Acta Neurol Scand 2014: 130: 73–80 DOI: 10.1111/ane.12256

© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd ACTA NEUROLOGICA SCANDINAVICA

Review Article

Stroke service: How can we improve and measure outcomes? Consensus summary from a global stroke forum Rymer MM, Anderson CS, Harada M, Jarosz J, Ma N, Rowley HA, Summers D, Tastula K, Williams O, Bornstein NM. Stroke service: How can we improve and measure outcomes? Consensus summary from a global stroke forum. Acta Neurol Scand 2014: 130: 73–80. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. The success of acute stroke treatment is first and foremost timedependent, and the need for improvement in acute stroke management is demonstrated by the fact that only a minority of patients gain access to treatment – in particular, intravenous recombinant tissue plasminogen activator (IV tPA) – within the necessary time window. Standards of acute stroke care vary widely both regionally and nationally; consequently, various healthcare organizations have undertaken initiatives to measure and improve quality of care. To date, most quality measures have been processbased, focusing primarily on metrics of patient care in the acute hospital-based setting (e.g., time to recombinant tPA administration). Therefore, there remains a need for metrics designed to assess how improvements in process translate into patient outcomes. A global forum was convened to share best practice and provide consensus recommendations on core metrics for measuring improvements in access to care and patient outcomes. Recommendations for core metrics of patient outcomes include hospital-based outcomes (e.g., neurological status at 24 h, ambulatory status at discharge) and postdischarge outcomes (e.g., modified Rankin Scale score at 30 and/or 90 days). Recommendations for best practice relating to aspects of people, process, and technology involved in the stroke treatment pathway that may help provide improvements in these core outcome measures are also outlined.

Introduction: the global burden of stroke

Stroke, the second leading cause of death worldwide, is a major global healthcare challenge. Annually, 15 million people worldwide suffer a stroke, of whom five million die and another five million are left permanently disabled (1). Rates of stroke mortality and morbidity vary widely geographically, the burden of stroke being greatest in low-income countries (2, 3). It is nevertheless important to note that although stroke incidence is declining in many developed countries – largely due to improvements in blood pressure control

M. M. Rymer1, C. S. Anderson2, M. Harada3, J. Jarosz4, N. Ma5, H. A. Rowley6, D. Summers7, K. Tastula8, O. Williams9, N. M. Bornstein10 1

The University of Kansas Hospital, Kansas City, KS, USA; 2The George Institute for Global Health, Royal Prince Alfred Hospital, University of Sydney, Sydney, NSW, Australia; 3University of Tokushima, Tokushima, Japan; 4King’s College Hospital, London, UK; 5Beijing Tiantan Hospital, Beijing, China; 6School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA; 7St Luke’s Neuroscience Institute, Kansas City, MO, USA; 8Royal Prince Alfred Hospital, Sydney, NSW, Australia; 9Columbia University, New York, NY, USA; 10Tel-Aviv Medical Center, Tel-Aviv University, Tel-Aviv, Israel

Key words: acute stroke; health services; management; outcome metrics; quality measures; recombinant tissue plasminogen activator M. M. Rymer, The University of Kansas Hospital, 3901 Rainbow Boulevard, Mail Stop 3011, Kansas City, KS 66160, USA Tel.: +1 913 588 3152 Fax: +1 913 588 1280 e-mail: [email protected] Accepted for publication April 3, 2014

and reduced levels of smoking – stroke prevalence continues to increase due to the aging population (1). Globally, the burden of stroke is expected to rise from approximately 38 million disability-adjusted life years (DALYs) in 1990 to 61 million DALYs in 2020 (1). The management of acute stroke spans the time course that starts with symptom recognition and emergency medical evaluation and ends with the patient being discharged with strategies in place to optimize their rehabilitation and community reentry and minimize the likelihood of stroke recurrence. Key issues in the delivery of optimal 73

