PennCERT - Major Projects

Major Projects

Project 1.
Effectiveness of an Information Technology Intervention to Improve Prophylactic Antibiotic Use in the Perioperative Period

Project 2.
Impact of Clinical Microbiology Laboratory Text Message Alerts on Institution of Appropriate Antimicrobial Therapy

Project 3.
Effect of Public Reporting on Incidence of Hospital-Acquired Infections

Project 4.
Evaluation of Dissemination of Pediatric Anti-microbial Stewardship

Project 1. Effectiveness of an Information Technology Intervention to Improve Prophylactic Antibiotic Use in the Perioperative Period

PI: Eric Pifer, MD & Kevin Haynes, PharmD, MSCE. Co-Investigators: Warren Bilker, PhD; Neil Fishman, MD; Sean Hennessy, PharmD, PhD

Specific Aims. The primary aim of this study is to measure the effectiveness of a computerized decision support system on reducing the continuation of prophylactic antibiotics beyond 24 hours after surgery. The secondary aims are to examine the effectiveness of this intervention on administration of prophylactic antibiotics within one hour prior to surgical incision, and on appropriate selection of prophylactic antibiotics.

Background and Significance. Surgical wound infections affect 2-5% of clean extra-abdominal procedures, and 20% of intra-abdominal operations. In 2002, the CDC initiated its national surgical infection project (NSIP) aimed at lowering the rates and severity of perioperative surgical wound infections through use of prophylactic antibiotics. Further, the appropriate selection, use, and prompt discontinuation of prophylactic antibiotics surrounding surgery have all become national patient safety goals. However, a 2005 report from the NSIP indicated that only 56% of patients receive an antibiotic within 1h of incision, and in only 41% of those receiving prophylactic antibiotics are they stopped within 24h of the end of surgery. Two key reasons for this poor performance are gaps in the knowledge base of caregivers and the need for coordination of care between pre-, intra-, and post-operating room staff and physicians. Electronic order entry systems with clinical decision support are a promising yet unproven approach to improving this performance. Electronic order sets have shown promise as a means of integrating guideline information and facilitating safer, more effective care for conditions such as acute myocardial infarction (69). However, the effectiveness of this approach needs to be demonstrated for prophylactic antibiotic administration before it is implemented widely.

Intervention. Inappropriate antibiotic choices will be removed from myriad order sets where they are now. A prophylactic surgical antibiotic order set will be implemented that will contain recommendations for the antibiotic type needed based on surgery type. Housestaff will be trained on using the order set as part of their routine pre-operative orders. If providers do not complete orders as appropriate for prophylactic antibiotics, then CPOE reminders will arise, warning of the need to complete the order set. Orders from this set will automatically enter “pending activation” status. When the patient arrives in the PACU, anesthesiologists will be expected to activate the orders and document the first dose administered in the order entry system. Upon discharge from the PACU, housestaff will be required to verify the prophylactic antibiotic orders. The order set is designed to automatically discontinue the antibiotic orders at 24 hours after surgery.

Implications. The UPHS CPOE system is Sunrise Clinical Manager. This is one of the top selling CPOE systems in the US and Canada. If effective, the intervention will be made available to other Sunrise customers through user group meetings and via download on a support website. Also, any CPOE software package certified through the government certification programs for health IT will be able to reproduce the intervention with minimal effort. Finally, this model will serve as a model for how such technology could be rolled out.

Publications:

Haynes K, Linkin DR, Fishman NO, Bilker WB, Strom BL, Pifer E, Hennessey S. Effectiveness of an Information Technology intervention to Improve Prophylactic Antibacterial Use in the Post-operative Period. Journal of American Medical Informatics Association 2011 Jan 24. [Epub ahead of print]
Pub Med ID: 21262922

Project 2.
Impact of Clinical Microbiology Laboratory Text Message Alerts on Institution of Appropriate Antimicrobial Therapy

PI: Ebbing Lautenbach, MD, MPH, MSCE; Co-Investigators: Kevin Haynes, PharmD, MSCE, Warren B. Bilker, PhD; Neil O. Fishman MD; Leanne B. Gasink, MD, MSCE; Darren R. Linkin, MD, MSCE; John Holmes, PhD; Mark Weiner, MD

Specific Aims. The specific aim of this randomized controlled trial (RCT) is to measure the impact of an automated text page alert system reporting all new microbiology data in real time for patients with bloodstream infections. We will focus specifically on bloodstream infections, as they are associated with the greatest morbidity and mortality. The hypothesis is that the intervention will significantly increase adequate antimicrobial therapy (AAT), defined as receipt, within 48 hours of the culture being obtained, of at least one antibiotic to which the organism is ultimately identified as being susceptible in vitro.

