Moving CAR T-Cell Treatment to Outpatient Setting: A Real-World Case Study

CAR T-cell therapy has the potential to be transferred to the outpatient setting, according to Jennifer Peterson, MS, RN, OCN, BMTCN. She shared that implementing this move at City of Hope required input from an interdisciplinary team to establish workflows and patient throughput. The result was not only clinically successful but resulted in patient satisfaction and had a positive financial impact for the institution.

Peterson, who is a clinical practice education specialist at City of Hope in Duarte, California, presented on the implications for outpatient CAR T administration during the 2023 Tandem Meetings. She discussed how her team approached the transition, and what factors make a patient eligible for outpatient treatment.

This initiative stemmed from inpatient capacity issues. The goal of the initiative was to transition 25% of patients receiving CAR T-cell therapy from the inpatient to outpatient setting. This included creating workflows and processes for the safe care of patients in the outpatient setting, and providing training and education for the RN staff to care for the special needs of patients following CAR T-cell therapy.

City of Hope has approximately 215 licensed beds on the inpatient side. The institution performs approximately 800 hematopoietic cell transplants annually, and according to Peterson, has been involved with CAR T-cell therapy research since the late 1990s. Of note, Kaiser patients of Southern California and Hawaii travel to City of Hope to receive transplant and IEC therapy.

As of March, 2022, when this project was launched, there were two 36 inpatient bed units. These units were staffed with RNs trained in hematologic clinical trials, autologous and allogeneic hematopoietic stem cell transplant (HSCT), CAR T-cell therapy, and clinical trial IEC settings.

Peterson’s team created a standard operating procedure (SOP) to encompass the different aspects of outpatient care. As part of this SOP, MD and nurse coordinators would facilitate appropriate placement of patients in the outpatient setting. Caregiver and patient education would be conducted, and patient proximity to the hospital would need to be determined.

“There were a lot of criteria set in order to determine if a patient and their caregiver were appropriate for outpatient care,” Peterson said. “One of the biggest criteria was distance from the hospital.”

Because the institution was based in Los Angeles, which is a very large area and challenging to navigate, the nurse investigators chose to measure distance by time rather than milage.

Patients needed to be within a 30-minute drive of the institution for the first 14 days following infusion. For the remaining 28 days following infusion, they needed to be within 2 hours from the hospital. City of Hope did open a hotel on their campus in 2022; this 147-room hotel allows certain patients to stay within the 30-minute radius if their home did not meet this requirement.

Moreover, patients had to understand the lymphodepletion schedule as what the requirements for outpatient care entailed. They also needed to have a reliable caregiver.

“[This is] someone who would spend time with [the patient] 24-hours-a-day to be able to monitor them for signs and symptoms, [to] monitor their vital signs and take their temperature and to accompany them back to the hospital if they did exhibit any signs or symptoms post CAR T-cell infusion,” Peterson said.

Lastly, financial screening was conducted to determine if insurance would cover care in an outpatient setting.

Staff attended training on an overview of CAR T-cell therapy encompassing the commercially available products, as well as Risk Evaluation and Mitigation Strategy (REMS) training. Each nurse had to demonstrate their knowledge and skill of the infusion process, as well as the documentation process for infusion of commercial CAR T-cell products.

“Training was a big component of this transition from inpatient to outpatient.”

The first outpatient CAR T-cell infusion was on May 5, 2022. Peterson noted that since then the program has evolved to meet the capacity challenges so that patients can receive both their lymphodepletion therapy and subsequent CAR T-cell infusion, in the outpatient setting. Alternatively, patients can receive lymphodepletion in the outpatient setting, and be admitted for infusion and postinfusion monitoring.

Postinfusion follow-up included developing a process for reporting adverse effects(AEs)/onset of cytokine release (CRS) and neurotoxicity symptoms. Patients are evaluated daily by either an MD or APP for AEs. They have their labs drawn and receive IV hydration for the 14 days following infusion. Moreover, 1 of the 2 inpatient units has a blocked bed, so there is always an available bed in the event that a patient does exhibit signs or symptoms of CRS and needs to be admitted.

This institution does not have an emergency department, so if a patient does exhibit these signs or symptoms, or any uncontrolled symptoms from the lymphodepletion, they present to the evaluation and treatment center.

The first outpatient infusion was a big day for the unit, Peterson explained.

“It was very exciting,” she said. “Lots of people wanted to watch and make sure that they were part of the first infusion and the big day.”

Reference

Peterson J. Moving the CARs: transitioning chimeric antigen receptor T cell therapy from inpatient to outpatient. Presented at: 2023 Transplantation & Cellular Therapy Meetings; February 15-19, 2023; Orlando, FL. Abstract 107.