Rymer et al. stroke care include the challenge of timely access to stroke centers with appropriate technology, personnel, and protocols to deliver time-dependent acute therapies. Following a stroke, ‘time is brain’ and the earlier the treatment is administered, the better the outcome. When intravenous recombinant tissue plasminogen activator (IV tPA) is administered within 3 h of symptom onset, there is 5% lower odds of mortality for every 15-min reduction in door-to-needle time (P = 0.0007) (4). The full potential of tPA therapy has yet to be realized, as only a small minority of stroke patients can gain access to treatment within the required time period (5, 6). Over recent years, various healthcare organizations have undertaken initiatives designed to measure and improve the quality of care provided to patients with acute stroke (7). To date, most of these efforts have focused on determining how to measure the quality of stroke care (8–10). Consequently, the majority of currently endorsed quality measures for stroke are process-based, focusing particularly on metrics addressing patient care in acute hospital-based settings (such as time to brain imaging and time to tPA administration) (7). There is therefore a need for the development and testing of metrics designed to assess how adherence to stroke performance measures translates into improvements in patient outcomes (such as long-term functional status and quality of life) (7). This paper is the outcome of a global forum that brought together stroke experts from around the world to share best practice. Its objectives are to present consensus recommendations on core metrics for measuring improvements in access to care and patient outcomes and to outline best practice along the acute stroke treatment pathway, focusing on people, process, and technology (all of which will be dependent on the resources available regionally) to help deliver improvements in these core outcome metrics. Stroke centers and regional networks: a systems approach to improving outcomes

As acute stroke treatment is time-dependent, the optimization of patient outcomes is also dependent on early intervention. Stroke victims need to be taken to a facility that can provide appropriate care as fast as possible, and the facility must be ‘stroke ready’ when the patient arrives (11). Standardized, evidence-based systems of care can result in improved access, treatment, and clinical outcomes for stroke victims (12, 13). Such systems of care require the development and 74

organization of specialized stroke centers and regional networks (11). Stroke victims who are managed in an organized stroke center have been shown to have better outcomes and reduced mortality rates compared with those who are managed in other settings (12, 13). Stroke care requires coordination of multiple clinical services, and a stroke center must therefore have strong leadership and be backed by organizational will to be successful (11). When building a stroke center, the first issue to be addressed is whether the following key aspects of care can be realistically provided: acute stroke diagnosis, interventions and management, prevention of complications, secondary stroke prevention, and early rehabilitation (14). These aspects of care must be standardized and evidence-based, requiring a basic infrastructure comprising care paths, standard order sets, and specialized nursing staff (11). Access to stroke care is a major challenge globally, particularly in rural communities. The success of stroke centers is therefore dependent on the development and support of regional referral networks, and efficient transfer processes must be in place (11, 13). If a stroke center is unable to provide acute stroke therapy (e.g., tPA) 24 h a day, it should consider establishing a transfer agreement with a facility that can (14). In the USA, the Brain Attack Coalition has proposed two levels of stroke centers, primary and comprehensive, to provide appropriate care to patients requiring basic and more advanced interventions, respectively (15, 16). These recommendations are based on the premise that although some patients can be treated appropriately at primary stroke centers, many patients may require intensive care and specialized techniques at a comprehensive stroke center (17). When such distinctions are in place, regional referral networks must take into consideration the level of care required for each individual case. The challenges involved in improving acute stroke management require incremental changes in the way that services are organized and implemented, and it is important to continually collect and analyze comprehensive patient data in order to validate whether these changes translate into improvements in outcomes. Ideally, such analyses should be benchmarked against national data. In the USA, the lack of a national stroke registry has hampered quality benchmarking analysis. However, a recent analysis of access to acute stroke therapy and clinical outcomes at Saint Luke’s Neuroscience Institute – a full-service stroke center with an associated stroke referral

