IMPACT OF PROTOCOL WATCH ON COMPLIANCE WITH THE SURVIVING SEPSIS CAMPAIGN. Critical Care Techniques

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1 Critical Care Techniques IMPACT OF PROTOCOL WATCH ON COMPLIANCE WITH THE SURVIVING SEPSIS CAMPAIGN By Karen K. Giuliano, RN, PhD, Michele Lecardo, RN, BSN, CCRN, and LuAnn Staul, RN, MN 2011 American Association of Critical-Care Nurses doi: /ajcc Purpose Clinical decision support systems are intended to improve patients care and outcomes, particularly when such systems are present at the point of care. Protocol Watch was developed as a bedside clinical decision support system to improve clinicians adherence to the Surviving Sepsis Campaign guidelines. This pre/post-intervention pilot study was done to evaluate the effect of Protocol Watch on compliance with 5 guidelines from the Surviving Sepsis Campaign. Methods Preintervention data on rates and time to complete the resuscitation and management bundles from the Surviving Sepsis Campaign and time to administer antibiotics were collected from intensive care units at 2 large teaching hospitals in the United States. Training on the Protocol Watch application was then provided to clinical staff in the units, and Protocol Watch was installed at all critical care beds in both hospitals. Data were collected on rates and time to completion for 5 Surviving Sepsis Campaign guidelines after installation of Protocol Watch, and univariate analyses were done to evaluate the effect of Protocol Watch on compliance with the guidelines. Results Implementation of Protocol Watch was associated with significant improvements in compliance with the resuscitation bundle (P =.01) and decreased time to administer antibiotics (P =.006). No significant changes were achieved for compliance with the management bundle or time to complete the resuscitation or management bundles. Conclusions Clinical decision support systems such as Protocol Watch may improve adherence to the Surviving Sepsis Campaign guidelines, which potentially may contribute to reduced morbidity and mortality for critically ill patients with sepsis. (American Journal of Critical Care. 2011;20: ) AJCC AMERICAN JOURNAL OF CRITICAL CARE, July 2011, Volume 20, No

2 Severe sepsis and septic shock affect millions of individuals worldwide and are leading causes of death among hospitalized patients. 1-3 The annual estimated incidence of sepsis in the United States is 3.0 cases per 1000 persons or approximately cases each year. 4 It is further estimated that 52% to 71% of patients in whom severe sepsis develops progress to septic shock, for an annual prevalence of cases in the United States. 5 Twenty percent of admissions to intensive care units (ICUs) are attributed to sepsis and septic shock. 1-3 Mortality rates attributed to severe sepsis and septic shock are estimated at 25% or greater. 1-3 Optimal outcomes are achieved for sepsis management when interventions are administered in a bundle. The Surviving Sepsis Campaign (SSC) was established in 2004 to improve outcomes in patients with severe sepsis or septic shock. 6,7 Eleven organizations participated in this international effort to establish and disseminate 45 evidence-based guidelines for the management of severe sepsis and septic shock. The guidelines were updated in 2008 by using an evidence-based method for assessment of the quality of evidence and strength of recommendations. 8 Key recommendations include initiation of early goaldirected therapy (EGDT) during the first 6 hours following onset of indications of sepsis, including hypoperfusion to sustain central venous pressure between 8 and 12 mm Hg, mean arterial pressure at 65 mm Hg or greater, urine output at 0.5 ml/kg per hour, and central or mixed oxygen saturation of at least 70% or 65%. 8 In addition, SSC guidelines recommend early administration of broad-spectrum antibiotic therapy following evaluation of appropriate cultures and reassessment of the impact of such therapy based on microbiologic assays and clinical responses to refine coverage. 8 One of the most important evaluations of EGDT for treatment of severe sepsis and septic shock assessed the effect of EGDT on the clinical outcomes of patients with severe sepsis or septic shock treated at About the Authors Karen K. Giuliano is a principal scientist at Philips Healthcare in Andover, Massachusetts. Michele Lecardo was a clinical nurse educator at St Vincent's Medical Center in Bridgeport, Connecticut at the time of the study. LuAnn Staul is a clinical nurse specialist at Legacy Health System in Portland, Oregon. Corresponding author: Karen K. Giuliano, RN, PhD, Philips Healthcare, 3000 Minuteman Road (MS 500), Andover, MA ( Karen.giuliano@philips.com). an urban emergency department. 