Guidelines published by the American College of Cardiology. Original Article

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1 Original Article Care Processes Associated With Quicker Door-In Door-Out Times for Patients With ST-Elevation Myocardial Infarction Requiring Transfer Results From a Statewide Regionalization Program Seth W. Glickman, MD, MBA; Barbara L. Lytle, MS; Fang-Shu Ou, MS; Greg Mears, MD; Sean O Brien, PhD; Charles B. Cairns, MD; J. Lee Garvey, MD; David J. Bohle, MD; Eric D. Peterson, MD, MPH; James G. Jollis, MD; Christopher B. Granger, MD Background The ability to rapidly identify patients with ST-segment elevation myocardial infarction (STEMI) at hospitals without percutaneous coronary intervention (PCI) and transfer them to hospitals with PCI capability is critical to STEMI regionalization efforts. Our objective was to assess the association of prehospital, emergency department (ED), and hospital processes of care implemented as part of a statewide STEMI regionalization program with door-in door-out times at non-pci hospitals. Methods and Results Door-in door-out times for 436 STEMI patients at 55 non-pci hospitals were determined before (July 2005 to September 2005) and after (January 2007 to March 2007) a year-long implementation of standardized protocols as part of a statewide regionalization program (Reperfusion of Acute Myocardial Infarction in North Carolina Emergency Departments, RACE). The association of 8 system care processes (encompassing emergency medical services [EMS], ED, and hospital settings) with door-in door-out times was determined using multivariable linear regression. Median door-in door-out times improved significantly with the intervention (before: 97.0 minutes, interquartile range, 56.0 to minutes; after: 58.0 minutes, interquartile range, 35.0 to 90.0 minutes; P ). Hospital, ED, and EMS care processes were each independently associated with shorter door-in door-out times ( 17.7 [95% confidence interval, 27.5 to 7.9]; 10.1 [95% confidence interval, 19.0 to 1.1], and 7.3 [95% confidence interval, 13.0 to 1.5] minutes for each additional hospital, ED, and EMS process, respectively). Combined, adoption of EMS processes was associated with the shortest median treatment times (44 versus 138 minutes for hospitals that adopted all EMS processes versus none). Conclusions Prehospital, ED, and hospital processes of care were independently associated with shorter door-in doorout times for STEMI patients requiring transfer. Adoption of several EMS processes was associated with the largest reduction in treatment times. These findings highlight the need for an integrated, system-based approach to improving STEMI care. (Circ Cardiovasc Qual Outcomes. 2011;4: ) Key Words: STEMI care emergency medical services outcomes Guidelines published by the American College of Cardiology and American Heart Association state that, as a systems goal, patients with ST-segment elevation myocardial infarction (STEMI) should be treated with primary percutaneous coronary intervention (PCI) within 90 minutes of their first medical contact. 1 Only 1200 of 5000 acute care hospitals in the United States are capable of performing PCI, and the logistical challenges to rapidly identify and transfer patients from non-pci hospitals to PCI-capable facilities are significant. 2 Notably, a study of 4278 STEMI patients in the National Registry of Myocardial Infarction (NRMI) found that only 4% of patients with STEMI transferred for PCI had first door-to-device times of 90 minutes. 3 Although this has improved to 17% in the latest National Cardiovascular Data Registry Acute Coronary Treatment Intervention Outcomes Network Registry Get With The Guidelines (ACTION Registry, GWTG) data, shortening transfer delays remains a top priority to improve care and, ultimately, to save lives. 4 Editorial see p 376 Recent national efforts have focused on prompt recognition and treatment of STEMI, including geographic regionaliza- Received October 18, 2010; accepted April 27, From the Duke Clinical Research Institute and the Department of Medicine, Duke University School of Medicine, Durham, NC (S.W.G., C.B.G., F.O., S.O., B.L., E.D.P., J.G.J.); the Department of Emergency Medicine, Carolinas Medical Center, Charlotte, NC (J.L.G.); the Division of Cardiology, Forsyth Medical Center, Winston-Salem, NC, (D.J.B.); and the Department of Emergency Medicine, University of North Carolina School of Medicine, Chapel Hill, NC (S.W.G., C.B.C., G.M.). Correspondence to Seth Glickman, MD, MBA, Department of Emergency Medicine, University of North Carolina, 170 Manning Dr, CB #7594, Chapel Hill, NC, swglick@med.unc.edu 2011 American Heart Association, Inc. Circ Cardiovasc Qual Outcomes is available at DOI: /CIRCOUTCOMES

