Abstract

What is the standard of care for patients with ST-segment myocardial infarction?It is 1:30 am; the chirping device on your nightstand awakens you from a sound sleep. You struggle to recognize the annoying sound and quickly realize it is your pager: 5 minutes to call the hospital operator. You jump out of bed in the middle of the night knowing that a patient in the emergency department (ED) who is experiencing an ST-segment elevation myocardial infarction (STEMI) is depending on your expertise. The on-call interventional cardiologist wants to emergently take this patient to the cardiac catheterization laboratory. You call the operator to confirm your page, get dressed, drive yourself to the hospital, and prepare to receive your patient, all within 30 minutes. Minutes matter.Mr C, your patient, a 54-year-old firefighter, transported by emergency medical services (EMS), arrives in the ED cold and clammy with chest pain rated 10/10. On the basis of the EMS assessment and a 12-lead electrocardiogram (ECG) from before Mr C arrived at the hospital that shows ST-segment elevation in leads II, III, and AVF, the ED physician activates the cardiac catheterization laboratory’s percutaneous coronary intervention (PCI) team while the patient is en route to the hospital. By the time Mr C arrives in the ED, the PCI team has arrived and prepared the procedure room to receive the patient. Mr C is assessed in the ED and minutes later is quickly transferred to the cardiac catheterization laboratory, placed on the procedure table, and prepared and draped for the procedure. Mr C has coronary angiography, followed by balloon angioplasty and placement of a stent (primary PCI) in the right coronary artery. You note the time, 2:35 am . . . a door-to-balloon time of 60 minutes.After the procedure, Mr C is pain-free and normotensive, and his ST-segment elevations have returned to baseline. Now that Mr C is pink, warm, and dry, you move him off the table and prepare him for transfer to the cardiac step-down unit. Mr C wants to know when he can go home. During his hospitalization, Mr C has his lipid profile and glycosylated hemoglobin level assessed, and an echocardiogram shows a preserved ejection fraction. Mr C is prepared for discharge and referred to the cardiac rehabilitation program.This scenario is common across the United States, as an estimated 900000 people will have a myocardial infarction this year. About 42% of these patients will die within the year, with half of these deaths occurring before the patient reaches the ED. Patients who survive a myocardial infarction are at risk for subsequent sequelae, including recurrent myocardial infarction, heart failure, sudden cardiac arrest, stroke, and death.1 Pharmacological reperfusion (fibrinolytic therapy) and mechanical reperfusion (PCI) can restore blood flow to the occluded coronary artery. The goal in STEMI management is to achieve patency of the coronary artery.2 PCI during an acute myocardial infarction is often referred to as primary PCI. PCI, an umbrella term for procedures performed during a coronary intervention, includes one or more of the following: balloon angioplasty, stent implantation, rotablation, atherectomy, rheolytic thrombectomy, and intravascular ultrasound.The revised “Guidelines for the Management of Patients with STEMI” from the American College of Cardiology (ACC)/American Heart Association (AHA) includes a class I recommendation that all patients undergo rapid evaluation for reperfusion therapy and have a reperfusion strategy promptly implemented.2 The reperfusion strategy chosen is dependent on the onset of the patient’s signs and symptoms, time to presentation, coronary artery involvement, medical history, and the availability of a 24-hour-a-day/ 7-day-a-week skilled PCI center. The timeline for reperfusion therapy for fibrinolytic therapy is described as the performance measure “door-to-needle” time of 30 minutes, and the timeline for primary PCI is the performance measure “door-to-balloon” (DTB) time of 90 minutes. Despite the evidence, data suggest that delays persist in either treatment strategy today.3 Fewer than 40% of patients who receive primary PCI do so within the 90-minute goal time defined by the ACC/AHA.4Cardiology publications are rich with evidence-based articles, expert opinions, and consensus statements that support best practices of both the fibrinolytic therapy approach and the PCI approach to management of patients with STEMI. Yet controversy abounds about which reperfusion strategy is the ideal intervention because of the timing of the proposed interventions.5–7 The ACC/AHA guidelines support primary PCI (Table 1) as the best practice if the start of treatment is not delayed. If delays are longer than 90 minutes, the guidelines support fibrinolysis as a rapid reperfusion strategy. If primary PCI is performed in an expeditious manner after the onset of signs and symptoms of ischemia, the benefit is clear, with improved short- and long-term outcomes for