Improving and measuring stroke outcomes network of over 70 hospitals – addressed this problem by benchmarking its patient data against three national datasets: the Get With The Guidelines-Stroke registry, the Premier Perspective database, and the Mechanical Embolus Removal in Cerebral Ischemia (Merci) Registry (13). This allowed Saint Luke’s Neuroscience Institute’s performance to be compared against other hospitals in terms of metrics that included access to care (e.g., tPA, computed tomography), administration of IV tPA within 4.5 h of stroke onset, National Institutes of Health Stroke Scale (NIHSS) scores, embolectomy outcomes (e.g., discharge to home), and occurrence of intracranial hemorrhage following tPA therapy (13). The results of this assessment not only provide further evidence that standardized systems of care can result in improved clinical outcomes for stroke victims (e.g., lower stroke severity at discharge), but also demonstrate that a full-service, regional stroke management program can be coordinated effectively by a tertiary care community hospital, providing a model that could be adopted by similar facilities worldwide (13). What are the core metrics that should be measured for assessing quality of care?

Over recent years, many initiatives have been undertaken in different countries to measure and improve the quality of care provided to patients with acute stroke. In the USA, examples of these include the Get With The Guidelines-Stroke program (18), the Primary Stroke Center Certification Program (19), and the Stroke Quality Enhancement Research Initiative (20). Similar initiatives have been undertaken in other counties, including Canada (21), the UK (22), Austria (23), Germany (24), Sweden (25), Denmark (26), Australia (27), and New Zealand (28). Quality metrics can essentially be classified into four groups – process, structure, outcome, and efficiency measures (8). Current stroke quality measures have a number of limitations (7). Firstly, most are process-based, focusing primarily on the measurement of patient care in acute hospital-based settings. Secondly, there is a lack of evidence to demonstrate that adherence to these process measures results in improved patient outcomes. Some studies have attempted to address this limitation; for example, studies conducted in Denmark have demonstrated that adherence to relevant processes of stroke care (e.g., early initiation of antiplatelet or oral anticoagulant therapy, early brain imaging) is associated with lower risk of mortality (29) and in-hospital medical complications,

such as pneumonia and urinary tract infection (30), and a shorter length of stay in hospital (31). Such medical complications were in turn shown to be associated with increased length of stay in hospital and increased risk of mortality (particularly relating to pneumonia) (32). However, few such studies have been conducted to date. Finally, as with all quality measures, there are inherent limitations when using a set number of metrics to define the complexity of healthcare quality (7). There is therefore a need for specific measures that focus on patient outcomes to provide evidence that improvements in the process of acute stroke management translate into clinical benefits for patients. The complexities in meeting this need on a global basis are immediately apparent when the variability in resources and culture on a regional or national level, and the diversity of ‘stroke’ on the individual case level, are considered. Age, employment status, family support, and economic resources impact the subjective perception of a ‘good functional outcome’, and there is also the issue of when to assess the outcome. Clinical trials have generally used functional status as measured by the modified Rankin Scale (mRS) (33) at 90 days as a ‘gold standard’, although current recommendations from the American Stroke Association advocate assessment at 30 days as the final outcome (34). Once the patient has been discharged from the acute care setting, it can be difficult to obtain the functional outcome information. However, status at discharge may not predict the recovery that occurs with natural healing in combination with the essential role of formal rehabilitation in the next 30–90 days and beyond. It would be a useful goal to create metrics that would reflect worldwide improvements in access to care and outcome, based on the current available evidence. Consensus proposals for such metrics are summarized in Tables 1 and 2. Metrics for access to care for stroke centers (Table 1)

Table 1 Access to care metrics for stroke centers Volume of cases arriving within the IV tPA treatment time window Volume of cases arriving by emergency medical services transport Percentage of eligible patients treated with IV tPA Percentage of stroke cases for which a cause for the stroke is identified Percentage of discharged cases of stroke where Target blood pressure is defined and treatment initiated Statin is initiated in appropriate cases Smoking cessation is addressed Antithrombotic therapy is initiated IV, intravenous; tPA, recombinant tissue plasminogen activator.

