Abstract
Background and Purpose—We have previously shown that treatment of acute stroke patients in our stroke unit (SU) compared with treatment in general ward (GWs) improves short- and long-term survival and functional outcome and increases the possibility of earlier discharge to home. The aim of the present study was to identify the differences in treatment between the SU and the GW and to assess which aspects of the SU care which were most responsible for the better outcome.
Methods—Of the 220 patients included in our trial, only 206 were actually treated (SU, 102 patients; GW, 104 patients). For these patients, we identified the differences in the treatment and the consequences of the treatment. We analyzed the factors that we were able to measure and their association with the outcome, discharge to home within 6 weeks.
Results—Characteristic features in our SU were teamwork, staff education, functional training, and integrated physiotherapy and nursing. Other treatment factors significantly different in the SU from the GW were shorter time to start of the systematic mobilization/training and increased use of oxygen, heparin, intravenous saline solutions, and antipyretics. Consequences of the treatment seem to be less variation in diastolic and systolic blood pressure (BP), avoiding the lowest diastolic BP, and lowering the levels of glucose and temperature in the SU group compared with the GW group. Univariate analyses showed that all these factors except the level of glucose were significantly associated with discharge to home within 6 weeks. In the final multivariate Cox regression model, shorter time to start of the mobilization/training and stabilized diastolic BP were independent factors significantly associated with discharge to home within 6 weeks.
Conclusions—Shorter time to start of mobilization/training was the most important factor associated with discharge to home, followed by stabilized diastolic BP, indicating that these factors probably were important in the SU treatment. The effects of characteristic features of an SU, such as a specially trained staff, teamwork, and involvement of relatives, were not possible to measure. Such factors might be more important than those actually measured.
Several trials have shown better outcome for stroke patients treated in stroke units (SUs) compared with stroke patients treated in general wards (GWs).
1 2 3 4 5 6 7 8 9Meta-analysis of all available randomized controlled trials has shown that care of stroke patients in an SU reduces mortality, institutionalization, and dependency.
1011 Why SU treatment works is still under discussion.
12 Focus on rehabilitation, teamwork, education of the staff, and involvement of both the patients and their relatives in the rehabilitation process have been identified as characteristic features in most of the SUs that have proved to be effective.
11 12 The focus on the acute treatment has been more modest, but in some trials from combined acute and rehabilitation SUs
2 5 8 9 there have existed acute medical treatment programs that may have been of importance for the results in favor of SU treatment. SU care consists of many elements working together, and it may be difficult to identify which specific factors are the most responsible for the better outcome.
However, if we want to develop SU care further, it is necessary to get more information about which aspects are most important. The first step is to identify all differences that exist between SU care and GW care. For some factors a second step is possible, in which we may analyze which aspects are most strongly related to the better outcome. From these 2 steps it will not be possible to prove a causal relationship to the outcome, because the factors identified may be confounders. The third step, and the final proof of the importance of a factor, will be to conduct prospective trials where, one by one, the factors identified are examined. However, in this article we have looked at the first 2 steps mentioned, which we need to examine first to develop more effective SU care.
Subjects and Methods
We have previously performed a randomized controlled trial
9 in which 110 patients with symptoms and signs of acute stroke were on admission randomly allocated to treatment in the SU and 110 to treatment in GWs. The details about the inclusion criteria and the study design have previously been described.
9 Fourteen of the 220 patients included (8 allocated to SU and 6 allocated to GW) were, for varying reasons, returned to nursing homes or transferred to other hospitals or departments soon after admission.
9 Hence, 206 patients (102 allocated to SU and 104 allocated to GW) were actually treated. In the previous analysis of the effects of SU care, we have mainly used an “intention-to-treat” approach.
9 13 14 In the present paper we have included only patients actually treated (on treatment analysis), as we wished to identify characteristic features of the SU and the GW. The aim was to identify the differences in treatment between the SU and the GW and to assess which aspects of the SU care are most important for the better outcome. The average/maximum treatment period in the SU was 16 days/6 weeks. Hence, the outcome at 6 weeks is probably most closely related to the acute care in the SU. After 6 weeks, the most significant difference in outcome in favor of SU care was the proportion of patients who lived at home
9 :59.8% of the patients from the SU versus 34.6% from the GW were at home after 6 weeks (
P=0.0003).
