Nickolas J Nahm MD1 Heather a Vallier MD2 Authors Note

Medical Research Archives. Volume 5 Issue 5.May 2017. Early appropriate care and opportunities for integrated care pathways in orthopaedic trauma

Authors: Abstract Early appropriate care (EAC) is a treatment Nickolas J Nahm MD 1 protocol for trauma patients with unstable fractures of Heather A Vallier MD 2 the thoracolumbar spine, pelvis, acetabulum, and/or femur. The protocol was designed to expedite treatment Authors note: based on patient physiologic readiness for definitive fracture surgery. In the EAC protocol, patients are 1Department of aggressively resuscitated and managed by a Orthopaedic Surgery, multidisciplinary team. Upon achieving predefined Henry Ford Hospital, thresholds for adequate resuscitation, patients undergo Detroit, MI. Email: definitive stabilization of their fractures with the goal of [email protected] performing surgery within 36 hours of injury. As an integrated care pathway, the EAC protocol defines a time 2Department of dependent strategy to trauma care and minimizes Orthopaedic Surgery, complications and reduces cost through a MetroHealth Medical multidisciplinary approach. Adoption of the EAC Center, Case Western protocol was achieved through buy-in from all involved Reserve University, parties in the development phase and contributed to Cleveland, OH. subsequent adherence to the protocol. As such, lessons learned from the development, institution and study of Email: the EAC protocol may be applied to other clinical [email protected] challenges in orthopaedic trauma, including fracture management in high-energy geriatric injuries as well as head injury. Keywords: pathway, early appropriate care, timing fixation, multiply-injured

Medical Research Archives. Volume 5 Issue 5.May 2017. Early appropriate care and opportunities for integrated care pathways in orthopaedic trauma

1. Introduction Prolonged bed rest is associated with Trauma care is provided in a poor pulmonary compromise and multidisciplinary fashion and is most thromboembolic disease (12). For these effective and efficient in regionalized reasons, many authors advocate early trauma centers (1). In particular, the definitive fracture fixation in order to multiply-injured patient requires promote mobility, reducing immediate care from several specialists complications and length of stay (LOS) and availability of intensive care units (13-15). However, the balance between and operating rooms. As a result, the early fracture fixation and patient’s care of the trauma patient is resource ability to tolerate surgery has been intensive but cost effective due to debated within the literature (16, 17). improved clinical outcomes achieved in The EAC protocol addresses these issues trauma centers (2). Nevertheless, trauma by defining specific resuscitation centers face challenges in financial thresholds for fracture fixation with the viability, and continuous efforts are goal of definitive fracture surgery within required to establish practice patterns 36 hours of injury. In this review, we that result in optimal patient outcomes provide an overview of the factors and are also cost-efficient (3, 4). leading to the development of the EAC One avenue for achieving protocol, discuss outcomes associated excellent clinical outcomes in a cost- with the EAC protocol, and define the efficient manner in trauma care is the use of and opportunities available for integrated care pathway (ICP) (5). ICPs ICPs in orthopaedic trauma. are time-dependent treatment protocols utilizing a multidisciplinary approach. 2. Regionalization of trauma care: With respect to orthopaedic practice, background for Early Appropriate ICPs have been studied extensively in Care the total joint arthroplasty literature and The trauma patient is frequently are associated with decreased associated with injuries that span the complications and cost in this population domain of many specialties and (6, 7). They have also been utilized with therefore requires a multidisciplinary success in geriatric patients with hip approach for treatment (18). Substantial fracture (8, 9). However, their use is not investment in resources is required to as well-established in the management maintain readiness for trauma care, and, of the multiply-injured patient requiring as a result, the care of the trauma patient fracture care. is regionalized (19). The American The Early Appropriate Care College of Surgeons (ACS) formalized (EAC) protocol is a type of ICP this regionalization in 1976 by developed to address the timing of categorizing hospitals based on definitive surgery in unstable fractures resources needed to provide different of the spine, pelvis, acetabulum, and levels of care for trauma (20). femur (10). In the trauma patient, these Subsequent to the development fractures are similar injuries because of trauma center status, multiple studies they predispose to systemic demonstrated the benefit of Level I inflammation and require patients to trauma centers on clinical outcomes and maintain bed rest prior to fixation (11). cost. Nathens et al showed that states

