(Stroke. 2005;36:e100.)
© 2005 American Heart Association, Inc.
AHA/ASA-Endorsed Practice Guidelines |
Stroke is a leading cause of disability in the United States.1 The Veterans Health Administration (VHA) of the Department of Veterans Affairs (VA) estimates that 15 000 veterans are hospitalized for stroke each year (VA HSR&D, 1997).
Forty percent of stroke patients are left with moderate functional impairments and 15% to 30% with severe disability.2 Effective rehabilitation interventions initiated early after stroke can enhance the recovery process and minimize functional disability. Improved functional outcomes for patients also contribute to patient satisfaction and reduce potential costly long-term care expenditures.
There are only 45 rehabilitation bed units (RBUs) in the VA today. Many veterans who have a stroke and are admitted to a VA Medical Center will find themselves in a facility that does not offer comprehensive, integrated, multidisciplinary care. In a VA rehabilitation field survey published in December 2000, more than half of the respondents reported that the "rehabilitative care of stroke patients was incomplete, fragmented, and not well coordinated" at sites lacking a RBU (VA Stroke Medical Rehabilitation Questionnaire Results, 2000).
In Department of Defense (DoD) medical treatment facilities, approximately 20 000 active-duty personnel and dependents were seen in 2002 for stroke and stroke-related diagnoses according to ICD-9 coding.3 Comprehensive treatment for stroke patients in DoD medical facilities is given primarily at medical centers. Smaller DoD community hospitals may have limited resources to see both inpatients and outpatients, relying more on the TRICARE network for ongoing stroke rehabilitation services.
A growing body of evidence indicates that patients do better with a well-organized, multidisciplinary approach to post-acute rehabilitation after a stroke.46 The VA/DoD Stroke Rehabilitation Working Group only focused on the postacute stroke rehabilitation care.
Duncan and colleagues7 found that greater adherence to post-acute stroke rehabilitation guidelines was associated with improved patient outcomes and concluded "compliance with guidelines may be viewed as a quality of care indicator with which to evaluate new organizational and funding changes involving post-acute stroke rehabilitation." The VA developed an algorithm for the Stroke/Lower-Extremity Amputee Algorithms Guide 1996 (see Algorithms![]()
), and the results of implementation of this guideline demonstrated the utility of the algorithm as well as the feasibility of implementing a standard algorithm of rehabilitation care in a large healthcare system.8
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The VA/DoD Stroke Rehabilitation Working Group built on the 1996 VA Stroke/Lower-Extremity Amputee Algorithms Guide and incorporated information from the following existing evidence-based guidelines/reports (see Appendix B, Guideline Development Process):
The most important goal of the VA/DoD Clinical Practice Guideline for the Management of Stroke Rehabilitation is to provide a scientific evidence base for practice interventions and evaluations. The guideline was developed to assist facilities to put in place processes of care that are evidence based and designed to achieve maximum functionality and independence and improve patient/family quality of life. It will provide facilities lacking an organized RBU with a structured approach to stroke care and assure that veterans who suffer a stroke will have access to comparable care, regardless of geographic location. The algorithm will serve as a guide that clinicians can use to determine best interventions and timing of care for their patients, better stratify stroke patients, reduce readmission, and optimize healthcare utilization. If followed, the guideline is expected to have an impact on multiple measurable patient outcome domains.
Finally, new technology and more research will improve patient care in the future. The clinical practice guideline can assist in identifying priorities for research efforts and allocation of resources. As a result of implementing evidence-based practice, followed by data collection and assessment, new practice-based evidence may emerge.
A. Key Points
B. Outcome Measures
Effective rehabilitation improves functional outcome. An indicator for improvement is the positive change in the Functional Independence Measures (FIM; see Appendix C) score over a period of time in the post-acute care period. Within the Veterans Health Administration (VHA) this measure is captured in the Functional Status and Outcomes Database for rehabilitation. All stroke patients should be entered into the database, as directed by VHA Directive 2000-016 (dated June 5, 2000; Medical Rehabilitation Outcomes for Stroke, Traumatic Brain, and Lower-Extremity Amputee Patients).12
Additional indicators that should be measured at 3 months after the acute stroke episode may include the following:
The primary outcome measure for assessment of functional status is the FIM (see Appendix C).13 The FIM has been tested extensively in rehabilitation for reliability, validity, and sensitivity and is by far the most commonly used outcome measure. A return to independent living requires not only the ability to perform basic ADLs but also the ability to carry out more complex activities (ie, IADLs), such as shopping, meal preparation, use of the phone, driving a car, and money management. These functions should be evaluated as the patient returns to the community. New stroke-specific outcome measures, such as the Stroke Impact Scale,14 may be considered for a more comprehensive assessment of functional status and quality of life.
II. The Provision of Rehabilitation Care
A. Organization of Post-Acute Stroke Rehabilitation Care
Background
Stroke rehabilitation begins during the acute hospitalization, as soon as the diagnosis of stroke is established and life-threatening problems are under control. The highest priorities during this early phase are to prevent a recurrent stroke and complications, ensure proper management of general health functions, mobilize the patient, encourage resumption of self-care activities, and provide emotional support to the patient and family. After the "acute" phase of stroke care, the focus of care turns to assessment and recovery of any residual physical and cognitive deficits, as well as compensation for residual impairment.
