Crit Care Nurs Q Vol. 37, No. 4, pp. 377–383 c 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins Copyright 

Development of a Therapeutic Hypothermia Protocol Implementation for Postcardiac Arrest STEMI Patients Mari-Newton Dixon, DNP, NP-C; Michelle Keasling, MSN, RN Therapeutic hypothermia (TH) reduces neurologic injury and mortality in out-of-hospital cardiac arrest survivors. Myocardial infarction (MI) is one of the main causes of cardiac arrest and primary percutaneous coronary intervention (PCI) is recommended as initial treatment for patients who present with acute ST-segment elevated MI (STEMI). Cape Fear Valley Medical Center (CFVMC) was the only designated PCI center in the state of North Carolina without a TH protocol. The purpose of this quality improvement initiative was to develop and implement a TH protocol for postcardiac arrest STEMI patients at CFVMC. The existing STEMI process was adapted to include the use of TH for STEMI patients who presented from out-of-hospital cardiac arrest. Steps to development of the protocol included creation of TH STEMI flow map, reallocation of nursing staff, exploration of cooling methods and equipment options, development of a evidence-based physician order set, creation of nursing documentation process and competency assessment, organization of educational sessions, and approval through multiple hospital committees. The development of a postarrest STEMI TH protocol involved multiple disciplines and required approval from several committees. Lack of physician and nursing knowledge of the protocol proved to be the greatest challenge. The TH protocol is a step forward in implementing evidence-based practice and improving the quality of postresuscitation care provided to postcardiac arrest STEMI patients. Key words: acute ST-elevation myocardial infarction, protocol development, therapeutic hypothermia

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ORE THAN 300 000 out-of-hospital cardiac arrests occur each year in the United States, and in patients with a return of spontaneous circulation the rate of survival to hospital discharge is only 9.5%.1 One study revealed that 46% of postarrest patients died from neurologic injury.2 Following cardiac arrest, hypoxemia results in a cascade of physiologic events leading to neurologic demise and cellular death. One way to decrease

Author Affiliations: Cape Fear Valley Health System, Fayetteville, North Carolina. The authors have not disclosed any potential conflicts of interest. Correspondence: Mari-Newton Dixon, DNP, NP-C, Cape Fear Valley Health System, 1638 Owen Dr, Fayetteville, NC 28304 ([email protected]). DOI: 10.1097/CNQ.0000000000000037

cellular death is to deliberately reduce the core body temperature to 32◦ to 34◦ C. This therapy, known as therapeutic hypothermia (TH), reduces inflammation, cerebral edema, and cerebral metabolism, thereby, preserving brain cells. After the initiation of TH, the temperature is maintained for 24 hours and then the body is slowly rewarmed over 12 to 24 hours.3 Two landmarks studies led the way for TH to become standard practice after cardiac arrest. In 2002, the Hypothermia after Cardiac Arrest Study Group completed a randomized controlled trial that revealed improved functional status in postarrest patients who received TH. Fifty-five percent of patients in the hypothermia group had a positive outcome at discharge compared with 39% in the normothermia group. In addition, there was only a 41% mortality rate in the 6 months after TH compared with a 55% mortality rate in the 377

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normothermia group.4 A study by Bernard et al5 produced similar results with 49% of the hypothermia group achieving a good outcome, but only 26% in the normothermia group. These 2 studies led to the recommendation by the Advanced Life Support Task Force of the International Liaison Committee on Resuscitation for the use of TH in unconscious adult patients with a return of spontaneous circulation after ventricular fibrillation cardiac arrest.6 In the 2010 guidelines update, the American Heart Association also recommended the use of TH for all patients after cardiac arrest.7 Myocardial infarction (MI) is one of the main causes of cardiac arrest and primary percutaneous coronary intervention (PCI) is recommended as initial treatment for patients who present with acute ST-segment elevated MI (STEMI).8 Additional research on the use of TH during primary PCI after MI in postcardiac arrest survivors demonstrates enhanced survival and good neurologic outcomes in this patient population. When used with PCI, TH can reduce myocardial damage and reperfusion injury. Wolfram et al8 conducted a study evaluating the use of TH in postarrest patient who presented with STEMI. Therapeutic hypothermia was started in 16 of 33 patients immediately after admission and continued in the catheterization laboratory during PCI. At 6 months, the patients treated with PCI and TH had a survival rate of 75% compared with the control group survival rate of 65%. The authors recommended that TH in combination with PCI should be strongly considered as standard therapy in postcardiac arrest STEMI patients.8 In the 2013 STEMI guidelines update, the American Heart Association specified that TH should be initiated before or during PCI for postcardiac arrest STEMI patients.9 The literature supports TH as an intervention to improve neurologic outcome and reduce mortality after cardiac arrest. The development of a TH protocol takes coordinated effort by members of an administrative and multidisciplinary team to implement care that optimizes outcomes.