Medical Research Archives. Volume 5 Issue 5.May 2017. Early appropriate care and opportunities for integrated care pathways in orthopaedic trauma with trauma system implementation had (26.3%), and cardiac care (15.6%) (24). an 8% reduction in motor vehicle crash The authors concluded that the mortality compared to states without an investment necessary to maintain trauma organized system of trauma care, after center status is sustained by favorable adjusting for restraint laws, laws that contributions to hospital net revenue. deter drunk driving, and laws that allow Despite improved and cost- for highway speeds greater than 55 mph effective care provided by trauma (21). The findings of this study were centers, trauma centers face significant verified in the National Study on the challenges to financial viability, Costs and Outcomes of Trauma particularly due to issues surrounding (NSCOT), a large multi-center study patient transfer. In an analysis of the examining mortality from all National Trauma Data Bank, Koval et al mechanisms of injury. In this study, studied patients with low Injury Severity MacKenzie et al showed that both in- Scores (ISS ≤ 9) (26). They found that hospital mortality (relative risk of 0.80) 21% of patients with low severity as well as one year mortality (relative injuries were transferred to a Level I risk of 0.75) were significantly lower in trauma center. Compared to patients who level I trauma centers compared to were not transferred, transferred patients hospitals without trauma center with low severity injuries were more designation (22). likely to have Medicaid insurance versus In addition to improved clinical other types of insurance (OR 2.02, 99% outcomes, care provided by trauma CI 1.89-2.15), were more likely to centers has been shown to be cost- present during evenings or nights effective. In an analysis of the NSCOT compared to mornings or afternoons data, Mackenzie et al showed that the (OR 2.25, 99% CI 2.15-2.35), and be added cost of treatment at a trauma African American versus Caucasian race center was $36,319 per life year gained (OR 1.28, 99% CI 1.21-1.36), after compared to hospitals without trauma controlling for confounding factors. The center designation (2). Although the authors concluded that transfer of economic value of a statistical year of injured patients occurs for reasons other life has been debated, a commonly cited than medical necessity, as outlined by benchmark is $50,000 to $200,000 (23). the Emergency Medical Treatment and Based on this estimate, the authors Active Labor Act. In another study of concluded that the more expensive care patients treated at a Level I trauma provided at trauma centers is more cost- center, transfer patients were found to effective. Furthermore, trauma care has have lower ISS compared to patients been shown to positively impact the who were not transferred (27). financial characteristics of a trauma Furthermore, the authors found that a center (24, 25). In a retrospective study higher proportion of patients with low of a single Level I trauma center, severity injury (ISS < 18) had no Breedlove et al showed that Level I insurance versus patients with ISS ≥ 18. trauma care had favorable contribution Transferred patients were also more margins (40.2%) relative to other service likely to undergo delayed definitive lines at their hospital, including fixation of their fractures, which is orthopaedics (29.8%), oncology associated with higher complications in

