ACADEMIA
AND
CLINIC
Results of a Program to Reduce Admissions for Adult Asthma Paul H. Mayo, MD; Julieta Richman, RN, MS, FNP; and H. William Harris, MD
Study Objective: To determine the effect of an outpatient program designed to reduce readmissions for asthma exacerbations among adults with asthma. Design: Randomized patient selection with crossover. Setting: Bellevue Hospital, New York City, New York. Patients: We identified 104 adult asthmatics who had previously required multiple hospitalizations for asthma attacks. Forty-seven patients were randomly assigned to an intensive outpatient treatment clinic and 57 patients continued to receive their previous outpatient care. Nineteen patients from this latter group were then crossed to the intensive outpatient therapy clinic. Interventions: Attenders of the intensive outpatient treatment program were treated with a vigorous medical regimen and educational program. Emphasis was placed on teaching patients aggressive self-management strategies in case of marked asthma exacerbation. Measurements and Main Results: The main measurement used to determine efficacy of the study program was readmission rate and hospital days used. Prospective comparison of treated compared with untreated patients indicated that program enrollment resulted in a threefold reduction in readmission rate and a twofold reduction in hospital day use rate (P < 0.004 and P < 0.02, respectively). Using retrospective data with patients serving as their own controls, we found a threefold reduction in readmission rate and in hospital day use (P < 0.003) during a 32-month follow-up period. A similar magnitude of reduction in hospital utilization was found when patients were crossed over to the intensive treatment group (P < 0.004). Conclusions: By using a vigorous medical regimen and intensive educational program, we were able to decrease hospital use among a group of adult asthmatics who had previously required repeated readmissions for acute asthma exacerbations.
I t has been estimated that 5% of American adults have asthma, and in the United States, asthma exacerbations resulted in 459 000 hospital admissions in 1983 (1). Asthma mortality may be increasing as well (2). The large number of hospitalizations and deaths due to asthma exist despite readily available and effective treatment. This dichotomy is especially prominent among patients who are not compliant with treatment regimens. Bellevue Hospital Center in New York City is a large municipal hospital serving the southeastern area of Manhattan. The lower east side of New York City is densely populated and socio-economically depressed. Asthma, especially in patients from the lower east side, constituted a common cause for adult admissions to Bellevue Hospital from 1982 to 1985, with an average of 670 adult hospitalizations per year that used 4700 hospital days. On the basis of posted daily hospital charges, the annual cost was at least two million dollars. The accompanying loss of work and school time and the occasional loss of life constituted an immeasurable burden of suffering and disruption caused by this very common disease. It has long been apparent to Bellevue Hospital staff that, among patients with asthma, certain ones required frequent admissions for asthma exacerbation. Although the emergency room and inpatient care is of high quality, we suspected that suboptimal outpatient care might influence the pattern of repeated admissions observed in these patients. Thus, we developed a special outpatient treatment program for these difficult patients, designed so that its effect on adult readmissions for asthma exacerbations could be studied. We describe this special asthma clinic and indicate its influence on hospital admissions for asthma. Methods Description of the Clinic Program
Annals of Internal Medicine. 1990;112:864-871. From Bellevue Hospital, New York, New York; and the New York University School of Medicine, New York, New York. For current author addresses, see end of text. 864
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All patients were treated by the same physician in the Bellevue Hospital Center chest clinic. Maximum efforts were made to reduce waiting time, to encourage frequent visits, and to maintain an open-door policy during clinic hours for any patient who wished to see the physician between scheduled visits. A full-time nurse practictioner shared patient care responsibilities with the full-time clinic physician in the last 12 months of the study. The two initial visits lasted at least 1 hour and involved detailed repetitive discussion of pathophysiologic concepts and treatment modalities, and emphasized self-management strategies designed to fit each patient's particular asthma pattern and personality. Subsequent visits were scheduled to allow at least half an hour per patient. All discussion was in the patient's native language with the exception of a single Bengali patient. The frequency of visits was determined by the patient's preference and the level of asthma activity. Patient education oc-
curred during repeated contacts between the patient and health care provider. No written, lecture, or audiovisual materials were used. All patients were provided with the clinic telephone number for use during clinic hours and the telephone number of a clinic answering machine for use during nonbusiness hours. All patients were encouraged to contact special clinic staff if any questions arose between scheduled visits. In the event of an asthma exacerbation that occurred when the clinic was closed, patients were instructed and encouraged to initiate vigorous self-treatment until they could contact clinic staff. All patients were instructed to seek early emergency room treatment for asthma exacerbation if self-management was ineffective and the clinic physician was not available. The clinic staff made concerted efforts to contact patients by phone or letter or both if they missed follow-up visits or were known to be in an asthma exacerbation. The clinic physician was excluded from decisions regarding hospital admission of patients seen in the emergency room. If patients were admitted to the hospital, the clinic physician made suggestions to the Bellevue Hospital Center housestaff regarding inpatient management and helped with patient education but was not involved directly in decisions as to the time of discharge. Medical regimens were tailored to each patient's asthma pattern and were designed to encourage compliance as much as possible. To this end, the fewest possible medicines were prescribed with attention to patient convenience as well as desired pharmacologic effect in the dosing schedule. Between exacerbations, medication was withdrawn or reduced to the lowest required to control symptoms. Patients were trained to vary the treatment regimen independently according to the intensity of their asthma and to treat severe exacerbations promptly and aggressively. Patients were encouraged to participate in decisions regarding therapy, and their preferences were respected. All patients used inhaled beta agonists on an "as needed" basis. The preparation used was based on patient preference; albuterol or metaproterenol was prescribed most often. Peroral beta agonists were rarely used. Cromolyn sodium was used only at patient request and if the patient had been using it before clinic enrollment. Peroral theophyllines were used based on symptom level and patient preference. Emphasis was placed on inhaled corticosteroids with the specific preparation predicated on Bellevue Hospital Center pharmacy availability and patient preference. The dosage range was variable with the upper limit being 32 puffs per day of beclomethasone (1600 /xg/d) or 24 puffs per day of triamcinolone (4800 jLtg/d). Typical maintenance doses totaled 16 puffs per day of beclomethasone given twice a day. Patients were instructed to vary the amount used according to level of asthma symptoms, increasing the dose as tolerated during periods of exacerbation, not to exceed 32 puffs per day. All patients were given prednisone for emergency use during severe exacerbations and specifically trained in its appropriate use and attendant hazards. Standard self-treatment for severe attacks was 40 mg of prednisone once a day for only 3 days. They were instructed to increase the inhaled corticosteroid while using prednisone and to continue the higher dose of inhaled corticosteroid for at least 1 week before reducing it to previous chronic usage levels. All patients were given portable reservoir spacer devices (Schering, Springfield, New Jersey) and encouraged to use them regularly, particularly when using inhaled corticosteroids. Each visit included a specific check of reservoir technique and detailed retraining as required. Patients were specifically discouraged from using meter-dose inhalers without the reservoir unit. All patients were equipped with portable peak flow meters (Healthscan, Cedar Grove, New Jersey), and trained in their use to identify asthma attacks that might require brief prednisone pulses.
Patient Selection for the Clinic Program Between 1 July 1985 and 31 December 1985, all adult patients admitted to Bellevue Hospital Center with a primary diagnosis of acute asthma exacerbation were reviewed within 1
Figure 1. Diagram of assignment to special clinic group, routine follow-up group, or ineligible patient status for adult patients admitted for asthma exacerbation to Bellevue Hospital Center from 1 July 1985 through 31 December 1985. BHC Bellevue Hospital Center; ER = emergency room; IVDA = intravenous drug abuser; CNS = central nervous system; LMD = local medical doctor.
to 3 days after readmission by one of the investigators. All patients fulfilled the American Thoracic Society definition of asthma (3) and were 18 years of age or older. By predetermined criteria (Figure 1), certain of these patients were excluded from the study. The remaining patients, who had had at least two hospitalizations for asthma in the previous 12 months or at least five emergency room visits for asthma in the previous 24 months, were considered eligible for the study. All eligible patients received a standard interview, were examined by one of the investigators, and were randomly selected according to the last digit of the hospital chart number for assignment to one of two different outpatient treatment plans: the special clinic treatment group or the routine clinic treatment group. The special clinic group patients were enrolled in the asthma program and treated as previously described. The routine clinic group patients were discharged to their previous regular outpatient care in the Bellevue Hospital chest clinic or medical clinic, to clinics of other local hospitals, to neighborhood clinics, or to local physicians. No attempt was made by the special clinic staff to alter their treatment. After an 8-month period of comparison between the two groups, a total of 19 patients were selected from the routine clinic group and crossed over to special clinic treatment. This crossover group was selected on the basis of having required multiple hospitalizations for asthma. M e a s u r e s of Effect of Special Clinic T r e a t m e n t We sought to measure whether special clinic treatment would reduce hospitalizations and hospital day use for acute exacerbations. Patient selection allowed us to do this in several ways. First, from 1 July 1985 to 28 February 1986 the readmission rate and the hospitalization day rate were compared in parallel between the special clinic group and the routine clinic group. Second, the readmission rate and hospitalization day rate before and after clinic enrollment were compared- for patients in the special clinic group. Admission records of patients in the special clinic group were obtained from 1 January 1982 until their enrollment in the clinic. The Bellevue Hospital Cen-
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Table 1. Demographic Characteristics of Special Clinic Group, Routine Clinic Group, and Crossover Group Patients* Characteristic
Special Clinic Group (n = 47)
Routine Clinic Group (n = 57)
Crossover Group (n = 19)
Age, y Gender Male Female Race Hispanic Black White Other Grade level attained Spanish as sole language.,% Fully employed,, % Present or past smoking, %
42 ± 15t
42 ± 13t
44 ± 12t
14 33
24 33
10 9
40 6 1 0 9 ± 3t 23 36 38
43 10 3 1 9 ± 4t 18 39 39
15 3 0 1 9 ± 3t 16 37 42
* There are no significant group differences. t Values are expressed as mean ± 1 SD.
