A multicenter, phased, cluster-randomized controlled trial to reduce central line-associated bloodstream infections in intensive care units

From the Department of Health Policy and Management (JAM, JBS, Y-JH, C-JH, PJP), Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
Critical care medicine (Impact Factor: 6.31). 08/2012; 40(11):2933-9. DOI: 10.1097/CCM.0b013e31825fd4d8
Source: PubMed


: To determine the causal effects of an intervention proven effective in pre-post studies in reducing central line-associated bloodstream infections in the intensive care unit.
: We conducted a multicenter, phased, cluster-randomized controlled trial in which hospitals were randomized into two groups. The intervention group started in March 2007 and the control group started in October 2007; the study period ended September 2008. Baseline data for both groups are from 2006.
: Forty-five intensive care units from 35 hospitals in two Adventist healthcare systems.
: A multifaceted intervention involving evidence-based practices to prevent central line-associated bloodstream infections and the Comprehensive Unit-based Safety Program to improve safety, teamwork, and communication.
: We measured central line-associated bloodstream infections per 1,000 central line days and reported quarterly rates. Baseline average central line-associated bloodstream infections per 1,000 central line days was 4.48 and 2.71, for the intervention and control groups (p = .28), respectively. By October to December 2007, the infection rate declined to 1.33 in the intervention group compared to 2.16 in the control group (adjusted incidence rate ratio 0.19; p = .003; 95% confidence interval 0.06-0.57). The intervention group sustained rates <1/1,000 central line days at 19 months (an 81% reduction). The control group also reduced infection rates to <1/1,000 central line days (a 69% reduction) at 12 months.
: This study demonstrated a causal relationship between the multifaceted intervention and the reduced central line-associated bloodstream infections. Both groups decreased infection rates after implementation and sustained these results over time, replicating the results found in previous, pre-post studies of this multifaceted intervention and providing further evidence that most central line-associated bloodstream infections are preventable.