Over the years, the organization and delivery of stroke care have taken many forms. With the growth of physical medicine, occupational therapy, and physical therapy, varying therapeutics and treatment settings have evolved. Assessment of the effect of stroke care organization and settings is difficult because of the extreme variability of organizational settings. For example, on the one extreme, rehabilitation services can be provided in an outpatient setting, 1 hour per day, 3 days per week, by 1 therapist. At the other end of the structural continuum, rehabilitation services can be provided in a rehabilitation hospital setting, 5 hours per day, 7 days per week, by a team made up of several clinicians.
The Agency for Healthcare Policy and Research Guideline for Post-Stroke Rehabilitation (AHCPR, 1995) has concluded9: "A considerable body of evidence, mainly from countries in Western Europe, indicates that better clinical outcomes are achieved when patients with acute stroke are treated in a setting that provides coordinated, multidisciplinary stroke-related evaluation and services. Skilled staff, better organization of services, and earlier implementation of rehabilitation interventions appear to be important components."
The VA/DoD Working Group reviewed several studies and trials addressing the question of organization of care. Although the reviews and trials make it clear that rehabilitation is a dominant component of organized services, it is not possible to specify precise standards and protocols for specific types of specialized units for stroke patients. Their limitations stem from imperfections in the way the reviews and trials controlled for differences in the structure and content of multidisciplinary/standard care programs, the period defined as post-acute stroke care, staff experience and staff mix, and patient need for rehabilitation therapy (ie, stroke severity and type).
Recommendations
Discussion
The evidence for both acute and post-acute (rehabilitation) stroke care suggests that organized care for poststroke patients is worthwhile to achieve optimal outcomes, and the outcomes measured are substantial (ie, mortality and dependency and return to community living). In several randomized controlled trials (RCTs),1620 stroke unit care or organized inpatient multidisciplinary rehabilitation showed improved outcome compared with "standard" care (see Table 1).
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Studies of Care in the Acute and PostAcute Stroke Rehabilitation Settings
The Stroke Unit Trialists Collaboration review16 (which was updated in 20016) concluded, "Patients receiving organized inpatient stroke unit care were more likely to survive, regain independence, and return home than those receiving a less organized service." The Cochrane review further concluded, "Acute stroke patients should be offered organized inpatient stroke unit care, typically provided by a coordinated multidisciplinary team operating within a discrete stroke ward that can offer a substantial period of rehabilitation, if required. There are no firm grounds for restricting access according to a patients age, sex, or stroke severity." However, the reviewers also cautioned that there could be a wide range of results because of varying outcome rates and confidence intervals. The most recent update of this systematic review involved investigators from nearly all the trials,6 to try to determine why stroke unit care was superior. They found little evidence of differences in staff numbers or mix, although a tendency was shown for assessment and therapy to begin earlier in organized settings.
Evans and colleagues5 compared the effectiveness of multidisciplinary inpatient physical rehabilitation programs with standard medical care. On the basis of 11 studies, the researchers found that rehabilitation services improved short-term survival, functional ability, and most independent discharge location. However, they did not find long-term benefits. The authors suggested, "The lack of long-term benefits of short-term rehabilitation may suggest that therapy should be extended to home or subacute care settings, rather than being discontinued at discharge."
In 1999, Cifu and Stewart4 reviewed studies that investigated the type of inpatient rehabilitation (interdisciplinary versus multidisciplinary) as a predictor of outcome after a stroke. The authors concluded that an interdisciplinary setting (ie, services "provided by diverse professionals who constitute a team that communicates regularly and uses its varying expertise to work toward common goals") is strongly related to improved outcome. A specialized multidisciplinary team (which usually includes similar professionals as an interdisciplinary team, but with less consistent "regular communication and common goal orientation") appears to be less effective if it lacks the organizational structure provided by regular communication. Other predictors for improved outcome at hospital discharge and follow-up were increased functional skills on admission to rehabilitation and early initiation of rehabilitation services. Specialized therapy and a greater intensity of therapy services had "a weak relationship with improved functional outcome at hospital discharge and follow-up," and the authors observed that the "current literature is too limited to allow an assessment of the relationship of specific types of noninpatient rehabilitation services after stroke and functional outcome."
Indredavik et al1922 examined the long-term benefits for a combined acute and rehabilitation stroke unit in Norway. Starting with 220 patients, the researchers compared outcomes for surviving patients at 5 years (n=77) and 10 years (n=31) after discharge. Differences in treatment were confined to the first 6 weeks of treatment. Reportedly, there were no differences in the severity of the strokes in the control and experimental groups. Quality of life was measured by the Frenchay Activities Index (FAI), Nottingham Health Profile (81% of patients), and a visual analog scale (86% of patients). Functional status was measured using the Barthel Index (BI).23,24 More patients in the stroke unit group had an FAI score greater than 30 than did patients in the general ward. The FAI and visual analog scale scores favored stroke unit patients (34.2 versus 27.2; P=0.01 for FAI and 72.8 versus 50.7 mm; P=0.002 for the visual analog scale). Patients in both groups who had better functional status measured by the BI also had higher quality of life scores. Acute care in a stroke unit improved quality of life for patients at 5 years.20 The researchers also studied survival, proportion of patients living at home, and functional status measured by the BI. Intention-to-treat analysis was used. At 5 years, the Kaplan-Meier survival curve analysis showed that survival was higher in the stroke unit group than in the ward care group (41% versus 29%; P=0.04). More patients who received stroke unit care were living at home (P=0.006), were independent (BI score >95; P=0.004), or were at least partly independent (BI score >60; P=0.006).22 The groups did not differ for help or support received at home. Stroke unit care improved long-term survival and functional status and increased the number of patients living at home.