patients.8 Regardless of the reperfusion strategy chosen, the timeliness of the intervention influences patients’ outcomes.7,9–11 The old adage was “time is muscle” but in the words of Jeffrey J. Cavendish, MD, FACC, from the Naval Medical Center in San Diego, California, the message should now be “time is life.”12Caring for STEMI patients and achieving a DTB that is congruent with the ACC/AHA guidelines requires provision of expert care for critically ill patients along with a collaborative approach to care.2 The expert care begins before the EMS delivers the patient to the hospital and continues through the ED and into the cardiac catheterization laboratory. In this article, I describe the collaborative, interdisciplinary, cross-campus quality improvement approach to improving processes of care that was used to decrease the DTB time at the North Shore Medical Center (NSMC). In this article, DTB times do not include transfer patients.NSMC-Salem Hospital, in Salem, Massachusetts, launched the PCI program in November 2003, offering angioplasty services to residents north of Boston. NSMC is a member of an integrated health care delivery system with 2 acute care hospitals, NSMC- Salem Hospital and NSMC-Union Hospital. NSMC-Salem Hospital has 151 medical-surgical beds, 24 critical care beds, maternity beds, and psychiatry beds as well as a level 3 ED. A member of the Partners Healthcare System, NSMC is a community teaching hospital with a long history of “cardiac firsts” in the community.Beginning in 1964, NSMC-Salem became the first community hospital in Massachusetts to have an intra-aortic balloon pump program with a full-service cardiac catheterization laboratory. NSMC continued to advance cardiology care on the North Shore by implementing programs often found at academic, tertiary centers. NSMC is 1 of only 3 community-based hospitals in Massachusetts that are credentialed to open a coronary artery bypass program and to provide PCI services. On an annual basis, the NSMC performs 900 diagnostic cardiac catheterizations and 375 PCI procedures. Primary PCI represents approximately one-third of the total number of PCI procedures performed.Massachusetts enacted legislation requiring that its Department of Public Health collect, manage, and evaluate data on patients’ outcomes for all PCI and cardiothoracic surgical programs in the state. As such, the Massachusetts Data Analysis Center (Mass-DAC) was established and is located in the Department of Health Care Policy at the Harvard Medical School, Boston, Massachusetts. An external cardiac advisory committee provides clinical expertise to Mass-DAC. All PCI programs in Massachusetts collect and submit data by using the ACC-National Cardiovascular Data Registry (ACC-NCDR) instrument. The ACC-NCDR provides a national outcomes benchmarking registry, whereas the Mass-DAC data are used for statewide benchmarking.13As a component of the accreditation process, the Joint Commission requires health care organizations to participate in the core measures, an evidence-based, comparative performance measurement initiative.14 The NSMC’s cardiology service line participates in the Joint Commission’s heart failure and acute myocardial infarction (AMI) quality improvement projects. The reperfusion time or DTB time is but 1 of the Joint Commission’s 6 AMI performance measures that is publicly reported. The DTB time is defined as the time from medical contact to an open/patent artery, and the goal time established by the ACC/AHA is 90 minutes or less, a daunting goal. The shorter the time from the onset of signs and symptoms to treatment, the greater the survival benefit.9,11According to the Institute of Medicine’s 2 landmark reports To Err Is Human15 and Crossing the Quality Chasm,16 patients’ safety is compromised in hospitals today. Layering concerns about patients’ safety onto a health care environment that is challenged by cost containment efforts, a nursing shortage, work redesign, pay-for-performance quality initiatives, and consumers who are savvy about health care options offers an opportunity to deliver safer, quality care that promotes the best outcomes for patients.17 The state of the health care system, the increasing transparency of hospital-specific performance measures, and soon to be physician-specific outcome data, provide an impetus for interdisciplinary collaboration to improve patients’ outcomes. The timeliness of treatment for AMI patients (DTB) is a major focus for health care organizations, quality improvement organizations, and credentialing programs with a vested interest in the quality of cardiovascular care.Because the decision pathway for STEMI patients requires timely, accurate decision making, we established regularly scheduled meetings with our EMS colleagues before we implemented the NSMC PCI program. Working with the EMS providers, we made a decision to enhance their understanding of STEMI care. The meetings led to the development of a comprehensive STEMI management education