2 Glickman et al Care Processes 383 tion programs to integrate care between hospitals with and without PCI capability to minimize time to reperfusion. 5,6 Current national recommendations are that reperfusioneligible patients should be transferred to PCI centers with a door-in door-out time within 45 minutes. 7 Previous studies have evaluated system factors associated with faster door-todevice times at PCI hospitals. 8,9 Nevertheless, there exists a paucity of data regarding specific factors that contribute to shorter door-in door-out times among patients evaluated at non-pci hospitals, who are transferred out for primary PCI. In 2006, the state of North Carolina implemented a statewide STEMI regionalization program called the Reperfusion of Acute Myocardial Infarction in North Carolina Emergency Departments (RACE). 10,11 As part of this program, a coronary reperfusion plan and an overall set of recommendations was established for each hospital, including a plan for patients transferred for primary PCI. Using data from RACE, the objectives of the current study were to assess the association of 8 specific prehospital, emergency department (ED), and hospital processes of care implemented at 55 non-pci hospitals on door-in doorout times for patients with STEMI. WHAT IS KNOWN Shortening transfer delays from hospitals without percutaneous coronary intervention (PCI) to hospitals with PCI capability remains a top priority to improve ST-segment elevation myocardial infarction (STEMI) care and patient outcomes. There are few data identifying factors that contribute to shorter door-in door-out times among STEMI patients evaluated at non-pci hospitals. WHAT THE STUDY ADDS Prehospital, emergency department, and hospital processes of care adopted as part of a statewide STEMI regionalization program were each independently associated with shorter door-in door-out times for STEMI patients requiring transfer. Adoption of several emergency medical services care processes was associated with the largest absolute reduction in treatment times. Integrated, system-based approaches are promising strategies with which to improve regionalized STEMI care. Methods This study analyzed data collected as part of the RACE regionalization program. The design and methods for this study and data collection have been previously published. 10,11 Briefly, the RACE program was a coordinated statewide system of STEMI reperfusion therapy that was implemented in 2006 and comprised 65 hospitals, including 10 PCI and 55 non-pci hospitals. The RACE program focused on the coordination of each aspect of care from the initial emergency medical response to reperfusion itself (eg, fibrinolytic therapy or primary PCI) whichever was most appropriate for a given setting. Non-PCI hospitals adopted 1 of 3 primary reperfusions strategies fibrinolysis, transfer for PCI, or mixed depending on whether expedient transfer was possible according to geography, local weather, and equipment availability. The program had institutional review board approval for analyses and Table 1. Recommendations to Improve Door-In Door-Out Times Percentage of Hospitals (n 55) Before Intervention After Intervention P Value Hospital processes Dedicated STEMI reperfusion team with committed leadership Hospital-specific reperfusion protocol ED processes System for obtaining ECGs within min of ED arrival Single call No. to activate PCI center cardiac catheterization lab EMS processes EMS has equipment to perform prehospital ECGs Program for paramedics to recognize STEMI on 12-lead ECGs Use local ambulance to transport patients within 50 miles Keep patient on local stretcher as part of AMI AMI indicates acute myocardial infarction. publication of the findings and the study was monitored by an independent oversight board. The RACE paramedics, nurses, physicians, administrators, and technicians used practice guidelines, published reports, and quality improvement principles to create a RACE operations manual containing a set of recommendations for each point in care. Recommendations were established for reducing time delays for each component of the reperfusion process: emergency medical services (EMS), ED, catheterization laboratory, and interhospital transfer. An important principle was to create, as much as possible, a single plan for each hospital that would be systematically applied to each patient. These systematic plans were established and supported through numerous local, regional, and statewide meetings and conference calls with local leaders involved in plan components. The RACE coordinators at each hospital were surveyed both before and after the RACE intervention about which of the recommendations from the operations manual were adopted. If the RACE coordinator was unsure as to whether or not a specific recommendation had been uniformly applied, then the answer was set to