In a RCT,25 457 acute stroke patients were assigned to 3 different levels of treatment (stroke unit, general ward, and domiciliary care). Patients who survived without severe disability at 1 year after stroke in the 3 groups were as follows: 129 (85%), 99 (66%), and 102 (71%), respectively. Stroke unit care was significantly better than that at the 2 lower levels of care. The net effect of the stroke unit was profoundly different for approximately 30 patients (20% of sample).
Studies of Care in the PostAcute Stroke Rehabilitation Setting
Langhorne and Duncan17 conducted a systematic review of a subset of the studies identified by the Stroke Unit Trialists Collaboration, those that deal with postacute rehabilitation stroke services. They defined intervention as "organized inpatient multidisciplinary rehabilitation commencing at least 1 week after stroke" and sought randomized trials that compared this model of care with an alternative. In a heterogeneous group of 9 trials (6 involving stroke rehabilitation units and 3 involving general rehabilitation wards) that recruited 1437 patients, organized inpatient multidisciplinary rehabilitation was associated with a reduced odds of death (OR=0.66; 95% CI, 0.49 to 0.88; P<0.01), death or institutionalization (OR=0.70; 95% CI, 0.56 to 0.88; P<0.001), and death or dependency (OR=0.65; 95% CI, 0.50 to 0.85; P<0.001), which was consistent across a variety of trial subgroups. For every 100 patients receiving organized inpatient multidisciplinary rehabilitation, an extra 5 returned home in an independent state. This review of postacute stroke care concluded that there can be substantial benefit from organized inpatient multidisciplinary rehabilitation in the post-acute period, which is both statistically significant and clinically important.
One RCT has been published26 since the most recent update of the collaborations work. This study, which deals with both acute and rehabilitative care, sought to quantify the differences between staff interventions in a stroke unit versus staff interventions on a general ward supported by a stroke specialist team. Observations were made daily for the first week of acute care but only weekly during the post-acute phase. During the observation period, the stroke unit patients were monitored more frequently and received better supportive care, including early initiation of feeding.
Because of the heterogeneity of the literature with regard to patient samples, structural design, and outcome measures, it is difficult to identify a "best practice" that applies to all patients with stroke. The evidence does not indicate the specific nature of the intervention or provide explanation of the nature of the team approach or which factor has the greatest impact on patient outcome. The very nature of stroke and its multifaceted effects create the need for a flexible and multifaceted treatment approach.
Evidence
See Table 1.
B. The Use of Standardized Assessment Tools
Background
Comprehensive assessment of patients with stroke is necessary for appropriate clinical management and evaluation of outcomes for quality management and research.27 The AHCPR Post-Stroke Rehabilitation Guideline recommends the use of well-validated, standardized instruments in evaluating stroke patients. These instruments help to ensure reliable documentation of the patients neurological conditions, levels of disability, functional independence, family support, quality of life, and progress over time.9
Recommendations
Discussion
The AHCPR guideline9 recommends that "Screening for possible admission to a rehabilitation program should be performed as soon as the patients neurological and medical condition permits. The individual(s) performing the screening examination should be experienced in stroke rehabilitation and preferably should have no direct financial interest in the referral decision. All screening information should be summarized in the acute medical record and provided to the rehabilitation setting at the time of referral" (Research evidence=NA; Expert opinion=strong consensus).
The AHCPR guideline panel evaluated the strengths and weaknesses of a battery of standardized instruments for assessment of stroke patients. Appendix D includes a list of preferred standard instruments recommended by the AHCPR guideline panel for patient assessment in stroke. Certain tests have established protocol for credentialing that must be adhered to (eg, Functional Independence Measure [FIM], National Outcome Measure System [NOMS], and National Institutes of Health Stroke Scale [NIHSS]). However, only the FIM and the NIHSS are widely used.
A partial listing of standardized tools can be found at The University of Kansas Landon Center on Aging Web site at www2.kumc.edu/coa/Pepper/pepper.htm. Although the listing is not all-inclusive, it provides references, tools, and an Access database (toolbox) that may be useful to the coordinated rehabilitation team in completing formal assessments.
New stroke-specific outcome measures that may be useful for assessing functional status and quality of life are currently under development (see Appendix D).
The NIHSS Score
The NIHSS score (see also Section III-C "Assess Stroke Severity" below) strongly predicts the likelihood of a patients recovery after stroke. A score of greater than 16 forecasts a high probability of death or severe disability, whereas a score of less than 6 forecasts a good recovery.28
Patients with a severe neurological deficit after stroke, as measured by the NIHSS, have a poor prognosis. During the first week after acute ischemic stroke, it is possible to identify a subset of patients who are highly likely to have a poor outcome.29
The Veterans Health Administration has issued a directive that all individuals who have rehabilitation potential have a functional status outcome assessment, which includes the FIM.12 These data are captured in a functional outcomes database maintained by the physical medicine and rehabilitation service.
Evidence
See Table 2.
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C. Intensity/Duration of Therapy
Background
There has been controversy in the past about the timing of initiation of therapy and intensity of therapy required for the acute stroke patient to gain maximum functional outcome. Although patients who are medically unstable are considered not to be suitable for any rehabilitation program, studies generally support early mobilization of the patient with an acute stroke to prevent deep vein thrombosis (DVT), skin breakdown, contracture formation, constipation, and pneumonia. Early therapy initiation, including range-of-motion exercises and physiologically sound changes of bed position on the day of admission, followed by a progressive increase in the level of activity, should be provided as soon as medically tolerated. Early mobilization should also include encouraging the patient to resume self-care activities and socialization.