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Rymer et al. Table 2 Outcome metrics for stroke centers Neurological status at 24 h and discharge, compared with baseline, measured by NIHSS score or another validated scale Discharge disposition Ambulatory status at discharge Communication status at discharge mRS score at 30 and/or 90 days Quality of life metric (country specific) mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.

include measurement of the increase over time in the volume of cases that arrive at the stroke center within the time window for IV tPA (including identification of the number of referring hospitals in the region) and how many of these cases arrive via emergency medical services transportation. Measurement of the percentage of eligible patients treated with IV tPA would encompass several process measures, including time to computed tomography scanning and interpretation, and emergent laboratory results. The term ‘eligible’ would need to be carefully defined, so as not to exclude ‘rapidly improving and mild strokes’ from treatment. Measurement of the percentage of stroke cases for which the cause of stroke is identified would encompass access to extracranial and intracranial assessment procedures. Assessment of patients’ ongoing care and treatment at point of discharge would measure access to secondary stroke prevention strategies. Patient outcome metrics are associated with challenges regarding objective and subjective functional recovery, including cognition and quality of life, and when and how these should be assessed. Outcome metrics for stroke centers (Table 2) therefore comprise both hospital-based and post-discharge outcomes. Hospital-based outcome metrics include neurological status at 24 h and discharge, compared with baseline, measured by NIHSS score or another validated scale, such as the modified NIHSS (35), which is achievable by most hospitals in the world. Measurement of discharge disposition is likely to be variable in different cultures; for example, discharge to a skilled nursing facility in the USA is generally associated with a poorer functional outcome than discharge to home (36), but in other countries, patients are routinely discharged home if family support is available. Discharge disposition is therefore not likely to be a metric that could be compared worldwide for assessment of outcome. Ambulatory and communication status at discharge are reasonable proxies for outcomes. Postdischarge outcomes include mRS score at 30 and/ or 90 days. This measures multiple aspects of 76

function; the most important being motor function, speech, and ‘independence’. Independence is both objective and subjective and may relate to ability to drive, read, stay by oneself without supervision, and other elements that are subjective and culturally defined. It may therefore be appropriate to employ a patient-driven metric to measure the patient’s own perception of return to normality or independence; for example, ‘Have I achieved an outcome that (i) I am happy with, (ii) I can function with, (iii) I can tolerate, (iv) is very difficult, or (v) is impossible (I would rather not have survived)?’. People want to return to a good quality of life and function, but the definition of this will vary depending on a number of factors, including culture. Therefore, a quality of life metric would need to be country specific and validated accordingly. The continuum of care for stroke

This section outlines those aspects of people, process, and technology involved in the stroke treatment pathway that may help with improvements in the core outcome measures discussed previously. Symptom recognition

Recognition of stroke symptoms by the public and activation of the emergency medical services are the crucial first steps to achieve optimal outcomes for time-dependent acute stroke treatment. Poor recognition of the warning signs of stroke and their urgency is the main cause of delay in accessing acute treatment, and studies have shown that stroke literacy (awareness of stroke symptoms and their urgency, and risk factors) is generally low among the public (37–40). Community education programs have been developed with the specific aim of improving the public’s stroke literacy (41–43). These include ‘Hip Hop Stroke’, a community-based program conducted in central Harlem, New York, which uses culturally and age-specific music and dance to improve stroke literacy among elementary school children, thereby also helping to improve stroke literacy in the children’s parents (44, 45). Emergency response and transport to the emergency department

Emergency call-takers, including 999/911, the physician’s office, and hospital call-center staff, require training in stroke symptom recognition. This is because they play a vital role in the acute stroke treatment pathway, by alerting the