series designed specifically for EMS providers. The relationship gave us, as hospital-based providers, a more complete understanding of the pre-hospital care of patients transported to NSMC. EMS providers consulted with NSMC to reach the consensus that EMS providers would obtain and interpret ECGs to detect STEMI before patients arrived at the hospital. This process would allow the ED to prepare for the patient’s arrival and alert the cardiac catheterization laboratory before the patient arrives. Because of the enhanced relationships and understanding of the prehospital care delivery, NSMC did not require EMS providers to transmit ECGs from the field and instead relied on the expertise of the EMS providers.The NSMC PCI program began in November 2003. At the time, the ACC/AHA DTB goal time was 120 minutes and the mean DTB time for NSMC was 134 minutes. As a comparison, the ACC-NCDR database indicated a mean DTB time of 163 minutes. Performing primary PCI by day, with only 2 patients represented in the mean DTB and a brand new program, we anticipated that our DTB times would improve. In May 2004, the ACC/AHA guidelines for STEMI reduced the DTB goal from 120 minutes to less than 90 minutes.2 In January 2004, NSMC began off-hours or 24/7 primary PCI services, and the mean DTB time was 109.5 minutes for 74 patients in 2004. The mean DTB reported by the ACC-NCDR decreased to 155 minutes in the fall of 2004.In response to our internal DTB data and the new ACC/AHA DTB goal of less than 90 minutes, in 2005, the NSMC assembled a DTB quality improvement committee whose goal was to identify process improvement opportunities to decrease DTB times. We realized that a quality improvement project was necessary but were unable to proceed before we completed the process of data denial and worked through the following stages: we knew the data were wrong; we thought the data were right but not really a problem—we would get better; we agreed the data were right but it was not our clinical area that was responsible for the DTB times. We were finally able to acknowledge that the data were correct and that each clinical area owned shared responsibility for the DTB times.Representatives on this committee included physician and nurse leadership representatives from the Union Hospital and Salem Hospital EDs, the Salem Hospital cardiac catheterization laboratory, the interventional cardiology physician assistant, and the ACC-NCDR data manager. We agreed to meet monthly. In addition, we held separate meetings with representatives from EMS.When this article was written, DTB times for patients transferred between facilities were not publicly reported, but the NSMC made a clear decision to include the Union Hospital transfer patients and internally recorded the same data. This interdisciplinary leadership team reached a consensus that quality improvement is a team sport and, as such, each member had to commit to this team. Accountability was paramount, and each team member was committed to influencing practice changes. Reviewing the DTB data was agonizing, and members of each department were sure that their staff was performing superbly and the other departments were responsible for the DTB times. This team defined objectives and acknowledged that the data (however painful) would drive practice changes that are evidence-based. This committee embraced the no-blame model of quality improvement in that processes of care could be enhanced to produce improved outcomes for patients. The team consensus for no-blame meant that we needed to address systems issues, how we deliver care, to influence the DTB times. We did not impose blame on any department or practitioner when delays in treatment occurred; we instead attempted to understand how the delay occurred and how we as a team could influence the care delivery to improve the processes. Although we collected provider level data, this was not a focus of this initiative, we checked the provider level data only periodically and did not identify practice variances among providers. The DTB performance improvement team continues to meet monthly to review all patient outlier cases and, equally important, to celebrate the successes. The commitment shown by this team was pivotal in the deliberations, literature reviews, consensus building, and data sharing that occurred during these meetings. Without the monthly meetings, the project would not have realized this positive outcome. Although nursing leaders represented the respective departments, the committee membership needed to fully appreciate the reality and clinical challenges of caring for STEMI patients. The perspective of the clinical staff in caring for these patients was missing from this committee, so clinical staff nurses from the cardiac catheterization laboratory and the ED were invited to participate on this committee. The nurses were able to refine the crucial elements for the handoff of patient information, how patients were prepared, and what the expectations were on