ter computer identified which of these admissions were for asthma exacerbations. Hospital utilization thus derived was compared to hospital utilization by the special clinic group patients after their enrollment date through 29 February 1988. Third, a similar measure of effect was calculated for the patients who were crossed over from the routine follow-up group. Hospital utilization before and after special clinic enrollment was tabulated for these patients. Finally, we established a longitudinal comparison of the crossover group by measuring the hospital utilization of this group of 19 crossover patients before clinic enrollment from 1 July 1985 to 28 February 1986. This was compared with their hospital utilization from 1 July 1987 to 29 February 1988. Statistical Analysis Continuous data are presented as mean ± 1 SD and were compared with use of /-tests with application of the Bonneferoni-Ryan correction mechanism for multiple significance testing. Frequency data were compared using chi-square tests. Effect of intervention on clinical outcomes were assessed by multivariate analysis of variance performed through general linear models procedure. All P values less than 0.05 were considered significant. Computational procedures used the SAS statistics program (SAS, Carey, North Carolina). Results Patient Selection As shown in Figure 1, between 1 July 1985 and 31 December 1985, 212 adult patients were admitted to
Bellevue Hospital Center with a primary diagnosis of acute asthma exacerbation. Of these patients, 108 were excluded from the study by predetermined criteria (Figure 1). The remaining 104 patients were eligible for random allocation by the last digit of the hospital number (Figure 1). Forty-seven patients were assigned to the special clinic group and 57 patients to the routine clinic group. Of the 47 special clinic group patients, 10 chose never to attend the special asthma clinic. Three of these nonattenders refused outright to attend. Three other patients agreed but failed to keep appointments and could not be located by phone or letter. The remaining nonattenders repeatedly stated their intention to attend but never actually kept an appointment. All four of these patients habitually abused nasal cocaine or nasal heroin or both. Thus, of 47 patients randomized to the special clinic group, 37 patients actually attended the clinic. After 8 months of follow-up in the routine clinic group, 19 patients were selected on the basis of poorly controlled asthma for transfer to the special clinic group. These 19 plus the original 37 special clinic group clinic attenders resulted in a group of 56 clinic attenders who were followed prospectively through 29 February 1988. Of this group, 1 patient moved away and was lost to follow-up. Patient Characteristics Demographic characteristics for the special clinic group, the routine clinic group, the crossover group, and the markers of severity of asthma are presented in Table 1 and Table 2. There are no statistically significant differences between the three groups with the exception that a history of previous intubation for asthma in the crossover group was significantly less than in the two other groups. Patterns of outpatient care before the study are presented in Table 3. There were no statistically significant differences in the source of outpatient care among the three groups. All patients were asked to demonstrate metered-dose inhaler technique at their initial interview. Technical faults varied widely but no patient demonstrated satisfactory technique defined by widely accepted criteria (4). In general, patients' knowledge of asthma and treatment options was so vague and disorganized as to make formal assessment of this knowledge difficult. Table 3 summarizes some examples of the pa-
Table 2. Markers of Severity of Asthma for Special Clinic Group, Routine Clinic Group, and Crossover Patients* Marker
Mean number of admissions at BHC per patient 1-1-82 through 30-6-85 Mean number of hospital days at BHC per patient 1-1-82 through 30-6-85 Patients using chronic daily corticosteroids, % Patients requiring intubation for asthma, % Duration of asthma, v
Group
Special Clinic Group (n = 47)
Routine Clinic Group (n = 57)
Crossover Group (n = 19)
4.4 ± 4.5t 27 ± 28t 21 11 16 ± 13t
4.5 ± 6.1t 34 ± 57t 26 18 16 ± l i t
6.6 ± 8.01 45 ± 60t 26 0* 13 ± l i t
* There are no significant group differences except for percentage of crossover patients requiring intubation for asthma before the study. BHC Bellevue Hospital Center. t Values are expressed as mean ± 1 SD. t P < 0.02.
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Table 3. Patterns of Outpatient Follow-up of Special Clinic Group, Routine Clinic Group, and Crossover Group Patients before the Study Period* Pattern
Special Clinic Group (n = 47)
Routine Clinic Group (n = 57)
Crossover Group (n = 19)
M
n
BHC clinic Clinic other than BHC Local physician Emergency room only Patients knowing physician's name Patients knowing difference in action of beclomethasone and beta agonists Patients trained in self-treatment with prednisone Patients with adequate MDI technique Patients contacting physician by phone between scheduled visits
>
55 11 19 15 49
63 12 9 16 53
84 0 5 11 74
0
0
0
0
0
0
0
0
0
0
0
0
* There are no significant group> differences. BHC = 13ellevue Hospital Center; MDI = metered dose inhaler.
dents' profound lack of knowledge regarding information important to basic self-management issues. Pattern of Treatment The specific medical regimens used in the 56 clinic attenders before and after enrollment as of December 1987 are documented in Table 4. The main difference in therapy after clinic enrollment was in the use of inhaled corticosteroids, reservoir spacer devices, home peak flow meters, and self-initiated prednisone pulses. Peroral beta agonist use was markedly reduced. Of the 14 patients initially on daily corticosteroids, 10 patients were able to discontinue use and the remaining four used lower doses than before clinic enrollment. One patient not previously on daily chronic corticosteroids required daily use after entering special asthma clinic care. No patient who used high-dose inhaled corticosteroids but not chronic daily prednisone showed clinical evidence of hypercorticism. A key element in preventing severe asthma attacks was training patients to initiate early therapy with peroral prednisone with the onset of an attack as judged by symptoms and a marked decline in peak expiratory flow. Table 5 summarizes outpatient use of pulsed prednisone by clinic attenders. The table excludes periods of prednisone use that occurred in the days after a hospital discharge or during a prolonged taper required in the context of weaning from long-term corticosteroid use antedating clinic attendance. The data represent prednisone used by patients attempting to abort asthma exacerbations that might have led to hospitalization. No patient appeared to use prednisone out of proportion to that required by good medical judgment, and all expressed concern about potential side effects.
The frequency and duration of clinic visits for clinic attenders was highly variable. One patient visited the clinic at least once a week for the duration of the study. An occasional patient preferred to maintain physician contact by telephone after training and visited the clinic every 6 months, spending an hour at each visit. Telephone contact varied even more and depended on the severity and frequency of asthmatic exacerbations in each patient. For the duration of an exacerbation, physician and patient might talk on a daily basis and then not speak by telephone until another episode occurred. Hospital Use Between 1 July 1985 and 28 February 1986, the hospital readmission rate and the hospital day rate for acute exacerbation were followed prospectively for the special clinic group and the routine clinic group (Table 6). Because the two groups are of unequal size, results are expressed as readmissions and rehospitalization days per patient. The hospital use of the special clinic group was significantly less than that of the routine clinic group. Hospital usage for the special clinic group includes all asthma admissions to other hospitals in the city as well as Bellevue during the study period. Routine clinic group hospital usage includes only readmissions at Bellevue because reliable information could not be obtained as to hospital usage elsewhere. Of the 47 patients originally selected for the special clinic group, 10 never attended clinic. These 10 patients accounted for 9 admissions and 76 hospital days assigned to the special clinic group during the 8-month study. Seven of these patients were questioned in depth regarding any admissions at hospitals other than Bellevue Hospital Center. None had been hospitalized elsewhere. Three nonattending patients were lost to followup. Hospital usage from 1 January 1982 until clinic enrollment and from clinic enrollment until 29 February 1988 was calculated for 34 of 37 attending patients in the special clinic group for whom data was available. The readmission rate per patient per month before enrollment was 0.13 ± 0.11 and after enrollment was 0.04 ± 0.09 (P = 0.003). The rehospitalization day rate per patient per month before and after enrollment was Table 4. Medical Treatment c)f Special Clinic AJ tenders before and after Special Clin ic Enrollment
Daily theophylline Oral beta agonist Inhaled beta agonist Chronic inhaled corticosteroids Chronic daily prednisone Brief prednisone pulses Reservoir device Home peak flow meter
100 50 100 20 25 0 0 0
82 13 100 82 9 89 100 100
* Data on clinic attenders after enrc>llment was dete rmined in Decernber 1987.