missing. Study Population The starting study population included all STEMI patients treated at 55 non-pci hospitals both before (July 2005 to September 2005) and after (January 2007 to March 2007) the RACE intervention (n 925). Because our focus was on door-in door-out among STEMI patients transferred for primary PCI, patients who were not transferred for PCI (eg, received fibrinolytic therapy) (n 445) or who were missing door-in door-out times (n 44) were excluded, leaving a total of 436 patients. Statistical Analysis Hospital-Level Process Data Hospital care processes adopted at each hospital both before and after the RACE intervention were abstracted from the hospital survey of RACE administrators. Because of colinearity among use of individual care processes, the care processes were reviewed and organized into broad factors by the research team to form taxonomy for classifying quality improvement efforts according to a previously defined methodology. 12 Eight individual care processes targeting

3 384 Circ Cardiovasc Qual Outcomes July 2011 Table 2. Patient Characteristics Variable Level (n 436) Overall (n 217) Before (n 219) After P Value Demographics Age, y Median th th Sex Male Female Presentation/physical examination Arrival model Self-transport Ambulance Systolic blood pressure, mm Hg Median th th Pulse, bpm Median th th Killip class No CHF Rales, JVD Pulmonary edema Cardiogenic shock First door-in to 1st door-out (among Median transfer for primary PCI patients) 25th th Prehospital ECG Yes Door-to-ECG (among patients Median without prehospital ECG) 25th th Transfer method to next hospital EMS (dispatched locally) (overall) Ground (dispatched from PCI center) Air (dispatched from PCI center) Other CHF indicates congestive heart failure; JVD, jugular venous distension. door-in door-out times among patients transferred for primary PCI were organized into the following 3 categories of care: (1) EMS, (2) ED, and (3) hospital-level (Table 1). Emergency medical services processes included (1) having ECG equipment to do prehospital ECGs for patients with chest pain, (2) developing a formal program for paramedics to recognize ST-elevation on 12-lead ECGs, (3) using local ambulances to transport patients if destination is within 50 miles, and (4) keeping patients on local ambulance stretchers. ED processes included having a separate system for obtaining ECGs within 10 minutes of ED arrival and using a single call number to activate PCI center catheterization laboratory teams. Hospital processes included creation of a dedicated cross-functional RACE team with committed leadership and establishing a single designated hospital-specific reperfusion plan and protocol. The 8 variables were mathematically combined and allocated to 1 of 3 categories. For each care process that was adopted within a given category, the hospital was assigned 1 point to the category. For example, for the hospital category, if a hospital implemented a RACE leadership team but did not establish a designated hospitalspecific reperfusion plan, then this hospital received 1 point for this category. Similarly, incorporation of a reperfusion plan but not a RACE leadership team would also result in a single point. Implementation of both care processes would result in 2 points. In cases in which the RACE administrator at a hospital was unsure whether a hospital process had been universally adopted, the variable was set to missing, and multiple imputation with 10 imputations was used to impute the missing values. Patient-Level Data Patients who were transferred for primary PCI and had recorded door-in door-out times were included in the analysis, as described above. Hospital-level data (care processes) and patient-level data (treatment times) were merged on the basis of time period (before or after RACE). Descriptive Data for Individual Factors Next, we examined the association between the individual care process and the door-in door-out time. The median (interquartile range) door-in door-out times were calculated according to whether each care process was present or absent. Statistical analyses were performed separately for each of the 10 imputed data sets. The 10 sets of results were then aggregated (ie, combined) into a single result. A single probability value was generated for comparison of door-in door-out times for each individual factor (present or absent). This single probability value was obtained from the 10 2 values that were generated from Wilcoxon rank-sum tests. 13 We repeated the analysis described above after combining the 8 different care processes into the 3 a priori categories (EMS, ED, and hospital). Similarly, analyses were performed separately for each of the 10 imputed data sets. The 10 sets of results for each category