Local Problem There are 21 designated PCI centers in the state of North Carolina. Cape Fear Valley Medical Center (CFVMC) is the only designated PCI center of the 21 centers in North Carolina that does not utilize a TH protocol. Between 2011 and 2013, 30 postcardiac arrests patients arrived to the emergency department (ED) with a STEMI and received primary PCI. The standard of care for patients arriving with a STEMI consisted of rapid transfer to the cardiac catheterization laboratory for PCI followed by transfer to the intensive care unit (ICU) for stabilization. Cape Fear Valley Medical Center is a regional PCI center and must have proper protocols in place that are congruent with the standards of practice nationally and internationally. Hospital administrators and physicians supported the development of a TH protocol as a standard of care for postcardiac arrest STEMI patients arriving to the hospital. The purpose of this quality improvement initiative was to develop and implement a TH protocol for postcardiac arrest STEMI patients at CFVMC. The goal of the TH protocol was to improve the quality of care by (1) initiating the TH protocol in a timely manner for STEMI patients, who met inclusion criteria, (2) expediting transfer of patients from the ED to the cardiac catheterization laboratory to the ICU, (3) providing comprehensive, evidence-based TH care by a multidisciplinary team, and (4) improve neurologic outcome and reduce mortality for postcardiac arrest STEMI patients. METHODS Initial Steps Initially, an informal gap analysis was completed to identify current processes, anticipated resource needs, and potential barriers. The planning process began with a small working group in 2011. The working group consisted of physicians, nurses, pharmacists, clinical educators, and hospital administration. Initial priorities included

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identifying nursing and physician champions in the group, collaborating with multiple disciplines (emergency medicine, critical care, cardiology, neurology), and scheduling regular meetings to discuss each stage of protocol development and implementation. Physicians voiced their concerns regarding the complexity of TH therapy. These patients have a high acuity and need close monitoring by the care management team. The primary concern was which specialist would be responsible for the care of the patient during the initiation, cooling, and rewarming phases of TH. The internal medicine hospitalists managed the ICU patients; however, they were not comfortable treating these complex patients and the organization did not have a critical care intensivist group to assume care. After much discussion, a small group of cardiologists agreed to pilot the TH protocol with postcardiac STEMI patients who met inclusion criteria. Notification and Process Flow The hospital is part of a regional STEMI network and has a well-established process with an average door-to-balloon time of 50 minutes. Emergent cardiac catheterization and PCI is performed if there is ST elevation of 1 mm or greater in 2 contiguous leads on the first postresuscitation electrocardiogram and coexisting symptoms of acute coronary syndrome. This process was adapted to include the use of TH for STEMI patients who presented from out-of-hospital cardiac arrest. In addition, the established burst paging system was modified for postcardiac arrest STEMI patients to include “Code COOL STEMI” if the patient was to undergo TH. This single page allows for prompt deployment of key hospital personnel to prepare for patient arrival and intervention. The TH STEMI flow map was created to visually display the levels of communication within the process (Figure 1). To ensure a seamless transition of care for the patient from unit-to-unit, multiple meetings were held with ED and ICU administration, nursing supervisors, and cardiac catheterization personnel.

Figure 1. TH process flow for postcardiac arrest STEMI patients.