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Clinic Attenders., n = 56 After Before Enrollment* Enrollment
Medical Treatment
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Table 5. Outpatient Prednisone Use by 56 Special Attenders to Treat Severe Asthma Exacerbation 1 July 1985 to 29 February 1988
Clinic from
Patients
Pulsed Dose of Prednisone dly
n
0 I to 10 II to 20 21 to 30 31 to 40 41 to 73 Continuous daily use
14 10 15 6 3 3 5
0.73 ± 0.67 and 0.26 ± 0.58, respectively (P = 0.003). Special clinic attendance resulted in a statistically significant reduction in hospital use in these 34 patients. Similarly, we calculated hospital usage for the 19 patients crossed from the routine follow-up group. The readmission rate per patient per month before and after enrollment was 0.19 ± 0.15 and 0.09 ± 0.16, respectively (P = 0.06). The rehospitalization day rate per patient per month before and after enrollment was 1.16 ± 1.23 and 0.48 ± 9.94, respectively (P = 0.06). These 19 crossover patients were selected on the basis of having unusually problematic asthma. One patient in particular represented an unusual management problem. In addition to severe asthma, she had extensive bronchiectasis and severe restrictive lung disease related to inactive pulmonary tuberculosis, and pleural fibrosis with dense calcification related to previous therapeutic pneumothoraxes. The other 18 patients in the crossover group had asthma without additional lung disease. This single patient had higher hospital usage after clinic attendance than before. Excluding this unusual patient, the hospital usage before and after clinic enrollment for the other 18 of the 19 crossover patients was as follows: before and after readmission rate per patient per month, 0.18 ± 0.15 and 0.07 ± 0.16, respectively (P = 0.03) and before and after rehospitalization day rate per patient, 1.11 ± 1.24 and 0.31 ± 0.55, respectively (P = 0.02). For these 18 patients, clinic attendance resulted in a statistically significant reduction in hospital usage. Between 1 July 1985 and 28 February 1986, before enrollment in the clinic, the 19 crossover patients had 53 admissions and used 286 hospital days. After enroll-
ing in the clinic program, and during an identical calendar period, from 1 July 1987 through 29 February 1988, these same 19 patients totaled 14 admissions and 49 hospital days, representing a statistically significant reduction in hospital usage (P < 0.004). In all cases, the hospital usage before clinic enrollment includes only admissions at Bellevue Hospital Center. The hospital usage after clinic enrollment includes Bellevue Hospital Center admissions as well as those at other area hospitals. In order to determine whether the effect of special clinic enrollment could be sustained over time, the readmission rate for the 56 clinic attenders was determined for each of the 32 months of follow-up management in the special clinic. The fact that the monthly readmission rate remained quite constant, not increasing with time, suggests that the benefit of clinic enrollment was not a transient effect. Severe Morbidity and Mortality No patients died from asthma in the special clinic group during the 8 months of comparison. One patient died from asthma in the routine clinic group during this period. During the 32 months of follow-up of special clinic attenders, four patients required intubation for severe asthma. Three of these episodes occurred in the context of a very abrupt asthma attack with severe respiratory failure occurring within half an hour of the onset of the attack. All four patients recovered fully. Level of Asthma Activity Although many patients kept written log books of peak flow values and all were interviewed concerning interim levels of asthma activity between clinic visits, no reliable method could be developed to quantify the overall control of asthma symptoms for any given patient. Because many of the patients were unemployed, loss of work days was not a useful guide. On the basis of patient interviews, we believed that reduction in hospital use was paralleled by a reduction in overall asthma activity. Some patients were entirely free of asthma attacks at times, whereas others continued to have chronic wheezing; however, the symptoms were usually less troublesome than before entry into the special clinic. Discussion
Table 6. Readmissions and Rehospitalization Days for Special Clinic Group and Routine Clinic Group from I July 1985 to 28 February 1986 Variable
Hospital admissions Hospital admissions per patient Rehospitalization days Rehospitalization days per patient
Special Clinic Group (n = 47)
Routine Clinic Group (n = 57)
19 0.4 144 3.1
70 1.2* 384 6.7t
* P < 0.004 compared with special clinic group. t P < 0.02 compared with special clinic j*roup.
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We sought to design an outpatient treatment program specifically targeted at adults with a history of repeated hospitalizations for severe asthma exacerbations and to test its efficacy in reducing their rehospitalizations. We did not attempt to identify which, if any, particular aspect of the program was essential but to examine whether a combination of vigorous patient education, physician accessibility, and flexible but intensive use of a few appropriate medications might be successful. During the patient acquisition period, over 50% of possible candidates were excluded from treatment in the special asthma clinic. Most patients were ineligible because their asthma was mild. These patients were
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excluded because they were not likely to require frequent hospitalizations, and it was therefore unlikely that any measurable effect would result. Study criteria also excluded a number of patients with substance abuse or severe psychiatric illnesses. The decision to exclude them was based on the low probability of obtaining patient compliance using methods available to us. The 104 eligible patients were fairly heterogenous in the pattern and severity of their asthma. Their outstanding characteristic was a history of repeated attacks severe enough to require hospitalization. Allocation resulted in two groups that were similar in demographic characteristics, severity of asthma, and patterns of previous medical treatment. These two groups of hospitalized patients, one assigned to the special asthma clinic and the other discharged to their previous medical follow-up, were compared prospectively for a maximum of 8 months. The group treated in the special asthma program had a significant reduction in their rehospitalization rate when compared with the control group. Certain patients from the control group were then selected and entered into the special asthma clinic. These patients were not randomly selected but chosen on the basis of having frequent episodes of severe asthma in need of improved preventive treatment. Their hospital utilization compared with a similar calendar period 2 years before was also reduced significantly. The hospitalization usage of the special clinic group was determined before and after clinic enrollment. The clinic program caused a significant reduction in hospital usage. Similarly, the hospitalization usage of 18 of the 19 crossover patients declined significantly after clinic enrollment. One patient in this group presented a special management problem, as severe co-existing lung disease greatly complicated management of her asthma. We chose to consider her separately, as she was the only patient with co-existent pulmonary disease. To test whether the effect of the special asthma clinic could be sustained, the hospital readmission rate for clinic attenders was followed for up to 32 months. The rate did not increase over time. This finding suggests that the beneficial effect of the special clinic was not a transient phenomenon and could be sustained for up to 32 months. Overall, these results indicate that the special clinic program caused a marked and sustainable reduction in hospital admissions and hospital days use among clinic attenders. The effect of the special clinic is probably underestimated. In the parallel comparison of the special clinic group and routine clinic group, admissions of the special clinic group include those that occurred at other area hospitals as well as at Bellevue Hospital Center. Readmissions of the routine follow-up group were documented only at Bellevue Hospital Center; although some of these patients may have been admitted elsewhere during the follow-up period, we were unable to document this hospital usage. Similarly, the before-andafter comparison of the special clinic group and crossover patients may underestimate the effect of clinic enrollment. We were unable to determine accurate hospital usage before clinic attendance except at Bellevue Hospital Center, whereas hospital admissions after
clinic enrollment include those at Bellevue Hospital Center and other area hospitals. We have chosen to report our data in this form so as to give the most conservative estimate of clinic effect. Several questions should be examined regarding these conclusions: Is it possible that the special clinic group and routine clinic group were not truly equivalent and that the special clinic group contained patients who had milder asthma or were more educatable? Available demographic data suggest that this is not the case. In particular, available markers of severity of asthma seemed comparable in the two groups. Additionally, the facilities used for prestudy treatment were similar, and all patients showed a similar profound ignorance of medications and self-management strategy. Were admission criteria used by emergency room personnel different for special clinic group patients than for routine clinic group patients? When we examined this possibility we found that patients in the special clinic group who required emergency room treatment at Bellevue Hospital Center were almost invariably admitted. It appeared as if asthma exacerbations that these patients could not control themselves without emergency room intervention generally were severe enough to prompt admission. Because it could introduce bias into the study findings, special clinic personnel were not involved in any decisions regarding admission. Readmissions and rehospitalization days were selected as the most practical means for measuring the effect of special clinic intervention on asthma activity. The primary reason these variables were chosen was that they could be reliably measured. Another indirect measurement of a reduction in asthma activity was the number of patients who could be taken off chronic peroral corticosteroids. Chronic users fell from 14 to 5, and those on chronic daily prednisone therapy at the end of the study period were using lower doses than before clinic attendance. We were unsuccessful in developing a reliable method for measuring everyday activity of patients' asthma. Although all special clinic group patients had peak flow meters, none of the routine clinic group did; and, in any case, the use pattern of peak flow meters was quite variable. Likewise, self-reporting of symptoms was of no objective use in assessing disease activity. Patients had marked differences in their subjective response to their asthma, and self-reporting was found generally unreliable. Profound socioeconomic problems were everyday features of most patients' lives, which complicated attempts at measuring the influence of asthma episodes on absenteeism from work or school. Fortunately, there were insufficient deaths in either the special clinic group or the routine clinic group to comment on any effect that the clinic may have had on mortality. Likewise, no comment on reduction in intubation risk is possible on the basis of available data. Our experience with asthmatic attacks sufficiently severe to warrant intubation during the 32 months of clinic follow-up emphasized the problem of so-called "blitz" asthma. Three of these four attacks resulted in severe respiratory failure within one-half hour of the