Medical Research Archives. Volume 5 Issue 5.May 2017. Early appropriate care and opportunities for integrated care pathways in orthopaedic trauma medically stable patients. These studies study evaluating early ( ≤ 24 hours after suggest that initial triage and transfer injury) versus delayed (> 48 hours after processes require optimization so that injury) treatment of femoral shaft trauma centers can continue to maintain fractures (28). They reported more financial viability and provide pulmonary complications (acute expeditious fracture care. In this setting respiratory distress syndrome (ARDS), of financial challenges, trauma centers pneumonia, and fat embolism), greater must seek patient care strategies that hospital costs, and longer LOS in produce excellent clinical outcomes but multiply-injured patients treated on a are also cost-effective. delayed basis. This study was foundational for the philosophy of early 3. Development of the Early total care in which all fractures are Appropriate Care protocol treated on an early basis. The authors Trauma centers are able to suggested that early total care allows provide better patient outcomes in part patients to avoid bed rest and recumbent due to patient care algorithms that positioning, which are associated with continuously evolve based on research poor pulmonary toilet and efforts. The management of unstable thromboembolic complications (12). axial fractures (spine, pelvis, The paradigm of early total care acetabulum, and femur) in the multiply- shifted with the introduction of damage injured patients remains an area of active control orthopaedics (DCO) (29). In this investigation. Based on this treatment approach, the initial injury investigation, fracture care in these event is described as a “first hit,” which patients has changed dramatically with primes an inflammatory response (30). respect to timing of definitive surgery. Fracture surgery is the “second hit” that Early Appropriate Care (EAC) is a aggravates the inflammatory response protocol driven pathway for fracture care and predisposes the trauma patient to in multiply-injured patients that emerged immune-mediated complications, from this investigation (10). Based on including systemic inflammatory measures of resuscitation, including response syndrome, ARDS, and multiple lactate, arterial pH, and base excess, organ dysfunction syndrome. In order to patients with unstable fractures of the minimize the “second hit,” many authors axial skeleton undergo definitive suggested that definitive fracture surgery treatment of their fractures within 36 should be delayed in favor of hours of injury. Efforts are made in temporizing stabilization, such as patients who do not meet these external fixation (31-33). In particular, thresholds to continue resuscitation so subgroups of “borderline” and unstable that fracture care may be undertaken in patients were thought to be vulnerable to an expeditious manner. the “second hit” phenomenon, and DCO The EAC protocol was was recommended in these patients (34). developed in the background of a In a randomized controlled trial, the significant volume of work in the area of European Polytrauma Study on the fracture care in multiply-injured patients. Management of Femur Fractures study In a landmark paper, Bone et al group compared DCO to early definitive performed a prospective, randomized treatment of femoral shaft fractures (16).

Medical Research Archives. Volume 5 Issue 5.May 2017. Early appropriate care and opportunities for integrated care pathways in orthopaedic trauma

Among stable patients, DCO was undertaken in a large cohort of patients associated with increased time on (n=1,443) with unstable injuries of the ventilation but no differences in thoracolumbar spine, pelvis, acetabulum, pulmonary complications. However, in and/or femur in order to identify injuries, borderline patients, early definitive physiology, or laboratory parameters treatment was associated with higher associated with complications (10). This rate of acute lung injury, with no set of injuries was selected for review difference in other pulmonary due to bed rest and recumbent complications. positioning required prior to fixation, as The DCO strategy set the stage these activity restrictions portend a for EAC. DCO studies emphasized that common pathway of poor pulmonary subgroups of patients require further toilet and thromboembolic disorders resuscitation prior to definitive fracture (12). Definitive fracture fixation within surgery. The main question was which 36 hours of injury was recommended in patients require further resuscitation or patients with lactate < 4.0 mmol/L, pH ≥ should be delayed for other reasons. In 7.25, or base excess ≥ -5.5 mmol/L developing the EAC protocol, (Table 1). multivariable regression analysis was

Table 1. Early Appropriate Care protocol Timing of fracture fixation Parameter* ≤36 hours >36 hours pH ≥7.25 <7.25 Base excess (mmol/L) ≥-5.5 <-5.5 Lactate (mmol/L) <4.0 ≥4.0 *Definitive fracture fixation recommended when a patient has responded to resuscitation and any one parameter is met

In the EAC protocol, findings are similar to the results of resuscitation is ongoing and other investigators who found that continuously monitored in order to diligent resuscitation after injury expedite definitive fracture surgery. In a promotes early fracture care and limits prospective evaluation of the EAC the use of DCO (35), preventing protocol, Vallier et al found that all additional hospital stay and costs patients (n=335) achieved adequate associated with a secondary surgery. resuscitation within 36 hours of injury (11). Definitive fracture fixation was 4. Cost and outcomes associated with delayed most commonly due to surgeon Early Appropriate Care preference. Patients treated on an early The EAC protocol was basis experienced fewer complications developed in the context of increasing and shorter length of stay. These challenges to the viability of trauma