4 Glickman et al Care Processes 385 Figure 2. Number and type of processes adopted at non-pci hospitals. This figure displays the overall number and type of practices, including EMS, ED, and hospital, adopted by non-pci hospitals after the RACE program. Figure 1. Changes in door-in door-out times with the RACE intervention. Among the 436 patients in this study, median doorin door-out times improved significantly with the RACE intervention (before: 97.0 minutes [interquartile range, 56 to 160]; after: 58.0 minutes [interquartile range, 35 to 90]; P ). were then aggregated (ie, combined) into a single result. A single probability value was obtained from the 10 2 values that were generated from Kruskal-Wallis tests. 13 Median Regression Finally, multivariable regression was used to look at the number of processes adopted within each category with median door-in doorout times. Median regression was used because door-in door-out times were not normally distributed. For the unadjusted model, the 3 categories were entered in the model as continuous variables. The interpretation of the regression model estimate is the reduction in median door-in door-out time associated with a 1-point increase in the number of care processes adopted within each category. The model adjusted for patient-level factors known to be associated with STEMI treatment times, including age, sex, and cardiogenic shock at presentation. Time period (pre- versus post-race intervention) was also included as a covariate. We also tested for interactions between time and each category of care process. A probability value of 0.05 was considered significant for all tests. No adjustments were made for multiple comparisons because all analyses were exploratory in nature. All statistical analyses were performed using SAS software (version 9.0, SAS Institute, Cary, NC). Results Patient demographics, presenting clinical characteristics, and transfer characteristics for STEMI patients treated at the 55 non-pci hospitals are shown in Table 2. Among the 436 patients in this study, median door-in door-out times improved significantly with the RACE intervention (before: 97.0 minutes [interquartile range, 56 to 160]; after: 58.0 minutes [interquartile range, 35 to 90]; P ) (Figure 1). Table 1 shows the proportion of non-pci hospitals that adopted each of the care process recommendations from the RACE operations manual. Individual care processes are displayed according to whether they were implemented for the prehospital, ED, or hospital settings. Overall use of the 8 recommended care processes increased significantly as part of the RACE program. Figure 2 displays the overall number and type of practices adopted by non-pci hospitals after the RACE program. In general, hospitals that adopted more EMS processes tended to implement the recommended ED and hospital processes as well. However, there was heterogeneity among the hospitals in terms of both the number and type of processes adopted. Table 3 displays the association between each of the individual care processes and median door-in door-out times. In the univariable analysis, each care process was associated with significantly shorter door-in door-out times. When the individual processes were grouped into the 3 categories (prehospital, ED, and hospital), adoption of additional processes within each category was associated with shorter door-in door-out times (P for all comparisons) (Figure 3). Median door-in door-out times among hospitals that adopted 0, 1, 2, 3, or 4 recommended EMS care processes were 138, 102, 85, 65, and 44 minutes, respectively. Median door-in door-out times among hospitals that adopted 0, 1, or 2 recommended ED care processes were 110, 75, and 54 minutes, respectively. Median door-toballoon times associated with hospitals that adopted 0, 1, or 2 recommended care hospital processes were 110, 95, and 48 minutes, respectively. Overall, if all processes were adopted, then the category of care that was associated with the greatest reduction in delay was EMS. That is, the adoption of all EMS processes was associated with the shortest median treatment times (44 minutes for hospitals which adopted all 4 EMS processes versus 138 minutes for hospitals which adopted none) compared with ED and hospital processes. Median-door-toballoon times associated with hospitals that adopted 0 to 2, 3 to 5, versus 6 to 8 total care processes were 119, 91, and 45 minutes, respectively. In a multivariable analysis, each of the 3 categories of care processes (prehospital, ED, and hospital) was independently associated with shorter door-in door-out times (Table 4). Adoption of 1 additional care process within each of the categories was associated with shorter door-in door-out times (17.7 minutes shorter for each additional hospital process, 10.1 minutes shorter for each additional ED process, and 7.2 minutes shorter for each additional EMS process). There was a significant interaction between time and ED care processes (P 0.007),