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    • "Reduction in health care infections and especially CRBSIs has been the goal of many quality improvement programmes internationally and within the UK (Marsteller et al., 2012; McPeake et al., 2012; Bion et al., 2013; Palomar et al., 2013). It has been repeatedly demonstrated, that robust education and implementation of a bundle approach can significantly reduce the incidence of these potentially deadly infections (Pronovost et al., 2006; Munoz-Price et al., 2012; Bion et al., 2013). "
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    ABSTRACT: Health care associated infections are a major contributor to avoidable harm experienced by patients in modern health care settings. Recent reports suggest that electronic checklists for the documentation of a central line bundle may significantly enhance documented process compliance and help to reduce catheter-related bloodstream infection rates. This paper describes the use of our electronic tool to monitor and feedback process compliance in conjunction of introducing bespoke central line insertion packs to tackle catheter-related bloodstream infections in our intensive care unit in a medium-sized district general hospital. Continuous quality improvement programme with 'Plan-Do-Study-Act' cycles was implemented. The central venous catheter insertion and maintenance bundle was rolled out in 2007. To monitor compliance with the bundle elements, an electronic tool was designed as part of our bedside Clinical Information System. From 2009, regular quarterly feedback was provided on the number of central venous catheter lines inserted, compliance with the insertion and maintenance bundle and catheter-related bloodstream infection rate using the data collected through the Clinical Information System. We have also introduced dedicated line insertion trolleys and factory-prepared insertion packs. We used segmented regression analysis to assess the changes in the catheter-related bloodstream infection rate before and after implementation of the central venous catheter bundle. Bundle compliance increased during the implementation period and reached over 95% within 6 months. We observed a significant reduction in the catheter-related bloodstream infection rate from 15·6/1000 days to 0·4/1000 days. Regression analysis showed that only the compliance had significant effect on the number and prevalence of catheter-related bloodstream infections. Implementation of evidence-based care bundles reinforced by real-time feedback on the performance of caregivers can significantly reduce the rate of catheter-related bloodstream infection in the intensive care unit. Ensuring that change processes are seamlessly integrated in the workflow with minimal administrative burden is crucial to the quality improvement process. © 2015 British Association of Critical Care Nurses.
    Nursing in Critical Care 05/2015; 20(4). DOI:10.1111/nicc.12186 · 0.65 Impact Factor
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    • "One retrospective analysis reported decreased in-hospital mortality in 95 of the Keystone hospitals compared with 364 control hospitals in the surrounding region [5], though declines in 30-day mortality were not significantly different in Keystone. A cluster randomised trial in a new non-Keystone setting found that hospitals using the program outperformed the secular trend towards decreasing infection rates [6]. "
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    ABSTRACT: Quality and safety improvement initiatives in healthcare often display two disconcerting effects. The first is a failure to outperform the secular trend. The second is the decline effect, where an initially promising intervention appears not to deliver equally successful results when attempts are made to replicate it in new settings. Matching Michigan, a patient safety program aimed at decreasing central line infections in over 200 intensive care units (ICUs) in England, may be an example of both. We aimed to explain why these apparent effects may have occurred. We conducted interviews with 98 staff and non-participant observation on 19 ICUs; 17 of these units were participating in Matching Michigan. We undertook further telephone interviews with 29 staff who attended program training events and we analyzed relevant documents. One Matching Michigan unit transformed its practices and culture in response to the program; five boosted existing efforts, and 11 made little change. Matching Michigan's impact may have been limited by features of program design and execution; it was not an exact replica of the original project. Outer and inner contexts strongly modified the program's effects. The outer context included previous efforts to tackle central line infections superimposed on national infection control policies that were perceived by some as top-down and punitive. This undermined engagement in the program and made it difficult to persuade participants that the program was necessary. Individual ICUs' histories and local context were also highly consequential: their past experience of quality improvement, the extent to which they were able to develop high quality data collection and feedback systems, and the success of local leaders in developing consensus and coalition all influenced the program's impact on local practices. Improved implementation of procedural good practice may occur through many different routes, of which program participation is only one. The 'phenotype' of compliance may therefore arise through different 'genotypes.' When designing and delivering interventions to improve quality and safety, risks of decline effects and difficulties in demonstrating added value over the secular trend might be averted by improved understanding of program mechanisms and contexts of implementation.
    Implementation Science 06/2013; 8(1):70. DOI:10.1186/1748-5908-8-70 · 4.12 Impact Factor
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    • "The goal of this study is to demonstrate that a short instrument, the Team Check-up Tool (TCT), can provide reliable and valid contextual data for monitoring team progress within a QI intervention. This instrument and an earlier version have been used to monitor team progress and implementation context for large-scale QI interventions to reduce bloodstream infections in the ICU [12,13]. Evidence of temporal reliability, responsiveness and construct validity of the TCT will support its future use as the intervention spreads to additional hospitals and other settings. "
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    ABSTRACT: ABSTRACT: Team-based interventions are effective for improving safety and quality of healthcare. However, contextual factors, such as team functioning, leadership, and organizational support, can vary significantly across teams and affect the level of implementation success. Yet, the science for measuring context is immature. The goal of this study is to validate measures from a short instrument tailored to track dynamic context and progress for a team-based quality improvement (QI) intervention. Design: Secondary cross-sectional and longitudinal analysis of data from a clustered randomized controlled trial (RCT) of a team-based quality improvement intervention to reduce central line-associated bloodstream infection (CLABSI) rates in intensive care units (ICUs).Setting: Forty-six ICUs located within 35 faith-based, not-for-profit community hospitals across 12 states in the U.S.Population: Team members participating in an ICU-based QI intervention.Measures: The primary measure is the Team Check-up Tool (TCT), an original instrument that assesses context and progress of a team-based QI intervention. The TCT is administered monthly. Validation measures include CLABSI rate, Team Functioning Survey (TFS) and Practice Environment Scale (PES) from the Nursing Work Index.Analysis: Temporal stability, responsiveness and validity of the TCT. We found evidence supporting the temporal stability, construct validity, and responsiveness of TCT measures of intervention activities, perceived group-level behaviors, and barriers to team progress. The TCT demonstrates good measurement reliability, validity, and responsiveness. By having more validated measures on implementation context, researchers can more readily conduct rigorous studies to identify contextual variables linked to key intervention and patient outcomes and strengthen the evidence base on successful spread of efficacious team-based interventions. QI teams participating in an intervention should also find data from a validated tool useful for identifying opportunities to improve their own implementation.
    Implementation Science 10/2011; 6(1):115. DOI:10.1186/1748-5908-6-115 · 4.12 Impact Factor
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