Medical Research Archives. Volume 5 Issue 5.May 2017. Early appropriate care and opportunities for integrated care pathways in orthopaedic trauma care. Specifically, disproportionately fractures and US $4,304 for patients frequent care for the underinsured, with pelvis or acetabulum fractures (38). declining reimbursement from payers, The authors estimated that the reduction and fewer available subspecialists, in complications associated with represent threats to high quality care implementation of the EAC protocol provided by Level I trauma centers (4, resulted in annual cost savings of US 27, 36). The EAC protocol not only $2,227,151 to their trauma center. In addresses clinical outcomes but also sum, these data represent compelling optimizes efficiency and cost associated support for the use of the EAC protocol, with trauma care. both with regard to improved patient Because the EAC protocol outcomes as well as systems based emphasizes the resuscitation process, processes and cost savings. patients are continuously monitored for adequacy of resuscitation and undergo 5. Integrated care pathways in fracture fixation in an expeditious orthopaedic trauma manner when thresholds for surgery are The EAC protocol represents one met. As a result, patients recover and example of the increasing trend toward participate with physical therapy after the use of integrated care pathways surgery and are on their way to hospital (ICPs) in orthopaedics and medicine as a discharge in a time-efficient manner. whole (5). An ICP standardizes care at Indeed, prospective review of the EAC specific time points during a treatment protocol at a Level I trauma center course (39). ICPs are dependent on a demonstrated that patients undergoing multidisciplinary approach to achieve early fixation ( ≤ 36 hours after injury) predefined outcomes (40). ICPs in had shorter mean intensive care unit trauma, as well as other subspecialties, (ICU) stays (4.5 vs 9.4 days, p < 0.0001) including total joint arthroplasty and and hospital LOS (9.4 vs 15.3 days, p < pediatric orthopaedics, have also 0.0001) compared to delayed fixation demonstrated success by reducing (>36 hours after injury) (37). The complications, hospital LOS, and cost increased LOS for patients treated on a (6, 41-43). As an ICP, the EAC protocol delayed basis translated to a mean loss has an established track record for fewer of revenue of US $6,380 per patient. complications, shorter hospital LOS, and Furthermore, the authors estimated that lower costs of care (11, 37, 38, 44). the facility revenue loss associated with Because multidisciplinary care is a hospital bed that could not be used for necessary for the care of the orthopaedic an additional trauma patient was US trauma patient, the opportunities for $35,330. ICPs in orthopaedic trauma are Furthermore, the reduction in substantial. Geriatric fracture cares for complications associated with the EAC both low-energy and a high-energy protocol translates to more cost-effective injury is an area of particular interest, care. In another study analyzing the given the aging population (45). ICPs financial impact of the EAC protocol, have been studied extensively in Childs and Vallier found that a geriatric hip fracture literature. In a complication increased the cost of care study evaluating co-management of by US $4,368 for patients with femur geriatric patients with hip fracture by

Medical Research Archives. Volume 5 Issue 5.May 2017. Early appropriate care and opportunities for integrated care pathways in orthopaedic trauma orthopaedic surgeons and geriatricians, with normal vital signs (50). The authors Friedman et al found lower complication found that mortality associated with a rates (30.6% versus 46.3%), shorter LOS heart rate greater than 90 in elderly (4.6 versus 8.3 days), and shorter time to patients did not equal mortality in a surgery (24.1 versus 37.4 hours) for co- younger cohort until heart rate was managed patients compared to standard greater than 130. The authors concluded care (46). In another study, the authors that increased caution is required in found that this co-managed protocol geriatric trauma patients and new triage driven program resulted in significant set points of HR > 90 and SBP < 110 cost savings, 66.7% of the expected mmHg should be considered. Another costs nationally (47). Co-management study examined the impact of increased services and treatment protocols vigilance in geriatric trauma patients by optimize the treatment of this fragile initiating trauma team activation for all population and reduce expenses. patients age 70 years or more with early The study of ICPs in high-energy aggressive monitoring and resuscitation geriatric trauma is more limited. The (51). The authors found significantly high-energy geriatric trauma patient reduced mortality after the initiation of represents unique challenges. Due to the this ICP (34.2% versus 53.8%, p=0.003). physiology and comorbidities specific to The importance of recognizing occult the geriatric population (48), this shock was emphasized by another study subgroup of trauma patients may benefit examining the impact of aggressive significantly from a multidisciplinary monitoring and resuscitation in the approach available through an ICP. Of geriatric population who presented with note, trauma centers that provide pedestrian versus motor vehicle effective care for younger adult trauma mechanism of injury, having multiple patients do not necessarily provide the fractures, head injury, initial blood same level of care for geriatric patients. pressure less than 150 mmHg, or In a retrospective review of the Quebec acidosis (52). In this study, Scalea et al Trauma Registry, Moore et al showed found that early invasive monitoring that risk-adjusted mortality rate for improved survival in patients older than younger adult trauma patients did not 65 years-old from 7% to 53%. These necessarily correlate with risk-adjusted studies suggest that recognizing occult mortality rate for geriatric patients (49). shock with early invasive monitoring These findings suggest that trauma and providing aggressive resuscitation principles utilized for young adult are key elements of an ICP for high- patients may not necessarily apply to energy geriatric trauma. geriatric patients. In an example of applying these Furthermore, geriatric trauma principles to practice, Bradburn et al patients often present with normal vital established an ICP for geriatric trauma signs but are under-resuscitated. In a patients (53). Their ICP consisted of retrospective study, elderly patients ( ≥ identifying high-risk geriatric patients 65 years old) presenting with normal based on injury profile, medical history vital signs were found to have a higher indicators, and physiologic parameters. mortality rate compared to other adult After identifying a high-risk patient, patients (17 to 35 years old) presenting markers of resuscitation, including ABG

