Change Management across Disciplines: Implementation of Standardized Outpatient Clinical Trial Procedures

Introduction The increasing number of investigational cell therapies and their expanding indications have made it challenging to provide access to the latest clinical trials given limited inpatient bed capacity . Scheduling conflicts arise between clinical trial patients and those requiring beds for commercially approved cell therapies or transplants. Objectives Many research teams are led by clinicians from non-hematological specialities who are not accustomed to managing adverse events associated with cell therapies. To meet these needs, institutional leadership called for standardized outpatient treatment procedures and patient education resources. Methods Standard operating procedures were drafted for the management for clinical trial patients in our Autologous Transplant Day Hospital (ADH) unit in consultation with clinicians. The nature and scope of outpatient monitoring was stratified into three risk levels (low, medium, high) based on the expected frequency and severity of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome . Patients receiving high-risk products were seen daily for the first 1 to 2 weeks, then twice weekly with daily telephone follow-up assessments up to 30 days after the cell product administration. Patients and caregivers were provided with equipment for daily home monitoring and worksheets to record vitals, neurotoxicity score, fluid intake, and bowel movements. The research ethics board was engaged to approve research-specific patient educational material. Procedures were rolled out in two stages over a 1.5 year period. Stage 1 included follow-up in ADH for 30 days post inpatient cell infusion, followed by stage 2 which added the cell infusion and acute care in ADH. A dry-run walk through was completed before stage 2. Each stage included a pilot period followed by a debrief meeting to obtain feedback. Results Feedback focused on clarifying roles & responsibilities (40%), documentation expectations (23%), and improving communication between the research team and ADH unit (17%). Responses resulted in the modification of patient educational material, development of a triage pathway for research patient calls, and designation of a single telephone number to receive all patient calls for the first month post-infusion at all hours of the day, regardless of disease program. A protocol was created to delineate the responsibilities of the research team and clinical unit staff with positive feedback from staff. Conclusion Capacity to provide novel investigational cell therapies to a wider patient population has increased. To date, over 50 infusions have been delivered in the outpatient setting supporting 6 clinical trials , including collaborations with solid tumor and neurology teams. Examples of patient educational material will be available for review together with the poster presentation.

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