Clinical Resources Nurses are essential care managers for this therapy. The initiation and management of TH patient requires critical care training as well as knowledge of cooling devices and care of the hypothermic patient. Nurses must be proficient in using established hospital guidelines for sedation, glucose management, ventilator management, vasoactive drip titration, arterial pressure monitoring, and specialized temperature monitoring. Because of the intense nature and quick transitions, extra personnel should be available when the patient arrives. Patients with TH are often cared for on a

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1 nurse to 1 patient ratio due to the high acuity and time required for care. This can put a strain on staffing as well as budgeting for the units, so accommodations must be made to provide the best care for the patient. In the ED and cardiac catheterization units, extra staff is available during emergency situations in the event increased needs arise. In the ICU, it is not feasible to have a nurse on call at all times due to the low volume of TH patients. To make sure the ICU has a safe nurse-topatient ratio while also accommodating the incoming TH patient, the unit charge nurse collaborates with the nursing house supervisor and formulates a plan. Patients are either laterally transferred to other ICUs, or transferred to step-down units if medically stable, to lower the unit census so that a nurse is free to provide care to the single TH patient. Having an open bed available for the TH patient is not a concern because the majority of the time there is a bed reserved specifically for a STEMI case. If a bed is not available when the patient arrives to the ED, the house supervisor makes it a priority to have a bed ready by the time the PCI procedure is complete. Cooling Equipment As evidenced in the literature, there are 2 main cooling methods, surface and endovascular. Endovascular cooling has been shown to cool the patient faster and provide more precise temperatures. However, this method also requires a special invasive catheter and is more expensive.10 After discussing the options, the working group decided to use surface cooling only for the protocol to prevent delay PCI due to placement of the specialized catheter as well as delay cooling. Multiple commercial devices are available for purchase. The group spoke with several representatives, watched demonstrations, and spoke with other product users. Also taken into consideration was the cost component as these cooling machines are very expensive. Because the capital budget did not include funding for this new equipment, an agreement was made with a com-

pany to lease the cooling machine and purchase only the cooling pads. Accurate temperature monitoring is necessary as patients are rapidly cooled and then slowly rewarmed. Methods of temperature monitoring include blood, bladder, esophageal, rectum, and tympanic.11 Considerations were made for the accuracy, usability, and cost-efficiency for the facility and nursing staff. The decision was made to use esophageal temperature probes because they were easy to insert, cost efficient, and compatible with other bedside monitoring equipment. Physician Order Set The team looked to other institutions for guidance and experts in the field were consulted. Representatives attended a national TH conference to network with other professionals and become up-to-date with the latest evidence. Information from these encounters was used to create a physician order set that would meet the needs of the patients and be achievable for Cape Fear Valley. The order set was organized to include the 4 phases of cooling: preparation, initiation, maintenance, and rewarming. Under each phase section are nursing orders, laboratory tests, and medications (Figure 2). The order set includes specific evidence-based guidelines regarding hemodynamic monitoring, electrolyte replacement, and glucose management. In addition, a physician champion formulated clinical practice guidelines that offered a detailed description of TH phases, expected physiologic changes, and monitoring parameters. The guidelines were attached to the nursing policy for easy access but were useful for all disciplines in the management of TH patients. Nursing Documentation and Policy Nursing documentation is typically done in the electronic medical record (EMR). However, frequent monitoring and documentation was needed for TH patients and therefore EMR documentation was not feasible for the

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Figure 2. Physician order set.

bedside nurse. The ED and cardiac catheterization laboratory would maintain their current documentation system. A paper TH nursing flow sheet was created for the ICU nurses to document frequent vital signs and assessments. The flow sheet is scanned into the EMR upon patient discharge. To validate the advanced competency of the ICU nurse, an equipment policy was created for the cooling equipment and insertion of the esophageal temperature probe. Every ED, catheterization laboratory, and ICU nurse was required to demonstrate set-up, maintenance, and troubleshooting of the cooling equipment. This took place at the initial education sessions and will continue at annual competency fairs. Hospital Approval Process The hospital approval process was one of the most challenging steps in protocol development. After creation of the policies and order set, the protocol went through multiple committees in a predetermined sequence for final approval. At each committee level, recommendations for revisions were received, the forms were incorporated and submitted for review for the next committee. First, the nursing policy and competency was approved

by the Nursing Policy and Procedure Committee followed by the Advanced Critical Care Competency Committee. Next, the order set was taken to the Pharmacy and Therapeutics Committee and the Medical Executive Committee for final approvals. Following all committee approvals regarding content, the order set and nursing documentation form went to the Patient Record Management Committee for formatting. This process took approximately 3 months to accomplish. The final TH protocol was given to the hospital Change Management Committee for dissemination through all departments. Education The TH protocol was the latest treatment the Cardiac Services Division had implemented in a few years and was highly anticipated among the nursing staff. With the excitement came much needed preparation to ensure the nurses were are able to safely care for the patients. The equipment company representatives and the critical care clinical educator provided education. This education was mandatory for all nurses in the ED, catheterization laboratory, ICU, and rapid response team. Optional sessions were offered for physicians who were interested in learning more about