9 The possibility of finding important differences in the treatment program that are related to outcome is probably greatest if we choose the outcome with the clearest difference between the 2 treatment groups. “Discharge to home within 6 weeks” was therefore chosen as the primary outcome in the present study.
SU Treatment Program
Before the start of the trial, we developed in our SU an acute treatment package for management of acute stroke patients consisting of 2 main components: (1) an acute medical treatment program and (2) an early and intensive mobilization/rehabilitation program.
The acute medical treatment program was standardized with regard to diagnostic evaluation and systematic observation of each patient during the first 72 hours. All patients received a CT scan within 24 hours, and most of them within 6 hours, after admission. ECG and routine blood tests were performed on admission, and other diagnostic procedures were performed when indicated. During the first days in the SU, all patients went through a standardized systematic observation and examination of neurological deficits, blood pressure level, cardiac and pulmonary disorders, temperature, glucose level, and fluid and electrolyte balance. Most of these observations were performed 4 to 6 times a day by the nurses on duty. Oxygen therapy was used in the presence of decreased oxygen saturation, in drowsy patients, and in patients with heart disease. Patients with temperatures >38.0°C received systematic treatment with paracetamol. Glucose infusions were avoided during the first 2 days, but saline solutions were often used immediately after admission to avoid dehydration and variation or drop in blood pressure. Hypertension was not treated during the acute stage except for very high blood pressure levels (>250/130 mm Hg). Antiedema agents were not given to any patient. In patients with suspected cardiac embolic stroke or progression of neurological deficits, the early use of anticoagulants was standard treatment. Low doses of heparin (5000 IU SC twice a day) were used to prevent deep venous thrombosis in ischemic stroke patients with extensive paresis. The benefit of aspirin in acute stroke was not known at the time of this trial and was not routinely given during the first days in either the SU or GW.
15 16
The SU was organized with a team approach to nursing and rehabilitation, emphasizing patient and family participation. The key members of the team were a specially trained stroke nurse who had a coordinating function, a physiotherapist who developed our mobilization program, and a physician who was a specialist both in rehabilitation medicine and internal medicine and was specially trained in acute care and cardiology. Functional training and a modified motor relearning program were the basic rehabilitation approaches.
17
When a patient arrived, diagnostic and functional evaluation were done immediately and the basic team (the physician, the physiotherapist and the stroke nurse) made a treatment plan. Further plans were developed during staff meetings once a week.
The staff was well trained in the rehabilitation of stroke patients, and a systematic program for recovery of function was started soon after arrival. Early mobilization was strongly emphasized: the main rule was that every patient should out of bed within 24 hours, and no difference in mobilization existed between ischemic and hemorrhagic stroke.
Most of the training in activities of daily life, and speech training was performed by the specially trained staff. Through this organization we were able to offer training during 24 hours a day. Dedicated speech therapy and occupational therapy were recommended in the same manner as in the GW. The procedures during the first days in the SU are summarized in Table 1
⇓. During all these procedures we tried to encourage the patients. Focus on motivation, stimulation, and psychological support were emphasized, and some of the training was also performed in groups. By this approach we tried to create a sort of “enriched environment.”
Table 1.
Program for Diagnosis, Observation, Acute Treatment, and Acute Rehabilitation in the Stroke Unit From Admission to 72 Hours
GW Treatment Program
The patients in the GW were treated according to generally accepted guidelines regarding medical treatment and rehabilitation of stroke patients in our country. However, neither a systematic standardized program specially dedicated to stroke patients nor a systematic team approach existed. As in the SU, a CT scan was requested but not routinely as an emergency examination. Subcutaneous heparin to prevent deep venous thrombosis was given to most of the long-term immobilized patients. Other indications for anticoagulation were seldom considered. There was no standardized treatment program for antipyretics and intravenous saline solutions.
Physiotherapy and occupational therapy were given when the physicians in the ward prescribed it. The procedure for prescription and use of occupational therapy was similar in the SU and the GW, whereas the function of the physiotherapist in each was quite different. No close cooperation between the physiotherapist and the staff existed in the GW. The staff was trained to give a generally good quality of care but was not specially trained in stroke care. Mobilization and training were usually started within 3 to 4 days after admission. The principles of rehabilitation were not a motor relearning approach
17 but were instead based more on a modified Bobath concept.
