimilars, the clinical and informatics teams should determine the role of biosimilars at the institution, identify drug-specific product characteristics that affect medication build, and characterize implications of future formulary changes or drug shortages. Leveraging an orderable record provides the ability to include logic that maps to multiple products and also allows for future implementation of changes within the medication record rather than requiring “swaps” at the treatment protocol level. The institutional review board should coordinate changes in affected research protocols and consent forms and work with principal investigators to amend protocols when necessary. Pharmacy leaders should develop processes to oversee inventory during the transition period and minimize the risk of errors. Conclusion The development of a standardized approach for evaluating and implementing biosimilar products improves efficiency and collaboration among the various team members responsible for the products’ integration into existing workflows, including implications for clinical research. Implementing biosimilars for agents used to treat cancer will pose new challenges and require additional considerations. Partial implementation of biosimilars continues to pose multiple challenges in the provision of patient care.

Snapshot of an outpatient supportive care center at a comprehensive cancer center.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 145-145
Author(s):  
Lindsey E Pimentel ◽  
Maxine Grace De la Cruz ◽  
Angelique Wong ◽  
Debra Castro ◽  
Eduardo Bruera
Keyword(s):  
End Of Life ◽  
Care Center ◽  
Case Manager ◽  
Symptom Assessment ◽  
Assessment Tools ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Early Integration ◽  
Team Members ◽  
Outpatient Supportive Care

145 Background: Integration of Palliative Care (PC) in oncology has been found to improve symptom distress, quality of life and survival in patients with advanced cancer. Early integration is most appropriate in the outpatient (OP) setting. However, most PC services in the U.S. do not have an OP component. Our study aims to provide a snapshot of the type of patients that are referred to this novel setting for the delivery of early PC. Methods: We reviewed a day in the SCC to illustrate the structure and process involved in the delivery of outpatient PC. We highlighted 9 patients seen that day to show the variety of patients, scope of services, and the unique roles that PC interdisciplinary team members perform. Results: 41 patients were seen that day in the SCC: 10 scheduled consults, 22 scheduled follow-ups, 9 (22%) same-day unscheduled patients: 4 follow-ups, 1 consult and 4 nurse triages. There were also 31 telephone encounters. Most patients seen were for routine follow-up and symptom assessment. However, 10 presented with worsening symptoms with one needing hospital admission. 21 patients required additional counseling: 2 for hospice transitioning, 12 for psychosocial distress, 7 for opioid education. PC was delivered predominantly by physicians and nurses with collaboration with our pharmacist, counselors, and case manager. Conclusions: Traditionally, PC has been delivered predominantly to patients with advanced disease and to aid in transition to end of life. In recent years, OP centers have dramatically changed the nature of PC work as in our snapshot. In addition to patients regarded as traditional PC patients, such as those transitioning to end of life, there are now patients who come in soon after arrival to a cancer center requiring specialized care to address a variety of symptom and educational needs, thus requiring adaptation of structure and processes to allow access for frequent follow ups and counseling and flexibility for walk-in visits. Our findings suggest that SCC needs to practice in a very different way which requires certain skills and assessment tools that are not conventionally present in traditional oncology clinic setting. More research is needed to identify the type of patients that would benefit most from a PC referral.

Implementation of chemotherapy treatment plans (CTP) in a large comprehensive cancer center (CCC): The key roles of infrastructure and data sharing.

2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 20-20 ◽  
Author(s):  
Julie M. Bryar ◽  
Carole Kathleen Dalby ◽  
Susan Anastas ◽  
Lauren Brady ◽  
Michael J. Hassett ◽  
...  
Keyword(s):  
Performance Status ◽  
High Volume ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Tumor Characteristics ◽  
Communication Tool ◽  
Chemotherapy Treatment ◽  
Team Members ◽  
Patient Diagnosis ◽  
Treatment Plans

