2. Materials and Methods
The following activities were reviewed by the University of Iowa Institutional Review Board and deemed a quality improvement project as they were designed to implement processes that will improve patient care at our program and may not be generalizable due to variation in institutional resources.
2.1 Setting/Population
Starting in March 2020, pediatric ALL patients treated at the University of Iowa Stead Family Children’s Hospital were given the option to have LPs with or without sedation. This was offered to most patients and families, regardless of age, with a few notable exceptions: patients with an underlying condition such as anxiety or ADHD that might affect their ability to remain calm and still during the procedure, patients in Induction therapy (to reduce the risk of diagnostic LP blood contamination, medication-induced behavioral challenges, and coincidental bone marrow procedures), and patients with anticipated anatomic challenges due to body habitus or a history of multiple attempts with sedated LPs. Two patients with T-lymphoblastic lymphoma were also included in this study due to the similarity of treatment. Sedated and unsedated protocols utilized the same safety checklist protocols ensuring patient identification, consent, and chemotherapy verification. If vincristine was to be delivered on the same day as an unsedated procedure, the vincristine (always dispensed in a mini-infuser bag) was delivered and completed prior to the start of the procedure.
2.2 Intervention
At an appointment leading up to an LP, the entire procedure was explained to the patient (when age-appropriate) and guardian. If the patient and family agreed to consider an unsedated LP, a simulation including positioning and palpation of landmarks was performed. If the patient was able to remain still throughout the simulation, the upcoming LP was scheduled without sedation.
All patients had topical lidocaine applied to the lumbar area upon arrival to clinic. Most patients received a dose of an anxiolytic medication, either lorazepam (0.05 mg/kg/dose PO/IV, max dose 2 mg) or midazolam (0.2 mg/kg PO, max dose 20 mg) 30 minutes prior to the LP. The guardian was given the option to be present with the patient in the room along with a Child Life team member to aid in keeping the patient distracted and calm. Buffered lidocaine was used according to the discretion of the provider performing the procedure. Unsedated LPs were performed in a clinic or procedure room in the Pediatric Hematology/Oncology clinic, whereas patients requiring sedated LPs were transported to another floor with procedure rooms and pre- and post-anesthesia recovery rooms. Sedated and unsedated LPs were performed by pediatric oncology faculty, fellows, and advanced practice providers.
2.3 Aims
Our primary aim was to decrease the number of post-Induction sedated LPs performed in pediatric patients with ALL at the University of Iowa by 50%. Our secondary aims were to compare sedated and unsedated LPs with regards to patient/caregiver preferences , time spent in clinic, percentage of successful and blood-contaminated LPs, and overall costs, and to perform value stream mapping to improve efficiency of the LP process.
2.4 Measures
2.4.1 Quantifying Sedated and Unsedated Lumbar Punctures
The intervention period lasted for approximately seven months (3/2020-10/2020), during which time we educated staff, performed the visual process mapping, and refined our policies and procedures for unsedated LPs. The electronic medical records of all pediatric patients with ALL undergoing active treatment at the University of Iowa during the post-intervention period (10/1/2020-12/31/2020) were retrospectively reviewed and the numbers of sedated and unsedated LPs for each patient were recorded. For this patient cohort, the same data was recorded from an equivalent defined pre-intervention period (10/1/2019 to 12/31/2019), if those patients were undergoing treatment at that time.
2.4.2 Observations and Process Mapping
Our quality improvement intervention utilized a value stream mapping approach to identify efficiency gaps in our institution’s sedated and unsedated LP processes. Members of the University of Iowa Quality Improvement Program helped create process maps for sedated and unsedated LPs after performing observations of clinic visits for patients receiving both types of procedures to quantify the time utilized for each step of the process. These steps were characterized as “value added” (directly relating to patient care) and “non-value added” (not relating to patient care, such as waiting time, transportation, etc.).
2.4.3 CSF Characteristics
To evaluate the quality of cerebrospinal fluid (CSF) samples obtained during both types of procedures, data on the number of red blood cells were retrospectively reviewed.
2.4.4 Sedation Preference Survey
Patient guardians, as well as patients over the age of 7, were given a two-question survey to assess their preference between LPs with and without sedation. The survey was developed by the authors, then tested and revised according to feedback from members of the nursing and quality team prior to dissemination. The surveys were introduced and handed out to guardians and age-appropriate patients by nursing staff and returned the same day. The two questions and response options were, “Please indicate your overall preference for sedated versus unsedated LPs on a scale from 0 to 10. A rating of 0 indicates you strongly prefer LPs with sedation and a 10 means you strongly prefer LPs without sedation.” and “How much do the current COVID-19 swab requirements influence your answer to the previous question? Unsure/Not at all/A little/A lot”.
2.4.5 Costs
Overall charges associated with the patient visit on procedure days with and without sedation were tabulated and compared. The number of cancelled procedures during the post-intervention period was collected.