Intrathecal baclofen pumps are placed for movement disorders, such as dystonia and spasticity. Surgical site infections and deep infections related to implant surgery are a problem in this challenging patient population.1 Known risk factors and special considerations include low body mass index, presence of percutaneous gastrointestinal access, and scoliosis, among others. Most infections occur within 60 days of an operation, reported at a rate of 4 percent in the first 60 days and 1 percent per year thereafter.1,2
Using national benchmarks, Texas Children’s Hospital, Houston, found it had an unacceptably high rate of infection (23 percent) in comparison with other hospitals.3 Surgical team leaders aimed to address implant-related infections. Specifically, they conducted a quality improvement (QI) initiative, following an infection prevention bundle with evidence-based best practices,2,4 and examined the pre- and post-protocol-implementation outcomes of perioperative infection and postoperative complications.
Putting the QI activity in place
Texas Children’s Hospital is a freestanding metropolitan quaternary referral and teaching hospital with more than 650 beds. Advanced QI is valued in the organization. In addition, the neurosurgery division runs a data-driven research program, which further motivated this QI activity.
In weekly ongoing quality assurance conferences, the team reviewed American College of Surgeons National Surgical Quality Improvement Program® Pediatric metrics and ongoing occurrences. All stakeholders recognized the need for QI over the course of information dissemination.
The team designed an intervention for QI using a plan-do-study-act model.5 The treating physicians conducted a literature review of best practices; the pediatric neurosurgery team reached consensus for steps in the perioperative treatment pathway where no recommendation could be found in the literature. As a result, the team developed and implemented an infection prevention bundle, which included preoperative, intraoperative, and postoperative steps. We modeled our process after the Hydrocephalus Clinical Research Network shunt infection protocol, which is a successful example of QI in pediatric neurosurgery.4
The implementation was pushed forward with team effort from surgery, perioperative nursing, and acute care nursing “micro-team” fronts. Each micro-team had a point person in charge of peer education and compliance with steps of the protocol pertaining to their field. With a surgical schedule and team members on different working schedules, it was difficult to carve out in-person meeting times. It was reassuring to find over time that the contemporaneous efforts of different micro-teams worked well, with monthly check-ins via e-mail reporting. Weekly Surgical Quality Assurance case conferences also provided a forum for adjustments in workflow and for addressing any problems or concerns that arose.
The protocol was implemented starting in August 2014. Our QI project was published in Journal of Neurosurgery: Pediatrics in 2018.3
Resources used and skills needed
This QI effort received no funding and had no additional staff support beyond the usual clinical care efforts. Workflow and clinical care processes were restructured according to an agreed-upon protocol, and in so doing, allowed for standardization of workflow. The goal was to reduce variation in care, which, in turn, produced improved clinical results.
The implementation depended on efforts from surgery, perioperative nursing, and acute care nursing micro-team fronts. The lead surgeon knew the protocol (and provided education to other surgeons), and asked for the protocol form and help in adherence to the steps during operations. The lead operating room nurse educated the rest of the perioperative nursing team, filled out the protocol forms, ensured adherence to the protocol steps by providing supplies and reminders, and made enhancements in operative workflow to make the protocol the “default” behavior. The lead acute care nurse educated peers, ensured adherence to the protocol steps, and activated enhancements in workflow to make the protocol the default behavior in the postoperative phase.
A total of 128 cases were included for study: 64 cases in each of the preimplementation and postimplementation groups. In the preimplementation group, 15 complications (23.4 percent) and eight infections (12.5 percent) with Clavien-Dindo grade II or higher were documented. After protocol implementation, six total complications (9.4 percent) with four (6.3 percent) infections were documented. The total complication rate was significantly reduced after protocol implementation (p = 0.032), with absolute and relative risk reductions of 14.1 percent [95 percent confidence interval (CI): 1.5–26.7 percent] and 60 percent, respectively.
The infection rate essentially was cut in half, from 12.5 percent to 6.3 percent. The infection rate was not a statistically significant reduction (p = 0.225), with absolute and relative risk reductions of 6.3 percent [95 percent CI: -3.8–16.3 percent] and 50 percent, respectively. A relatively small sample size to date may contribute to limited ability in achieving statistical significance.
Compliance to every step of the protocol was 88 percent. Barriers included personnel turnover. Education of all perioperative and acute care nursing members took some time; new nursing staff members were continually coming on board as well. The surgical team also had rotating trainees who switched on and off service every four months. There was no “hard stop” mechanism to ensure full compliance in every operation, so implementation depended on people and their behaviors. The 88 percent compliance rate is viewed favorably and is higher over time given penetration of educational efforts across the entire surgical and nursing team.
The protocol was reviewed monthly, and steps of the protocol were discussed regularly, seeking to enhance workflow to prepare for and ensure proper execution of each step at the right time. For instance, storage places of specific dressings were relocated to allow for easier access.
Because this project had no budget and required no additional personnel, the amount invested is not quantifiable in financial terms. The team ultimately believes that quality improvement initiatives are the right thing to do for patient care. The key to physician-led and provider-led QI without additional financial support is designing a clinical workflow that can be incorporated into daily practice.
Savings per case have not been fully quantified in our patient population. Extrapolating from comparative literature of spinal surgery infections—which have reported incrementally increased treatment costs (compared with non-infection controls) of $12,619 to $38,701—total savings in the reduction of complications would range from $113,571 to $348,309 in inpatient hospital costs alone.
Implications for quality of life of the patient and family are targets for future study.
Tips for others
In a surgical team setting, implementation did not require multiple meetings, which would take away from clinical care or require cancellation of scheduled operations. Once motivated stakeholders were on board, feedback continued regularly with updates and scorecards on compliance and complications. Existing in-person clinical quality assurance conferences provided a forum for weekly check-ins as needed.
Regularly updated data and feedback are essential, as is providing meaning to daily work. Positive feedback functions as a great motivator. On the other hand, setbacks also provide extra incentive to do better. A shared value of striving to improve for our patients provided the best reason to come together as a team and to do our best.
Special thanks to JoWinsyl Montojo, RN; Valentina Briceno, RN; Virendra R. Desai, MD; Jeffrey S. Raskin, MD, MS; and the entire pediatric neurosurgery and movement disorders team at Texas Children’s Hospital, including consultants, trainees, nursing staff, allied health staff, office staff, and operating room staff.
- Spader HS, Bollo RJ, Bowers CA, Riva-Cambrin J. Risk factors for baclofen pump infection in children: A multivariate analysis. J Neurosurg Pediatr. 2016;17(6):756-762.
- Albright AL, Turner M, Pattisapu JV. Best-practice surgical techniques for intrathecal baclofen therapy. J Neurosurg. 2006;104(4 Supp):233-239.
- Desai VR, Raskin JS, Mohan AC, et al. A standardized protocol to reduce pediatric baclofen pump infections: A quality improvement initiative. J Neurosurg Pediatr. 2018;21(4):395-400.
- Kestle JR, Riva-Cambrin J, Wellons JC 3rd, et al. A standardized protocol to reduce cerebrospinal fluid shunt infection: The Hydrocephalus Clinical Research Network Quality Improvement Initiative. J Neurosurg Pediatr. 2011;8(1):22-29.
- Taylor MJ, McNicholas C, Nicolay C, Darzi A, Bell D, Reed JE. Systematic review of the application of the plan-do-study-act method to improve quality in healthcare. BMJ Qual Saf. 2017;23:290-298.