18
Statistical Analysis
For dedicated therapies such as oxygen, intravenous saline solution, heparin, insulin, paracetamol, and aspirin, we analyzed the differences in proportions of patients in the 2 groups receiving the different therapies with the χ2 test. The differences in amount (hours) of physiotherapy or occupational therapy and time from admission to the start of mobilization/training were analyzed by the Mann-Whitney test.
Differences in the variables that may have been affected by the treatment, such as the levels of temperature, glucose, and blood pressure, were analyzed by the Student t test. The blood pressure on admission and the morning and evening measurements during the following 2 days were analyzed. For temperature, admission and morning and evening temperatures during the first 5 days were analyzed; for glucose, the level on admission and the level the first morning after admission were analyzed. Finally, for those variables for which significant differences were present, we performed univariate and multivariate Cox proportional hazards analyses to assess the predictivity of these variables on the possibility of staying at home 6 weeks after the stroke. In the Cox analyses we adjusted for age and severity of the stroke by the prognostic score of the Scandinavian Stroke Scale.
Results
Characteristics of the treatment in the SU not present on the same level in the GW were team approach; systematic observation; staff education; dedicated physiotherapy performed in the ward; integration of physiotherapy and nursing; involvement of relatives in the rehabilitation process; and the stimulation and encouragement of, and creating an enriched environment for, each patient (Table 2
⇓).
Table 2.
Differences in Organization of Care in the SU and the GWs
Differences in treatment in the 2 groups were as follows (Table 3
⇓): A higher proportion of patients in the SU received intravenous saline solutions during the first 12 hours. Oxygen therapy, heparin and antipyretics (paracetamol) were also more often used in the SU group, whereas there were no significant differences in the use of aspirin and insulin. The use of other drugs was also recorded but showed no significant differences between the 2 groups.
Table 3.
Proportion of Patients Receiving Different Types of Treatment in the SU and GWs, Physiotherapy/Occupational Therapy per Patient, and Time Period From Admission to Start of Mobilization in the SU and GWs
Regarding physiotherapy and occupational therapy, there were no differences in hours of physiotherapy and occupa-tional therapy during the first 6 weeks, but more therapy was given the first 3weeks and less the last 3 weeks in the SU compared with the GW. Mobilization started significantly earlier in the SU group (Table 3
⇑). We do not have figures for the extensive rehabilitation efforts performed by the staff in the SU. If we combine the efforts from physiotherapy and occupational therapy with the rehabilitation efforts from the staff, the SU patients received more stimulation and training than the GW group during the first few weeks.
Table 4
⇓ shows differences in blood pressure, temperature, and glucose levels that may have occurred because of the differences in the 2 treatment programs. There was a significant difference in the reduction of the level of glucose from admission to day 1. Differences were also present regarding the variation of blood pressures and the temperatures. The proportion of patients who during the first 5 days experienced a temperature of ≥38.5°C, or who during the first 48 hours had a diastolic blood pressure variation of ≥20 mm Hg or diastolic blood pressure of ≤80 mm Hg, was higher in the GW group (Figure 1
⇓).
Figure 1.
The proportion of patients from the stroke unit (SU) and the general wards (GW) who at least on 1 occasion during the first 48 hours had a diastolic blood pressure (DBP) of ≤ 80 mm Hg or a difference between the highest and lowest DBPs (diff DBP) of ≥20 mm Hg, or during the first 5 days had a temperature of ≥38.5°C.
Table 4.
Blood Pressure During the Period From Admission to 48 Hours, Temperature from Admission to Day 4, and Glucose Level on Admission and Day 1 in SU-Treated Patients1 Versus GW-Treated Patients2
Table 5
⇓ presents all significant differences in blood pressure, temperature, glucose levels, and time to mobilization in an adjusted univariate analysis corrected for age and severity of the stroke by the prognostic score of the Scandinavian Stroke Scale at admission. Variables significantly associated with better outcome were short time to start of the mobilization/training, low variation of diastolic and systolic blood pressures, and avoidance of low diastolic blood pressures and high temperatures. The reduction in glucose level from admission to day 1 was not significantly related to outcome.
Table 5.