20 Background: ASCO recommends that prior to initiating chemotherapy, a synoptic CTP should be created. At a large CCC, there was no tool to consistently or clearly communicate chemotherapy plans within the electronic health record (EHR). Methods: In 2011, a structured tool was created in the EHR to document patient diagnosis, tumor characteristics, planned regimen, side effects, performance status, and other elements when starting a new chemotherapy. Completion of a CTP generates a synoptic note in the EHR, pre-populates a chemotherapy consent form and computerized chemotherapy ordering template, helping to integrate CTPs into normal workflow and removing steps for possible errors. Completed CTPs can be accessed by care team members and sent to external referring providers. Implementation strategy included education on the importance of and how to complete CTPs and sending monthly compliance reports to disease centers (DC) and regional sites (RS). Compliance was defined as number completed CTPs / number new chemotherapy starts. Results: The CTP tool was introduced in a staggered rollout in mid-2011 (compliance reporting began in 2012). Six DC and 3 RS presently complete and use CTPs. 3,569 CTPs were completed since 2012. The table shows compliance by quarter, demonstrating significant variation among DC and RS. We attribute increased compliance to introduction of formal feedback reports that allow for identification of high-volume providers not completing CTPs, triggering individual interventions, especially targeted re-education. We also suspect shared reporting led to competition among providers, further improving performance. No incentives were provided for CTP completion. Conclusions: By creating a tool within the existing workflow and providing formal feedback, CTPs have been implemented as a communication tool at a CCC. [Table: see text]

Genomic profiling of young adults with colorectal cancer: A single-institution experience.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15168-e15168
Author(s):  
Kristin Lynn Koenig ◽  
Christina Sing-Ying Wu ◽  
Wei Chen ◽  
Wendy L Frankel ◽  
Daniel Jones ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Care ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Genomic Profiling ◽  
Braf Mutations ◽  
Genomic Alterations ◽  
Institutional Review ◽  
Significant Difference ◽  
The Ohio State University

e15168 Background: 2-8% of all colorectal cancer (CRC) cases are in younger adults (YAs), patients (pts) less than age 50. However, current understanding of CRC in YAs is inadequate, especially that of sporadic onset. We conducted a study to describe the landscape of genomic alterations in YA CRC pts presenting to a large academic practice. Methods: Adult pts with CRC presenting to The Ohio State University Comprehensive Cancer Center oncology clinics were offered next generation sequencing (NGS) through a customized 22-gene Ion AmpliSeq Mutation Panel as part of clinical care. Commonly mutated areas of select genes (including AKT1, ALK, BRAF, EGFR, ERBB2/4, FBXW7, FGFR1/2/3, KRAS/NRAS, MET, NOTCH1, PIK3CA, PTEN, TP53) were sequenced from tumor sections. Institutional review board approval was obtained to retrospectively analyze this NGS testing between 1/2013-3/2016. Results: 258 CRC pts underwent genomic profiling. 57 pts (22.1%) were YAs at diagnosis (range 22-49 years); 20 pts (7.8%) were 40 years old or younger. 31 YA pts (54.4%) had metastatic disease. Of the YAs with CRC, 18 pts (31.6%) were diagnosed with R-sided colon, 16 pts (28.1%) with L-sided colon, and 22 pts (38.6%) with rectal cancer. 110 genomic alterations were found in YA pts, with a mean of 1.9 mutations per tumor (range 0-6); 35 (31.8%) of these in 32 (56.1%) YA pts were actionable. Of these 110 alterations, 41.8% were in TP53, 28.2% in KRAS/NRAS, 10.0% in PIK3CA, 3.6% in BRAF, 3.6% in FBXW7, and 2.73% in PTEN. 6 YA pts (10.5%) had microsatellite instability (MSI-H). Only 1 pt had concomitant MSI-H and a BRAF mutation; 4 pts with BRAF mutations were microsatellite stable. Comparing our YA pts to a separate cohort of pts age > 50 who had testing done, no significant difference was seen in mutation incidence in KRAS/NRAS (p = 1.0), TP53 (p = 0.3), PIK3CA (p = 0.128), or BRAF (p = 1.0). Conclusions: Genomic profiling through a targeted NGS panel is feasible as part of routine clinical practice. There is disagreement in the literature on genetic mutations in YA compared to older age CRC pts. Knowledge of the genomic landscape in YAs with CRC will lead to improved understanding of the underlying biology of CRC in YAs as it differs from CRC in older pts, and could impact future care of this cohort.

