INTRODUCTION

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Several studies have looked at the benefits of asthma education in adults with asthma. Results from the earliest studies were often difficult to interpret because of a lack of control groups and concomitant initiation of inhaled corticosteroids therapy (1). Three randomized controlled trials have shown that asthma education can lower asthma morbidity in specific subgroups of individuals with asthma characterized by a high utilization of health services such as those having been hospitalized once or more before enrollment in the study (6). In patients with one visit to the emergency room in the last 12 mo, two of three studies have demonstrated a decrease in the number of subsequent urgent visits for asthma (9). In studies that have shown a decrease in the use of medical services, the content of the educational program included different elements (6). A metaanalysis has confirmed that asthma training programs based on a written self-management plan are more likely to decrease the utilization of health services (13). Unfortunately, the research design used in these trials does not allow us to identify the specific component that was most relevant to the improved outcome. In fact, limited or shorter interventions might prove more cost effective.

In a previous randomized control study by our group of well-controlled patients with moderate or severe asthma, we observed among educated patients a significant improvement in knowledge and treatment observance. However, after optimization of treatment, no further reduction in morbidity related to the educational intervention could be shown (14). Similar results have been obtained by other groups (15). We have also demonstrated that long-term compliance with peak-flow monitoring was poor (18). Our program has since been changed to use the PRECEDE model for health education, focusing more intensively at improving patient confidence in adjusting their medication and modifying the format of the teaching to suit patient needs (19, 20). This randomized controlled study with parallel groups was designed to compare the impact of our structured educational program on urgent visits for asthma and other clinical parameters with a more limited program that includes only teaching of inhaler technique and the prescription of a written self-action plan to adult patients presenting with an acute exacerbation of asthma.

	METHODS

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Selection of Patients

We enrolled consecutive patients who visited either the emergency room or outpatient clinic for an acute exacerbation of asthma from April 1996 up to January 1997. Patients were included if they were older than 18 yr of age and had not previously taken part in any asthma educational program. To avoid enrolling patients with chronic obstructive lung disease, we excluded patients older than 40 yr of age in whom the best forced expiratory volume in 1 s (FEV₁) was lower than 80% of predicted. All patients with concurrent medical illnesses that in the judgment of the investigators contraindicated study participation were also excluded. The study was conducted at two university hospitals in Sainte-Foy and in Québec City. The research protocol was approved by both hospital ethics committees and all patients signed a written consent form.

Randomization

All patients were stratified for treatment center. To avoid contamination of the control group, the first 45 patients were recruited in the control group (11). Subsequent eligible patients were randomized in the two educated groups. At this point in time, physicians unfamiliar with the prescription of self-action plans were given information either by the study coordinator or the investigator.

Control group (Group C). The patients in Group C received the usual treatment given for an acute asthma exacerbation. They were taught inhaler technique if the physician was willing.

Limited educational intervention group (Group LE). In addition to standard treatment as for Group C treatment, patients in Group LE were given a self-action plan that was explained by the on call physician (14). The self-action plan was based on the color of traffic lights:

Green zone. Able to do usual activities without being short of breath, using bronchodilator less than once a day, not awakened by asthma at night (peak expiratory flow [PEF] values are greater than 85% of predicted or personal best value [PBV]): continue the same treatment.

Yellow zone. For the previous 24 h, using bronchodilator twice a day, moderate exercise induces unusual breathlessness (PEF values are between 60 and 85% of predicted or PBV) (1) For subjects not using any inhaled corticosteroids, physicians were asked to prescribe an equivalent dose of beclomethasone dipropionate (BDP), 500 to 1,000 µg/d for 14 d; (2) for those already using inhaled corticosteroids, physicians were asked to recommend patients to double the dose of inhaled corticosteroids up to a maximal BDP dose of 2,000 µg/d; (3) for those already taking more than an equivalent BDP dose of 1,000 µg/d, physicians were recommended to prescribe oral prednisone for 10 to 14 d.

Red zone. In the previous 24 h, bronchodilator has been relieving asthma symptoms for less than 4 h, using more than 10 puffs of bronchodilator per day, daily life activities cause breathlessness or breathlessness is present at rest: contact a physician or go to the emergency room. In such instances, physicians were recommended to prescribe oral prednisone for 10 to 14 d.

The patient could choose between a self-action plan based on PEF or symptoms (14). Of those who decided to monitor themselves, using a peak-flow meter, they could measure PEF daily or when asthma symptoms deteriorated, according to their motivation. The self-action plan based on PEF was initially prescribed according to predicted values, and could at follow-up visits be modified according to personal best value.

Subjects were all instructed in the proper use of their inhaler device either by the respiratory therapist or the study nurse.

