Medical and Rehabilitation Innovations
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1 Medical and Rehabilitation Innovations Disorders of Consciousness Programs Paradigm Management Services, LLC ( Paradigm ). No part of this publication may be reproduced, transmitted, transcribed, shared, disseminated, summarized, stored in a retrieval system, adapted, or translated into any language in any form by any means without the written permission of Paradigm. Trademarks, service marks, products names, company names or logos of Paradigm are protected by trademark and other laws of the United States, as well as international conventions and the laws of other countries.
2 Background Over the past two decades, advances in the medical management of traumatic injuries have improved the survival of patients with severe brain injuries (TBI). As a result, there are a significant number of severe TBI survivors experiencing extended (greater than 21 days) states of disorders of consciousness (DoC) such as coma, vegetative state (VS), and minimally conscious state (MCS). It has been estimated that as many as 30-40% of severe TBI survivors will remain in prolonged states of severely impaired consciousness. Recently, both research and clinical experience have suggested that outcomes after prolonged DoC are much better than previously thought. Hence, there is a growing consensus that patients with a disorder of consciousness may benefit from the services provided by specialized DoC programs. Definitions It is crucial to understand the terms used in disorders of consciousness, as the distinctions they describe are clinically significant. Consciousness is characterized by awareness of self and/or the environment. Coma is state of unconsciousness characterized by the complete loss of spontaneous or stimulusinduced arousal (as evidenced by the lack of eye opening). It is a self-limited state, lasting no longer than four to six (4-6) weeks, followed by evolution to either the vegetative state or minimally conscious state. Vegetative state (VS) is a state of unconsciousness with preserved capacity for spontaneous arousal; although patients have periods of wakefulness (as evidenced by eye opening), they remain unconscious. For this reason, the vegetative state can be considered a state of wakeful unconsciousness as opposed to coma, which can be thought of as a state of unarousable unconsciousness. Unlike coma, the vegetative state can be a chronic condition. Minimally Conscious state (MCS) is a condition of severely altered consciousness in which minimal but definite behavioral evidence of self and/or environmental awareness is demonstrated, although the behaviors can be subtle and inconsistent. Like the vegetative state, the minimally conscious state can be a chronic condition. Emergence from the minimally conscious state occurs when the patient demonstrates functional object use and/or functional communication. Known Challenges with DoC Diagnostic error Multiple studies have found high rates of diagnostic error in DoC, especially in regard to differentiating the vegetative state (VS) from the minimally conscious state (MCS). Across these studies, up to 42% of patients thought to be vegetative (and thus unconscious) are, in fact, at least in a MCS (and thus conscious). Reasons for the high rate of diagnostic error include issues related to the patients as well as 2
3 to the examiners. With regard to the patients, it is notable that conscious behavior in MCS is very inconsistent and subtle and thus easily missed. With regard to the examiners these patients most frequently encounter, there is widespread confusion and perhaps lack of knowledge about the various disorders of consciousness as well as lack of experience in systematically assessing these patients. Misdiagnosis of the VS can have significant and even devastating consequences. For example, life support measures may be withdrawn from a patient thought to be vegetative when, in fact, they are indeed conscious. Alternatively, patients thought to be vegetative may not be referred for appropriate services. This might set into motion a self-reinforcing set of circumstances with regards to suboptimal outcomes: a misdiagnosis of VS leads to an unduly pessimistic prognosis about outcome, resulting in referral to a minimal (and inappropriate) level of service, which itself increases the likelihood of a suboptimal outcome. Reversible causes of impaired consciousness There are a number of reversible factors that can impair consciousness, including the presence of sedating medications, hydrocephalus, subclinical seizures, and neuroendocrine abnormalities. These conditions can prolong, often indefinitely, a DoC state in a patient who would otherwise be much less impaired or even possibly fully conscious. Unfortunately, clinicians without expertise in DoC frequently fail to identify and address these conditions, with obvious deleterious and potentially devastating consequences. Severe impairments of neuromuscular function Not surprisingly, patients with severe alterations in consciousness often have significant neuromuscular impairment such as weakness (due to both central and peripheral neurologic causes), hypertonicity, and contractures. Beyond the well-known consequences of these impairments (such as pain, skin breakdown and increased caregiver burden), there are specific issues that arise in patients with DoC. Most notably, these impairments can complicate the assessment of a patient s level of consciousness. For example, neuromuscular impairments might prevent a patient with the necessary cognitive capacities from being able to follow a command and thus lead to an underestimation of a patient s level of consciousness. And these impairments often are the primary barriers to establishing a communication system and the ability to control the environment, two