9 Inpatient mortality rates were 30.5% for patients randomly assigned to EGDT compared with 46.5% for those treated with usual standard of care (P <.001). 9 Subsequently, a number of clinical trials involving more than patients indicated that EGDT administered as rapidly as possible following onset of severe sepsis and septic shock was associated with favorable outcomes and reduced health care costs EGDT requires prompt identification and diagnosis of sepsis in patients who are experiencing signs and symptoms. In addition, optimal outcomes are achieved for sepsis management when a group of interventions are administered in a bundle These bundles are structured as a package of interventions intended to be collectively and reliably implemented in a timely manner. 20 Despite strong evidence for the efficacy and cost-effectiveness of systematic implementation of the SSC guidelines, translation of the guidelines into clinical practice has been inconsistent, incomplete, and delayed A variety of barriers to implementation of the guidelines have been identified despite the fact that clinicians perceptions of the guidelines are generally favorable. 4,22-26 These include environmental and structural bar-riers to implementation of the SSC guidelines, which require multidisciplinary, coordinated care that is delivered in a time-sensitive manner. 19,22 A national survey of physicians and nurses in emergency departments located throughout the United States revealed that more than half of respondents indicated that monitoring clinical indicators of sepsis and response to therapy were significant barriers to adherence to EDGT for severe sepsis and septic shock. 22 The complex and invasive nature of the sepsis treatment bundles has also been identified as a significant barrier to implementation of the bundles because of lack of time and resources as well as inadequate awareness of the full details of the recommended sepsis management bundles. 4, AJCC AMERICAN JOURNAL OF CRITICAL CARE, July 2011, Volume 20, No. 4

3 Clinical decision support systems (CDSS) have the potential to modify clinicians behavior and promote translation of research findings into clinical practice Implementation of CDSS has improved the quality of care for patients with diabetes, asthma, and infectious diseases in ICU settings These findings suggest that CDSS may increase awareness and implementation of the SSC guidelines among clinicians. Protocol Watch is a proprietary CDSS application for bedside monitoring of patients that was designed by Philips Healthcare (Andover, Massachusetts) to assist clinicians in implementing the SSC guidelines. Using the SSC criteria, Protocol Watch monitors and screens patients for signs and symptoms of sepsis, and when physiological criteria for sepsis are detected, a series of prompts is displayed on Protocol Watch monitors that prompts clinicians to implement the SSC recommendations (see Figure). Protocol Watch was designed as an automated version of the SSC recommendations, residing on the bedside patient monitor. The Protocol Watch application works in the background and initiates the series of prompts intended to guide clinicians through the SSC guidelines only if patients meet 1 or more of the criteria for sepsis or septic shock. The goal of Protocol Watch is to decrease the amount of time between onset, recognition, and initiation of treatment for sepsis. This pilot study was conducted to evaluate the impact of Protocol Watch on compliance rates with the SSC guidelines for the resuscitation and management bundles, time to completion of these 2 bundles, and time to administration of antibiotics for patients in ICUs. These elements of the SSC guidelines were chosen as the main outcome variables for this pilot study because each has been associated with improved clinical outcomes. 