A staff leadership model in an NCI-designated comprehensive cancer center: Quality begins with the team.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 73-73
Author(s):  
Juee Kotwal ◽  
Matthew J. Loscalzo ◽  
Karen L. Clark ◽  
William Dale ◽  
Natalie Schnaitmann
Keyword(s):  
Cultural Change ◽  
High Performance ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Team Approach ◽  
Leadership Model ◽  
Team Members ◽  
Complex Needs ◽  
Management Staff

73 Background: Patients with cancer face a range of complex biopsychosocial needs and challenges. To manage the complex needs of such “high-risk, high-cost” patients, an integrated interdisciplinary team approach is crucial. Although team members are highly skilled, cancer settings are emotionally charged environments which may create high levels of distress in providers. In 2007, the Department of Supportive Care Medicine (DSCM) at City of Hope (COH) developed the nation’s first Staff Leadership Model (SLM) to enhance relationships among team members which has been demonstrated to improve both the quality of patient care and safety. Within this model, the focus was on creating a high-performance team where team members are as valued as patients and families. Methods: DSCM implemented methods centered on maximizing team engagement by creating trusting relationships, detoxifying conflicts, depersonalizing feedback, and taking personal accountability. Cultural change was achieved by implementing the following interventions: communication skills to manage conflict, frequent team check-ins to identify areas of growth, non-management staff assuming responsibility for meetings and annual retreats and a “buddy” system to orient new team members. Results: Gallup scores increased from 4.46 in 2015 to 4.62 in 2017 (much higher than COH overall). Transition to Press Ganey in 2018 resulted in 2nd highest engagement score across COH departments (4.42 compared to COH overall 4.16). Conclusions: Results suggest support for the relationship between the SLM and the high quality of team relationships as reflected by the consistent increase in engagement scores. The department philosophy focuses on consciously, systematically and strategically activating the best of each team member in an environment of courageous, compassionate and relentless honesty.

Impact of early release of oral investigational prescriptions on safety and efficiency at a comprehensive cancer center.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 257-257
Author(s):  
Alan H. Breaud ◽  
Audrea H Szabatura ◽  
Laura Cedro ◽  
Anna Shanedling ◽  
Hakim Lakhani ◽  
...  
Keyword(s):  
Processing Time ◽  
Pilot Project ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Pharmacy Staff ◽  
Processing Times ◽  
Research Protocols ◽  
Qualitative Feedback ◽  
Specific Protocol ◽  
Patient Appointment

257 Background: At Dana-Farber Cancer Institute (DFCI), timing of order release to the pharmacy is a contributing factor to safety and processing concerns for oral investigational medications. Day-of release can lead to delayed delivery to the patient, creating a risk of missing timed specific protocol data collection, and rushed critical pharmacy safety checks, an issue raised in a comprehensive proactive systems safety risk assessment. We conducted a pilot project aimed at improving the safety and efficiency of oral investigational medication processing within the pharmacy by releasing prescription orders at least 24 hours in advance of a patient’s appointment. Methods: A team of pharmacists, nurses, process improvement professionals, and a physician designed a pilot project where the prescriber released oral investigational prescriptions, from 9 selected research protocols, at least 24 hours before a patient’s appointment. From 11/2/2018-3/1/2019, we used manual timestamp data to compare prescription processing times for prescriptions released at least 24 hours in advance (“released early”) to prescriptions released less than 24-hours in advance (“not released early”). Qualitative feedback was obtained to assess pilot impact on prescription processing safety. Results: As shown in the table below, prescription processing time on day of patient appointment for prescriptions released early was shorter, on average, compared to those not released early (p < 0.05). Due to orders being released early, pharmacy staff noted feeling less pressure during prescription checks and a better ability to proactively assess inventory and prescription issues. Conclusions: Releasing oral investigational prescriptions early reduced the prescription processing time and increased time available for safety checks. Expanding this workflow change to all investigational medication orders can increase the safety and efficiency of prescription processing at DFCI. [Table: see text]

Performance teamwork training in ambulatory oncology.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16559-e16559
Author(s):  
Anne Gross ◽  
Susan Mann ◽  
Michael Kalfin ◽  
Sharon Lane ◽  
Saul Weingart ◽  
...  
Keyword(s):  
Data Collection ◽  
Multimodality Treatment ◽  
Team Training ◽  
Training Data ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Team Members ◽  
Communication Task ◽  
Ambulatory Oncology ◽  
Patient Reported