5 386 Circ Cardiovasc Qual Outcomes July 2011 Table 3. Patient Door-In Door-Out Times According to Hospital Processes Before Intervention After Intervention Processes Yes No Dif, P Value Yes No Dif, P Value Hospital leadership RACE team 63 (42 96) 111 (68 192) (32 80) 87 (58 141) Single designated reperfusion plan 67 (43 104) 115 (68 192) (36 90) 73 (35 98) ED processes Separate system for ECGs 79 (48 162) 110 (67 160) (27 66) 74 (48 112) Single call No. for PCI centers 79 (49 166) 108 (62 160) (35 90) 150 (74 166) EMS processes Equipment for prehospital ECGs 90 (55 153) 137 (95 235) (35 89) 149 (86 167) Paramedic program for ECGs 77 (45 122) 117 (70 213) (35 86) 78 (39 113) Keep patient on local ambulance stretcher 67 (47 87) 101 (56 166) (29 64) 77 (44 118) Local ambulance for transfer 50 miles 81 (47 125) 104 (60 191) (33 79) 84 (46 127) Values are median (interquartile range). suggesting that the RACE program played an important role in optimizing ED-related STEMI care. There was no significant interaction with time and hospital or EMS care processes (P and 0.658, respectively). Discussion To the best of sour knowledge, our study is the first to evaluate the association of specific care process and system factors with better time to reperfusion therapy for STEMI patients requiring transfer. First, we found that median door-in door-out times among transferred patients improved nearly 30 minutes overall among STEMI patients participating in a statewide regionalization program (P ). Second, we identified 8 care processes that were each individually associated with significant reductions in doorin door-out times among patients treated at non-pci hospitals. In a multivariable analysis, EMS, ED, and hospital care processes were all independently associated with shorter door-in door-out times, thus highlighting the need for an integrated, system-based approach to improving STEMI treatment times at non-pci hospitals. Third, we identified EMS processes as the most important single focus for reducing transfer delay. Hospitals without PCI capability play a critical role in STEMI regionalization efforts, yet there are unique challenges to providing timely STEMI care at non-pci hospitals and rural EMS settings. Rural hospitals and EMS systems have more limited financial and personnel resources than Figure 3. Median door-in door-out times for hospital, ED, and EMS. A total of 8 individual processes were grouped into hospital (n 2), ED (n 2), and EMS (n 4) categories. The figure shows median door-in door-out times according to number of quality processes adopted within each category and in aggregate.

6 Glickman et al Care Processes 387 Table 4. Change in Door-In Door-Out Times Among Patients Transferred for Primary PCI for Each Additional Quality Process Adopted STEMI Care Process Change in Treatment Time 95% CI P Value Hospital to ED to EMS to Time (before vs after) to Times are in minutes and are adjusted for patient age, sex, and presenting characteristics. CI indicates confidence interval. their urban counterparts as well as fewer standardized hospital clinical protocols for acute myocardial infarction care. 14,15 Furthermore, as illustrated by RACE, smaller non-pci hospitals generally care for a relatively small number of STEMI patients. This lack of experience and formal quality management may contribute to uncertainty about how to arrange for urgent coronary interventions at tertiary centers. The RACE program addressed these challenges by working directly with EMS and hospital administrators, nurses, and physicians. Although previous studies have described system factors associated with faster door-to-device times at PCI hospitals, comparatively fewer studies have quantified specific factors that contribute to quicker door-in door-out times among patients transferred for primary PCI. Our findings are consistent with those of other regionalized systems of STEMI care. These systems, such as the Stat Heart Program and Minneapolis Heart Institute, have used similar strategies to facilitate timely transfer for patients with STEMI, including having a single call activation system, use of prehospital ECGs, rapid availability of ECGs to the ED physician, standardized algorithms for STEMI care, and immediate access to EMS ground transportation A unique feature of our study is quantifying the improvement attributed to each process and finding that EMS, ED, and hospital processes are all independent predictors of faster door-in door-out times. This finding highlights the need for a coordinated approach to STEMI care at non-pci hospitals. We also found that time delays at referring institutions accounted for approximately 50% of total door-to-device time for transfer patients, a proportion similar to other recent studies. 