14,34 Research Methods This pre/post-intervention, nonrandomized pilot study was done to evaluate the effect of Protocol Watch on adherence to 5 SSC guidelines for treatment of critically ill adult patients with sepsis. Participants were patients 18 years or older who were admitted to the adult ICUs at 1 of 2 tertiary care centers in the United States (St Vincent s Medical Center in Bridgeport, Connecticut and Legacy Healthcare Good Samaritan Hospital in Portland, Oregon). The patients enrolled had sepsis develop at some point during their ICU stay or had sepsis as their admitting diagnosis to the ICU. Both facilities had previously implemented the SSC guidelines and were using paper systems to track their compliance with the guidelines. This study was approved by the A, Prompt screen for the sepsis screening criteria, which is available once any of the physiological triggers are detected by the monitor. B, Details screen provides the Surviving Sepsis Campaign s definitions for persistent hypotension if the clinician chooses to review. C, Prompt screen that requires a clinician to review the patient before the monitor is enabled to display the sepsis resuscitation bundle. D, Sample of the screen for the sepsis resuscitation bundle, which lists all the elements of the bundle at the left side. Those actions that are highlighted have not been completed yet. The timer starts as soon as the resuscitation bundle is initiated, so clinicians know exactly how long it has been since treatment was started. The bar graphs display (Horizon Trends) the physiological parameters that are pertinent for early goal-directed therapy. The right side of the screen displays the most recent values that were entered manually. Figure Examples of prompts and screens from Protocol Watch. AJCC AMERICAN JOURNAL OF CRITICAL CARE, July 2011, Volume 20, No

4 Table 1 Data collection tool for study variables: before and after intervention Variable Response 1. Protocol Watch site 2. Subject number 3. Age of subject 4. Sex of subject 5. In what hospital unit did the patient first present with sepsis? 6. Time of presentation of sepsis (use 24-hour clock time) a. ED: record triage time b. In hospital, not ICU: if resuscitation was begun on transferring unit, record this time if not, use ICU admission time c. For ICU patients, record time when patient screened in for sepsis and resuscitation was begun 7. APACHE II score (first 24 hours of ICU admission) 8. Was the patient discharged from the ICU alive? 9. ICU LOS (in days to 1 decimal point-for patients who had sepsis develop in ICU, start with sepsis diagnosis) 10. Was the patient discharged alive from the hospital? 11. Elapsed time between time of presentation (question 7) and Abx administration (in minutes) 12. What percentage of the resuscitation bundle was completed during the 6-hour time window? a. Serum lactate b. Blood cultures before Abx administration c. Broad-spectrum Abx within 3 hours of ED admission and 1 hour from in-hospital unit) d. Fluid resuscitation/vasopressors (if appropriate) for MAP e. CVP greater than 8 mm Hg (no mechanical ventilation), or 12 mm Hg (mechanical ventilation) f. ScvO 2 or SvO 2 at or above goal Time between presentation (question 7) and completion of 6-hour bundle (in hours to 1 decimal point) 13. What percentage of the management bundle was completed during the 24-hour time window? a. Appropriate use/no use of steroids b. Appropriate use/no use of Xigris c. Glucose control to target d. Appropriate management of IPP 14. Time between presentation (question 7) and completion of the management bundle (in hours to 1 decimal point) 1 = Male 2 = Female 1=ED 2 = In hospital, not ICU 3 = In hospital, ICU 4 = Transfer from another hospital 0=No 1=Yes 0=No 1=Yes 1 = 16.7% (1/6) 2 = 33.3% (2/6) 3 = 50% (3/6) 4 = 66.6% (4/6) 5 = 83.3% (5/6) 6 = 100% (6/6) 1 = 25% (1/4) 2 = 50% (2/4) 3 = 75% (3/4) 4 = 100% (4/4) Abbreviations: Abx, antibiotics; APACHE II, Acute Physiology and Chronic Health Evaluation II; CVP, central venous pressure; ED, emergency department, ICU, intensive care unit; IPP, inspiratory plateau pressure; LOS, length of stay; MAP, mean arterial pressure; ScvO 2, central venous oxygen saturation; Xigris, drotrecogin alfa (activated). institutional review boards at both institutions and was conducted in compliance with the Declaration of Helsinki guidelines for protection of human subjects. Informed consent was not obtained from patients because no interventions differed from usual care except for the addition of the Protocol Watch. The 5 primary end points for the study were compliance with the resuscitation and management sepsis bundles, time to completion for these 2 bundles, and time to antibiotic administration. The study was conducted in 2 phases: before the intervention (phase 1) and after the intervention (phase 2). Data for the 5 study end points were collected before and after implementation of Protocol Watch at both health care facilities. The instrument used to collect data before and after intervention is shown in Table 1. After all data for before the intervention had been collected, clinical nurse specialists from Philips Healthcare provided training on the Protocol Watch application to ICU and emergency department staff nurses at both clinical facilities and to the emergency department staff at St Vincent s Medical Center. 316 AJCC AMERICAN JOURNAL OF CRITICAL CARE, July 2011, Volume 20, No. 4