Adjusted Univariate Proportional Hazards Regression Analysis (Cox) of Factors’ Predictivity for Discharge to Home Within 6 Weeks (Adjusted for Age and Severity of Stroke)
The result of a multivariate analysis in which we included all variables that showed a significant difference in univariate analysis (Table 5
⇑) demonstrated that shorter time to start of systematic mobilization and stabilized diastolic blood pressure were the only factors significantly associated with “discharge to home within 6 weeks” (Table 6
⇓). Before adjusting for these factors, the relative risk for living at home 6 weeks after the stroke was 2.53 for SU patients versus GW patients. When we adjusted for those 2 factors, the relative risk was reduced to 1.42 and the benefit of SU treatment was no longer significant.
Table 6.
Relative Risk for Discharge to Home Within 6 Weeks for SU-Treated Patients Versus GW-Treated Patients by Adjusted Univariate and Multivariate Proportional Hazards Regression Analysis (Cox)
Discharge may depend on several factors other than the functional level of the patient. We have therefore analyzed the Barthel Index (BI) score at 6 weeks for patients at home. Table 7
⇓ shows that most of the patients at home after 6 weeks had a BI score of >75, indicating that independence or partial independence in activities of daily living was important for the possibility of staying at home.
Table 7.
Number and Proportion of Patients From the SU and the GWs Who 6 Weeks After Stroke Stayed at Home, Had a Barthel Index Score of >75, or Both
Discussion
Teamwork, specially trained staff, and focus on rehabilitation are well-known and important features of SU care,
11 12 but for the first time we now have analyses which indicate that the very early start of mobilization/training, systematic hydration (which may stabilize blood pressure), and systematic use of antipyretics (which probably causes a lowering of the highest temperatures) may also be important aspects of acute treatment in an SU (Table 5
⇑). Of these factors, the early start of mobilization/training seems to be the most important, followed by stabilized diastolic blood pressure (Table 6
⇑). When adjusted for the latter factors, the benefit of SU care was no longer significant (Table 6
⇑), indicating that these 2 factors are important aspects of SU care, or are at least linked to aspects that are important.
Unfortunately, the direct effects of each factor listed in Table 2
⇑ are difficult to measure. Any general clinical strategy to treat stroke patients will face the problem of isolating the specific components that are most important to the better outcome. The specially trained staff, which was able to put all the components of SU care together into a systematic, standardized treatment program, was probably essential for the positive effects in our SU. Enriched environment improves recovery for stroke-prone rats,
19 and social support is shown to be important for the recovery of stroke patients.
20 The term “enriched environment” is difficult to define. In animal models the term has been used for rats housed in cages that allow various physical activities and social interaction as well as more stimulation from having people around.
19 In our setting it means that the surrounding staff is able to create the appropriate stimulation and challenges for the patients and also that groups of patients are sometimes trained together, which create social interaction. Some of the effects of SU care may be caused by such an “enriched environment” created by a specially trained staff.
The better outcome in our SU seems not to be due to more occupational therapy, because no difference existed in the amount or organization of the occupational therapy. The hours of physiotherapy were also similar in the 2 groups, but the physiotherapist in the SU was dedicated to the unit and was working “inside” the ward and in very close cooperation with the nurses. The physiotherapist trained the nurses to be “experts” in early mobilization and training, so this training could take place 24 hours a day. Hence, the total amount of training and stimulation was higher in the SU than in the GW. The number of hours the physiotherapist spent on educating the nurses were not recorded. The total amount of physiotherapist resources used in the SU was therefore higher than in the GW. In addition, the physiotherapy started definitely earlier in the SU, where all patients were assessed by a physiotherapist within 24 hours and most of them within 8 hours. In the GW the physiotherapy had to be ordered by a physician, and there was often a delay of 2 to 3 days before the patient received physiotherapy and mobilization/training started (Table 3
⇑).
The physiotherapy in the SU had a modified motor relearning approach consisting of intensive functional training,
17 an approach quite different from the Bobath concept.
18 Some observations
21 22 23 have indicated that the Bobath approach may slow down the speed of recovery. Although the physiotherapy in GW was not a “purist” Bobath approach, the functional training was not emphasized as strongly as in the SU. Hence, there existed many qualitative differences between the physiotherapy in the SU and in the GW. These differences may have contributed to the better outcome in the SU group.