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Table. Therapeutic Hypothermia Nursing Education Session Outline Pathophysiology Review of literature and current trends Care of the cooling patient Future research Cape Fear Valley Medical Center process flow Equipment training and competency check-off Q&A

the topic. The outline for education sessions is provided in the Table. Methods of Evaluation During the development process, plans were made for how to evaluate the success of the protocol after implementation. A survey tool was created to obtain feedback from physicians and nurses in the ED, cardiac catheterization laboratory, and ICU. It was important to evaluate the process flow; inclusion and exclusion criteria; order set; and documentation for clarity, usability, functionality, and efficiency. In addition, a chart audit tool was created to retrospectively look at all TH patients to determine timeliness and effectiveness of the protocol. Ongoing surveillance of the literature was done by working group members to ensure the protocol is reflective of evolving evidence-based practice and national standards. Changes were to be considered during annual reviews of the pro-

tocol unless new evidence or patient safety concerns warrant more urgent revisions. DISCUSSION Therapeutic hypothermia has emerged as a standard in postresuscitation care over the last 10 years. It has been shown to reduce mortality and improve neurologic outcomes at discharge. More specifically, when used for postcardiac arrest STEMI patients with primary PCI, TH reduces myocardial reperfusion injury, thereby, improving survival to hospital discharge. The TH protocol at CFVMC was a highly anticipated project that was met with great enthusiasm within the hospital. However, the novelty of this treatment was a barrier that was encountered. Lack of knowledge among medical and nursing staff proved to be challenging as attempts were made to obtain buy-in from key stakeholders. Providing evidence-based literature helped to overcome this limitation by emphasizing the necessity of TH as a standard of care at the hospital. As this treatment becomes more familiar and frequent in practice, the next goal is to expand the TH inclusion criteria to include all postcardiac arrest patients and begin the cooling process in the field by emergency medical services. As the protocol is expanded, further planning will be needed to handle increased patient volume and data collection. The development of a TH protocol was a step forward in improving overall postresuscitation care for the facility.

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3. Deckard M, Ebright P. Therapeutic hypothermia after cardiac arrest: what, why, who, and how. Am Nurse. 2011;6(7):13-17. 4. The Hypothermia After Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002;346(8):549-556. 5. Bernard SA, Gray TW, Buist MD, et al. Treatment of comatose survivors of out-of-hospital cardiac

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Development of a Therapeutic Hypothermia Protocol arrest with induced hypothermia. N Engl J Med. 2002;346(8):557-563. 6. Nolan JP, Morley PT, Hoek TL, et al. Therapeutic hypothermia after cardiac arrest: an advisory statement by the Advancement Life Support Task Force of the International Liaison Committee on Resuscitation. Resuscitation. 2003;57:231-235 7. Peberdy MA, Callaway CW, Neumar RW, et al. Part 9: post-cardiac arrest care: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010;122(18, suppl 3):S768-S786. 8. Wolfram S, Pierau C, Radke P, et al. Mild therapeutic hypothermia in patients after out-of-hospital cardiac arrest due to acute ST-segment elevation myocardial

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infarction undergoing immediate percutaneous coronary intervention. Crit Care Med. 2008;36(6):17801786. 9. O’Gara PT, Kushner FG, Ascheim DD, et al. ACCF/AHA Guideline for the management of STelevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61(4):e78-e140. 10. Seder DB, Van der Kloot TE. Methods of cooling: practical aspects of therapeutic temperature management. Crit Care Med. 2009;37:S211-S222. 11. Polderman KH. Mechanisms of action, physiological effects, and complications of hypothermia. Crit Care Med. 2009;37(suppl 7):S186-S202.

Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Development of a therapeutic hypothermia protocol: implementation for postcardiac arrest STEMI patients.

Therapeutic hypothermia (TH) reduces neurologic injury and mortality in out-of-hospital cardiac arrest survivors. Myocardial infarction (MI) is one of...
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