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onset of the attack. The self-management strategy used probably would not be effective on such short notice. Our results support the view that intensive outpatient therapy can positively influence the rate of rehospitalization in a group of adult asthmatics who had previously been admitted frequently. We did not attempt to identify which specific aspect of the special clinic design was responsible for the reduction in readmissions. Most studies regarding treatment of asthma seek to isolate a therapeutic modality and examine its effect on disease activity. Under field conditions, however, treatment must necessarily be multifaceted. We therefore attempted to develop a simple system of patient education, physician involvement, and vigorous medical treatment that could be applied readily to a group of relatively uneducated and unsophisticated patients. We specifically avoided treatment modalities that have not been widely validated by others. For example, the practical aspects of clinic design included several that have been specifically demonstrated to improve clinic attendance and compliance. Short waiting times (5); long, personalized visits (6); easy accessibility by phone or walk-in visits (5); intensive education (7); simplification of medical regimens and reduction in number of medicines prescribed (7, 8) are widely accepted methods that were used with all patients. In general, we found that each patient required an individualized approach in terms of education, self-management strategy, and attempts to improve compliance with their medical regimen. We initially attempted to use written materials but found that many patients could not read well; and those that did were not particularly diligent in their study. We also considered establishing an organized educational program using lectures, support groups, and an assigned educator. However, it rapidly became evident that the face-to-face interaction of the medical care provider and patient resulted in the most meaningful transfer of information. Several convincing studies have demonstrated the efficacy of patient-education programs that have resulted in decreased hospital usage. Most of these studied pediatric patients (9-13). There are fewer studies regarding the efficacy of education in improving outcome with adult asthmatics. Hilton and colleagues (14) reported no improvement in outcome resulting from a relatively nonintensive education program; their methods are probably not directly comparable to ours. Maiman and colleagues (15) reported reduced emergency department usage after education efforts provided by nursing personnel, particularly if the nursing personnel were themselves asthmatic. Hindi-Alexander and colleagues (9) developed a vigorous educational program successfully applied to children and recently reported decreased hospital use in an adult population as well (16). The distinguishing feature of all these studies is that the role of educator is clearly separate from medical provider. We sought to combine the two functions. As observed by others (17), patient knowledge regarding their disease and its treatment was slight on enrollment in the special clinic. We elected to improve this deficit by using, as a main technique, a direct patient-physician interaction. Patient education and accessibility of care were key elements in the asthma clinic. Without the benefit of 870
appropriate medications, however, these factors would be without effect. The medical regimen selected was individualized to each patient's particular needs. The fewest possible medicines in the simplest possible frequency was the main thrust of therapy. Some patients required varying amounts of chronic medication, whereas others discontinued medications completely between attacks. All patients were taught to vary medications according to disease activity and to treat exacerbations very vigorously. In line with recent trends in asthma therapy (18, 19), we emphasized inhaled medication, in particular, vigorous doses of inhaled corticosteroids. We specifically discouraged oral beta agonists and attempted to withdraw methylxanthines whenever possible. As inhaled corticosteroids were an essential of therapy, proper metered-dose inhaler technique was of great importance. As others have observed (20, 21), the patients' metered-dose inhaler technique was initially suboptimal, and we had little success in training patients to use the metered-dose inhaler properly. Therefore, all patients were equipped with reservoir spacer devices and trained intensively in their correct use. One aspect of the program that was somewhat out of the ordinary was the use of a self-management strategy that included the specific encouragement of patients to self-treat with prednisone, if they suspected an attack sufficiently severe to have led to hospitalization. Simultaneously, patients were trained to increase their inhaled corticosteroids, thereby permitting short courses of prednisone with no tapering required. This strategy did not appear to lead to excessive prednisone use by patients. Patients in general expressed fear of prednisone side effects, and chronic use was discouraged by the clinic physician. All patients were equipped with peak flow meters. In keeping with the heterogenous personalities and motivations of clinic attenders, use of this device varied from occasional use by some patients when symptoms became particularly bothersome, to others who regularly measured their peak flow several times per day and who kept detailed diaries of their readings. The exact effect of peak flow measurements was difficult to assess but some patients found them a useful adjunct to self-management decisions. They were invaluable as objective evidence during phone communication that required management decisions. Accessibility of the physician was an important feature of the special asthma clinic. Walk-in visits and telephone visits were encouraged if asthma activity increased between scheduled appointments. Some patients preferred to stay in close contact with the clinic physician whereas others chose to manage their asthma without much input from the physician once they had completed an initial training period. Lack of 24-hour accessibility by the clinic physician may have resulted in some hospitalizations, but most patients adapted very well to the level of access provided them. No particular facet of the clinic program was of greater importance than any other. The combination of intensive personalized patient education, the emphasis on self-management methods, an effective and simple medical regimen, and physician accessibility were crit-
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ical elements leading to the reduction in rehospitalization. They were all absolutely interdependent. Before this study, when patients were readmitted frequently with recurrent asthma, the tendency of the hospital staff was to blame the patients' lack of compliance rather than inadequacies of outpatient care delivery. Many patients had developed reputations as "difficult" patients and were caught in a vicious cycle of frequent readmissions related to inadequate outpatient care. Assigning one specific physician to this group of patients made the physician clearly accountable for therapeutic failure or success. The physician could no longer blame the patient, as failure was likely to be the physician's fault. The physician was therefore stimulated to become deeply concerned and involved in patient outcome. We feel that physician accountability was a key element in the success of the clinic program. We were interested in demonstrating whether methods used in the special asthma clinic might be applied successfully by nonphysician personnel such as nurse practitioners. A full-time nurse practitioner has been working in the clinic since January 1987, allowing for an increase in clinic population to 150 patients. Preliminary results suggest that a nurse practitioner is as effective as a physician in reducing readmission rates among difficult adult asthmatics. We believe that the treatment of adult asthmatics using the methods described is cost effective. Including the cost of salaries, equipment, and hospitalization, the cost of care in the first 8 months of clinic operation was approximately $2100 per patient assigned to the special clinic group. As previously described, 10 of these 47 patients never attended the special clinic. These nonattenders utilized 76 hospital days during the 8-month period. Excluding these patients yields $1500 per patient as a more realistic estimate of the cost of care for clinic attenders. In comparison, using similar techniques of estimate, the cost of care for routine follow-up group patients for the same 8 months was approximately $4000 per patient. One interesting corollary of this study is our impression that certain patient personality characteristics seemed to predict a highly successful outcome of treatment independent of severity of asthma. It is beyond the scope of this paper to discuss these predictors. Obviously, if patients are selected carefully using criteria predictive of success, this type of clinic operation can result in impressive cost reductions by markedly reducing readmission rates. Since 1987 we have expanded our clinic population selectively, and we have found that the cost per patient has declined much below that indicated above. We implemented a program of outpatient therapy that combined patient education and self-management training with a simple but effective medical regimen. The program was successful in reducing readmission rates
and chronic oral corticosteroid use of a group of adult asthmatics who had previously required repeated readmissions for acute asthma exacerbations. These straightforward methods may have practical application in any hospital that is burdened by a similar population of adult asthmatics. Acknowledgment: assistance.
The authors thank Dr. Frank Lessa for technical
Requests for Reprints: Paul Mayo, MD, Room 7 North 24, Bellevue Hospital Center, 27th Street and First Avenue, New York, NY 10016. Current Author Addresses: Drs. Mayo and Harris: Room 7 North 24, Bellevue Hospital Center, 27th Street and First Avenue, New York, NY 10016. Ms. Richman: Bellevue Hospital Center, Chest Clinic, 2 South, 27th Street and First Avenue, New York, NY 10016.