Improving and measuring stroke outcomes emergency medical service providers and ensuring that patients are directed to the correct services as soon as possible (46). Stroke recognition screening tools can assist prehospital emergency medical staff to rapidly identify patients with stroke, minimize prehospital delays, and provide advance notification of arrival to the emergency department. This helps to improve the timeliness of stroke treatment and increase the proportion of stroke victims who are able to receive thrombolytic therapy within the necessary time window (47–49). Despite the proven benefits of hospital prenotification, a recent analysis of data from over 370,000 patients with acute ischemic stroke transported by emergency medical services and enrolled in the Get With The Guidelines-Stroke Program revealed that hospital prenotification occurred in only twothirds (67.0%) of cases (49). Emergency department examination, diagnosis, and treatment

Once a patient has arrived at the emergency department, the streamlining of acute stroke care is dependent on having a clear care path, standardized order sets, and highly trained nursing staff (13, 14). The use of a rapid triage protocol can reduce intrahospital delay by quickly identifying patients eligible for IV tPA, allowing the stroke team to be notified, and the necessary imaging studies and laboratory tests to be arranged immediately upon arrival at the emergency department (50). Tight control of physiologic parameters, including blood pressure, temperature, oxygen saturation, and glucose levels, should be maintained without delaying acute treatment (11, 51). Intravenous recombinant tissue plasminogen activator is the only therapy approved by the US Food and Drug Administration for the treatment of ischemic stroke and is associated with improved outcomes for a broad spectrum of patients, with earlier treatment (within 60 min) more likely to result in a favorable outcome (51). Access to IV tPA therapy can be improved by employing a ‘drip and ship’ paradigm, whereby eligible patients begin IV tPA within the 3.0- to 4.5-h treatment window in the emergency department of initial presentation, before transferring to a specialized stroke center (52). ‘Telestroke’ networks, using audio and video conferencing, can enhance this process (53). The overall success of IV tPA is dependent on early presentation at hospital and the shortest possible door-to-needle time (54). Intra-arterial thrombolysis and/or mechanical embolectomy can be used in cases unresponsive to,

or ineligible for, IV tPA. Although the safety of these techniques has been established, randomized controlled trials are needed to validate efficacy. Prevention of complications

An important component of the continuum of stroke care is the prevention of complications. This includes early mobilization, prophylaxis for deep vein thrombosis, swallowing assessment to prevent aspiration pneumonia, the limited use and early discontinuation of urinary catheters to prevent urinary tract infection, and the prevention of falls post-stroke (55). Complications arising from immobility – including actelectasis, pneumonia, deep vein thrombosis, and pulmonary embolism – account for over 50% of deaths in the 30 days following ischemic stroke (56). Early mobilization reduces the risk of such complications and has been shown to be feasible and safe (57), although initial transfer from bed to an upright position should be monitored closely for signs of neurological worsening during movement (55). Rehabilitation

The majority of stroke patients require rehabilitation to optimize their recovery and minimize disability (58). Post-stroke rehabilitation involves a multidisciplinary team and can be provided in the hospital and/or community setting, its objectives being to optimize patients’ functional capacity and to successfully reintegrate them into family, social, and work life (59). Well-organized multidisciplinary stroke rehabilitation programs in the post-acute period have been shown to reduce mortality, morbidity, and dependency and improve functional outcomes (58). Intensive rehabilitation immediately post-stroke is therefore required to limit disability and improve recovery (60). Rehabilitation therapy should commence as soon as possible after the patient becomes medically stable, and continue as needed and tolerated until the patient is able to adapt, recover, and/or reestablish optimal functional independence (60). It is critically important to include an assessment and plan for cognitive and emotional rehabilitation. Formal neuropsychological testing or screening tools for cognitive impairment, such as the Folstein test (Mini-Mental State Examination; MMSE) (61), Montreal Cognitive Assessment (MoCA) (62), or Saint Louis University Mental Status examination (SLUMS) (63), and depression screening can be initiated in the acute or post-acute setting. 77