5 This training included both a review of the SSC guidelines and instruction on how to use the features and information provided by Protocol Watch. Upon completion of this training, phase 2 of the study was initiated and the Protocol Watch application was enabled at all the bedside ICU monitors at both St Vincent s and Legacy and in the emergency department at St Vincent s. The Protocol Watch software was then used for all consecutive, eligible patients at both hospitals. The 2 phases of the study were completed between March 1, 2006 and August 5, During this time, neither the practice environment nor the care delivery process at either of the 2 participating facilities changed in a way that might have confounded the effects of the Protocol Watch intervention on compliance with the SSC guidelines. Statistical Analysis Data analysis included descriptive statistics for patients demographic and clinical characteristics including number and percentage for categorical variables and mean and standard deviation for continuous variables that meet the assumptions of normality. Both χ 2 tests and t tests were conducted to determine if patients demographic and clinical characteristics differed significantly from before to after the intervention. Whenever possible, t tests were used to evaluate for differences for each of the 5 primary end points between study phases 1 and 2. When that was not possible, nonparametric tests were used. All data analyses were completed by using SPSS (Version 15.0, SPSS, Inc, Chicago, Illinois). Results Characteristics of Patients The demographic and clinical characteristics of patients in the 2 phases of the study are shown in Table 3 Univariate analysis of patients demographic and clinical characteristics by study phase Table 2 Demographic and clinical characteristics of patients in study Variable Clinical site St Vincent s Legacy Health Patient s sex Male Female Location where sepsis diagnosed a Emergency department Medical/surgical unit Intensive care unit Another hospital Unknown Discharged alive from intensive care unit Yes No Unknown Discharged alive from hospital Yes No Unknown Phase 1, before intervention No. (%) of patients 42 (65) 23 (35) 29 (45) 36 (55) 49 (75) 9 (14) 1 (2) 4 (6) 2 (3) 42 (65) 15 (23) 8 (12) 45 (69) 20 (31) 0 Phase 2, after intervention 41 (59) 29 (41) 30 (43) 40 (57) 36 (51) 13 (19) 12 (17) 8 (11) 1 (1) 47 (67) 20 (29) 3 (4) 45 (64) 23 (33) 2 (3) Tables 2 and 3. More patients were enrolled from St Vincent s Medical Center in phase 1 and 2 of the study (n = 42 and 41, respectively) than from Legacy Health (n = 23 and 29, respectively). Both phases of the study involved a slightly higher proportion of 0.5 < a χ 2 test indicated significant differences between phase 1 and phase 2. χ P No. (%) of patients Characteristic Phase 1, before intervention (n = 65) Phase 2, after intervention (n = 70) F P Age, mean (SD), y 67.6 (15.3) 69.1 (17.5) APACHE II, mean (SD) 21.4 (7.2) 22.3 (7.2) Intensive care unit length of stay, mean (SD), days 7.4 (7.7) 10.3 (10.6) Hospital length of stay, mean (SD), days 15.7 (24.7) 17.8 (18.5) Abbreviation: APACHE, Acute Physiology and Chronic Health Evaluation. AJCC AMERICAN JOURNAL OF CRITICAL CARE, July 2011, Volume 20, No

6 Table 4 Results of univariate analysis of variance for main outcome measures No. (%) of patients End point Phase 1, before intervention (n = 65) Phase 2, after intervention (n = 70) Levene test F P % Compliance with resuscitation bundle, mean (SD) Time to completion of resuscitation bundle, mean (SD), h % Compliance with management bundle Time to completion of management bundle, h Time to antibiotic administration, min 57.6 (19.8) 68.2 (20) (20.8) 12.7 (17.2) 86.8 (17) 19.2 (1.2) (90.5) a (19) 22.2 (2.6) (150.6) a After square root transformation. Each facility had implemented the guidelines and were using paper systems for guideline compliance. female than male patients, and most patients were admitted to the ICU from emergency departments in both phase 1 (75.4%) and phase 2 (51.4%) at both sites. Chi-square analyses revealed no statistically significant differences between phase 1 and phase 2 for ICU mortality or hospital mortality (Table 2). Unpaired t tests confirmed no statistically significant differences between phase 1 and phase 2 with respect to age and score on the Acute Physiology and Chronic Health Evaluation II. These variables were of particular interest for this study because both are independent risk factors for sepsis. For ICU length of stay and hospital length of stay, data transformation was required because both of these variables had severe deviations from normality and therefore did not meet the requirements for parametric testing. Log transformations produced values that performed better on normality tests and met the requirement for heterogeneity. The means of the log transformed variables (noted in the footnote to Table 4) are presented as the back-transformed, geometric means. Please note that the standard deviation, variance, or standard errors of transformed variables or distributions are not presented because they are not meaningfully reported. Evaluation of Primary End Points Before the intervention (phase 1), data for the 5 study end points were collected for a total of 65 patients at both institutions; after the intervention (phase 2), data on each end point were obtained for 70 patients at the 2 facilities (Table 2). Tests for normality revealed that the variables of time to completion of the resuscitation bundle, time to completion of the management bundle, and time to antibiotic administration did not meet the guidelines for parametric testing. Log transformations were applied to time to completion for both resuscitation and management in order to normalize the data. A root transformation was applied to the time to antibiotic administration as it normalized the data, whereas the log transform did not. Results of these analyses are presented in Table 4. The difference in time to antibiotic administration is highly significant, with patients in the phase 2 portion of the study receiving their antibiotics in significantly less time than patients in phase 1. Parametric tests were not appropriate for compliance with either the resuscitation (6 hour) bundle or the management (24 hour) bundles, given the significant violations of normality displayed by these variables. This abnormality could not be repaired through transformations because the data were not continuous. Instead, the Wilcoxon rank sums test (nonparametric) were used. The Wilcoxon test uses the rank of an observation rather than the observation value itself in the calculation of the P value, the P value obtained from the Wilcoxon test is based on rank order rather than the specific percentage value. The Kolmogorov-Smirnov test was used to test equality of distributions before the Wilcoxon test was conducted to verify that distributions before and after the intervention were similar. The results suggest that the percentage of compliance differs significantly between the 2 groups for the resuscitation bundle (z = , P =.01), with the phase 2 group having a significantly higher amount of resuscitation bundle completion than the phase 1 group. For the percentage of compliance for the management bundle, no significant difference was found between phase 1 and phase 2 test groups (z = , P =.60). 318 AJCC AMERICAN JOURNAL OF CRITICAL CARE, July 2011, Volume 20, No. 4

7 Discussion This study is the first one known to evaluate a CDSS tool designed to improve compliance with the SSC guidelines by using automated prompts automatically generated by a bedside monitor. The current study provides an important evaluation of the effect of an innovative CDSS tool in actual clinical settings by using all ICU staff at 2 tertiary care facilities. CDSS tools should provide decision support automatically as part of clinicians work flow, deliver decision support at the time and location of decision making, provide recommendations for action, and use computational analysis to support clinicians efforts to make evidence-based care decisions. 35 Effective CDSS tools should not interrupt work flow or force clinicians to spend more time interacting with the technology rather than with patients, 35 especially in the busy environment of critical care. The results of this study suggest that the Protocol Watch intervention was able to facilitate a significant improvement in some SSC measures for critically ill patients with sepsis: greater compliance with the resuscitation bundle and shorter time to antibiotic administration. These 2 outcomes are of particular importance because both are associated with improvements in patient mortality. 