References 1. Evans R 3d, Mullally DI, Wilson RW, et al. National trends in the morbidity and mortality of asthma in the U.S. Chest. 1987; 91(Suppl):65S-74S. 2. Sly RM. Increases in deaths from asthma. Ann Allergy. 1984;53: 20-5. 3. American Thoracic Society Committee on Diagnostic Standards. Definition and classification of chronic bronchitis, asthma, and pulmonary emphysema. Am Rev Respir Dis. 1962;85:763-4. 4. Dolovich M, Ruffin RE, Roberts R, Newhouse MT. Optimal delivery of aerosols from metered dose inhalers. Chest. 1981;80(Suppl): 911-5. 5. Finnerty FA Jr, Mattie EC, Finnerty FA 3d. Hypertension in the inner city: I. Analysis of clinic dropouts. Circulation. 1973;47:73-5. 6. Coe RM, Wessen AF. Social-psychological factors influencing the use of community health resources. Am J Public Health. 1965; 55:1024-31. 7. Matthews D, Hingson R. Improving patient compliance: a guide for physicians. Med Clin North Am. 1977;61:879-89. 8. Hulka BS, Kupper LL, Cassel JC, Efird RL. Medication use and misuse: physician-patient discrepancies. J Chronic Dis. 1975;28: 7-21. 9. Hindi-Alexander MC, Cropp GJ. Evaluation of a family asthma program. J Allergy Clin Immunol. 1984;74:505-10. 10. McNabb WL, Wilson-Pessano SR, Hughes GW, Scamagas P. Selfmanagement of children with asthma: AIR WISE. Am J Public Health. 1985;75:1219-20. 11. Lewis CE, Rachelefsky G, Lewis MA, de la Sota A, Kaplan M. A randomized trial of A.C.T. (asthma care training) for kids. Pediatrics. 1984;74:478-86. 12. Fireman P, Friday GA, Gira C, Vierthaler WA, Michaels L. Teaching self-management skills to asthmatic children and their parents in an ambulatory care setting. Pediatrics. 1981;68:341-8. 13. Clark NM, Feldman CH, Evans D, Levinson MJ, Wasilewski Y, Mellins RB. The impact of health education on frequency and cost of health care use by low income children with asthma. J Allergy Clin Immunol. 1986;78:108-15. 14. Hilton S, Sibbald B, Anderson HR, Freeling P. Controlled evaluation of the effects of patient education on asthma morbidity in general practice. Lancet. 1986;1:26-9. 15. Maiman LA, Green LW, Gibson G, MacKenzie EJ. Education for self-treatment by adult asthmatics. JAMA. 1979;241:1919-22. 16. Hindi-Alexander M, Throm J, Zielezny M, Green AW, Middleton E Jr. Results of training and education on the course of asthma in adults [Abstract]. J Allergy Clin Immunol. 1987;79:140. 17. Avery CH, March J, Brook RH. An assessment of the adequacy of self-care by adult asthmatics. J Community Health. 1980;5:167-80. 18. Newhouse MT, Dolovich MB. Control of asthma by aerosols. N Engl J Med. 1986;315:870-4. 19. Bone RC. Step care for asthma [Editorial]. JAMA. 1988;260:543. 20. Shim C, Williams MH Jr. The adequacy of inhalation of aerosol from canister nebulizers. Am J Med. 1980;69:891-4. 21. Oprehek J, Gayard P, Grimaud C, Charpin J. Patient error in use of bronchodilator metered aerosols. Br Med J. 1976;1:76.
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CLINIC
Results of a Program to Reduce Admissions for Adult Asthma Paul H. Mayo, MD; Julieta Richman, RN, MS, FNP; and H. William Harris, MD
Study Objective: To determine the effect of an outpatient program designed to reduce readmissions for asthma exacerbations among adults with asthma. Design: Randomized patient selection with crossover. Setting: Bellevue Hospital, New York City, New York. Patients: We identified 104 adult asthmatics who had previously required multiple hospitalizations for asthma attacks. Forty-seven patients were randomly assigned to an intensive outpatient treatment clinic and 57 patients continued to receive their previous outpatient care. Nineteen patients from this latter group were then crossed to the intensive outpatient therapy clinic. Interventions: Attenders of the intensive outpatient treatment program were treated with a vigorous medical regimen and educational program. Emphasis was placed on teaching patients aggressive self-management strategies in case of marked asthma exacerbation. Measurements and Main Results: The main measurement used to determine efficacy of the study program was readmission rate and hospital days used. Prospective comparison of treated compared with untreated patients indicated that program enrollment resulted in a threefold reduction in readmission rate and a twofold reduction in hospital day use rate (P < 0.004 and P < 0.02, respectively). Using retrospective data with patients serving as their own controls, we found a threefold reduction in readmission rate and in hospital day use (P < 0.003) during a 32-month follow-up period. A similar magnitude of reduction in hospital utilization was found when patients were crossed over to the intensive treatment group (P < 0.004). Conclusions: By using a vigorous medical regimen and intensive educational program, we were able to decrease hospital use among a group of adult asthmatics who had previously required repeated readmissions for acute asthma exacerbations.
I t has been estimated that 5% of American adults have asthma, and in the United States, asthma exacerbations resulted in 459 000 hospital admissions in 1983 (1). Asthma mortality may be increasing as well (2). The large number of hospitalizations and deaths due to asthma exist despite readily available and effective treatment. This dichotomy is especially prominent among patients who are not compliant with treatment regimens. Bellevue Hospital Center in New York City is a large municipal hospital serving the southeastern area of Manhattan. The lower east side of New York City is densely populated and socio-economically depressed. Asthma, especially in patients from the lower east side, constituted a common cause for adult admissions to Bellevue Hospital from 1982 to 1985, with an average of 670 adult hospitalizations per year that used 4700 hospital days. On the basis of posted daily hospital charges, the annual cost was at least two million dollars. The accompanying loss of work and school time and the occasional loss of life constituted an immeasurable burden of suffering and disruption caused by this very common disease. It has long been apparent to Bellevue Hospital staff that, among patients with asthma, certain ones required frequent admissions for asthma exacerbation. Although the emergency room and inpatient care is of high quality, we suspected that suboptimal outpatient care might influence the pattern of repeated admissions observed in these patients. Thus, we developed a special outpatient treatment program for these difficult patients, designed so that its effect on adult readmissions for asthma exacerbations could be studied. We describe this special asthma clinic and indicate its influence on hospital admissions for asthma. Methods Description of the Clinic Program
Annals of Internal Medicine. 1990;112:864-871. From Bellevue Hospital, New York, New York; and the New York University School of Medicine, New York, New York. For current author addresses, see end of text. 864
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All patients were treated by the same physician in the Bellevue Hospital Center chest clinic. Maximum efforts were made to reduce waiting time, to encourage frequent visits, and to maintain an open-door policy during clinic hours for any patient who wished to see the physician between scheduled visits. A full-time nurse practictioner shared patient care responsibilities with the full-time clinic physician in the last 12 months of the study. The two initial visits lasted at least 1 hour and involved detailed repetitive discussion of pathophysiologic concepts and treatment modalities, and emphasized self-management strategies designed to fit each patient's particular asthma pattern and personality. Subsequent visits were scheduled to allow at least half an hour per patient. All discussion was in the patient's native language with the exception of a single Bengali patient. The frequency of visits was determined by the patient's preference and the level of asthma activity. Patient education oc-
curred during repeated contacts between the patient and health care provider. No written, lecture, or audiovisual materials were used. All patients were provided with the clinic telephone number for use during clinic hours and the telephone number of a clinic answering machine for use during nonbusiness hours. All patients were encouraged to contact special clinic staff if any questions arose between scheduled visits. In the event of an asthma exacerbation that occurred when the clinic was closed, patients were instructed and encouraged to initiate vigorous self-treatment until they could contact clinic staff. All patients were instructed to seek early emergency room treatment for asthma exacerbation if self-management was ineffective and the clinic physician was not available. The clinic staff made concerted efforts to contact patients by phone or letter or both if they missed follow-up visits or were known to be in an asthma exacerbation. The clinic physician was excluded from decisions regarding hospital admission of patients seen in the emergency room. If patients were admitted to the hospital, the clinic physician made suggestions to the Bellevue Hospital Center housestaff regarding inpatient management and helped with patient education but was not involved directly in decisions as to the time of discharge. Medical regimens were tailored to each patient's asthma pattern and were designed to encourage compliance as much as possible. To this end, the fewest possible medicines were prescribed with attention to patient convenience as well as desired pharmacologic effect in the dosing schedule. Between exacerbations, medication was withdrawn or reduced to the lowest required to control symptoms. Patients were trained to vary the treatment regimen independently according to the intensity of their asthma and to treat severe exacerbations promptly and aggressively. Patients were encouraged to participate in decisions regarding therapy, and their preferences were respected. All patients used inhaled beta agonists on an "as needed" basis. The preparation used was based on patient preference; albuterol or metaproterenol was prescribed most often. Peroral beta agonists were rarely used. Cromolyn sodium was used only at patient request and if the patient had been using it before clinic enrollment. Peroral theophyllines were used based on symptom level and patient preference. Emphasis was placed on inhaled corticosteroids with the specific preparation predicated on Bellevue Hospital Center pharmacy availability and patient preference. The dosage range was variable with the upper limit being 32 puffs per day of beclomethasone (1600 /xg/d) or 24 puffs per day of triamcinolone (4800 jLtg/d). Typical maintenance doses totaled 16 puffs per day of beclomethasone given twice a day. Patients were instructed to vary the amount used according to level of asthma symptoms, increasing the dose as tolerated during periods of exacerbation, not to exceed 32 puffs per day. All patients were given prednisone for emergency use during severe exacerbations and specifically trained in its appropriate use and attendant hazards. Standard self-treatment for severe attacks was 40 mg of prednisone once a day for only 3 days. They were instructed to increase the inhaled corticosteroid while using prednisone and to continue the higher dose of inhaled corticosteroid for at least 1 week before reducing it to previous chronic usage levels. All patients were given portable reservoir spacer devices (Schering, Springfield, New Jersey) and encouraged to use them regularly, particularly when using inhaled corticosteroids. Each visit included a specific check of reservoir technique and detailed retraining as required. Patients were specifically discouraged from using meter-dose inhalers without the reservoir unit. All patients were equipped with portable peak flow meters (Healthscan, Cedar Grove, New Jersey), and trained in their use to identify asthma attacks that might require brief prednisone pulses.
