Quality improvement initiative standardizes biTE therapy workflows, improving access in rural northern New England.
176 Background: Bispecific T-cell engagers (BiTEs) are a promising class of therapies for both hematologic and solid tumors. However, its administration requires careful monitoring, often necessitating inpatient observation during the initial step-up dosing phase. This is due to potential risks such as cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. The Dartmouth Cancer Center (DCC) faces additional challenges in providing BiTE therapy across a large rural region. This project aims to identify and address these challenges to optimize the continuum of care for BiTE therapy. Methods: This quality improvement initiative, conducted at DCC, focuses on standardizing BiTE therapy workflows, with tarlatamab as the initial model. Phase I involves identifying current workflows, engaging stakeholders for insights (administrative support, social work, case management, nurses, pharmacists, clinicians), and surveying workflow efficiency. Deliverables include developing a Standard Operating Procedure (SOP) for step-up dosing, creating standardized documentation in electronic health records, and optimizing DCC's immune effector cell therapy guidelines. Phase II will reassess workflows post-SOP implementation, create standardized documentation for all BiTEs, model outpatient transition for tarlatamab, and establish an SOP for transitioning BiTE therapy to satellite sites thereby reducing patient travel burden and enhancing care continuity for rural patients. Results: Among survey respondents (n = 87), clinicians represented 36.8% (n = 32), followed by nurses providing direct patient care at 21.8% (n = 19), and pharmacists at 18.4% (n = 16). Initial surveys identified key challenges: limited space and inefficient patient flow, particularly during step-up dosing and monitoring. A lack of clear transition processes between outpatient, inpatient (step-up phase), and discharge was noted, leading to uncertainty in admission responsibilities, post-discharge follow-up, and clinic return coordination. The need for precise, standardized monitoring and toxicity management protocols, including defined observation times, was also highlighted. Conclusions: Standardizing BiTE therapy is anticipated to lead to significant improvements in care accessibility and continuity for patients, especially those in rural Northern New England. This initial phase, focusing on tarlatamab and step-up dosing, will lay the groundwork for a broader rollout to include all BiTE therapies and expansion to satellite sites. Future efforts will include evaluating healthcare utilization patterns pre- and post-implementation, as well as assessing time-to-treatment and adverse event rates to further refine coordination between the primary and satellite sites.
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