Optimizing processes for adverse event management for bispecific antibodies for diffuse large b-cell lymphoma in community practice: Insights from a quality improvement initiative

Abstract

Abstract Background In a previous quality improvement (QI) study designed to assess and address barriers to the adoption of novel therapies for diffuse large B-cell lymphoma (DLBCL) in community practice (Riedell ASH 2023), gaps were found in clinic processes for identification and management of adverse events (AEs) with emerging therapies. As administration of bispecific antibody (bsAb) therapy for DLBCL is becoming more frequent in the outpatient setting, clinic workflows are needed to support effective bsAb care coordination and AE management. This QI study focused on development and adoption of evidence-based protocols for bsAb therapy-related AE management and care transitions in community oncology clinics. Methods The initiative is comprised of baseline (N = 56) and follow-up (N = 13) provider surveys, and pre- (N = 44) and post-surveys (N = 36) of providers participating in small-group, team-based audit-feedback (AF) sessions across 4 community clinics. Survey questions were designed to assess knowledge, confidence, experiences with bsAb AE management and care coordination, and reported clinic process changes. Care teams from each clinic, along with a DLBCL expert, participated in AF sessions to (a) assess clinic-specific practice gaps identified via the provider surveys, (b) prioritize areas for improvement, and (c) develop action plans for addressing underlying root causes of identified gaps. Results Baseline Survey: Top reported challenges in managing bsAb therapy-related AEs include monitoring and managing delayed or long-term AEs (40%) and staff is not prepared/trained to manage CRS and neurotoxicity (32%). When asked to rate the level of collaboration and communication between academic centers and community clinics as it relates to referral, administration, and outpatient transition, only 26% of providers marked very good/excellent, stating that receiving guidelines and expectations from academic centers on the clinic's role in bsAb administration and management (40%) and paired education between centers regarding bsAb administration, care coordination, and AE management (37%) would help improve processes. AF Sessions: Providers participating in the sessions reported system-level barriers to changing current protocols and processes in place (36%) and poor communication with nearby hospitals to guide bsAb administration and AE management protocols (31%) as the biggest challenges to developing and implementing evidence-based workflows for bsAb AE management. Following the session, clinicians reported improvement in high/very high confidence in their ability to promptly recognize and manage AEs associated with bsAb for DLBCL (53% to 78%; p = 0.0018), which translated to improvement in case-based competency for grading and managing CRS (38% to 56%). Care teams set goals to develop/revise bsAb AE management protocols and improve communication with academic centers to guide transitions for outpatient bsAb administration and management. Action plans to achieve these goals include training with nearby hospitals to support community providers with outpatient administration. Follow-Up Surveys: 100% of clinic champions reported that their team has more closely aligned their clinical practices with evidence-based guidelines for recognition and management of CRS and neurotoxicity associated with bsAb therapy and refined their clinic's protocols for bsAb administration, AE management, and follow-up care. 54% of clinic champions stated the most significant improvements observed were in the sharing of patient information, including test results, premedication documentation, and details of prior bsAb treatment cycles. Conclusions Through this QI initiative, clinical teams identified barriers to AE management and care coordination for patients with DLBCL receiving bsAb therapy, creating and implementing process improvements, including optimizing protocols for bsAb administration and management of AEs, as well as bi-directional information sharing with academic centers, to improve care. While meaningful educational and action plan gains were demonstrated, these data underscore practice gaps in bsAb AE management and care transitions in the community setting to address in future initiatives to support evidence-based bsAb utilization for DLBCL in the community setting. Study Sponsor Statement The study reported was funded by an educational grant from Genmab US, Inc., who had no role in the study design, execution, analysis, or reporting.