14,34 Keeping in mind that both the resuscitation bundle and the administration of antibiotics have short time frames in which to be implemented (antibiotic administration is within 2 hours and the resuscitation bundle completion goal is 6 hours), these findings are particularly important. However, Protocol Watch was not associated with significant improvements in the 3 other SSC end points nor did length of stay in either the ICU or the hospital improve significantly, and patient mortality was not reduced. These results are inconsistent with previous research. 9,14,36 This finding has a number of possible explanations. Specifically, the postintervention changes in compliance with the 2 bundles and decreased time to administer the bundles did not meet the SSC goal of 100% compliance and initiation within 6 hours for the resuscitation bundle. Previous research demonstrating reductions in mortality indicate that these outcomes were achieved when the 6- and 24-hour time windows were met and 100% bundle compliance was achieved. In addition, some evidence suggests that completion of the 6-hour bundle is the most important predictor of clinical outcomes. 9,14 This finding is supported by clinical data indicating that early therapeutic fluid resuscitation and pharmacological interventions significantly reduce patient mortality. 4,8,35,37,38 In one study, 38 researchers reported significantly higher mortality rates for patients with early onset of sepsis for whom fluid administration was delayed by 27 minutes and pharmacological support was delayed by 310 minutes. Another study showed a 16% decrease in mortality with early treatment of sepsis. 9 Clearly, even short delays in treatment add to the already staggering human and economic costs associated with sepsis. The findings of this study regarding the lack of full compliance with the 6-hour resuscitation bundle provide additional confirmation regarding the imperative for early and aggressive treatment of patients with sepsis. The failure to achieve optimal compliance with the SSC recommendations in this pilot study may reflect difficulties in translation of research to clinical practice in a consistent and comprehensive manner without the use of additional resources such as education to reinforce the SSC guidelines. Practical Considerations, Study Limitations, and Future Research Protocol Watch has the potential to provide decision support at 3 stages of clinical decision making. First, Protocol Watch continually screens patients for the criteria for diagnosis of systemic inflammatory response syndrome (which can be an early indication of sepsis) and provides alerts to bedside clinicians to consider if symptoms could be related to new or presumed infections. Second, Protocol Watch displays the discrete components of the resuscitation bundle upon confirmation of sepsis. A timer display also appears that provides a constant visual cue to clinicians regarding the amount of time elapsed from identification of sepsis to the performance of the various bundle components. Additionally, the display of trends in arterial blood pressure, central venous pressure, and saturated venous oxygen level provides consistent visual cues regarding progress toward achievement of EGDT goals. Third, the elements of the management bundle are visually displayed on Protocol Watch once clinicians confirm completion of the resuscitation bundle. Thus, decision support via Protocol Watch may provide helpful reminders to clinicians of the time-sensitive sepsis management bundle priorities, particularly when Protocol Watch is offered in conjunction with educational reinforcement on the SSC guidelines. Some limitations should be considered when interpreting the results of this pilot study. The significant improvements in 2 of the 5 measures sug- Completion of the 6-hour resuscitation bundle is the most important predictor of clinical outcomes. AJCC AMERICAN JOURNAL OF CRITICAL CARE, July 2011, Volume 20, No