Table 3
⇑ shows several other differences in the care between SU and GW. Because of the design of the trial, it was not possible to decide whether differences in, for instance, oxygen and heparin therapy were of importance for the outcome. It was possible to relate directly to outcome only such factors as time to start of the mobilization and consequences of treatment on physiological variables like blood pressure, temperature, and glucose level.
The early mobilization may have reduced all “bed-associated” complications such as pneumonia, deep venous thrombosis, pulmonary embolism, contractures, pressure ulcers, and orthostatic blood pressure problems. Early mobilization may also have had important psychological effects. We believe that the very early mobilization is one of the key factors in our SU care. It is worth noting that in the GW group the mobilization program was in accordance with a recently published recommendation about the acute care of stroke.
24 In our opinion, there is no evidence to support a recommendation that advocates bed rest for several days.
24
A more pronounced and systematic use of IV saline solutions in the SU group may have reduced the tendency to dehydration and, through that, stabilized the blood pressure. Low blood pressure or treatment to reduce blood pressure in the acute stage probably has a negative effect.
25 26 27 28 In our analyses, the variations of diastolic blood pressure seem to be the most important of the differences in blood pressure measurements we have observed.
Systematic antipyretic medication may also have reduced the number of patients with high temperatures (Figure 1
⇑). The association we have found between lower temperature and better outcome seems reasonable, because experimental data in animals and observational studies in humans indicate that lower temperature may reduce the size of the brain injury after a stroke.
29 30 31 However, the importance of temperature seems to be more modest than that of blood pressure, because the significant effect of temperature disappeared in the multivariate analysis (Table 6
⇑). Our intervention toward glucose level was more modest, and the effect of lower glucose in the SU group was not significantly associated with outcome.
Our acute treatment program, with simple observations of vital signs and progression and regression of symptoms, can easily be managed by educated staff in a combined acute and rehabilitation unit like ours. With such a simple but systematic approach to acute care, we are able to manage acute treatment such as thrombolysis
32 while still maintaining the rehabilitation approach that the Stroke Unit Trialists’ Collaboration has identified as an essential feature of effective SU care.
11 12 For the general acute stroke patient, monitoring should probably not be so extensive that mobilization/rehabilitation is reduced or delayed.
The outcome chosen in our study may be open to discussion. It is evident that discharge to home does not depend only on the patients’ functional level after stroke. Nevertheless, being able to live at home is an important outcome, one which tells something about the disability and perhaps also about the handicap of a patient.
33 One of the goals in the treatment program in the SU was to adapt the patients as soon as possible to the demands of living at home. The fact that we involve both the patients and relatives in the rehabilitation process may have caused the patients to achieve more self confidence in living at home. Today we know that the patients in the SU did not receive more help at home than those in the GW group, and that the higher proportion of patients at home in the SU group has existed for at least 5 years.
9 13 From this point of view, the outcome chosen was probably a reasonable outcome for the measurement of the global or total effects of SU care.
The functional level assessed by the BI showed that there was a close association between a BI score of >75 and the possibility of staying at home after 6 weeks (Table 7
⇑). This association also indicates that the outcome chosen was an appropriate one.
In summary, we have now identified differences between SU care and GW care in our SU trial and tried to assess the effects of some of these differences. The direct effects of the characteristic features of an SU, such as a specially trained staff, a team and rehabilitation approach, emphasis on functional training, and integration between nursing and rehabilitation, were not possible to measure. Such factors are, however, probably the most important factors in our SU model as well as in other effective SU models.
11 12 Of the factors we were able to measure, a shorter time to start of the mobilization/training was the most important factor associated with discharge to home within 6 weeks, followed by stabilized diastolic blood pressure, indicating that these factors probably were of importance. Whether there exists a true causal relationship between these factors and the better outcome is not possible to prove from the results of our trial. The factors may only be markers or confounders linked to factors that were important in the SU treatment.
Hence, prospective trials are necessary before we can make definitive conclusions. Our SU trial indicates, however, that early mobilization, hydration to stabilize diastolic blood pressure, and antipyretics to reduce fever may be elements which should be added to the previous well-known characteristics of SU care. Acute stroke patients seem to need both systematic acute observation and medical care as well as acute mobilization/rehabilitation. From our experience, such a combination of acute care and acute rehabilitation is easiest to carry out in a combined acute and rehabilitation SU model like ours, which is specially designed for such a combination.
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