of the most important goals for patients who are minimally conscious. The proper management of these complex impairments requires a level of expertise and experience that is typically only found in specialized brain injury programs with sufficient volume of severe brain injuries. Medical complications Patients with disorders of consciousness have frequent and often severe medical/neurological complications that require management by clinicians with significant knowledge of and experience with severe brain injury. A study done by Whyte et al in 2013 found that, during the early months after severe TBI, there was on average one new medical complication event every two weeks. Another study found that 40% of patients in a specialized DoC program had at least one program interruption attributable to a complication or surgery. Examples of commonly encountered complications include: Neurological: hydrocephalus, paroxysmal sympathetic hyperactivity, seizures Neuromuscular: spasticity, contractures 3
4 Medical: infections (especially respiratory & urinary), venous thrombosis, blood pressure instability Other: skin breakdown, feeding tube issues Prognostication Although recent studies have shown that outcomes after traumatic DoC are significantly better than is often assumed, it is still very difficult to accurately prognosticate long-term outcome early after a traumatic DoC. Yet prognosis plays a crucial role in the care of these patients. Families identify the need for accurate prognostic information as one of their greatest needs after TBI. Moreover, beliefs about prognosis directly affect care (e.g., by influencing decisions about the level and extent of care to be provided). As with diagnosis, evidence suggests high rates of misprognostication in this population, underscoring the need for involvement by clinicians with knowledge of and experience with the longterm outcomes of these patients. Caregiver needs Family members and caregivers of patients with a DoC have unique educational needs. In particular, the concept of consciousness and the different categories of DoC are quite novel for most laypeople and require extensive explanation, especially initially, and need continuous reinforcement. Moreover, given the significant neurological and medical issues associated with prolonged DoC, families who will be taking these patients home require extensive training to manage the medical, neurological, neuromuscular, and nursing issues in order to minimize complications and medical care needs. Finally, families of patients with DoC are especially susceptible to the consequences of grief, depression, caregiver stress, etc., and often require support to address these issues. Ethical issues Because of the extreme nature of these conditions, ethical issues often arise in the care of these patients, even in the sub-acute or chronic phase. In particular, requests to limit treatment may arise and facilities that care for these patients need to be prepared to address these requests in a psychologically sensitive and ethically appropriate manner. LITERATURE SUMMARY Prior studies on DoC were limited by the significant challenges to research in this area, not the least of which was the fact that understanding and agreement about the very nature and definitions of disorders of consciousness is less than two decades old. As a result, earlier studies reported a wide range of outcomes: mortality rates ranged from 5-65%, while rates of recovery of consciousness ranged from 14-95% x. Fortunately, recently clarified guidelines from several professional groups (e.g. American Academy of Neurology, American Congress of Rehabilitation Medicine, NIDRR TBI Model Systems, etc.) have facilitated research in this area, grounded in common definitions of diagnoses and outcomes. Evidence of Efficacy Two recent prospective clinical studies suggest improved outcomes in severe TBI patients, including persons with DoC, when provided early and continuous rehabilitation as compared to those TBI patients 4
5 who did not receive early rehabilitation. A more recent study specifically addressed patients with a disorder of consciousness, utilizing data from the NIDRR TBI Model Systems database. The objective of this longitudinal study was to characterize the five-year outcomes of patients who were not following commands at the time of admission to acute inpatient rehabilitation. Contrary to the generally negative conventional perspective, this study showed substantial recovery among patients with DoC receiving rehabilitation therapy early after TBI, with two-thirds of patients regaining command-following ability during their rehabilitation admission and one-fourth of patients emerging from post-traumatic amnesia and regaining orientation. Of the patients who regained the ability to follow commands during inpatient rehabilitation, well over half were functioning independently by five years post-injury (range 56-85%, depending on the functional domain). Of special interest are the outcomes of the patients who were not following commands by the time of discharge from acute inpatient rehabilitation. Even in this group, a substantial number of patients were functioning independently by five years post-injury (range 19-36%, depending on the functional domain). These studies highlight the fact that patients with prolonged (>21 days) post-traumatic disorders of consciousness have a much better prognosis than is often believed. Moreover, the studies suggest the benefit of early rehabilitation in programs specializing in the care of patients with severe brain injuries. Disorders of Consciousness (DoC) Programs Indications Patients with a prolonged DoC (> 3 weeks after injury) should be considered for a specialized DoC program. Paradigm Outcomes Checklist for DoC programs Paradigm s DoC 7-point checklist: The following checklist must be