Structured educational intervention group (Group SE). In addition to what patients in Group LE received, the patients in Group SE participated in a structured asthma educational program based on the PRECEDE model of health education within 2 wk after their randomization (19). Briefly, this model takes into consideration three different issues that are important when dealing with health-related behaviors: predisposing factors (belief, attitude, knowledge), enabling factors (community resource, family support), and reinforcement. The teaching was provided individually or in small groups according to patient preference. The intervention focused mainly on self-management. To increase patient self-confidence in making his or her own treatment decisions, the interaction with the patient was based on the self-efficacy theory of Bandura (20). Reinforcement was provided at the 6-mo follow-up visit.

Outcomes

At the baseline visit, information was collected on demographic characteristics, medication, duration of asthma, atopy, and morbidity in the year before enrollment. All patients were seen by the study coordinator at the time of the first emergency visit (Visit 0), after 2 wk (Visit 1), and then 6 mo (Visit 2) and 12 mo later (Visit 3). During this time, patients continued to be monitored by their usual physician.

Number of urgent visits (primary outcome). The term "urgent" visits for an acute exacerbation of asthma includes all visits to the emergency room and unscheduled medical visits to the outpatient clinic. Patients were instructed in keeping a diary that included the number of urgent visits and the number of times they implemented the self- action plan (Groups LE and SE only).

Lung function tests. PEF measurement was done at each visit according to the guidelines of the American Thoracic Society (22).

Knowledge score. The knowledge score (minimal score = 0, maximal score = 25) was assessed at Visits 1 and 3 only, using a French language questionnaire previously validated in our institution. The knowledge score is reported as a percentage of the maximal score.

Quality of life score. The quality of life score was assessed using the quality of life (QOL) questionnaire validated by Juniper and coworkers, and was administered by the educator at Visits 1 and 3 (23, 24). QOL score was evaluated using a scale of 0 to 7, where 0 means a very poor quality of life and 7 the best possible.

Compliance with inhaled corticosteroids. Compliance was evaluated according to the patient's own estimation at Visits 1 and 3.

Statistical Analysis

We expressed continuous variables as means ± SEM. Differences between groups were assessed by one-way analysis of variance (ANOVA). The normality and variance assumptions were verified. The Fisher exact test or ² test was used to test differences between proportions. The Kruskal-Wallis test was performed for compliance data. Emergency room visits were analyzed by repeated measured analysis. Statistical significance was established at p < 0.05. All reported p values are two tailed.

	RESULTS

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION REFERENCES

Study Population

One hundred and twenty-six patients were enrolled and 98 patients completed the trial. At Visit 1, 21 subjects did not show up for randomization after their initial visit to the hospital. Only four subjects were lost to follow-up after Visit 1: two in Group LE and two in Group C. Finally, three other patients were withdrawn during the study period, two for psychiatric disorders and one in whom the diagnosis of chronic obstructive lung disease was subsequently made.

As summarized in Table 1, there was no difference between participants and nonparticipants (Group NP) in terms of age, education, duration of asthma, and atopy. There was a trend toward finding more male patients in Group NP (p = 0.05). Medication needs were similar among the three groups, with the majority of patients not having a prescription of inhaled corticosteroids before baseline. For all subjects who had used inhaled corticosteroids before enrollment, the average daily dose was 650 ± 171 µg. Few subjects took oral theophyllines and none of them used long-acting bronchodilator or regular oral corticosteroids.

Morbidity parameters among Groups C, LE, and SE in the year before enrollment were also similar. They had had, on average, two unscheduled medical visits per patient, few hospitalizations, and 67% of them had taken oral corticosteroids for an acute asthma exacerbation.

Primary Outcome: Number of Urgent Visits for an Acute Exacerbation of Asthma

As shown in Figure 1, all groups had a similar number of urgent Visits between Visits 1 and 2 (first 6-mo period, p = 0.7). In the last 6-mo period (between Visits 2 and 3), the total number of visits was different between the three groups (p = 0.026), the number of urgent visits that occurred in Group SE being significantly lower in comparison with Groups C (p = 0.01) and LE (p = 0.03). The number of urgent visits observed in Groups C and LE during this same time period was not significantly different (p = 0.84). As seen in Figure 2, the percentage of patients visiting the emergency room or outpatient clinic was significantly different between the three groups in the last 6-mo period (between Visits 2 and 3, p = 0.02). The percentage of patients was significantly lower in Group SE when compared with Groups C (p = 0.02) and LE (p = 0.03).

View larger version (16K): [in this window] [in a new window]   Figure 1.   Number of visits for an acute exacerbation of asthma between Visits 1 and 2 (first 6-mo period) and Visits 2 and 3 (last 6-mo period). It is shown that the number of urgent visits with asthma between Visits 1 and 2 was similar among the three groups (p = 0.1). However, in the last 6-mo period the number of visits was significantly lower in Group SE compared with Groups C and LE (p = 0.03).