both sides of the care delivery.Bradley et al18 identified that hospitals with outstanding DTB times share 8 characteristics, including an organizational culture of collaboration, commitment, and innovation (Table 2). In 2006, when the article by Bradley et al18 was published, our DTB performance improvement team already had these characteristics but we worked to strengthen them.To achieve the goal of reducing the DTB times, the first objective was to identify the steps (metric) from medical contact (door) to open artery, along with the observed time for each step in the process. The main categories of process steps (Table 3) include the door-to-ECG, ED to cardiac catheterization laboratory, and catheterization laboratory time, with the observed means for 2003 and 2004. The ACC-NCDR data manager created a comprehensive data collection tool (Table 4) that has been revised over time. This tool is a spreadsheet that allows the team to assess the multiple metrics in the DTB process measure. Patients who do not qualify for inclusion in the ACC-NCDR data submission are included in our data collection sheet to ensure that the processes of care are met.Many variables affect the DTB time, and after we assigned time goals attached to each metric, it was evident where we needed to focus our efforts. The interventions used by NSMC to improve the DTB times are summarized in Table 5. Before I describe the interventions to reduce the DTB, it is important to understand that the NSMC PCI program was new and as such, the clinical protocols were conservative in nature. The original process was as follows:This process is not unlike the process at many other PCI-capable institutions.The first metric addressed was the door-to-ECG time, which was assigned a goal time of 10 minutes. For patients with signs and symptoms suggestive of an ischemic event, performing a 12-lead ECG within 10 minutes of presentation is a class IC recommendation by the ACC/AHA.2 The 12-lead ECG is one of the most important diagnostic tools for risk stratification in the ED because it enables clinicians to identify which patients need immediate evidence-based reperfusion therapy. The NSMC-Salem ED employs a non-clinical greeter, and all walk-in patients register with the greeter. ED technicians perform the 12-lead ECG as directed by either a registered nurse or a physician.Barriers to achieving the 10-minute goal included the following: patient identification, the availability of an ECG machine, overcrowding in the ED, available personnel and a location to perform the ECG, and the synchronization of computers and clocks. The bulk of STEMI patients come to the ED with classic signs and symptoms of a myocardial infarction, chest discomfort, and they often report a “heavy weight on their chest.” Yet this scenario does not occur in all STEMI patients, and some exhibit an atypical presentation.19We reviewed the STEMI data collection (Table 4) tool at each monthly meeting and performed case reviews for each patient who fell outside the designated goal times. Along with discussions with the triage nurse, we scrutinized the triage notes to understand better why patients did not have an ECG within 10 minutes of arrival in the ED. By reviewing individual patients’ records for the chief complaint, we discovered that patients with an atypical ischemic presentation accounted for most of the long NSMC door-to-ECG times.A literature search provided examples of quality improvement processes that we adopted, which included the creation of a triage ECG policy intended for use by the triage registered nurse and a patient education flyer describing 12-lead ECGs, patients’ signs and symptoms, and the management of patients.20 The second approach was to educate and instruct the ED technicians to hand the 12-lead ECG directly to the physician, who would review and sign off on the 12-lead ECG. After much deliberation and consideration, we chose not to address the issue of synchronizing the time on the computers and multiple clocks, recognizing that this would be a labor-intensive step that would not add value. The ED took ownership of improving the door-to-ECG times, reporting monthly on their progress, and we continue to monitor the door-to-ECG times.The second step in the process of STEMI PCI care is the amount of time required in the ED to provide care safely and transport the patient to the cardiac catheterization laboratory. This step proved to be the greatest challenge: reducing the time spent in the ED to less than 40 minutes. On any given month, 65% to 100% of the primary PCI cases are performed during off hours. Off hours is defined as “after usual business hours” when the cardiac catheterization laboratory is not open and is covered by a PCI call team (Monday–Friday after 5:30 PM until 7 AM, all day Saturday and Sunday, and all major holidays). At the outset, the PCI call team of 3 staff members and 1 physician had 30 minutes from the time of the page to be in house and ready to receive the STEMI