ARTICLE IN PRESS American Journal of Infection Control 000 (2019) 1−4
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Brief Report
Holding firm: Use of clinical correlation to improve Clostridioides difficile testing Jonathan Baghdadi MD a,b,*, David A. Ganz MD, PhD a, Maryanne Chumpia MD, MS a,c, Evelyn T. Chang MD d,e,f, Shelly S. de Peralta DNP, RN, ACNP-BC a,g a
VA Quality Scholars Program, VHA Greater Los Angeles Healthcare System, Los Angeles, CA Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD Pediatrics, UCLA-Harbor Medical Center, Los Angeles, CA, USA d VHA Greater Los Angeles Healthcare System, Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), Los Angeles, CA e VHA Greater Los Angeles Healthcare System, Division of General Internal Medicine, Los Angeles, CA f University of California at Los Angeles, David Geffen School of Medicine, Division of General Internal Medicine, Los Angeles, CA g Cardiology, VA Greater Los Angeles, Los Angeles, CA, USA b c
Key Words: Diagnostic stewardship Quality improvement Clinical decision support Stakeholder engagement
A project involving 3 Plan-Do-Study-Act cycles was undertaken to improve testing for Clostridioides difficile at a Veterans Administration medical center. The Plan-Do-Study-Act process facilitated stakeholder engagement and allowed each successive intervention to build on the prior, resulting in a decline in the rate of hospital-onset C difficile infection. Published by Elsevier Inc. on behalf of Association for Professionals in Infection Control and Epidemiology, Inc.
Clostridioides difficile is the most common health care−associated pathogen.1 Many individuals tested for C difficile do not have symptoms consistent with infection or have other reasons for diarrhea, such as recent ingestion of laxatives.2 Uninfected carriers, also known as colonized, do not benefit from treatment.3 The optimal method of diagnosis for C difficile has not been established. Guidelines from the Infectious Diseases Society of America suggest that a multistep test, including stool toxin assay, rather than nucleic acid amplification testing (NAAT) alone, is appropriate when specimens submitted for testing are not screened based on clinical criteria.4 Prior to this project, our institution used NAAT alone. The Centers for Disease Control and Prevention’s National Healthcare Safety Network (NHSN) defines hospital-onset C difficile infection (HO-CDI) by any positive test ≥3 days after hospital admission, *Address correspondence to Jonathan Baghdadi, MD, Medical Student Teaching Facility, Suite 334, 10 S Pine St, Baltimore, MD 21201. E-mail address:
[email protected] (J. Baghdadi). Presentation: A portion of the data and findings from this manuscript were presented as an abstract at the VA Quality Scholars Summer Institute, a conference for faculty and fellows participating in the VA Quality Scholars program. Funding/support: J.B. was supported by the Veterans Administration Quality Scholars and the University of California, Los Angeles Specialty Training and Research program. The opinions expressed in this article represent those of the authors and do not necessarily represent the official views of the Department of Veterans Affairs or the US government. Conflicts of interest: None to report.
regardless of the clinical scenario.5 In 2017, our rate of HO-CDI was more than twice the Veterans Administration (VA) national average. A large, diverse group of stakeholders shared concerns that some of our cases might be colonized, but initially could not reach consensus on how to respond. This report describes the product of their discussions.
METHODS We conducted 3 interventions using the Plan-Do-Study-Act (PDSA) framework at a 600-bed VA medical center. There was no concurrent control group. The baseline period was from October 2017 to September 2018. The post-intervention period was from October 2018 through June 2019. The primary outcome was cases of HO-CDI meeting the NHSN definition. Secondary outcomes included days of contact precautions for HO-CDI, doses of vancomycin for HO-CDI, and cases of HO-CDI that were likely colonized. Outcome measures were standardized as monthly rates using number of acute care bed-days as the denominator. Rates of complications associated with HO-CDI (intensive care unit admission, colectomy, and death) were tracked as balancing measures. The definition of “likely colonized” was developed with local leaders in infectious diseases and infection control. Patients were considered unlikely to be colonized if (1) diarrhea was documented in the absence of laxatives or initiation of tube feeds, (2) the infectious diseases consultant recommended treatment, or (3) the discharge
https://doi.org/10.1016/j.ajic.2019.11.016 0196-6553/Published by Elsevier Inc. on behalf of Association for Professionals in Infection Control and Epidemiology, Inc.