Rymer et al. Secondary prevention

The final step in the acute stroke management pathway is the implementation of secondary prevention strategies to minimize the risk of stroke recurrence. Finding the cause of the stroke is the first step. If a structural cause of the stroke is identified, such as carotid stenosis, then it needs to be addressed. Patients should be assessed for vascular risk factors, such as hypertension, hyperlipidemia, and diabetes, and strategies should be put in place to treat these conditions. Antithrombotic therapy with anticoagulation for cardiogenic stroke and antiplatelet therapy for other etiologies should be initiated. Patients should also be advised regarding lifestyle modifications (e.g., smoking cessation, healthy eating, exercise). Long-term post-stroke care

Stroke survivors can experience long-term problems (e.g., disability, cognitive impairment, fatigue, pain, urinary incontinence, depression) for many years post-stroke, which can have a major impact on their overall health status, functional ability, and quality of life (64–68). A comprehensive stroke strategy is therefore required to ensure that the long-term needs of stroke survivors are recognized and addressed (69). The use of screening tools, such as the ‘post-stroke checklist’, may help to provide a standardized approach for healthcare providers to identify and manage long-term problems in stroke survivors (69). The post-stroke checklist is endorsed by the World Stroke Organization (70) and the Canadian Best Practice Recommendations for Stroke Care (71). In addition to these screening tools, there are excellent tools available for assessing cognition and mood that can be considered in the acute setting, as well as during long-term post-stroke follow-up, which can help direct further intervention, as indicated. Conclusion

Although there have been significant advances in the improvement and measurement of the quality of care for acute stroke patients, there remains a need to assess how these improvements translate into long-term outcomes that are meaningful to patients, in terms of overall health status, functional ability, cognition, and quality of life. The outcome metrics outlined in this paper are the consensus of a global forum of stroke experts and provide a framework for the assessment of acute stroke care provision, with regard to access to care and patient outcomes, in both the 78

hospital and post-discharge settings. Improvements can be made along the entire continuum of the stroke care pathway, depending on the resources available in each country and region. These improvements should be introduced incrementally. It is important to recognize that such improvements are not necessarily dependent on increasing resources, but, rather, on optimal organization of the resources that are already available; for example, effective collaboration between different stroke services and hospitals is likely to reduce prehospital delays and thereby improve patient outcomes. Alongside this, comprehensive patient data should be continually collected and analyzed using core metrics (as outlined here) to validate whether these incremental changes actually improve patient outcomes. Such analyses should be benchmarked against national and international data, where possible. Acute stroke management is evolving as new treatments and technologies emerge. It is therefore important to continually strive to improve the provision of stroke care, while ensuring that improvements in the process of stroke management lead to corresponding improvements in patient outcomes. Acknowledgments Editorial support for the preparation of this publication was provided by mXm Medical Communications and funded by GE Healthcare. The Global Stroke Forum was organized and funded by GE Healthcare.

Conflict of interest and sources of funding statement M. Rymer, Covidien Medical Inc (speakers bureau), Genentech Inc (research support), and Medtronic Inc (steering committee for research). N. Ma, The Medical Capital Development Fund (2009-1037). H. Rowley, consulting income from GE Healthcare, Lundbeck, HL Gore, and Bracco. O. Williams, (PI) NINDS 1U54NS081765-01, (PI) NINDS 1 R01 NS067443-01A1, and (PI) NYCDOH 11AC074301R0X00. C. Anderson, N. Bornstein, M. Harada, J. Jarosz, D. Summers, and K. Tastula have no conflict of interests to declare. The opinions expressed in this article are the independent consensus views of the authors and have not been influenced by third-party sponsorship.

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Stroke service: how can we improve and measure outcomes? Consensus summary from a global stroke forum.

The success of acute stroke treatment is first and foremost time-dependent, and the need for improvement in acute stroke management is demonstrated by...
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