patient.Care of patients with STEMI while in the ED includes registration of the patient, assessment, diagnosis, and routine medical and nursing care such as obtaining samples for laboratory tests, insertions of intravenous catheters, portable chest radiography, assessment of vital signs, hemodynamic management, administration of antiplatelet medications, pain management, preparing the patient for transport, and activation of the PCI call team. Agreement was reached that processes could occur simultaneously. Activating the PCI team while the patient is registered, having 2 nurses assigned to the patient so that the interventions just listed happened in concert, and having a nursing assistant prepare the stretcher and the patient for transport are examples of simultaneous processes that saved time spent in the ED. Once in-house, the PCI call team calls for the patient and the patient is transported regardless of whether all the ED medical and nursing orders have been carried out.A novel approach to reduce the time it takes to care for STEMI patients while in the ED was the creation of the PCI kit, stored in the automated medication cabinet (Omnicell, Mountain View, California). Elizabeth Coombes, RN, ED nurse manager and Julie Bunn, RN, clinical leader, along with the clinical staff nurses, identified all the necessary components (Table 6) from phlebotomy, catheter insertion, and medication administration to care for STEMI patients and packaged it as 1 kit that required 1 entry into the Omnicell system. This creative single step saved approximately 3 to 5 minutes of time when acquiring medications. If the time for gathering the paper documents and the added supplies is included, the total time saved is approximately 9 minutes.21The greatest impact of a process change was empowering the ED physician to activate the PCI call team. Originally, the ED physician was “required” to consult with the PCI physician. The PCI physician made the decision to bring the patient to the cardiac catheterization laboratory and then called the switchboard operator to activate the PCI call team. The PCI physician was confident that the ED physician could identify and appropriately handle the triage of STEMI patients for primary PCI. If one thinks back to the implementation of fibrinolytic therapy, the original protocols used by some institutions required the cardiologist to determine if the patient was a candidate for fibrinolytic therapy. Currently, it is commonplace for the ED physician to make this determination. After deliberations, a 2-tiered system was established, 1 for patients with clear-cut STEMI and 1 for consultative STEMI patients. Consultative STEMI patients are ones who may have confounding comorbid conditions, questionable ECG findings, or a differential diagnosis to be ruled out that could preclude primary PCI without discussion with the PCI physician. For consultative STEMI patients, the ED physician confers with the PCI physician directly. For patients with clear-cut STEMI, a 1-call system to the switchboard operator was instituted that activated the entire PCI call team, including the PCI physician. After each STEMI case, before and after primary PCI, pictures with a clinical summary were shared with the switchboard operators. It was considered crucial that the switchboard operators appreciate how important their role is in ensuring optimal outcomes for patients.After hours, the cardiac catheterization laboratory is not staffed, which presents yet another challenge to reducing the time that patients spend in the ED. The staff and physicians in the NSMC ED and cardiac catheterization laboratory were committed to improving the timeliness of STEMI PCI during off hours. Owing to the fiscal implications and staff competency challenges, around-the-clock staffing of the cardiac catheterization laboratory was not an option. To facilitate prompt arrival of the PCI team for EMS arrivals, the ED physician could activate the team before the patient’s arrival in the ED on the basis of the EMS team’s assessment and interpretation of the patient’s 12-lead ECG as showing STEMI. Prehospital activation of the PCI team remains a work in progress and would not be possible without collaborative working relationships with the local EMS providers. Positive relationships are fostered via ongoing education, prompt feedback, and open doors of communication. The interventional cardiologists, physician assistant, and cardiac catheterization laboratory staff have all taught classes on STEMI management and annual refresher classes. All EMS providers are invited to observe care in the cardiac catheterization laboratory. Direct feedback on the patient’s outcome is provided, with before and after pictures of the coronary anatomy. We are fortunate for the collaborative EMS relationships.An interdisciplinary driven, cross-campus, quality improvement committee was able to influence the process measure, DTB, for patients undergoing primary PCI. Clinical staff nurses and nurse