e16559 Background: Increasingly complex diagnostic and multimodality treatment algorithms have yielded superior outcomes, but also magnified the risk for adverse events precipitated by failures of communication and coordination. We implemented team training principles in 14 outpatient oncology practices across 3 campuses (community and academic) to reduce the risk of errors and increase operational efficiency and quality. Methods: Over 950 physicians, nurses, pharmacists, and staff were trained in evidence-based concepts of teamwork. Intervention included 1) baseline data collection regarding key clinical processes, (e.g. non-communication of same-day chemotherapy order changes); 2) observations/interviews with care team members; 3) process meetings to identify vulnerabilities and develop agreements and tools to support them; 4) Train the Trainer methodology; 5) staff training; 6) post-training data collection. Results: Despite the infrequency of non-communicated same-day changes in chemotherapy orders at baseline (~2%), a trend toward improvement was seen (chi-square p=0.068). The incidence of missing chemotherapy orders for infusion visits not associated with an MD visit decreased significantly. Staff reported improved practice efficiencies and a more respectful, safer environment. Press Ganey patient-reported perceptions of teamwork improved significantly. Conclusions: Team training improved communication, task coordination, perceptions of efficiency, quality, safety and interactions among team members, as well as patient perception of teamwork in both community and academic environments of a comprehensive cancer center. [Table: see text]

Predicting Patient Treatment Deferrals at an Outpatient Chemotherapy Infusion Center: A Statistical Approach

2017 ◽  
pp. 1-8
Author(s):  
Donald B. Richardson ◽  
Seth D. Guikema ◽  
Amy E.M. Cohn
Keyword(s):  
Treatment Protocol ◽  
Regression Tree ◽  
Comprehensive Cancer Center ◽  
Patient Specific ◽  
Brier Score ◽  
Cancer Center ◽  
University Of Michigan ◽  
Wide Range ◽  
Patient Will ◽  
The University

Purpose Patients scheduled for outpatient infusion sometimes may be deferred for treatment after arriving for their appointment. This can be the result of a secondary illness, not meeting required bloodwork counts, or other medical complications. The ability to generate high-quality predictions of patient deferrals can be highly valuable in managing clinical operations, such as scheduling patients, determining which drugs to make before patients arrive, and establishing the proper staffing for a given day. Methods In collaboration with the University of Michigan Comprehensive Cancer Center, we have developed a predictive model that uses patient-specific data to estimate the probability that a patient will defer or not show for treatment on a given day. This model incorporates demographic, treatment protocol, and prior appointment history data. We tested a wide range of predictive models including logistic regression, tree-based methods, neural networks, and various ensemble models. We then compared the performance of these models, evaluating both their prediction error and their complexity level. Results We have tested multiple classification models to determine which would best determine whether a patient will defer or not show for treatment on a given day. We found that a Bayesian additive regression tree model performs best with the University of Michigan Comprehensive Cancer Center data on the basis of out-of-sample area under the curve, Brier score, and F1 score. We emphasize that similar statistical procedures must be taken to reach a final model in alternative settings. Conclusion This article introduces the existence and selection process of a wide variety of statistical models for predicting patient deferrals for a specific clinical environment. With proper implementation, these models will enable clinicians and clinical managers to achieve the in-practice benefits of deferral predictions.

scholarly journals Cancer Center Clinic and Research Team Perceptions of Identity and Interactions

2017 ◽  
Vol 13 (12) ◽  
pp. e1021-e1029 ◽  
Author(s):  
Torsten Reimer ◽  
Simon J. Craddock Lee ◽  
Sandra Garcia ◽  
Mary Gill ◽  
Tobi Duncan ◽  
...  
Keyword(s):  
Group Dynamics ◽  
The Other ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Research Staff ◽  
Research Teams ◽  
Team Members ◽  
Clinic Staff ◽  
Impact Function ◽  
Shared Information

Purpose: Conduct of cancer clinical trials requires coordination and cooperation among research and clinic teams. Diffusion of and confusion about responsibility may occur if team members’ perceptions of roles and objectives do not align. These factors are critical to the success of cancer centers but are poorly studied. Methods: We developed a survey adapting components of the Adapted Team Climate Inventory, Measure of Team Identification, and Measure of In-Group Bias. Surveys were administered to research and clinic staff at a National Cancer Institute–designated comprehensive cancer center. Data were analyzed using descriptive statistics, t tests, and analyses of variance. Results: Responses were received from 105 staff (clinic, n = 55; research, n = 50; 61% response rate). Compared with clinic staff, research staff identified more strongly with their own group ( P < .01) but less strongly with the overall cancer center ( P = .02). Both clinic staff and research staff viewed their own group’s goals as clearer than those of the other group ( P < .01) and felt that members of their groups interacted and shared information within ( P < .01) and across ( P < .01) groups more than the other group did. Research staff perceived daily outcomes as more important than did clinic staff ( P = .05), specifically research-related outcomes ( P = .07). Conclusion: Although there are many similarities between clinic and research teams, we also identified key differences, including perceptions of goal clarity and sharing, understanding and alignment with cancer center goals, and importance of outcomes. Future studies should examine how variation in perceptions and group dynamics between clinic and research teams may impact function and processes of cancer care.