considered and completed by the Paradigm Management Teams before making the decision to pursue a specific DoC program for injured workers under a Paradigm case contract. Has the program has been in existence a minimum of 3 years? (1 point) Does the program admit a minimum of 20 patients per year? (1 point) Is the program housed in an inpatient rehabilitation facility? (1 point) Does the program have explicit entry and exit criteria? (1 point) Does the program collect and make accessible outcome data, including, but not limited to: (total of 1 point) o change in level of consciousness, o discharge disposition, o average/median lengths of stay, o rate of transfers to a higher level of care, o rate of emergence. Does the program have an expansive medical and surgical specialist support system? (1 point) Lastly, if and when there is a published DoC guideline developed by a DoC expert group or congress (e.g., NIDRR and VA TBI Model System Disorder of Consciousness Special Interest Group and ACRM Brain Injury I-SIG Disorder of Consciousness Task Force) 5
6 Does the program follow the minimal competency recommendations developed and adopted by the DoC expert group or task force? (1 point) PARADIGM POSITION Summary and External Messaging Due to the paramount importance of accurately diagnosing patients with a prolonged disorder of consciousness (> 21 days) as well as ensuring the provision of appropriate medical/rehabilitative care to maximize the likelihood of achieving the best functional outcomes, Paradigm Outcomes currently supports the use of provider facilities with comprehensive disorders of consciousness programs that explicitly meet the criteria listed above and scores at the minimum of 6 points in Paradigm s DoC 7 point checklist. Injured workers who are admitted into DoC programs must be flagged and Paradigm s Medical Affairs Division be notified (i.e., CMO or Clinical Analyst). In addition, the following clinical data must be collected for each of the cases referred to DoC program. o diagnosis at the time of DoC program entry o change in level of consciousness during and at discharge from DoC program (e.g., CRS-R) o discharge disposition o average/median lengths of stay o rate of transfers to a higher level of care o rate of emergence Paradigm s 3 Hs: Help: A comprehensive DoC treatment program meeting Paradigm s criteria can benefit injured workers in a prolonged DoC state by: accurately assessing the level of consciousness, implementing interventions that might accelerate the recovery of consciousness, maintaining and enhancing physical integrity, providing appropriate medical/nursing interventions to mitigate secondary complications, and educating & training caregivers. This early DoC treatment is likely to minimize complications as well as optimize neurological and functional outcomes. Hope: By enhancing neurological outcome and medical stability, DoC programs will (1) reduce the resources needed to manage secondary complications (including rehospitalization rates) and (2) increase the rate of successful discharge to home. Hype: All patients who participate in a disorders of consciousness program will emerge from their DoC and return to productive activity. Financial Impact The following clinical analysis is based upon the eleven (11) injured workers in our current Paradigm database, and we hope that the data will be helpful for budgeting and expectation setting. Paradigm s future DoC cases and the respective outcomes will be compiled and summarized annually. 6
7 The following table summarizes Injured Worker disposition from Initial Inpatient Rehab admission vs. Last Inpatient Rehab admission to-date on our DoC cases. Please note that the majority of our current DoC cases are still in active care management; hence, final placement location will be updated once the cases have come to completion in the near future. ENDNOTES Key References 1. Nakase-Richardson, Riza et al. Do Rehospitalization Rates Differ Among Injury Severity Levels in the NIDRR Traumatic Brain Injury Model Systems Program? Archives of Physical Medicine and Rehabilitation. 2013; 94: Giacino, Joseph et al. The Vegetative and Minimally Conscious States: A Comparison of Clinical Features and Functional Outcome. J. Head Trauma Rehabilitation. 1997; 12 (4): Seel, RT et al. Specialized Early Treatment for Persons With Disorders of Consciousness: Program Components and Outcomes. Archives of Physical Medicine and Rehabilitation. 2013; 94:
8 4. Whyte, John et al. Medical Complications During Inpatient Rehabilitation Among Patients With Traumatic Disorders of Consciousness. Archives of Physical Medicine and Rehabilitation. 2013; 94: Edlow, Brian et al. Unexpected Recovery of Function After Severe Traumatic Brain Injury: The Limits of Early Neuroimaging-Based Outcome Prediction. Neurocritical Care. July 17, 2013; DOI /s x 6. Ganesh, Shanti et al. Medical Comorbidities in Disorders of Consciousness Patients and Their Association With Functional Outcomes. Archives of Physical Medicine and Rehabilitation. 2013; 94: Acknowledgments Special thanks to Sunil Kothari, MD, Paradigm Medical Director; Paradigm ICMO group Chris Anderson & Laurie Anderson; and the Paradigm Outcomes Medical Affairs Leadership Michael Choo, MD & Steven Moskowitz, MD, for contributing to this paper Paradigm Management Services, LLC ( Paradigm ). No part of this publication may be reproduced, transmitted, transcribed, shared, disseminated, summarized, stored in a retrieval system, adapted, or translated into any language in any form by any means without the written permission of Paradigm. Trademarks, service marks, products names, company names or logos of Paradigm are protected by trademark and other laws of the United States, as well as international conventions and the laws of other countries. 8
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