Prospective Study to Reduce Clostridium Difficile Infection in Patients Receiving Autologous Stem Cell Transplantation
Authors: Maldonado Samuel David , Van Galen Joseph , Grose Kyle , Keng Michael K , Volodin Leonid 
Published: November 2021

Abstract
Background:
Clostridium difficile infection (CDI) is a major complication facing patients undergoing autologous stem cell transplantation (ASCT) and can be associated with increased morbidity and length of stay (LOS). Various institutional and multicenter studies have reported incidence rates in this population ranging from less than 5% to more than 10% in this high-risk population. CDIs are not only problematic for individual patient care, but CDI also negatively impact hospital resource utilization by increasing post-transplant LOS. A prospective quality improvement study was initiated at the University of Virginia (UVA) to decrease CDI.
Methods:
To decrease CDI rate, a multidisciplinary team comprised of oncology and infectious diseases physicians, pharmacists, and nurses was formed. The group used quality improvement principles to identify and target areas of greatest significance. Retrospective chart review was done of 65 consecutive patient ASCT encounters from June 2016 to July 2017 to establish the baseline cohort. For each of these encounters, extensive patient demographics, clinical, and inpatient event data were collected. Analysis of the data identified 17% CDI rate (n=11) in the 30-day period following ASCT. The aim of study was to decrease the CDI rate by 33%. The team used qualitative and quantitative tools to understand factors contributing to CDI, including: process map and a priority matrix categorizing potential interventions based on impact and ease of implementation. A statistical process control chart (p-chart with 3 sigma limits) depicted rates of CDI in the baseline cohort and intervention groups.
Results:
The baseline CDI rate was 17%. Three Plan-Do-Study-Act (PDSA) cycles of interventions were implemented; post-intervention data were collected and analyzed. From August 2017 to June 2018, the first PDSA cycle consisted of eliminating ciprofloxacin prophylaxis between T+0 and count recovery (which was standard of care) due to hypothesis that the prophylactic antibiotic itself was leading to increases in CDIs. The first PDSA cycle resulted in an increased CDI rate of 19% (n=12) and worsening of sepsis events. Ciprofloxacin prophylaxis was reinstituted. A second PDSA cycle was executed between July 2018 and January 2020 incorporating ultraviolet (UV) light equipment into existing post-discharge cleaning practices, resulting in a decreased CDI rate of 9% (n=11). A third PDSA cycle was conducted from February 2020 through current (July 2021) and added a 2-step C. diff PCR and toxin assay into testing protocols, leading to a further CDI rate decrease to 7% (n=9). P-chart depicting CDI reduction is shown in Figure 1. A significant difference in CDI incidence was found comparing patients before and after implementation of UV light cleaning practices (p&lt;0.01). Figure 2 is a XMR-chart showing a numerical decrease of hospital LOS from 14.6 to 13.8 days after the 3 PDSA cycles, although this did not reach statistical significance (p=0.055).
Conclusions:
This prospective study surpassed the goal to reduce CDI by 33% by using quality improvement methods to drive a clinically significant special cause variation reduction in the 30-day CDI incidence after ASCT and a trend towards decreased LOS at UVA. This study not only improved patient care, but likely represents increased patient quality of life and cost savings. Future PDSA cycles are scheduled and may include other cancer patients beyond those receiving ASCT.
Figure 1 Figure 1.

Disclosures
No relevant conflicts of interest to declare.