The physical demands of rehabilitation are substantial. The patients tolerance for therapy will depend on several factors including the severity of the stroke, medical stability, mental status, and level of function.
Recommendations
Discussion
Early Initiation of Therapy
One conclusion of a systematic review of 38 RCTs dating back to 1965 is that early rehabilitation therapy "appears to have a strong relationship" to improved functional outcome at hospital discharge and follow-up.4 However, the review does not present any quantitative information that indicates the differential gain associated with the provision of specific therapies at different times during the patients treatment. Nor is there any discussion of when therapy is early versus late/delayed or early relative to when it would be provided via standard care. Instead, the word "early" seems to have meant shortly after a stroke occurs, which could span a variable number of days.
Nine clinical trials focus with varying specificity on the early provision of rehabilitation therapy after a stroke. Importantly, using the word "early" as a search parameter did not ensure that an identified study would focus exclusively, primarily, or even secondarily on the scheduling of a service in its own right or compared with standard care. Instead, "early" often meant that the intervention began sometime shortly after a stroke, but with little empirical significance.30,31 "Early after stroke" simply meant whenever the therapy began.
One exception is a study by Paolucci and colleagues,32 which examined differences in outcomes for patients for whom therapy was initiated 20 days apart. The researchers found a strong inverse relationship between the start date and functional outcome (albeit with wide confidence intervals and a greater dropout risk). In other words, the earliest starters had significantly higher effectiveness of treatment than did the medium or latest groups. Treatment initiated within the first 20 days was associated with a significantly high probability of excellent therapeutic response (OR=6.11; 95% CI, 2.03 to 18.36), and beginning later was associated with a poor response (OR=5.18; 95% CI, 1.07 to 25.00). On the other hand, early intervention was associated with a 5 times greater risk of dropout than that of patients with delayed treatment (OR=4.99; 95% CI, 1.38 to 18.03).
A second study involved a comparison of an experimental group of patients who received 3 months of physiotherapy at home, immediately after a stroke, with a control group of patients who received therapy after a 3-month delay.33 The findings show that physiotherapy initiated early after stroke slightly improved gait speed (ie, a few seconds over 10 meters), but the improvement was not maintained 3 months after physiotherapy stopped.
Intensity of Therapy
The heterogeneity of the studies in all aspectspatients, designs, treatments, comparisons, outcome measures, and resultscombined with the borderline results in many of the trials limits the specificity and strength of any conclusions that can be drawn from them. Overall, the trials support the general concept that rehabilitation can improve functional outcomes, particularly in patients with lesser degrees of impairment. Weak evidence exists for a dose-response relationship between the intensity of the rehabilitation intervention and the functional outcomes. However, the lack of definition of lower thresholds, below which the intervention is useless, and upper thresholds, above which the marginal improvement is minimal, for any treatment, makes it impossible to generate specific guidelines.
Comparisons in many studies are between a more intense but also slightly different service than the controlany difference in outcome could be related to the difference in the nature of the treatment rather than just its intensity.
Despite all of these limitations, the conclusions of the systematic reviews are fairly consistent: The 2 meta-analyses both concluded that greater intensity produces slightly better outcomes.34,35 Langhorne et al concluded,34 "more intensive physiotherapy input was associated with a reduction in the combined poor outcome of death or deterioration and may enhance the rate of recovery." Kwakkel et al35 reported a small but statistically significant intensity-effect relationship in the rehabilitation of stroke patients. The recent meta-analysis of trials studying exercise therapy for arm function concluded,36 "the difference in results between studies with and without contrast in the amount or duration of exercise therapy between groups suggests that more exercise therapy may be beneficial." In all the reviews, insufficient contrast in the amount of rehabilitation between experimental and control conditions, organizational setting of rehabilitation management, lack of blinding procedures, and heterogeneity of patient characteristics were major confounding factors.
With regard to general factors affecting the effectiveness of rehabilitation, Cifu and Stewart4 concluded that greater intensity of therapy services has "a weak relationship with improved functional outcome." Only the early meta-analysis by Ottenbacher and Jannell30 has a neutral conclusion: "The improvement in performance appears related to early initiation of treatment, but not to the duration of intervention."
Four trials addressed intensity of physiotherapy or general rehabilitation services. The earliest trial randomized 133 discharged patients among intensive, routine, and no outpatient therapy and found a dose-response relationship with greater intensity, producing better performance on an index of ADLs.37 Sivenius et al38 divided 95 patients into intensive and normal treatment groups. Functional recovery, measured by motor function and ADLs, was slightly better in the intensive treatment group. Rapoport and Eerd39 found that adding weekend physiotherapy services reduced length of stay by comparing time periods during which 5-day-a-week or everyday therapy sessions were provided. Partridge et al40 did not find any differences in functional and psychological scores at 6 weeks in 104 patients randomized between a standard of 30 and 60 minutes of physiotherapy. Subgroup analyses suggested some subgroups might benefit.