Patient Selection for the Clinic Program Between 1 July 1985 and 31 December 1985, all adult patients admitted to Bellevue Hospital Center with a primary diagnosis of acute asthma exacerbation were reviewed within 1
Figure 1. Diagram of assignment to special clinic group, routine follow-up group, or ineligible patient status for adult patients admitted for asthma exacerbation to Bellevue Hospital Center from 1 July 1985 through 31 December 1985. BHC Bellevue Hospital Center; ER = emergency room; IVDA = intravenous drug abuser; CNS = central nervous system; LMD = local medical doctor.
to 3 days after readmission by one of the investigators. All patients fulfilled the American Thoracic Society definition of asthma (3) and were 18 years of age or older. By predetermined criteria (Figure 1), certain of these patients were excluded from the study. The remaining patients, who had had at least two hospitalizations for asthma in the previous 12 months or at least five emergency room visits for asthma in the previous 24 months, were considered eligible for the study. All eligible patients received a standard interview, were examined by one of the investigators, and were randomly selected according to the last digit of the hospital chart number for assignment to one of two different outpatient treatment plans: the special clinic treatment group or the routine clinic treatment group. The special clinic group patients were enrolled in the asthma program and treated as previously described. The routine clinic group patients were discharged to their previous regular outpatient care in the Bellevue Hospital chest clinic or medical clinic, to clinics of other local hospitals, to neighborhood clinics, or to local physicians. No attempt was made by the special clinic staff to alter their treatment. After an 8-month period of comparison between the two groups, a total of 19 patients were selected from the routine clinic group and crossed over to special clinic treatment. This crossover group was selected on the basis of having required multiple hospitalizations for asthma. M e a s u r e s of Effect of Special Clinic T r e a t m e n t We sought to measure whether special clinic treatment would reduce hospitalizations and hospital day use for acute exacerbations. Patient selection allowed us to do this in several ways. First, from 1 July 1985 to 28 February 1986 the readmission rate and the hospitalization day rate were compared in parallel between the special clinic group and the routine clinic group. Second, the readmission rate and hospitalization day rate before and after clinic enrollment were compared- for patients in the special clinic group. Admission records of patients in the special clinic group were obtained from 1 January 1982 until their enrollment in the clinic. The Bellevue Hospital Cen-
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Table 1. Demographic Characteristics of Special Clinic Group, Routine Clinic Group, and Crossover Group Patients* Characteristic
Special Clinic Group (n = 47)
Routine Clinic Group (n = 57)
Crossover Group (n = 19)
Age, y Gender Male Female Race Hispanic Black White Other Grade level attained Spanish as sole language.,% Fully employed,, % Present or past smoking, %
42 ± 15t
42 ± 13t
44 ± 12t
14 33
24 33
10 9
40 6 1 0 9 ± 3t 23 36 38
43 10 3 1 9 ± 4t 18 39 39
15 3 0 1 9 ± 3t 16 37 42
* There are no significant group differences. t Values are expressed as mean ± 1 SD.
ter computer identified which of these admissions were for asthma exacerbations. Hospital utilization thus derived was compared to hospital utilization by the special clinic group patients after their enrollment date through 29 February 1988. Third, a similar measure of effect was calculated for the patients who were crossed over from the routine follow-up group. Hospital utilization before and after special clinic enrollment was tabulated for these patients. Finally, we established a longitudinal comparison of the crossover group by measuring the hospital utilization of this group of 19 crossover patients before clinic enrollment from 1 July 1985 to 28 February 1986. This was compared with their hospital utilization from 1 July 1987 to 29 February 1988. Statistical Analysis Continuous data are presented as mean ± 1 SD and were compared with use of /-tests with application of the Bonneferoni-Ryan correction mechanism for multiple significance testing. Frequency data were compared using chi-square tests. Effect of intervention on clinical outcomes were assessed by multivariate analysis of variance performed through general linear models procedure. All P values less than 0.05 were considered significant. Computational procedures used the SAS statistics program (SAS, Carey, North Carolina). Results Patient Selection As shown in Figure 1, between 1 July 1985 and 31 December 1985, 212 adult patients were admitted to
Bellevue Hospital Center with a primary diagnosis of acute asthma exacerbation. Of these patients, 108 were excluded from the study by predetermined criteria (Figure 1). The remaining 104 patients were eligible for random allocation by the last digit of the hospital number (Figure 1). Forty-seven patients were assigned to the special clinic group and 57 patients to the routine clinic group. Of the 47 special clinic group patients, 10 chose never to attend the special asthma clinic. Three of these nonattenders refused outright to attend. Three other patients agreed but failed to keep appointments and could not be located by phone or letter. The remaining nonattenders repeatedly stated their intention to attend but never actually kept an appointment. All four of these patients habitually abused nasal cocaine or nasal heroin or both. Thus, of 47 patients randomized to the special clinic group, 37 patients actually attended the clinic. After 8 months of follow-up in the routine clinic group, 19 patients were selected on the basis of poorly controlled asthma for transfer to the special clinic group. These 19 plus the original 37 special clinic group clinic attenders resulted in a group of 56 clinic attenders who were followed prospectively through 29 February 1988. Of this group, 1 patient moved away and was lost to follow-up. Patient Characteristics Demographic characteristics for the special clinic group, the routine clinic group, the crossover group, and the markers of severity of asthma are presented in Table 1 and Table 2. There are no statistically significant differences between the three groups with the exception that a history of previous intubation for asthma in the crossover group was significantly less than in the two other groups. Patterns of outpatient care before the study are presented in Table 3. There were no statistically significant differences in the source of outpatient care among the three groups. All patients were asked to demonstrate metered-dose inhaler technique at their initial interview. Technical faults varied widely but no patient demonstrated satisfactory technique defined by widely accepted criteria (4). In general, patients' knowledge of asthma and treatment options was so vague and disorganized as to make formal assessment of this knowledge difficult. Table 3 summarizes some examples of the pa-
Table 2. Markers of Severity of Asthma for Special Clinic Group, Routine Clinic Group, and Crossover Patients* Marker
Mean number of admissions at BHC per patient 1-1-82 through 30-6-85 Mean number of hospital days at BHC per patient 1-1-82 through 30-6-85 Patients using chronic daily corticosteroids, % Patients requiring intubation for asthma, % Duration of asthma, v
Group
Special Clinic Group (n = 47)
Routine Clinic Group (n = 57)
Crossover Group (n = 19)
4.4 ± 4.5t 27 ± 28t 21 11 16 ± 13t
4.5 ± 6.1t 34 ± 57t 26 18 16 ± l i t
6.6 ± 8.01 45 ± 60t 26 0* 13 ± l i t
* There are no significant group differences except for percentage of crossover patients requiring intubation for asthma before the study. BHC Bellevue Hospital Center. t Values are expressed as mean ± 1 SD. t P < 0.02.
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Table 3. Patterns of Outpatient Follow-up of Special Clinic Group, Routine Clinic Group, and Crossover Group Patients before the Study Period* Pattern
Special Clinic Group (n = 47)
Routine Clinic Group (n = 57)
Crossover Group (n = 19)
M
n
BHC clinic Clinic other than BHC Local physician Emergency room only Patients knowing physician's name Patients knowing difference in action of beclomethasone and beta agonists Patients trained in self-treatment with prednisone Patients with adequate MDI technique Patients contacting physician by phone between scheduled visits
>
55 11 19 15 49
63 12 9 16 53
84 0 5 11 74
0
0
0
0
0
0
0
0
0
0
0
0
* There are no significant group> differences. BHC = 13ellevue Hospital Center; MDI = metered dose inhaler.
dents' profound lack of knowledge regarding information important to basic self-management issues. Pattern of Treatment The specific medical regimens used in the 56 clinic attenders before and after enrollment as of December 1987 are documented in Table 4. The main difference in therapy after clinic enrollment was in the use of inhaled corticosteroids, reservoir spacer devices, home peak flow meters, and self-initiated prednisone pulses. Peroral beta agonist use was markedly reduced. Of the 14 patients initially on daily corticosteroids, 10 patients were able to discontinue use and the remaining four used lower doses than before clinic enrollment. One patient not previously on daily chronic corticosteroids required daily use after entering special asthma clinic care. No patient who used high-dose inhaled corticosteroids but not chronic daily prednisone showed clinical evidence of hypercorticism. A key element in preventing severe asthma attacks was training patients to initiate early therapy with peroral prednisone with the onset of an attack as judged by symptoms and a marked decline in peak expiratory flow. Table 5 summarizes outpatient use of pulsed prednisone by clinic attenders. The table excludes periods of prednisone use that occurred in the days after a hospital discharge or during a prolonged taper required in the context of weaning from long-term corticosteroid use antedating clinic attendance. The data represent prednisone used by patients attempting to abort asthma exacerbations that might have led to hospitalization. No patient appeared to use prednisone out of proportion to that required by good medical judgment, and all expressed concern about potential side effects.