Background and Significance. Primary bloodstream infections (both community-acquired and healthcare-acquired) afflict 250,000 to 350,000 hospitalized patients in the US annually. Since the 1980s, the incidence of bloodstream infections has been rising. These infections impact patient outcomes (35% case fatality rate) and hospital costs, increasing lengths of stay and adding up to $40,000 per surviving patient.

Recent studies of bloodstream infections in hospitalized patients, including PennCERTs studies, suggest that a delay in adequate antimicrobial therapy results in poorer outcomes, even when controlling for predictors of mortality. Numerous reasons delayed adequate therapy have been identified, with the most common being choosing an empiric antimicrobial regimen that does not ultimately match the organism identified, and failure to respond to subsequent relevant microbiology information. Of particular relevance to this proposal, it has been well demonstrated that clinicians are often unaware of new microbiologic data that might influence antibiotic choices. Thus, efforts to provide clinical microbiology laboratory data and the timeliness of providing such data are critical in ensuring more timely institution of appropriate therapy.

Intervention. Each subject will be randomized to one of the two study arms:

Usual practice: If an organism is preliminarily identified in the blood culture via an initial Gram’s stain (e.g., gram positive cocci in clusters), the physician who ordered the test is called with the result. If this physician cannot be reached, a covering physician is notified. As the blood culture is worked up further, additional new information will be discovered including 1) the preliminary identification of the organism; and 2) final susceptibility profile of the organism. While these new data elements are entered into the computer system, no additional notification occurs.
Usual Practice plus Text Message Alerts: In this arm, usual practice will continue unchanged (i.e., lab notification via phone of positive Gram’s stain results). In addition, we will institute an additional system that sends an automatic text message to the primary or covering physician regarding any new information. These text messages will be delivered at three time points as a blood culture is being worked up: 1) when the initial Gram’s stain is characterized; 2) when the organism is identified; and 3) when the final susceptibility of the infecting organism is characterized. These messages will provide all new data available in text form regardless of whether the subject is already on adequate antimicrobial therapy. Text messages relaying the new information will be sent automatically upon entry of this new information into the microbiology laboratory information system (i.e., no additional human intervention will be required).

Implications. Our study will test a generalizable, efficient information technology intervention that rapidly communicates critical new microbiology laboratory data to clinicians caring for inpatients. If successful, our intervention will reduce the time to adequate therapy, and ultimately reduce patient mortality. If our intervention is successful, future studies will build on this experience. For example, the text message alerts intervention could be refined to send alerts only when current antimicrobial therapy does not have in vitro activity against the organism identified from blood culture. Such an alert system would facilitate prescribing of adequate antimicrobial therapy while minimizing potential alert fatigue.

Project 3. Effect of Public Reporting on Incidence of Hospital-Acquired Infections

PI: Darren R. Linkin, MD, MSCE; Co-Investigators: Neil O. Fishman MD; Ebbing Lautenbach, MD, MPH, MSCE; Judy A. Shea, PhD; A. Russell Localio, JD, MS, PhD

Specific Aim: To determine if state-legislated public reporting of hospital healthcare-associated infections (HAIs) results in (a) a greater proportion of Infection Control time being spent on HAI surveillance (vs. other activities, e.g., interventions to prevent HAIs, Occupational Health, and biological disaster preparedness) and (b) utilizing less time-consuming (and less valid) infection surveillance methods for ventilator-associated pneumonia. The secondary aim is to determine if hospitals in states legislating public reporting of hospital HAIs (compared to those in states without such requirements) are less willing to accept patients in transfer from other hospitals with an elevated risk of subsequent HAIs.