Four additional trials targeted more specific disabilities of extremity function or gait. Sunderland et al41 assigned 132 consecutive stroke patients to routine or enhanced treatment for arm function, the latter including both increased duration and behavioral methods. At 6 months, the enhanced group showed a slight but statistically significant advantage, concentrated in those patients with milder impairment. Richards et al42 did a pilot study of 27 patients randomized to intensive, gait-focused physical therapy; early, intensive, conventional therapy; and routine conventional therapy. At 6 weeks gait velocity was better for the intensive, gait-focused group, but this advantage was not sustained at 3 and 6 months. Lincoln et al43 randomized 282 patients with impaired arm function to routine physiotherapy, additional treatment by a qualified physiotherapist, or additional treatment by the physiotherapy assistant. There were no differences among the groups on outcome measures of arm function and ADLs at baseline, 5 weeks, 3 months, or 6 months. Parry et al31 performed subgroup analyses of the same study and noted that patients with severe impairment improved little, but patients with lesser impairment may have benefited. Kwakkel et al35 randomized 101 middle-cerebral-artery stroke patients with arm and leg impairment to additional arm training emphasis, leg training emphasis, or arm and leg immobilization, each treatment lasting 30 minutes, 5 days a week, for 20 weeks. At 20 weeks the leg training group scored better for ADLs, walking, and dexterity than the control group, whereas the arm training group scored better only for dexterity.
The clinical trials provide weak evidence for a dose-response relationship of intensity to functional outcomes. Caution is called for in the interpretation of these studies because some patients may not be able to tolerate higher-than-normal levels of therapy. Other patients may not benefit because they do not belong to a subset of patients for whom benefit has been demonstrated. Because of the heterogeneity of the studies, no specific guidelines about intensity or duration of treatment are justified.
Evidence
See Table 3.
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D. Patients Family and Caregivers
Background
With the changes that have occurred in healthcare in the last decade, family members have become an integral part of the long-term care picture. Provision of long-term care can place family members under significant emotional, financial, and physical stress. Although a number of services are available to families/caregivers, the dissemination of this information is sometimes poor. As a result, many families are not able to take advantage of the resources available for respite, support groups, and financial aid. The family member/caregivers quality of life may be improved if he/she is educated about potential sources of stress and resources. However, education alone has not been found to be sufficient to improve the caregivers quality of life. Research in this area is limited and of variable quality.
Recommendations
Discussion
Clinicians need to be sensitive to potential adverse effects of caregiving on family functioning and the health of the caregiver. They should work with the patient and caregiver to avoid negative effects, promote problem solving, and facilitate reintegration of the patient into valued family and social roles.9 In general, caregivers cope with physical limitations better than cognitive or emotional ones.44 Strong social support has been shown to improve outcomes, especially in patients with severe physical or cognitive deficits.45
Current evidence suggests that stroke caregivers have elevated levels of depression at both the acute stroke phase and the chronic stroke phase. However, major gaps are apparent in this literature, with few studies addressing such areas as caregiver physical health, caregiver ethnicity, and caregiver interventions. Given the increasing prevalence of stroke, as well as the increasing pressures on families to provide care, more research is needed to guide policy and practice in this understudied topic.46
E. Patient and Family/Caregiver Education
Background
The patient and family/caregivers should be given information and provided with an opportunity to learn about the causes and consequences of stroke, potential complications, and the goals, process, and prognosis of rehabilitation.
Recommendations
Discussion
Information provision or educational interventions have not been shown to be sufficient, by themselves, to improve patient outcomes (3 systematic reviews, 7 clinical trials; see Table 4). Provision of information in a passive format (eg, giving pamphlets to patients) is not as effective as educational interventions that also include some form of personal support, such as home visits or classes.
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Educational interventions have been successful in improving the patients and caregivers knowledge about stroke, and may assist patients and caregivers in making effective decisions about treatments (3 systematic reviews, 7 clinical trials; see Table 4).
Better knowledge about stroke does not necessarily translate into better overall health or well-being for either patients or caregivers (2 systematic reviews, 4 clinical trials; see Table 4). Likewise, better decision-making ability has not been shown to result in improved overall outcomes (1 systematic review, 1 clinical trial). Some small trials have claimed success in improving the patients health habits through educational interventions. Although these results are promising, they must be seen as speculative at present (2 clinical trials).
Systematic Reviews
The systematic reviews (Cochrane) examined 3 types of educational interventions:
OConnor et al47 reviewed 24 trials of decision aids, and concluded "they are superior to usual care interventions in improving knowledge and realistic expectations of the benefits and harms of options; reducing passivity in decision making; and lowering decisional conflict stemming from feeling uninformed." The advantages of decision aids, however, were considered to be mixed: "They have had little effect on anxiety or satisfaction with the decision-making process or satisfaction with the decision. Their effects on choices vary with the decision. The effects on persistence with chosen therapies and health outcomes require further evaluation."
Forster and colleagues48 reviewed 9 studies of educational intervention. The authors excluded trials in which information giving was only 1 component of a more complex rehabilitation intervention (eg, family support worker trials). Forster et al found that in 2 good-quality trials, information-plus-education improved knowledge.51,52 Information plus education, however, had no effect on perceived health status and quality of life or on the Caregiver Hassles scale. One of the 2 relevant trials found an association between education provision and 4 of 7 subscales of a family functioning scale. However, 58% of the patients in that study did not attend 3 or more of the 6 classes offered. Forster et al48 noted, "There is a suggestion that information provided in an educational context is more effective than the simple provision of a booklet or leaflet. However, the success of such strategies is limited if they are unacceptable to the patient." The authors concluded, "The results of the review are limited by the variable quality of the trials and the wide range of outcome measures used. The general effectiveness of information provision has not been conclusively demonstrated."
Haynes et al49 reviewed 19 studies (not all conducted among patients with stroke) of interventions to affect adherence with prescribed, self-administered medications. Although 10 of the studies demonstrated a positive effect of the intervention on medication adherence, "almost all of the interventions that were effective for long-term care were complex, including combinations of more convenient care, information, counseling, reminders, self-monitoring, reinforcement, family therapy, and other forms of additional supervision or attention." It is likely that educational interventions alone would not have had a significant effect on these patients.
