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.