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summary attributed symptomatic recovery from fever, leukocytosis, hypotension, or abdominal pain to treatment of C difficile. Otherwise, a positive test was considered colonization. The project working group included members from quality improvement, infectious diseases, infection control, the laboratory, medicine, and clinical informatics. Stakeholders included the hospitalist group, surgical services, outpatient primary care group, nursing (including nurse educators), the emergency department, and the divisions of gastroenterology, pulmonary and critical care, and geriatrics. Project activities were monitored by the infection control committee, medical executive committee, and various steering committees. Project activities began with a chart review of HO-CDI cases from the baseline period to identify reasons for inappropriate testing (Fig. 1A). Interventions targeting these testing practices were developed with input from multiple stakeholders and after a review of the literature. Early on, a fishbone diagram was used to help guide discussions of the different factors affecting whether and when to test for C difficile (Supplementary Figure S1).
Fig 1. Intervention preparation materials and Clostridium difficile order screen. (A) Pareto chart showing the frequency of different reasons why orders for Clostridium difficile from the baseline period might be considered inappropriate, as identified from chart review. (B) The electronic order screen for C difficile testing used during Plan-DoStudy-Act cycle 2 (PDSA2). Providers were allowed to proceed to test ordering regardless of what was entered in the 3 prompts. The order screen was required for inpatients only.
From October 2018 to January 2019 (PDSA1), we formally defined diarrhea at our institution as 100% liquid stool, issued correspondence re-affirming existing lab policy that “non-diarrheal” stools submitted for C difficile testing be rejected, and delivered education to bedside nursing, laboratory technicians, and medical providers. From February 2019 to April 2019 (PDSA2), we developed a new order screen in the electronic health record to guide testing based on pretest probability of infection (Fig. 1B). The order screen presented a “soft stop” that did not block testing. From May 2019 to July 2019 (PDSA3), we adopted a multistep testing algorithm in which a positive NAAT reflexed to stool toxin enzyme immunoassay. Inferential statistics included multivariable negative binomial regression for count outcomes. Statistical process control charts were used to evaluate each intervention on an ongoing basis. RESULTS In the 12 months preceding the intervention, 32 individuals were diagnosed with HO-CDI. These cases were almost exclusively male (94%) with an average age of 72 years. Only 4 (13%) of the patients had a documented history of C difficile. The most common site of testing was the intensive care unit (31%). Sixteen cases (50%) met the definition for colonization, including 11 patients who did not have diarrhea and 10 patients who received laxatives in the 24 hours preceding specimen collection. A total of 6 patients experienced complications, including 3 intensive care unit admissions (excluding those who were transferred prior to testing), 4 deaths within 30 days, and zero colectomies. The PDSA1 intervention was intended to reduce testing for C difficile among patients without diarrhea. During PDSA1, the average monthly rate of HO-CDI did not change significantly from baseline (7.2 § 0.9 per 10,000 acute care bed-days for PDSA1, compared with 9.1 § 5.5 in the baseline period). Although all cases of HO-CDI during PDSA1 had diarrhea, 6 of the 10 cases met the definition for colonization, primarily because of laxatives. The PDSA2 intervention targeted testing among patients receiving laxatives. During PDSA2, the average monthly rate of HO-CDI decreased to 3.0 § 3.0. When compared with previous periods, this change was a significant reduction (incidence rate ratio 0.33; 95% CI, 0.13-0.80). No HO-CDI events during PDSA2 met the definition for colonization. The purpose of PDSA3 was to sustain the preliminary success of prior PDSA cycles. In PDSA3, the average monthly rate of HO-CDI remained low at 4.3 § 2.1. No HO-CDI events met the definition for colonization. During PDSA3, the rate of HO-CDI marked its eighth straight month below the baseline average, suggesting a significant finding (Fig. 2). The median monthly rate of isolation days for C difficile per 10,000 acute care bed-days decreased from 66 at baseline to 33 days in PDSA1, 20 in PDSA2, and 28 in PDSA3 (Fig. 2). The rate of doses of enteral vancomycin administered was 125, 288, 116, and 192 in the 4 periods, respectively. The number of isolation days significantly decreased in PDSA2, but enteral vancomycin usage did not. The rates of complications associated with HO-CDI did not change during any study period when compared with baseline. During the study period, infection control staff performed routine surveillance on all positive tests for C difficile, including those ordered in affiliated clinics or long-term care facilities. No trends in the incidence of community-onset C difficile infections or the rate of complications owing to community-onset C difficile infection were detected. DISCUSSION We conducted a multifaceted, interdisciplinary project to reduce HO-CDI events at our institution by changing testing practices. As a
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Fig 2. Rates of primary and secondary outcomes. (A-D) The u charts that were used to track the rates of primary and secondary outcomes by month. U charts are a type of statistical process control chart used in quality improvement. (A, top left) The 8 consecutive points below the center line, beginning October 2018 signal a “shift,” a sign that a statistically significant change has occurred. (B, top right; C, bottom left) Points lying outside the control limits (red lines) during the baseline period render these charts uninterpretable. HO-CDI, hospital-onset Clostridium difficile infection.
