Establishing a Chimeric Antigen Receptor (CAR) T-Cell Program: Essential Tools for the Clinical Nurse Case Manager

Abstract

Topic Significance & Study Purpose/Background/Rationale CAR T-cell therapy is a complex medical intervention requiring extensive planning and development. A detailed process is required to ensure communication and collaboration between team members and identify role responsibilities. Tools are needed to assist the clinical nurse case manager to facilitate the coordination and provide the continuity required for the overall process. There is limited literature available regarding tools and processes for CAR T-cell therapy implementation. Methods, Intervention, & Analysis We developed several tools including a CAR T-cell flow sheet checklist, a product specific process with step-by-step instructions, and a patient tracking spreadsheet. These tools provide the case manager detailed guidelines for completion of each step including evaluation, enrollment, ordering, purchase order procedure, apheresis, chemotherapy, admission, infusion, and post infusion follow-up. The patient tracking spreadsheet allows multiple departments to quickly check each patient's stage in the therapy, healthcare status, and insurance coverage. We created documents for each product specific process and added details as we worked with the initial patients. Each case manager has a binder and access to online resources. The documents helped create the flow sheet checklist to ensure optimal patient safety and that all steps in the process are accomplished. The internal CAR T-cell policy and the product prescribing information provided guidance in creation of these tools. Findings & Interpretation After piloting use of the tools, several components were improved until the process was efficient and safety was optimized. Application of the tools has provided concrete guidelines for each case manager. This has increased confidence and consistency among case managers. Discussion & Implications CAR T-cell therapy is a novel treatment. Our tools are designed to educate and assist each nurse case manager, whether they are a novice or expert, in CAR T-cell therapy. Successful implementation of CAR T-cell therapy in our institution relies heavily on these processes and tools, allowing us to provide extraordinary care for this complex patient population. In the future, the resources will be updated as new products and indications are developed. These essential tools are useful to guide other institutions in the development of their CAR T-cell therapy programs.