A Pilot Study to Educate Nurses About Gene Therapy for Sickle Cell Patients on an Inpatient Hematology/Oncology Unit
Brenda F MerriweatherAbstract
Background
Sickle Cell Disease (SCD) is a chronic, painful, debilitating, and life-threatening disease. Two groundbreaking gene therapies, exagamglogene autotemcel and lovotibeglogene autotemcel, were approved by the FDA in December 2023. These gene therapies have been proven to correct genetic defects, reduce pain episodes, lower the incidence of infections, reduce organ damage, enhance quality of life, and demonstrate a potential for a cure. Gene therapies were still new in 2024, and many nurses had limited or no knowledge of gene therapies. Staff nurses are in a unique position to provide round-the-clock care to Sickle Cell patients undergoing gene therapy. These nurses must be competent and comfortable in providing this vitally important care. This pilot study aimed to determine if a detailed and comprehensive gene therapy education program could lead to enhanced knowledge of gene therapies and assist in the successful completion of our first patient to receive gene therapy at Boston Medical Center.
Methods
The educational program included a detailed PowerPoint presentation featuring both gene therapy products, the types of gene therapy, the goals of gene therapy, the cost, adverse reactions, drug interactions, safety precautions, nursing considerations, treatment plan orders, plerixafor details, a chemotherapy protocol, and details of the patient journey including meeting with the hematology team, eligibility screenings, consent, fertility preservation decision, prior authorization, gene therapy manufacturing slot reservation, hyper-transfusion, stem cell mobilization, continued mobilization, Stem cell apheresis, manufacturing of the gene therapy product, conditioning, infusion and post-infusion monitoring. During the presentation, all questions were answered and addressed. After the education program was conducted, an informational handout and a post-test were given to the nurses. A checklist was developed for the nurses for safety and continuous quality improvement purposes. Visual aids were used for the medication for conditioning and chemotherapy to simulate actual practice on the unit. Treatment plans were reviewed to have a preview of the contents of the treatment plan in the EPIC electronic health record. An EPIC training environment for a tutorial was made available to the nurses prior to our first patient starting gene therapy, so they could become familiar with the treatment plans. Case studies were used to stimulate analytical conversation. A modified training program was conducted for the nursing assistants on the unit as well. A gene therapy resource book was created and placed on the unit for reference. A gene therapy library was created for staff members and patients, which included resource materials on the two gene therapy products, package insert information, and patient support information. A multidisciplinary team call reference sheet was created to be able to get in touch with team members during the gene therapy process. Daily huddles were also conducted to run through the plans for each day and be proactive for any issues that may arise.
Results
The post-test included multiple choice, true and false, and fill in the blank questions. The post-tests were graded. Out of 79 nurses, who included 75 females and 4 males, 98% successfully made 100% on the post-test. We successfully treated our first gene therapy patient and subsequent others at Boston Medical Center. This study was not restricted to one gender, and the study did not include children.
Conclusions
The results demonstrated that a comprehensive program conducted to teach about the gene therapy process can be successfully taught to nursing staff to prove competency. The study was cost-effective as well as a safety initiative. A pilot study such as this one can be duplicated to perform a larger-scale study with a pre-test and post-test. An education program such as this one can be taught in other medical centers to ensure safety, improve outcomes, and to continue the technological advancement of gene therapy. Every effort should be made to ensure that nurses are competent and comfortable with the process of gene therapy for our Sickle Cell population. Understanding the content of the gene therapy process can increase confidence and autonomy and decrease anxiety.