View larger version (14K): [in this window] [in a new window]   Figure 2.   Percentage of patients with unscheduled medical visits for an acute asthma exacerbation between Visits 1 and 2 (first 6-mo period) and Visits 2 and 3 (last 6-mo period). It is demonstrated that there was a significant reduction in the percentage of patients that had to visit the hospital for an acute exacerbation of their asthma in the last 6-mo interval and in Group SE only (p = 0.02).

Lung Function Tests

At baseline, PEF values in Groups C, LE, and SE (252 ± 23, 263 ± 16, 245 ± 23 L/min) were similar between the three groups (p = 0.73). At Visit 2, PEF values were similar among the three groups (375 ± 21, 370 ± 24, 444 ± 21 L/min). However, at the time of Visit 3, PEF values (343 ± 18, 349 ± 19, 424 ± 25 L/min) were significantly higher in Group SE (p = 0.03).

Knowledge

Knowledge scores were similar between the three groups at baseline, being, respectively, 48, 56, and 52% in Groups C, LE, and SE (p = 0.11). At Visit 3, however, the knowledge score (C = 56%, LE = 60%, SE = 80%) was significantly higher in Group SE compared with Groups C and LE (p = 0.0001).

Use of an Action Plan

Figure 3 shows that the percentage of patients implementing their self-action plan was similar in Groups LE and SE at 6 mo (Visit 2, p = 0.18). However, at 12 mo (Visit 3) there was a significantly higher percentage of subjects using their self-action plan in Group SE compared with Group LE (p = 0.008). Seventy percent of the patients chose a self-action plan based on symptom monitoring. After their first educational visit, 60% of the patients chose to measure PEF regularly for 1 mo. Only 30% of the patients decided to perform long-term monitoring of PEF.

View larger version (21K): [in this window] [in a new window]   Figure 3.   Percentage of patients implementing their self-action plan at Visits 2 and 3 in Groups LE and SE. At Visit 2 (6 mo), there was no difference between the two groups with regard to the number of patients implementing their self-action plan. However, at Visit 3, 12 mo later, the percentage of patients using their self-action plan was significantly higher in Group SE compared with Group LE (p = 0.008).

Compliance with Inhaled Corticosteroids

From Visit 1 to Visit 3, the percentage of patients having a prescription of inhaled corticosteroids in Groups C, LE, and SE increased similarly in the three groups, from 43, 46, and 60% to 91, 97, and 100%, respectively (p = 0.7). However, there was a trend toward finding a significant improvement in compliance with inhaled corticosteroids from Visit 1 to Visit 3, only in Group SE (p = 0.06).

Quality of Life Score

QOL scores with respect to symptoms, physical activities, emotion, and environment were similar in the three groups at Visit 1. Figure 4 shows that there was a significant improvement in QOL score from Visit 1 to Visit 3 with respect to symptoms only in Group SE (p = 0.001). Similar findings were also obtained for physical activities (p = 0.02). No significant change was observed for emotion and environment QOL scores.

View larger version (26K): [in this window] [in a new window]   Figure 4.   Quality of life score related to symptoms in Groups C, LE, and SE at Visit 0 (baseline) and Visit 3. At the time of Visit 1, quality of life scores were similar among the three groups. Quality of life improved significantly at Visit 3, exclusively in Group SE (p = 0.001).

	DISCUSSION

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION REFERENCES

The study design used in our study helped us to discriminate between the benefits of the written action plan alone, given by the on-call physician, and those associated with a long and structured educational intervention. None of the previously published studies had specifically tried to determine what component of the educational intervention is important in the management of adults with asthma. Our results show that the single prescription of a self-action plan does not diminish asthma morbidity. When patients with asthma are not given sufficient information and reinforcement, they do not seem to have enough self-confidence to increase the dosage of inhaled corticosteroids according to asthma symptom severity or PEF. This is in keeping with the observations made earlier by Palen and coworkers (25).