8 gest that randomized, controlled trials of Protocol Watch may be warranted. Such studies should include power analyses in order to ensure that enough participants are enrolled in the study for significant differences to be detected. This study was implemented at only 2 facilities that had paper systems in place to monitor compliance with the SSC guidelines before implementation of this study. Although the highest enrollment site, St Vincent s, had the Protocol Watch application installed in both the emergency department and the ICU, the study was focused primarily on the ICU. However, only 6 patients in the Protocol Watch group were admitted through the emergency department at Legacy. Those patients did not have the Protocol Watch software enabled until they were transferred from the emergency department to the ICU, which took a mean of 3 hours (or halfway through the resuscitation bundle). Inclusion of a larger number of medical facilities, inclusion of the emergency department for all study sites, and including facilities that do not have formal systems already established to monitor implementation of SSC recommendations could be informative, as Protocol Watch might have a greater effect on facilities that currently have no SSC protocols in place. In addition, researchers in future studies might consider inclusion of a group of clinicians exposed to only the Protocol Watch application and a group exposed to Protocol Watch along with educational reinforcement of the SSC guidelines. The concomitant effects of the Protocol Watch CDSS tool and education might result in more significant improvements on all SSC measures. Future studies might also include longer exposure to the Protocol Watch application in order to determine the effects of extended exposure. Longer exposure could increase the impact of the Protocol Watch tool because clinicians would have greater confidence and experience with the technology, including evidence that it improves patients outcomes. Alternatively, there could be a tendency to regress to behavioral patterns that preceded implementation of Protocol Watch. Longitudinal studies would provide further clarification of these issues. Conclusions Health care is moving forward at a rapid pace, and at no time in history has the need for efficacious CDSS tools been greater. The time-dependent care needs of critically ill patients coupled with the widespread shortage of critical care clinicians present significant challenges to timely implementation of the evidence-based SSC guidelines. Results from this pilot study suggest that well-designed CDSS tools offered in conjunction with ongoing education can provide clinicians with the knowledge and patientrelated information that will increase timely delivery of evidence-based sepsis care when and where it is most needed. Financial Disclosures This work was supported by research grants or fulltime employment from Philips Healthcare, Andover, Massachusetts. eletters Now that you ve read the article, create or contribute to an online discussion on this topic. Visit and click Respond to This Article in either the full-text or PDF view of the article. REFERENCES 1. Angus DC, Linde-Zwirble WT, Lidicker J, et al. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001;29: Martin GS, Mannino DM, Eaton S, et al. The epidemiology of sepsis in the United States from 1979 through N Engl J Med. 2003;348: Dombrovskiy VY, Martin AA, Sunderaam J, et al. Rapid increase in hospitalization and mortality rates in the United States: a trend analysis from 1993 to Crit Care Med. 2007;35: Jones AE, Shapiro NI, Roshon M. Implementing early goaldirected therapy in the emergency setting: the challenges and experiences of translating research innovations into clinical reality in academic and community settings. Acad Emerg Med. 2007;14: Dellinger RP. Cardiovascular management of septic shock. Crit Care Med. 2003;31: Dellinger RP, Carlet JM, Masur H, et al. Surviving Sepsis Campaign guidelines for the management of severe sepsis and septic shock. Crit Care Med. 2004;32: Dellinger RP, Carlet JM, Masur H, et al. Surviving Sepsis Campaign guidelines for the management of severe sepsis and septic shock. Intensive Care Med. 2004;30: Dellinger RP, Levy MM, Carlet JM, et al. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock Crit Care Med. 2008;36: Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. New Engl J Med. 2001;345: Eichacker PQ, Parent C, Kalil A, et al. Risk and the efficacy of antiinflammatory agents: retrospective and confirmatory studies of sepsis. Am J Respir Crit Care Med. 2002;166: Ferrer R, Artigas A, Levy MM, et al. Improvement in process of care and outcome after a multicenter severe sepsis educational program in Spain. JAMA. 2008;299: Jones AE, Focht A, Horton JM, Kline JA. Prospective external validation of the clinical effectiveness of an emergency department-based early goal-directed therapy protocol for severe sepsis and septic shock. Chest. 2007;132: Kortgen A, Niederprum P, Bauer. Implementation of an evidence-based standard operating procedure and outcome in septic shock. Crit Care Med. 2006;34: Kumar A, Roberts D, Wood KE, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. 