19 Therefore, it is not surprising that the RACE processes aimed at reducing transport time in the EMS (using local stretchers and ambulances), ED (having a single call number), and hospital (dedicated reperfusion plan and protocol) were associated with significantly shorter door-in doorout times. In addition, hospitals that had a committed leadership team and a dedicated reperfusion protocol had the fastest treatment times (17.7-minute reduction; 95% confidence interval, 5.0 to 27.5 for each process in multivariable analysis). This finding reinforces the importance of hospital leadership as well as the integrated efforts from EMS, cardiology, nursing, and emergency medicine. Overall, comprehensive adoption of EMS processes versus those of the ED or hospital was associated with the shortest median treatment times (44 minutes for hospitals that adopted all 4 EMS processes versus 138 minutes for hospitals that adopted none). For the 50% of patients with chest pain who arrive to the hospital by EMS, earliest identification of STEMI depends on EMS obtaining and accurately interpreting a prehospital ECG Increasing the availability of prehospital ECG equipment and formal training programs for paramedics to learn how to interpret the ECGs were key components of the RACE intervention. Indeed, previous studies have shown that paramedics with formal training can interpret prehospital ECGs with a high degree of accuracy, with a sensitivity ranging from 71% to 97% and a specificity ranging from 91% to 100%. 23 Expanding access to prehospital ECG capability is a critical need, particularly in underresourced or rural EMS systems. Limitations The present study has several limitations. First, there was no regional or national comparator by which to judge the relative improvement in STEMI care. The NRMI registry closed in December 2006, before the postintervention data collection period. Comparison with NRMI reports was further limited by the lack of continuous data distribution availability and the reporting of treatment times in a rolling 12-month fashion. With these caveats in mind, a comparison with NRMI during a similar period suggests larger improvements with the RACE intervention. Second, because data from PCI hospitals were obtained from a voluntary registry and non-pci hospital data were collected by independent study personnel, we cannot exclude the possibility of selection bias in the reporting of patient data. Nevertheless, the data collected in this study are consistent with overall estimates of STEMI prevalence in North Carolina. Finally, our analysis used multiple imputations to address missing information about whether care processes were adopted. However, the overall rate of missing data was low, and any missing data create a bias against finding a statistically significant association between care processes and treatment times. Conclusions Prehospital, ED, and hospital processes of care were independently associated with shorter door-in door-out times for STEMI patients requiring transfer. Adoption of several EMS processes was associated with the largest reduction in treatment times. These findings highlight the need for an integrated, system-based approach to improving STEMI care, including a special focus on EMS. Sources of Funding This work was supported by an award from the American Heart Association Pharmaceutical Roundtable. RACE was supported by grants from Blue Cross and Blue Shield of North Carolina, Genentech, and Sanofi Aventis and is endorsed by the North Carolina Chapter of the American College of Cardiology and the North Carolina Office of Emergency Medical Services. Dr Glickman was supported by a Physician Faculty Scholar Award from the Robert Wood Johnson Foundation. Disclosures Dr Bohle received funding as a speaker for AstraZeneca (modest) until September Dr Peterson received funding for research grants from Schering Plough (modest), Bristol Myers Squibb (mod-

7 388 Circ Cardiovasc Qual Outcomes July 2011 est), Merck/Schering Plough (modest), Sanofi Aventis (modest), Saint Jude, Inc (modest), and funding for serving as a consultant/ participant on advisory board for Pfizer (modest) and Bayer Corporation (significant). Dr Jollis received funding for research grants from Genentech and Sanofi Aventis (modest). Dr Granger received funding for research grants from AstraZeneca (modest), Boehringer Ingelheim (modest), Bristol Myers Squibb (modest), decode Genetics (modest), GlaxoSmithKline (modest), Novartis Pharmaceutical Co (modest), Sanofi Aventis (modest), The Medicines Company (modest), and funding for serving as a consultant/participant on advisory board for INO Therapeutics (modest). References 1. 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