leaders played an integral role in this initiative: serving as cochair of the committee, identifying systems challenges and potential solutions, and implementing the recommended changes in processes of care. The major focus for this quality improvement committee was to understand the variation in reperfusion times and concentrate on the process improvements that would facilitate a shorter stay in the ED and thereby improve the overall mean DTB time. During normal operating hours for the PCI team, the time from door to catheterization laboratory decreased from 55 minutes to approximately 30 minutes. The processes set in place facilitated a reduction in time spent in the ED during the off hours as well, though not as dramatic (Figure 1). With the defined interventions (Table 5), heightened awareness, and institution of the process improvements, the NSMC mean DTB decreased between 2004 and 2007.Detection of STEMI, triage, and transport to the cardiac catheterization laboratory for definitive treatment of the infarct-related artery requires timely coordination and collaboration of patient care, beginning with the prehospital providers and continuing with the staff in the cardiac catheterization laboratory. With a concerted effort in process improvement, the NSMC realized a 50-minute reduction in the mean DTB time to a mean of 75 to 80 minutes, well below the national ACC-NCDR mean DTB time (Figure 2). Philosophically and on the basis of the evidence, we believe that decreasing the time elapsed until the artery is open decreases mortality and that PCI is the preferred intervention. Whether your health care system is academic, community, for profit, or not for profit, each system has unique characteristics and resources that will require that the relevant evidence-based practices that shorten the DTB times and thereby affect patients’ outcomes be evaluated, tailored, and used. The next phase of this initiative is to ensure that the gains made in reducing the DTB are sustainable.Bradley et al18 identified 8 traits that are common in hospitals with outstanding DTB times, and the NSMC has embraced all 8 traits. The NSMC is fortunate to have senior leadership support of this quality improvement initiative and a committed DTB quality improvement committee that remains active after 2 years. The DTB quality improvement committee set the tone of interdisciplinary collaboration and resiliency, acknowledging that there would be setbacks, but that improvement efforts would not be hindered. The committee established innovative protocols with a commitment to refine the protocols as needed. The data manager provides prompt feedback, and each department assesses and identifies systems issues and most importantly identifies successes to share with the staff.To shorten the DTB time further, a regionalized field identification, triage, and transport system for paramedics must be used.18 Although we have an established protocol for EMS providers in our local area, further expansion beyond our local area is not within our scope and must be achieved at the state level. NSMC will continue to partner with our prehospital colleagues to assess and refine our protocols to decrease DTB times further and increase the percentage of patients with a DTB of less than 90 minutes. The ACC/ AHA initiated a national process improvement project, D2B Alliance, in which we participate and that will further our knowledge of STEMI best practices.This quality improvement initiative was very rewarding for the committee participants as well as the clinical staff from the various departments. Although many of the efforts were aimed at the continuum from the ED to the cardiac catheterization laboratory, this initiative has implications for critical care nurses across the spectrum of care delivery. Critical care nurses from all practice settings can apply the lessons learned from this initiative to their own practice environment. Patients can sustain a cardiac injury in any practice environment, and all clinical staff nurses, from medical-surgical to step-down to critical care units, must identify and promptly intervene for these patients. Acute care clinical nurses must acknowledge that care reaches beyond the traditional hospital walls, and we must engage all clinicians to improve the care of our patients. Finally, critical care nurses practicing in a variety of clinical settings can adapt the quality improvement principles used in this initiative to improve care delivery in their respective departments or units. With today’s complex health care environment, the expertise of an interdisciplinary team cannot be overlooked.This manuscript would not have been possible without the editorial guidance of Mary Jane Costa, rn, phd. Many thanks to the Door-to-Balloon Committee members along with the staff from the ED and the cardiac catheterization laboratory, whose passion, perseverance, and dedication are responsible for the outcomes achieved.

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