Our results showed a significant decrease in the number of urgent visits for asthma among educated patients who had visited the emergency department for an acute exacerbation of their asthma. Similar results have previously been reported by Bolton and coworkers in the United States (9). In contrast to this last study, we enrolled both patients coming either to the emergency room or to the outpatient clinic for an acute asthma exacerbation. This specific subgroup of patients also seems to be a good target for asthma education, as many of them had suboptimal care. In fact, more than 50% of the patients did not have a prescription for inhaled corticosteroids although they had visited the emergency room twice in the previous year. Only one study of a similar population of patients has not shown a reduction in the number of emergency room visits (11). In that trial the number of emergency room visits observed prospectively over 9 mo in the control group was so small that they could hardly find a significant difference between study groups. A contamination of the control group by community health programs and a change in the practice of general practitioners were hypothesized to explain the discrepancy between the number of visits expected to occur in the control group and that observed. Cowie and coworkers conducted a study of a group of patients comparable to ours (10). They could document a significant decrease in urgent visits only in the group of patients given a self-action plan based on PEF. No decrease in the use of health services was observed in the group of patients who had a self-management plan based on symptoms when compared with the control group. Although most of our patients had a self-action plan based on symptom monitoring, we were still able to identify marked benefits of asthma education on morbidity, suggesting that significant improvement in asthma outcomes can occur even though patients with asthma do not monitor their asthma by measuring PEF (26). As the usefulness of peak flow monitoring remains controversial due to poor patient compliance with such measurement (18) and the fact that worsening of asthma symptoms often antedates the fall in PEF (27, 28), we let the patients decide whether they wanted a peak flow meter. This study again confirms that only one-third of the patients were willing to monitor PEF for more than 1 mo. Physicians must adapt to this reality.

When we designed this study, we thought that the outcome of only those subjects who were given a self-action plan and teaching of inhaler technique (Group LE) would improve much. To prevent the contamination of participating physicians and to gain a true picture of patients making urgent visits with an acute asthma exacerbation, we decided to recruit the first 45 subjects of the control group before starting the randomization of patients to Groups LE and SE. So one may argue that the difference between Groups C and SE is due to the different time periods over which they were followed up. However, this argument cannot be supported, as significant differences in asthma morbidity and other clinical outcomes were observed between Groups LE and SE, the subjects of which were randomized during the same time interval, the only significant difference between these two groups being in the specific content of the educational program.

The selection of our patients was based on their utilization of health services, not on the dosage of medication required to maintain asthma control, and this approach seems fruitful. Up to now, four of the five randomized controlled studies done to evaluate the effectiveness of asthma education, including a self-management plan for moderate to severe asthma, have not shown a significant decrease in the number of emergency room visits. A possible explanation for this might be that the self-action plan based on doubling the dose of inhaled corticosteroids is more beneficial for patients with mild to moderate asthma, who had, before their urgent visit, used no inhaled corticosteroids or only a small dose, and consequently were on the most efficient part of the dose-response curve of inhaled corticosteroids.

In contrast to other trials done with a similar group of patients, all our patients were enrolled at the time of the urgent visit and the structured educational intervention began 2 wk later. The low dropout observed in our study, in contrast with others, suggests that this may therefore be a good period to start the educational process, as patient motivation to participate in an educational program may be higher shortly after a medical visit with asthma. Dropout rates as high as 40% have been observed in several trials (7, 9, 28). Another likely explanation is that our educational program was attractive because patients did not have to monitor PEF if they were not interested in doing so. Also, our subjects could choose between individual or small group sessions according to their own preference.

In our study there was a trend toward finding an improvement in compliance with inhaled corticosteroids. The statistical analysis of the change in compliance with such treatment could be performed only in 48 subjects because fewer than half of them had a prescription for inhaled corticosteroids at the time of enrollment.

In addition to measuring the impact of our asthma education program on asthma morbidity, other outcome parameters were assessed. Educated patients had a significant improvement in their PEF in comparison with the two other groups. The increase in compliance with inhaled corticosteroids is probably the best explanation for this.

These results are in contrast with the first randomized controlled study by our group of 150 patients with moderate to severe asthma, as no change in asthma morbidity was observed. This current study differs in two ways. First, we targeted a different group of patients with asthma, and the enrollment also took place at the time they were sick. Second, the educational intervention was further modified in order to focus on asthma self-management, using basic principles of health education (19, 20).

Significant improvement in patient outcomes, such as urgent visits to the hospital or implementation of the self-action plan, occurred only after 6 mo. This is not surprising, as a change in patient behavior takes time and reinforcement. In one study by Wilson and coworkers of patients with moderate to severe asthma, a decrease in asthma morbidity was observed only in the second year after the educational intervention (16). Our results suggest that when dealing with trials on asthma education, the period of observation should be longer than 6 mo and ideally at least 1 yr. However, asthma education is still not offered regularly to patients with asthma visiting the emergency room or outpatient clinic. Our results should motivate physicians to provide their patients with a written self-action plan, but also to complete their education by referring them to an asthma education center.

This study outlines the fact that the best method by which to manage patients with asthma consulting for acute exacerbation of their asthma is to provide them with an action plan, teach them the inhaler technique, and provide access to a long and structured educational intervention aimed at improving self-efficacy. Using this strategy, we observed a marked decrease in the number of unscheduled medical visits in the last 6 mo of the study. The percentage of patients visiting the emergency room or outpatient clinic for an acute exacerbation of asthma also diminished significantly in the same time period. Other important benefits were observed such as long-term improvement in knowledge score, compliance with inhaled corticosteroids, quality of life, and peak flow measurement.