Background and Significance: Most US states have enacted or are considering legislation requiring hospitals to report rates of HAIs publicly. Advocates contend that public access to this information will decrease HAI rates and inform consumer choices. However, a recent preliminary investigation by the CDC (noted as part of a 2009 national infection surveillance report) failed to find a decrease in HAIs in hospitals required to report them publicly. Even if public reporting reduced HAI rates, there could be unintended negative consequences. For instance, mandatory reporting could divert resources to reporting infections and collecting data for risk adjustment and away from interventions to improve patient care and prevent infections. This requirement could also result in unintended disincentives to admit or perform procedures on patients at higher risk for HAI. Similarly, mandated reporting of cardiac surgery mortality rates has led to reluctance to operate on severely ill patients. In addition, mandatory reporting could result in changes in surveillance methodology leading to less valid infection rate data.

Given the considerable expense and effort required to assess and report infections, elucidating the downstream effects of public reporting, including possible unintended negative effects, is critical. We will examine several potential negative unanticipated consequences of mandatory HAI reporting, comparing hospitals with and without reporting requirements

Implications: Public reporting of HAIs is becoming widespread, but there are few data to evaluate its downstream effects (both potentially positive and negative). We propose a national evaluation of potentially negative unanticipated effects of public reporting utilizing a pre-existing research network of Infection Control professionals. If mandated public reporting has negative consequences, it will suggest a need to more thoroughly investigate the benefits and the implementation of these public policies.

Project 4. Evaluation of Dissemination of Pediatric Anti-microbial Stewardship

PI: Theoklis Zaoutis, MD, MSCE; Co-Investigators: Ebbing Lautenbach, MD, MPH, MSCE; A. Russell Localio, JD, MS, PhD, Jason Newland, MD, Susan Coffin, MD, MPH, Mary Anne Jackson, MD, Cathryn Carroll, PhD.

Specific Aims: The specific aim of this study is to measure the impact of an antimicrobial stewardship program (ASP) in a children’s hospital on reducing the frequency and duration of use of selected antimicrobial agents. The primary hypothesis is that implementation of an ASP will reduce the frequency and duration of use of selected antimicrobial agents. The secondary aims are to: 1) to measure the ability of an ASP to reduce drug-bug mismatches in antimicrobial therapy for laboratory-confirmed infections; 2) measure the impact of an ASP on antimicrobial resistance among clinical isolates; 3) determine the impact of an ASP on length of hospital and intensive care unit (ICU) stay; and 4) assess healthcare-associated costs (including antimicrobial and non-antimicrobial costs) before and after the implementation of an ASP in a children’s hospital. The hypotheses for these secondary aims are that the ASP will result in: 1) an increase in the number of infections treated appropriately based on the susceptibility patterns of the pathogens; 2) a decrease in antimicrobial resistance; 3) a decrease in the length of hospital and ICU stay; and 4) reduced healthcare-associated costs.

Background and Significance: 22-65% of hospital antibiotic use is inappropriate. Hospital-based ASPs were developed to optimize clinical outcomes while minimizing the unintended consequences of antimicrobial use including toxicity, the selection of pathogenic organisms such as C. difficile, and the emergence of resistance.
CDC established a 12-step program for hospitalized children to combat antimicrobial resistance. In addition, the Infectious Disease Society of America and the Society for Healthcare Epidemiology of America are preparing guidelines for antimicrobial stewardship. Because of the limited number of rigorous studies addressing antimicrobial stewardship strategies, many of the recommendations are based on only anecdotal evidence. The draft guidelines also identify research priorities, including studies of the impact of antimicrobial cycling, formulary restrictions and pre-authorization requirements on antimicrobial usage and resistance, and computer based surveillance of targeted antimicrobial interventions and tracking of antimicrobial resistance patterns. Although some data exist to support the potential role of these interventions to curb inappropriate use of antibiotics, including data collected by PennCERT investigators, there is still much we do not know about the impact of these activities, either singly or in combination. Further, most of the evidence in these guidelines and on ASPs is derived from studies of interventions to improve antimicrobial use in hospitalized adults, while few have been performed in hospitalized newborns and children.

Implications: Antibiotic resistance and inappropriate use of antibiotics are problems for all hospitals. Although several institutions have developed ASPs that have been successful in the local control of antibiotic use, we do not know if such programs can be exported or whether they are effective in pediatric hospitals. This study will evaluate the ability of a defined ASP to be successfully implemented at a distant children’s hospital. The findings of this study will provide information about the ability to generalize patient safety programs such as ASPs to children across multiple institutions.