Teamwork and Electronic Health Record Implementation: A Case Study of Preserving Effective Communication and Mutual Trust in a Changing Environment

2016 ◽  
Vol 12 (11) ◽  
pp. 1075-1083 ◽  
Author(s):  
Anne H. Gross ◽  
Ryan K. Leib ◽  
Anne Tonachel ◽  
Richard Tonachel ◽  
Danielle M. Bowers ◽  
...  
Keyword(s):  
Electronic Health Record ◽  
Effective Communication ◽  
Similar Process ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Health Record ◽  
Mutual Trust ◽  
Team Members ◽  
Electronic Health

This article describes how trust among team members and in the technology supporting them was eroded during implementation of an electronic health record (EHR) in an adult outpatient oncology practice at a comprehensive cancer center. Delays in care of a 38-year-old woman with high-risk breast cancer occurred because of ineffective team communication and are illustrated in a case study. The case explores how the patient’s trust and mutual trust between team members were disrupted because of inaccurate assumptions about the functionality of the EHR’s communication tool, resultant miscommunications between team members and the patient, and the eventual recognition that care was not being effectively coordinated, as it had been previously. Despite a well-established, team-based culture and significant preparation for the EHR implementation, the challenges that occurred point to underlying human and system failures from which other organizations going through a similar process may learn. Through an analysis and evaluation of events that transpired before and during the EHR rollout, suggested interventions for preventing this experience are offered, which include: a thorough crosswalk between old and new communication mechanisms before implementation; understanding and mitigation of gaps in the communication tool’s functionality; more robust training for staff, clinicians, and patients; greater consideration given to the pace of change expected of individuals; and development of models of collaboration between EHR users and vendors in developing products that support high-quality, team-based care in the oncology setting. These interventions are transferable to any organizational or system change that threatens mutual trust and effective communication.

Team training in adult oncology.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 27-27
Author(s):  
Anne Gross ◽  
Susan Mann ◽  
Michael Kalfin ◽  
Sharon Lane ◽  
Saul Weingart ◽  
...  
Keyword(s):  
Qualitative Interviews ◽  
Team Training ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Staff Perceptions ◽  
Chi Square ◽  
Team Members ◽  
Train The Trainer ◽  
Manage Care ◽  
Communication Task

27 Background: In outpatient oncology, clinicians working in various locations and at different times, rely on each other for information to coordinate and manage care. Increasingly complex treatment algorithms magnify risk for adverse events precipitated by failures of communication/coordination. We implemented team training in 16 adult practices across five campuses (community and academic) to reduce errors and increase efficiency/quality. Methods: 1,000+ MDs, NPs, PAs, RNs, pharmacists, and support staff were trained in teamwork concepts. Interventions and methods included baseline data collection on key clinical processes, (e.g. same-day chemotherapy changes not communicated to treating RN); observations and interviews with teams; “train-the-trainer” sessions; identification of “pain points”; interdisciplinary "process meetings" to develop agreements, tools and systems changes to support better communication/efficiency; trained all staff; collected data six months post-training. Results: Despite infrequency of noncommunicated same-day changes in chemotherapy at baseline (~2%), an improvement trend was seen (chi-square p=0.068). Incidence of missing infusion orders, not associated with an MD visit, decreased significantly. Providers reported fewer unnecessary pages. Nurses reported quicker, more reliable responses to pages sent. Staff reported improved practice efficiencies and safer, respectful work environments. Qualitative interviews elicited patient perceptions of communication, teamwork, and care coordination. Patients’ quantitative perceptions of teamwork improved significantly. Conclusions: Team training improved communication, task coordination, interactions with team members, staff perceptions of efficiency, quality, and safety and patient perception of teamwork in the outpatient practices of a comprehensive cancer center. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document