The frequency and duration of clinic visits for clinic attenders was highly variable. One patient visited the clinic at least once a week for the duration of the study. An occasional patient preferred to maintain physician contact by telephone after training and visited the clinic every 6 months, spending an hour at each visit. Telephone contact varied even more and depended on the severity and frequency of asthmatic exacerbations in each patient. For the duration of an exacerbation, physician and patient might talk on a daily basis and then not speak by telephone until another episode occurred. Hospital Use Between 1 July 1985 and 28 February 1986, the hospital readmission rate and the hospital day rate for acute exacerbation were followed prospectively for the special clinic group and the routine clinic group (Table 6). Because the two groups are of unequal size, results are expressed as readmissions and rehospitalization days per patient. The hospital use of the special clinic group was significantly less than that of the routine clinic group. Hospital usage for the special clinic group includes all asthma admissions to other hospitals in the city as well as Bellevue during the study period. Routine clinic group hospital usage includes only readmissions at Bellevue because reliable information could not be obtained as to hospital usage elsewhere. Of the 47 patients originally selected for the special clinic group, 10 never attended clinic. These 10 patients accounted for 9 admissions and 76 hospital days assigned to the special clinic group during the 8-month study. Seven of these patients were questioned in depth regarding any admissions at hospitals other than Bellevue Hospital Center. None had been hospitalized elsewhere. Three nonattending patients were lost to followup. Hospital usage from 1 January 1982 until clinic enrollment and from clinic enrollment until 29 February 1988 was calculated for 34 of 37 attending patients in the special clinic group for whom data was available. The readmission rate per patient per month before enrollment was 0.13 ± 0.11 and after enrollment was 0.04 ± 0.09 (P = 0.003). The rehospitalization day rate per patient per month before and after enrollment was Table 4. Medical Treatment c)f Special Clinic AJ tenders before and after Special Clin ic Enrollment
Daily theophylline Oral beta agonist Inhaled beta agonist Chronic inhaled corticosteroids Chronic daily prednisone Brief prednisone pulses Reservoir device Home peak flow meter
100 50 100 20 25 0 0 0
82 13 100 82 9 89 100 100
* Data on clinic attenders after enrc>llment was dete rmined in Decernber 1987.
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Clinic Attenders., n = 56 After Before Enrollment* Enrollment
Medical Treatment
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Table 5. Outpatient Prednisone Use by 56 Special Attenders to Treat Severe Asthma Exacerbation 1 July 1985 to 29 February 1988
Clinic from
Patients
Pulsed Dose of Prednisone dly
n
0 I to 10 II to 20 21 to 30 31 to 40 41 to 73 Continuous daily use
14 10 15 6 3 3 5
0.73 ± 0.67 and 0.26 ± 0.58, respectively (P = 0.003). Special clinic attendance resulted in a statistically significant reduction in hospital use in these 34 patients. Similarly, we calculated hospital usage for the 19 patients crossed from the routine follow-up group. The readmission rate per patient per month before and after enrollment was 0.19 ± 0.15 and 0.09 ± 0.16, respectively (P = 0.06). The rehospitalization day rate per patient per month before and after enrollment was 1.16 ± 1.23 and 0.48 ± 9.94, respectively (P = 0.06). These 19 crossover patients were selected on the basis of having unusually problematic asthma. One patient in particular represented an unusual management problem. In addition to severe asthma, she had extensive bronchiectasis and severe restrictive lung disease related to inactive pulmonary tuberculosis, and pleural fibrosis with dense calcification related to previous therapeutic pneumothoraxes. The other 18 patients in the crossover group had asthma without additional lung disease. This single patient had higher hospital usage after clinic attendance than before. Excluding this unusual patient, the hospital usage before and after clinic enrollment for the other 18 of the 19 crossover patients was as follows: before and after readmission rate per patient per month, 0.18 ± 0.15 and 0.07 ± 0.16, respectively (P = 0.03) and before and after rehospitalization day rate per patient, 1.11 ± 1.24 and 0.31 ± 0.55, respectively (P = 0.02). For these 18 patients, clinic attendance resulted in a statistically significant reduction in hospital usage. Between 1 July 1985 and 28 February 1986, before enrollment in the clinic, the 19 crossover patients had 53 admissions and used 286 hospital days. After enroll-
ing in the clinic program, and during an identical calendar period, from 1 July 1987 through 29 February 1988, these same 19 patients totaled 14 admissions and 49 hospital days, representing a statistically significant reduction in hospital usage (P < 0.004). In all cases, the hospital usage before clinic enrollment includes only admissions at Bellevue Hospital Center. The hospital usage after clinic enrollment includes Bellevue Hospital Center admissions as well as those at other area hospitals. In order to determine whether the effect of special clinic enrollment could be sustained over time, the readmission rate for the 56 clinic attenders was determined for each of the 32 months of follow-up management in the special clinic. The fact that the monthly readmission rate remained quite constant, not increasing with time, suggests that the benefit of clinic enrollment was not a transient effect. Severe Morbidity and Mortality No patients died from asthma in the special clinic group during the 8 months of comparison. One patient died from asthma in the routine clinic group during this period. During the 32 months of follow-up of special clinic attenders, four patients required intubation for severe asthma. Three of these episodes occurred in the context of a very abrupt asthma attack with severe respiratory failure occurring within half an hour of the onset of the attack. All four patients recovered fully. Level of Asthma Activity Although many patients kept written log books of peak flow values and all were interviewed concerning interim levels of asthma activity between clinic visits, no reliable method could be developed to quantify the overall control of asthma symptoms for any given patient. Because many of the patients were unemployed, loss of work days was not a useful guide. On the basis of patient interviews, we believed that reduction in hospital use was paralleled by a reduction in overall asthma activity. Some patients were entirely free of asthma attacks at times, whereas others continued to have chronic wheezing; however, the symptoms were usually less troublesome than before entry into the special clinic. Discussion
Table 6. Readmissions and Rehospitalization Days for Special Clinic Group and Routine Clinic Group from I July 1985 to 28 February 1986 Variable
Hospital admissions Hospital admissions per patient Rehospitalization days Rehospitalization days per patient
Special Clinic Group (n = 47)
Routine Clinic Group (n = 57)
19 0.4 144 3.1
70 1.2* 384 6.7t
* P < 0.004 compared with special clinic group. t P < 0.02 compared with special clinic j*roup.
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We sought to design an outpatient treatment program specifically targeted at adults with a history of repeated hospitalizations for severe asthma exacerbations and to test its efficacy in reducing their rehospitalizations. We did not attempt to identify which, if any, particular aspect of the program was essential but to examine whether a combination of vigorous patient education, physician accessibility, and flexible but intensive use of a few appropriate medications might be successful. During the patient acquisition period, over 50% of possible candidates were excluded from treatment in the special asthma clinic. Most patients were ineligible because their asthma was mild. These patients were
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excluded because they were not likely to require frequent hospitalizations, and it was therefore unlikely that any measurable effect would result. Study criteria also excluded a number of patients with substance abuse or severe psychiatric illnesses. The decision to exclude them was based on the low probability of obtaining patient compliance using methods available to us. The 104 eligible patients were fairly heterogenous in the pattern and severity of their asthma. Their outstanding characteristic was a history of repeated attacks severe enough to require hospitalization. Allocation resulted in two groups that were similar in demographic characteristics, severity of asthma, and patterns of previous medical treatment. These two groups of hospitalized patients, one assigned to the special asthma clinic and the other discharged to their previous medical follow-up, were compared prospectively for a maximum of 8 months. The group treated in the special asthma program had a significant reduction in their rehospitalization rate when compared with the control group. Certain patients from the control group were then selected and entered into the special asthma clinic. These patients were not randomly selected but chosen on the basis of having frequent episodes of severe asthma in need of improved preventive treatment. Their hospital utilization compared with a similar calendar period 2 years before was also reduced significantly. The hospitalization usage of the special clinic group was determined before and after clinic enrollment. The clinic program caused a significant reduction in hospital usage. Similarly, the hospitalization usage of 18 of the 19 crossover patients declined significantly after clinic enrollment. One patient in this group presented a special management problem, as severe co-existing lung disease greatly complicated management of her asthma. We chose to consider her separately, as she was the only patient with co-existent pulmonary disease. To test whether the effect of the special asthma clinic could be sustained, the hospital readmission rate for clinic attenders was followed for up to 32 months. The rate did not increase over time. This finding suggests that the beneficial effect of the special clinic was not a transient phenomenon and could be sustained for up to 32 months. Overall, these results indicate that the special clinic program caused a marked and sustainable reduction in hospital admissions and hospital days use among clinic attenders. The effect of the special clinic is probably underestimated. In the parallel comparison of the special clinic group and routine clinic group, admissions of the special clinic group include those that occurred at other area hospitals as well as at Bellevue Hospital Center. Readmissions of the routine follow-up group were documented only at Bellevue Hospital Center; although some of these patients may have been admitted elsewhere during the follow-up period, we were unable to document this hospital usage. Similarly, the before-andafter comparison of the special clinic group and crossover patients may underestimate the effect of clinic enrollment. We were unable to determine accurate hospital usage before clinic attendance except at Bellevue Hospital Center, whereas hospital admissions after