Medical Research Archives. Volume 5 Issue 5.May 2017. Early appropriate care and opportunities for integrated care pathways in orthopaedic trauma and base excess, as well as ICU another study examining early femur admission and geriatric consultation fracture fixation in patients with head were obtained. Compared to a time injury, Scalea et al found no difference period prior to the initiation of this high- in discharge GCS, mortality, and CNS risk geriatric protocol, the authors found complications between patients treated a significant decrease in mortality after on an early basis ( ≤ 24 hours) and adjusting for confounding variables (OR patients treated on a delayed basis (> 24 0.63, p=0.046). In another study hours) (58). To our knowledge, high examining the use of the EAC protocol quality prospective evaluation has not in elderly trauma patients, Reich et al been performed. found no difference in complications for An ICP in this subgroup of patients ≤ 30 years-old (16%) compared patients with head injury requiring to patients ≥ 60 years-old (16%, p=0.84). fracture fixation would necessarily The authors concluded that the EAC involve a multidisciplinary team of protocol was a viable treatment neurosurgeons, intensivists, algorithm for elderly patients but that anesthesiologists, and orthopaedic further study was required to evaluate surgeons to determine preoperative pre-existing medical conditions. Future monitoring and resuscitation as well as study examining the impact of these appropriate anesthesia and intraoperative measures on hospital course and costs of monitoring. Intracranial pressure care will further delineate the effect of monitoring in these patients appears an ICP in elderly high-energy trauma warranted in many situations (58). patients. Furthermore, fluid resuscitation The presence of a head injury in supplemented by vasopressors as the patient requiring fracture fixation necessary is required to avoid central presents a unique challenge for which nervous system hypoperfusion (59). ICPs could play an important role. Future study examining thresholds for Specifically, the timing of definitive surgery and the impact of these fracture fixation in the setting of head thresholds on complications and costs is injury has been evaluated multiple times required for the development of an ICP. in prior literature, but evidence regarding Despite improved clinical timing of fracture surgery is still unclear outcomes and cost of care associated (54). The primary concern for early with ICP, the adoption and use of ICPs fracture fixation in this cohort of patients may represent a significant barrier (5). is intra-operative hypotension and Manning et al suggested that adoption of hypoxia with the potential to cause ICP may be limited by a culture of secondary brain injury (55, 56). Jaicks et physician autonomy, scarce resources, al found a trend toward increased and conflicting financial incentives hypotension and hypoxia in patients with between physicians and hospital head injury receiving early fracture management. Specifically, in the culture fixation (< 24 hours) versus patients of orthopaedics, independence is highly- receiving delayed fixation (> 24 hours) valued so with the implementation of an (57). The implications of these findings ICP, the surgeon may be reluctant to were unclear as the study found no participate (60). Furthermore, difference in mortality or LOS. In implementing an ICP represents a major