Clinical Trials
Each of the 7 clinical trials examined a different aspect of patient/caregiver education:
In a small study of 35 patients, Rimmer et al53 found improvements in the patients physical, mental, and social health after a 12-week health promotion intervention. Investigators for a self-management program for chronic disease54 found that "treatment subjects, when compared with control subjects, demonstrated improvements at 6 months in weekly minutes of exercise, frequency of cognitive symptom management, communication with physicians, self-reported health, health distress, fatigue, disability, and social/role activities limitations. They also had fewer hospitalizations and days in the hospital." Both of these studies included an educational component, but it is difficult to say how much of the patients improvement was due to education rather than the social context of the education or other factors.
In the remaining 5 studies,52,5558 researchers did not find any significant effect of the various interventions on patient clinical outcomes. The interventions did provide some benefit to patients and caregivers, however, such as increased knowledge about stroke and improved caregiver mental health58 and significantly increased social activities and improved quality of life for caregivers.57
Evans et al51 examined the effects of caregiver education with and without additional counseling. Both counseling and education significantly improved family functioning and caregiver knowledge. Counseling was more effective than education alone and also resulted in better patient functioning. Neither intervention affected use of social resources.
Forster et al48 provided evidence that passive education alone is not adequate to meet educational needs. Education should be interactive to be most beneficial to the patient and family/caregiver.
Evidence
See Table 4.
III. Rehabilitation During the Acute Phase
A. Patients With Stroke During the Acute Phase
AHCPR9 has defined "acute care" as "the period of time immediately following the onset of an acute stroke. A full-service hospital where patients with an acute stroke are treated either in a medical service or in a specialized stroke unit, and where rehabilitation interventions are normally begun during the acute phase."
Because of the nature of the neurological problems and the propensity for complications, most patients with acute ischemic stroke are admitted to a hospital. A recent meta-analysis demonstrates that outcome can be improved if a patient is admitted to a facility that specializes in the care of stroke. The goals of early supportive care after admission to the hospital are as follows:
After stabilization of the patients condition the following can be initiated, when appropriate: rehabilitation, measures to prevent long-term complications, chronic therapies to lessen the likelihood of recurrent stroke, family support, and treatment of depression.59
B. Obtain Medical History and Do Physical Examination
Objective
Obtain clinical data required to manage the stroke rehabilitation.
Background
Stroke rehabilitation begins during the acute hospitalization, as soon as the diagnosis of stroke is established and life-threatening problems are controlled. The highest priorities are to prevent recurrence of stroke and complications and begin mobilization.
Recommendations
B-1. Risk for Skin Breakdown
Background
Pressure ulcers affect approximately 9% of all hospitalized patients and 23% of all nursing home patients. This condition can be difficult and costly to treat and often results in pain, disfigurement, and prolonged hospitalization.9 It is crucial that healthcare personnel work collaboratively to prevent skin breakdown. Patients at highest risk for skin breakdown may have (1) dependence in mobility, (2) diabetes, (3) peripheral vascular disease, (4) urinary incontinence, (5) lower body mass index, and (6) end-stage disease.60,61
Recommendations
Discussion
A valid and reliable pressure ulcer risk assessment tool, such as the Braden Scale,62 can help predict the risk of pressure ulcer development and thus help the rehabilitation team to implement interventions to prevent skin breakdown. Such interventions may include, but are not limited to, the following: repositioning, mobilization, turning, proper transfer techniques, and the use of skin care/incontinence products and surface-pressurereducing devices. Treatment of any skin breakdown should begin promptly and be monitored daily.9,63
Evidence
See Table 5.
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B-2. Risk for Deep Vein Thrombosis
Background
There are several approaches to preventing DVT in stroke patients. Current practices include anticoagulation, intermittent pneumatic compression, compression stockings, and early mobilization. Walking as little as 50 feet per day, with or without assistance, significantly decreases the incidence of DVT after stroke.64
Recommendations
Discussion
The largest study for subcutaneous unfractionated heparin, the International Stroke Trial (IST),65 established that LDUH is safe in ischemic stroke. This trial also demonstrated a dose-response rate for hemorrhagic complications.
Comparative trials for DVT/PE prevention in a stroke population have not been performed; however, randomized trials of several LMWH and heparinoid products in ischemic stroke patients and other patient populations suggest an efficacy and safety superior to those of unfractionated heparin for DVT prevention. The Trial of ORG 10172 in Acute Stroke Treatment (TOAST) study66 demonstrated the safety of danaparoid in acute ischemic stroke patients, but the intravenous route, anticoagulation monitoring, and continuous dosing limit extrapolation to prophylactic use. Two meta-analyses found that LMWH reduced DVT and PE but increased bleeding in ischemic stroke victims.67,68 Another LMWH trial found a dose-response effect for DVT prevention and intracranial hemorrhage rate, both increasing at higher doses.69 Specific treatment recommendations about optimal LMWH agent and dosing cannot be made from the existing data.
The use of nonpharmacological approaches to DVT/PE prevention, such as intermittent pneumatic compression, graduated compression stockings, and early mobilization, appears to have some beneficial effect, although they were not tested in fully randomized controlled trials. Graded compression stockings produced a reduction in DVT incidence comparable to that in other patient groups (OR=0.43, 95% CI, 0.14 to 1.36), but the reduction was not statistically significant, and the magnitude of the effect size requires confirmation.70 Use of pneumatic compression devices combined with subcutaneous heparin and compression stockings reduce the risk of DVT and PE in stroke patients.71 The morbidity and mortality associated with DVT/PE is a sufficient reason to continue these clinical practices. These interventions can be used in combination with or as alternatives to anticoagulation.