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9 17. Otero RM, Nguyen HB, Huang DT, et al. Early goal-directed therapy in severe sepsis and septic shock revisited: concepts, controversies, and contemporary findings. Chest. 2006;130: Institute for Healthcare Improvement. Severe Sepsis Bundles /Tools/SevereSepsisBundle.htm. Accessed June 25, Nguyen HB, Corbett SW, Steele R, et al. Implementation of a bundle of quality indicators for the early management of severe sepsis and septic shock is associated with decreased mortality. Crit Care Med. 2007;35: Institute for Healthcare Improvement. What is a Bundle? /ImprovementStories/WhatIsaBundle.htm. Accessed 25 June Barletta JF, Thomas WL, Slot MG, Mingori TR, Morris-McCoy L, McAllen K. Compliance with guidelines for treating sepsis. Am J Health Syst Pharm. 2007;64: Carlbom DJ, Rubenfeld GD. Barriers to implementing protocolbased sepsis resuscitation in the emergency department: results of a national survey. Crit Care Med. 2007;35: Trzeciak S, Dellinger RP, Abate NL, et al. Translating research to clinical practice: a 1-year experience with implementing early goal-directed therapy for septic shock in the emergency department. Chest. 2006;129: Fong JJ, Cecere K, Unterborn J, Garpestad E, Klee M, Devlin JW. Factors influencing variability in compliance rates and clinical outcomes among three different sepsis bundles. Ann Pharmacother. 2007;41: Karlsson S, Varpula M, Ruokenen E, et al. Incidence, treatment, and outcome of severe sepsis in ICU-treated adults in Finland: the Finnsepsis study. Intensive Care Med. 2007; 33: Pogorzelska M, Larson EL. Assessment of attitudes of intensive care unit staff toward clinical practice guidelines. Dimens Crit Care Nurs. 2008;27(1): Jones AE, Kline JA. Use of goal-directed therapy for severe sepsis and septic shock in academic emergency departments. Crit Care Med. 2005;33: Kawamoto K, Lobach DF. Clinical decision support provided within physician order entry systems: a systematic review of features effective for changing clinician behavior. AMIA Annu Symp Proc. 2003: Leslie SJ, Denvir MA. Clinical decision support software for chronic heart failure. Crit Pathways Cardiol. 2007;6: Garg AX, Adhikari NKJ, McDonald H, et al. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. JAMA. 2005;293: Lehmann ED. Computerized decision-support tools in diabetes care: hurdles to implementation. Diabetes Technol Ther. 2004;6: McGowan C, Neville RG, Ricketts JW, et al. Lessons from a randomized controlled trial designed to evaluate computer decision support software to improve the management of asthma. Med Inform Internet Med. 2001;26: Schurink CA, Lucas PJ, Hoepelman IM, et al. Computerassisted decision support software for the diagnosis and treatment of infectious diseases in intensive care units. Lancet Infect Dis. 2005;5: Levy MM, Fink MP, Marshall JC, et al SCCM/ESICM/ ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2005;31: Kawamoto K, Houlihan CA, Balas EA, Lobach DF. Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. BMJ. 2005;330: Gao F, Melody T, Daniels DF, Giles S, Fox S. The impact of compliance with 6-hour and 24-hour sepsis bundles on hospital mortality in patients with severe sepsis: a prospective observational study. Crit Care Med. 2005;9:R Ely EW, Kleinpell RM, Goyette RE. Advances in the understanding of clinical manifestations and therapy of severe sepsis: an update for critical care nurses. Am J Crit Care. 2003:12: Lundberg J, Perl T, Wiblin T, et al. Septic shock: an analysis of outcomes for patients with onset on hospital wards versus intensive care units. Crit Care Med. 1998;26: To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA Phone, (800) or (949) (ext 532); fax, (949) ; , reprints@aacn.org. AJCC AMERICAN JOURNAL OF CRITICAL CARE, July 2011, Volume 20, No

10 Impact of Protocol Watch on Compliance With the Surviving Sepsis Campaign Karen K. Giuliano, Michele Lecardo and LuAnn Staul Am J Crit Care 2011; /ajcc American Association of Critical-Care Nurses Published online Personal use only. For copyright permission information: Subscription Information Information for authors Submit a manuscript alerts The American Journal of Critical Care is an official peer-reviewed journal of the American Association of Critical-Care Nurses (AACN) published bimonthly by AACN, 101 Columbia, Aliso Viejo, CA Telephone: (800) , (949) , ext Fax: (949) Copyright 2016 by AACN. All rights reserved.

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