result, we reduced waste, liberated patients from contact isolation, and improved performance on safety metrics. Many institutions have conducted projects tackling diagnostic stewardship in C difficile.6-10 Our study is worth considering, however, because of the use of iterative PDSA cycles. Initially, the number and diversity of stakeholders engaged in this project presented a challenge. One of the first ideas considered was to change from NAAT to a multistep test (which eventually occurred in PDSA3). This intervention, if performed at project outset, might have been sufficient and rendered subsequent PDSA cycles unnecessary. However, we were unable to rally all of our stakeholders around such a big change. Instead, we performed education and strengthened laboratory policy in PDSA1 because these interventions were not anticipated to disrupt clinical care processes (and no stakeholder objected).
Although PDSA1 did not affect our primary outcome, it did align our stakeholders toward making a more significant change in PDSA2. Then, because PDSA2 demonstrated success, we were empowered by leadership to adopt the multistep test. Although this project introduced barriers to testing for C difficile, we did not detect any harmful delays in diagnosis. Within our health system, no patients developed hospital-onset diarrhea only to be diagnosed with C difficile infection after discharge. Nonetheless, it is a limitation of this report that we cannot identify all patients in whom C difficile testing was withheld. Some patients may have been discharged and sought care outside of our VA for C difficile infection. However, no such instances were brought to our attention. The success of a project depends on the fit with its context. Other projects related to diagnostic stewardship and C difficile have made use
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of generous resources8 or a flexible electronic health record.9 Like others with resource constraints,10 we started by addressing issues in the laboratory. However, unlike others,10 our first intervention did not succeed. The use of iterative PDSA cycles engaged our stakeholders and facilitated further changes that eventually produced the desired result. Acknowledgments The authors would like to thank the multiple individuals from the medical center who contributed to this project, including Jeff Balsam, Manyee Gee, and Greg Orshansky from clinical informatics; Jamie Watanabe, Emelita Espina, and William Schwartzman from infection control, and Earleen Bernal and John Vallone from laboratory and pathology services. SUPPLEMENTARY MATERIALS Supplementary material associated with this article can be found in the online version at https://doi.org/10.1016/j.ajic.2019.11.016. References 1. Magill SS, Edwards JR, Bamberg W, Beldavs ZG, Dumyati G, Kainer MA, et al. Emerging infections program healthcare-associated infections and antimicrobial use prevalence survey team. N Engl J Med 2014;370:1198-208.
2. Buckel WR, Avdic E, Carroll KC, Gunaseelan V, Hadhazy E, Cosgrove SE. Gut check: Clostridium difficile testing and treatment in the molecular testing era. Infect Control Hosp Epidemiol 2015;36:217-21. 3. Johnson S, Homann SR, Bettin KM, Quick JN, Clabots CR, Peterson LR, et al. Treatment of asymptomatic Clostridium difficile carriers (fecal excretors) with vancomycin or metronidazole. A randomized, placebo-controlled trial. Ann Intern Med 1992;117:297-302. 4. McDonald LC, Gerding DN, Johnson S, Bakken JS, Carroll KC, Coffin SE, et al. Clinical Practice guidelines for Clostridium difficile infection in adults and children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis 2018;66:987-94. 5. Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care− associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control 2008;36:309-32. 6. Christensen AB, Barr VO, Martin DW, Anderson MM, Gibson AK, Hoff BM, et al. Diagnostic stewardship of C. difficile testing: a quasi-experimental antimicrobial stewardship study. Infect Control Hosp Epidemiol 2019;40:269-75. 7. Klatte JM, Selvarangan R, Jackson MA, Myers AL. Reducing overutilization of testing for Clostridium difficile infection in a pediatric hospital system: a quality improvement initiative. Hosp Pediatr 2016;6:9-14. 8. Madden GR, German Mesner I, Cox HL, Mathers AJ, Lyman JA, Sifri CD, et al. Reduced Clostridium difficile tests and laboratory-identified events with a computerized clinical decision support tool and financial incentive. Infect Control Hosp Epidemiol 2018;39:737-40. 9. Truong CY, Gombar S, Wilson R, Sundararajan G, Tekic N, Holubar M, et al. Realtime electronic tracking of diarrheal episodes and laxative therapy enables verification of Clostridium difficile clinical testing criteria and reduction of Clostridium difficile infection rates. J Clin Microbiol 2017;55:1276-84. 10. Yen C, Holtom P, Butler-Wu SM, Wald-Dickler N, Shulman I, Spellberg B. Reducing Clostridium difficile colitis rates via cost-saving diagnostic stewardship. Infect Control Hosp Epidemiol 2018;39:734-6.