Medical Research Archives. Volume 5 Issue 5.May 2017. Early appropriate care and opportunities for integrated care pathways in orthopaedic trauma undertaking requiring substantial ICP (63). This process ensures investments of time and money. The ownership and buy-in from the lack of resources and time was identified orthopaedic surgeon. Furthermore, as one of the greatest barriers to incentives for participation in the ICP, collaboration among providers (61). including financial bonuses and better Finally, cooperation between hospital operative room availability, may also management and physicians required for improve physician adoption of an ICP instituting an ICP may be limited by (64). Finally, penalties for non- reimbursement. Hospitals often receive adherence are viewed as a final resort one predefined payment for a patient’s and may have implications on hospital hospital stay based on a diagnosis, but credentialing and financial the physician may be reimbursed on a reimbursement (65). per procedure basis, which creates a Implementation of the EAC conflicting financial reimbursement protocol was noted to be successful structure (62). These barriers to ICP almost at the start and adherence adoption can be addressed by involving improved steadily over a two-year the orthopaedic surgeon in the period (Figure 1) (66). development and implementation of the

Figure 1. Delayed fixation by fracture type (66). Comparison of percentage (y axis) of patients treated on a delayed basis depending on the type of fracture: spine, pelvis, acetabulum, or femur. Comparisons are made with a historical group of patients treated for 3 years prior to the EAC protocol implementation and with the first and second years after the implementation of EAC.

50 historical EAC year 1 40 EAC year 2 30

0 spine acetabulum pelvis femur

Medical Research Archives. Volume 5 Issue 5.May 2017. Early appropriate care and opportunities for integrated care pathways in orthopaedic trauma

In the first three months after compared to 76% of similar fractures implanting the EAC protocol, 22% of treated historically (Table 2). fractures were treated on a delayed basis

Table 2. Fractures treated more than 36 hours after injury in the Early Appropriate Care protocol. 59 fractures in 54 patients were treated on a delayed basis. Fractures treated with Surgeon choice to treat definitive fixation more than 36 fractures more than 36 Quarter* hours after injury (%) hours after injury (%) 1 22.0 16.2 2 27.0 16.2 3 23.0 8.8 4 17.0 11.3 5 10.2 10.2 6 11.8 8.8 7 15.3 5.1 8 10.0 10.0 *Each quarter is defined by a sequential 3 month period Data are used with permission from the work of Vallier et al (66)

Furthermore, in the last three implementation. This process ensured months of the study period, <10% of ownership from all involved physicians. fractures were treated on a delayed basis. Finally, the authors noted that the EAC Of note, all patients met thresholds for protocol contains a simple set of resuscitation within 36 hours of injury, parameters, which assisted in adherence. but 54 patients were treated on a delayed Although implementation of the EAC basis. The most common reason for protocol was found to be successful, delayed treatment was surgeon continued study of processes relevant to preference (67%). The authors ICP implementation is needed to concluded that teamwork from providers optimize care and reduce cost. as well as institutional support in the 6. Conclusion form of operating room and equipment The regionalization of trauma accessibility contributed to the rapid care centralizes specialists and resources adoption of the EAC protocol. The necessary for the optimal care of the authors also reported that protocol trauma patient. In the setting of trauma development involved subspecialists centers, ICPs show promise in from general surgery, critical care, optimizing patient outcomes and anesthesiology, neurosurgery, and improving the efficiency and cost of orthopaedic trauma. All involved parties care. As an example of an ICP, the EAC took part in developing details of the protocol decreases complications and protocol and timeline for reduces costs among patients with

Medical Research Archives. Volume 5 Issue 5.May 2017. Early appropriate care and opportunities for integrated care pathways in orthopaedic trauma unstable fractures of the thoracolumbar pathways in geriatric trauma and head spine, pelvis, acetabulum, and femur. injury. Further examination of methods Certainly, ICPs have been used with for instituting and adopting ICPs success for patient populations within represents another avenue for orthopaedics with opportunities investigation. available for optimization of these

Medical Research Archives. Volume 5 Issue 5.May 2017. Early appropriate care and opportunities for integrated care pathways in orthopaedic trauma

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