clinic enrollment include those at Bellevue Hospital Center and other area hospitals. We have chosen to report our data in this form so as to give the most conservative estimate of clinic effect. Several questions should be examined regarding these conclusions: Is it possible that the special clinic group and routine clinic group were not truly equivalent and that the special clinic group contained patients who had milder asthma or were more educatable? Available demographic data suggest that this is not the case. In particular, available markers of severity of asthma seemed comparable in the two groups. Additionally, the facilities used for prestudy treatment were similar, and all patients showed a similar profound ignorance of medications and self-management strategy. Were admission criteria used by emergency room personnel different for special clinic group patients than for routine clinic group patients? When we examined this possibility we found that patients in the special clinic group who required emergency room treatment at Bellevue Hospital Center were almost invariably admitted. It appeared as if asthma exacerbations that these patients could not control themselves without emergency room intervention generally were severe enough to prompt admission. Because it could introduce bias into the study findings, special clinic personnel were not involved in any decisions regarding admission. Readmissions and rehospitalization days were selected as the most practical means for measuring the effect of special clinic intervention on asthma activity. The primary reason these variables were chosen was that they could be reliably measured. Another indirect measurement of a reduction in asthma activity was the number of patients who could be taken off chronic peroral corticosteroids. Chronic users fell from 14 to 5, and those on chronic daily prednisone therapy at the end of the study period were using lower doses than before clinic attendance. We were unsuccessful in developing a reliable method for measuring everyday activity of patients' asthma. Although all special clinic group patients had peak flow meters, none of the routine clinic group did; and, in any case, the use pattern of peak flow meters was quite variable. Likewise, self-reporting of symptoms was of no objective use in assessing disease activity. Patients had marked differences in their subjective response to their asthma, and self-reporting was found generally unreliable. Profound socioeconomic problems were everyday features of most patients' lives, which complicated attempts at measuring the influence of asthma episodes on absenteeism from work or school. Fortunately, there were insufficient deaths in either the special clinic group or the routine clinic group to comment on any effect that the clinic may have had on mortality. Likewise, no comment on reduction in intubation risk is possible on the basis of available data. Our experience with asthmatic attacks sufficiently severe to warrant intubation during the 32 months of clinic follow-up emphasized the problem of so-called "blitz" asthma. Three of these four attacks resulted in severe respiratory failure within one-half hour of the
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onset of the attack. The self-management strategy used probably would not be effective on such short notice. Our results support the view that intensive outpatient therapy can positively influence the rate of rehospitalization in a group of adult asthmatics who had previously been admitted frequently. We did not attempt to identify which specific aspect of the special clinic design was responsible for the reduction in readmissions. Most studies regarding treatment of asthma seek to isolate a therapeutic modality and examine its effect on disease activity. Under field conditions, however, treatment must necessarily be multifaceted. We therefore attempted to develop a simple system of patient education, physician involvement, and vigorous medical treatment that could be applied readily to a group of relatively uneducated and unsophisticated patients. We specifically avoided treatment modalities that have not been widely validated by others. For example, the practical aspects of clinic design included several that have been specifically demonstrated to improve clinic attendance and compliance. Short waiting times (5); long, personalized visits (6); easy accessibility by phone or walk-in visits (5); intensive education (7); simplification of medical regimens and reduction in number of medicines prescribed (7, 8) are widely accepted methods that were used with all patients. In general, we found that each patient required an individualized approach in terms of education, self-management strategy, and attempts to improve compliance with their medical regimen. We initially attempted to use written materials but found that many patients could not read well; and those that did were not particularly diligent in their study. We also considered establishing an organized educational program using lectures, support groups, and an assigned educator. However, it rapidly became evident that the face-to-face interaction of the medical care provider and patient resulted in the most meaningful transfer of information. Several convincing studies have demonstrated the efficacy of patient-education programs that have resulted in decreased hospital usage. Most of these studied pediatric patients (9-13). There are fewer studies regarding the efficacy of education in improving outcome with adult asthmatics. Hilton and colleagues (14) reported no improvement in outcome resulting from a relatively nonintensive education program; their methods are probably not directly comparable to ours. Maiman and colleagues (15) reported reduced emergency department usage after education efforts provided by nursing personnel, particularly if the nursing personnel were themselves asthmatic. Hindi-Alexander and colleagues (9) developed a vigorous educational program successfully applied to children and recently reported decreased hospital use in an adult population as well (16). The distinguishing feature of all these studies is that the role of educator is clearly separate from medical provider. We sought to combine the two functions. As observed by others (17), patient knowledge regarding their disease and its treatment was slight on enrollment in the special clinic. We elected to improve this deficit by using, as a main technique, a direct patient-physician interaction. Patient education and accessibility of care were key elements in the asthma clinic. Without the benefit of 870
appropriate medications, however, these factors would be without effect. The medical regimen selected was individualized to each patient's particular needs. The fewest possible medicines in the simplest possible frequency was the main thrust of therapy. Some patients required varying amounts of chronic medication, whereas others discontinued medications completely between attacks. All patients were taught to vary medications according to disease activity and to treat exacerbations very vigorously. In line with recent trends in asthma therapy (18, 19), we emphasized inhaled medication, in particular, vigorous doses of inhaled corticosteroids. We specifically discouraged oral beta agonists and attempted to withdraw methylxanthines whenever possible. As inhaled corticosteroids were an essential of therapy, proper metered-dose inhaler technique was of great importance. As others have observed (20, 21), the patients' metered-dose inhaler technique was initially suboptimal, and we had little success in training patients to use the metered-dose inhaler properly. Therefore, all patients were equipped with reservoir spacer devices and trained intensively in their correct use. One aspect of the program that was somewhat out of the ordinary was the use of a self-management strategy that included the specific encouragement of patients to self-treat with prednisone, if they suspected an attack sufficiently severe to have led to hospitalization. Simultaneously, patients were trained to increase their inhaled corticosteroids, thereby permitting short courses of prednisone with no tapering required. This strategy did not appear to lead to excessive prednisone use by patients. Patients in general expressed fear of prednisone side effects, and chronic use was discouraged by the clinic physician. All patients were equipped with peak flow meters. In keeping with the heterogenous personalities and motivations of clinic attenders, use of this device varied from occasional use by some patients when symptoms became particularly bothersome, to others who regularly measured their peak flow several times per day and who kept detailed diaries of their readings. The exact effect of peak flow measurements was difficult to assess but some patients found them a useful adjunct to self-management decisions. They were invaluable as objective evidence during phone communication that required management decisions. Accessibility of the physician was an important feature of the special asthma clinic. Walk-in visits and telephone visits were encouraged if asthma activity increased between scheduled appointments. Some patients preferred to stay in close contact with the clinic physician whereas others chose to manage their asthma without much input from the physician once they had completed an initial training period. Lack of 24-hour accessibility by the clinic physician may have resulted in some hospitalizations, but most patients adapted very well to the level of access provided them. No particular facet of the clinic program was of greater importance than any other. The combination of intensive personalized patient education, the emphasis on self-management methods, an effective and simple medical regimen, and physician accessibility were crit-
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ical elements leading to the reduction in rehospitalization. They were all absolutely interdependent. Before this study, when patients were readmitted frequently with recurrent asthma, the tendency of the hospital staff was to blame the patients' lack of compliance rather than inadequacies of outpatient care delivery. Many patients had developed reputations as "difficult" patients and were caught in a vicious cycle of frequent readmissions related to inadequate outpatient care. Assigning one specific physician to this group of patients made the physician clearly accountable for therapeutic failure or success. The physician could no longer blame the patient, as failure was likely to be the physician's fault. The physician was therefore stimulated to become deeply concerned and involved in patient outcome. We feel that physician accountability was a key element in the success of the clinic program. We were interested in demonstrating whether methods used in the special asthma clinic might be applied successfully by nonphysician personnel such as nurse practitioners. A full-time nurse practitioner has been working in the clinic since January 1987, allowing for an increase in clinic population to 150 patients. Preliminary results suggest that a nurse practitioner is as effective as a physician in reducing readmission rates among difficult adult asthmatics. We believe that the treatment of adult asthmatics using the methods described is cost effective. Including the cost of salaries, equipment, and hospitalization, the cost of care in the first 8 months of clinic operation was approximately $2100 per patient assigned to the special clinic group. As previously described, 10 of these 47 patients never attended the special clinic. These nonattenders utilized 76 hospital days during the 8-month period. Excluding these patients yields $1500 per patient as a more realistic estimate of the cost of care for clinic attenders. In comparison, using similar techniques of estimate, the cost of care for routine follow-up group patients for the same 8 months was approximately $4000 per patient. One interesting corollary of this study is our impression that certain patient personality characteristics seemed to predict a highly successful outcome of treatment independent of severity of asthma. It is beyond the scope of this paper to discuss these predictors. Obviously, if patients are selected carefully using criteria predictive of success, this type of clinic operation can result in impressive cost reductions by markedly reducing readmission rates. Since 1987 we have expanded our clinic population selectively, and we have found that the cost per patient has declined much below that indicated above. We implemented a program of outpatient therapy that combined patient education and self-management training with a simple but effective medical regimen. The program was successful in reducing readmission rates
and chronic oral corticosteroid use of a group of adult asthmatics who had previously required repeated readmissions for acute asthma exacerbations. These straightforward methods may have practical application in any hospital that is burdened by a similar population of adult asthmatics. Acknowledgment: assistance.
The authors thank Dr. Frank Lessa for technical
Requests for Reprints: Paul Mayo, MD, Room 7 North 24, Bellevue Hospital Center, 27th Street and First Avenue, New York, NY 10016. Current Author Addresses: Drs. Mayo and Harris: Room 7 North 24, Bellevue Hospital Center, 27th Street and First Avenue, New York, NY 10016. Ms. Richman: Bellevue Hospital Center, Chest Clinic, 2 South, 27th Street and First Avenue, New York, NY 10016.
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