There are no data from clinical trials on DVT/PE prophylaxis in intracerebral hemorrhage or hemorrhagic strokes. Because the risk of worsening brain hemorrhage is uncertain if LDUH or LMWH is used, graduated compression stockings or sequential compression devices are recommended.
Evidence
See Table 6.
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C. Assess Stroke Severity (NIHSS)
Objective
Stratify patients according to severity and likely outcome.
Background
The National Institutes of Health Stroke Scale (NIHSS) is a standardized, validated instrument that assesses severity of neurological impairment after stroke (see Appendix E). It is designed so that virtually any stroke will register some abnormality on the scale. The scale has an administration time of 5 to 10 minutes. The NIHSS score is based solely on examination and requires no historical information or contributions from surrogates. It can be administered at any stage by any trained clinician.
The original 11 items of the NIHSS do not test distal upper extremity weakness, which is more common in stroke patients than proximal arm weakness. An additional item examining finger extension is often added to the NIHSS. Although not contributing to the total NIHSS score, this item should be recorded as part of the NIHSS assessment.
Recommendations
Discussion
The NIHSS is used to guide decisions concerning acute stroke therapy.72 Initial scores have been used to stratify patients according to severity and likely outcome. The presentation NIHSS score was highly correlated with outcome in retrospective analyses of 2 randomized clinical trials.28,29 A second assessment serves as a recheck of the initial measurement and may be more accurate, because the patient will have been stabilized and may be better able to cooperate with the examiner, thus improving the accuracy of scoring.
Because the severity of stroke as assessed using the NIHSS may influence decisions concerning the acute treatment of stroke patients (such as the use of thrombolytic therapy), application of this scale in clinical settings is becoming more common.73
The NIHSS score strongly predicts the likelihood of the patients recovery after stroke. A score of greater than 16 forecasts a high probability of death or severe disability, whereas a score of less than 6 forecasts a good recovery.28 Patients with a severe neurological deficit after stroke, as measured using the NIHSS, have a poor prognosis. During the first week after acute ischemic stroke, it is possible to identify a subset of patients who are highly likely to have a poor outcome.29
Potential examiners become certified in the NIHSS by watching a training videotape and passing an examination that involves scoring patients shown on a test tape.72 Certified examiners may be of any background (eg, physician, nurse, therapist, or social worker).7476 Inter-rater reliability between examiners for most items of the NIHSS is high,77 making the scale highly reproducible. Retrospective estimation of the initial NIHSS score from the admission neurological examination is possible and fairly accurate,7880 although actual testing is preferable.
Continuing validation of the predictive value of the NIHSS within the VA/DoD healthcare system through ongoing prospective data collection is encouraged.
Evidence
See Table 7.
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D. Initiation of Secondary Prevention of Stroke and Atherosclerotic Vascular Disease
Objective
Reduce the risk for recurrence of stroke.
Background
After a stroke, patients are at increased risk for additional cerebrovascular events. Patients with ischemic stroke or nonischemic stroke in the setting of CHD risk equivalents (ie, coronary artery disease, peripheral vascular disease, diabetes) are also at increased risk for myocardial infarction and coronary heart diseasemediated death.
Recommendations
The need for secondary prevention of stroke is lifelong and is a critical component of rehabilitation with clear data on hypertension treatment, warfarin use in atrial fibrillation, and antiplatelet therapy use in cerebral ischemia.81 In patients with ischemic stroke or nonischemic stroke in the setting of CHD risk equivalents, the need for secondary prevention of coronary heart disease is also a critical component with clear data on antiplatelet therapy, hypertension control, consideration of ACE inhibitors, lipid-lowering therapy even in the setting of normal LDL cholesterol, exercise, and smoking cessation.
IV. Poststroke Rehabilitation
A. Assess PostAcute Stroke Patients for Rehabilitation Services
Post-acute stroke is defined as "the period of time immediately after discharge from acute care." At that point the stroke patient has achieved medical stability and the focus of care becomes rehabilitation. Stroke rehabilitation after discharge from acute care can be conducted in inpatient rehabilitation hospitals or rehabilitation units in acute care hospitals, nursing facilities, the patients home, or outpatient facilities. Some patients may recover from the acute phase with no need for rehabilitation services.
Inpatient rehabilitation is defined as "rehabilitation performed during an inpatient stay in a freestanding rehabilitation hospital or a rehabilitation unit of an acute care hospital. The term inpatient is also used to refer generically to programs where the patient is in residence during treatment, whether in an acute care hospital, a rehabilitation hospital, or a nursing facility."
Nursing facility rehabilitation is defined as "rehabilitation performed during a stay in a nursing facility. Nursing facilities vary widely in their rehabilitation capabilities, ranging from maintenance care to comprehensive and intense rehabilitation programs."
Outpatient rehabilitation is defined as "rehabilitation performed in an outpatient facility that is either freestanding or attached to an acute care or rehabilitation hospital. Day hospital care is a subset of outpatient rehabilitation in which the patient spends a major part of the day in an outpatient rehabilitation facility."
Home-based rehabilitation is defined as a "rehabilitation program provided in the patients place of residence."9
B. Obtain Medical History and Do Physical Examination
Determine nature and extent of rehabilitation services needed on the basis of stroke severity, functional status, and social support.
Objective
Obtain clinical data to determine the patients need for rehabilitation services.
Annotations
A thorough history and physical should be performed by the rehabilitation physician. The NIHSS score should be obtained at this time, if not previously determined by the referring team. The history, physical, and NIHSS score provide the framework to begin to determine the nature and extent of needed rehabilitation services.
The history and physical should cover the following areas:
C. Assess Risk for Complications
C-1. Assessment of Swallowing (Dysphagia)
Background
Dysphagia, an abnormality in swallowing fluids or food, is common, occurring in about 45% of all stroke patients admitted to the hospital. It can seriously affect the patients quality of life and potentially lead to death. It is associated with severe strokes and with worse outcome. The presence of aspiration may be associated with an increased risk of developing pneumonia after stroke. Malnutrition is also common, being present in about 15% of all patients admitted to the hospital, and increasing to about 30% over the first week after stroke. Malnutrition is associated with a worse outcome and a slower rate of recovery.11
Assessment of dysphagia by personnel who are not adequately trained in the anatomy and physiology of swallowing is oftentimes problematic. Traditionally, SLPs receive formal training in oropharyngeal anatomy and physiology. However, many medical centers may not have the availability of the SLP but may have other health professionals (eg, occupational therapists and nurses) with training in assessment and treatment of dysphagia. The availability of the SLP and education of other health professionals in dysphagia are essential to ensure that the rates of malnutrition and aspiration pneumonia are kept to a minimum.
Recommendations
Discussion
No controlled trials were found that compared the effectiveness of a screening program versus no screening for identifying patients who are at increased risk of pneumonia and nutrition problems. Two systematic reviews that included case series showed that patients who have abnormal screening tests are at increased risk of pneumonia and nutrition problems compared with patients who have normal screening tests.82,83
The only 2 signs that seem predictive of aspiration are severe dysphagia and abnormal pharyngeal sensation.82,83 The ECRI82 has reported that individual signs and symptoms do not adequately predict pneumonia or detect aspiration during a bedside evaluation.
The same 2 systematic reviews,82,83 along with a third,84 showed that routine screening compared with no screening may decrease the risk of pneumonia, but this is based on very limited data from case series, cohort studies, and a single historical-controlled trial. One systematic review included cost-effectiveness analyses, which suggested that routine screening with a preliminary bedside evaluation followed by either a full bedside evaluation or VFSS when the preliminary study is abnormal may be cost-effectiveif the assumptions used in the analyses are correct.82
BEDSIDE EXAMS.
Cohort studies have shown that full bedside evaluations can detect patients who are at risk for pneumonia and nutrition problems, but the magnitude of the increased risk for patients with abnormal tests is not clear. Water swallow tests alone do not seem to be as accurate as full bedside exams. Limited data suggest that the accuracy of water swallow tests or full bedside evaluations may be increased by combining these with an oxygen desaturation test.85
VIDEOFLUOROSCOPY/MODIFIED BARIUM SWALLOW.
Cohort studies have shown that patients who aspirate on VFSS are at higher risk of developing pneumonia and nutrition problems than are patients with normal tests. There is no good evidence that VFSS is more or less accurate than bedside exams in predicting pneumonia or other complications.82
FIBEROPTIC ENDOSCOPIC EXAMINATION OF SWALLOWING (FEES).
Case series comparing FEES and VFSS have shown that each test detects some patients who aspirate that the other test does not, and that neither test is clearly better than the other. One small cohort study showed that FEES was very sensitive, but not specific in predicting pneumonia.86
One cohort study (20 subjects) showed that FEESST with VFSS improved prognostication for pneumonia over VFSS alone.87 Additional research is needed.
Examination of treatment strategies by x-ray can impact diet and recovery from dysphagia. About 83% of patients receiving VFSS may receive changes in at least 1 of 5 important clinical variables: referrals to other specialists, swallowing therapy, compensatory strategies that improve swallowing, changes in mode of nutritional intake, and diet.88
Evidence
See Table 8.
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C-2. Treatment of Bowel and Bladder Incontinence
Background
Urinary incontinence is a common problem after stroke. Approximately 50% of stroke patients have incontinence during their acute admission for stroke.89 However, that number decreases to 20% by 6 months after stroke. Increased age, increased stroke severity, the presence of diabetes, and the occurrence of other disabling diseases increase the risk of urinary incontinence in stroke.
Most patients with moderate-to-severe stroke are incontinent at presentation, and many are discharged incontinent. Urinary and fecal incontinence are both common in the early stages. Incontinence is a major burden on caregivers once the patient is discharged home. Management of both bladder and bowel problems should be seen as an essential part of the patients rehabilitation, because they can seriously hamper progress in other areas. Acute use of an indwelling catheter may facilitate management of fluids, prevent urinary retention, and reduce skin breakdown in patients with stroke; however, the use of a Foley catheter for more than 48 hours after stroke increases the risk of urinary tract infection.
Fecal incontinence occurs in a substantial proportion of patients after a stroke, but clears within 2 weeks in the majority of patients.90 Continued fecal incontinence signals a poor prognosis. Diarrhea, when it occurs, may be due to medications, initiation of tube feedings, or infections; it can also be due to leakage around a fecal impaction. Treatment should be cause-specific.9
Constipation and fecal impaction are more common after stroke than incontinence. Immobility and inactivity, inadequate fluid or food intake, depression or anxiety, a neurogenic bowel or the inability to perceive bowel signals, lack of transfer ability, and cognitive deficits may each contribute to this problem. Goals of management are to ensure adequate intake of fluid, bulk, and fiber and to help the patient establish a regular toileting