A Randomized Controlled Trial of Self-Management Education for Asthma Patients in the Emergency Department Carol A. Mancuso, MD, Margaret G. E. Peterson, PhD, Theodore J. Gaeta, DO, MPH, José L. Fernández, MD, Robert H. Birkhahn, MD, MS, Lawrence A. Melniker, MD, MS, John P. Allegrante, PhD From the Department of Medicine (Mancuso) and Research Division (Peterson), Hospital for Special Surgery, New York, NY, and the Department of Emergency Medicine, New York Methodist Hospital, Brooklyn, NY (Gaeta, Birkhahn, Melniker), and the Department of Medicine, Division of Emergency Medicine, New York Presbyterian Hospital (Fernández), Weill Cornell Medical College, New York, NY; and the Department of Health and Behavior Studies, Teachers College and Mailman School of Public Health, Columbia University, New York, NY (Allegrante).
Study objective: Patients using the emergency department (ED) for asthma may benefit from self-management education. Our goal is to test an educational intervention in 296 asthma ED patients. Methods: This was a randomized controlled trial with concealed allocation. Controls received instruction from an asthma knowledge test, peak flowmeter training, and asthma brochures. Intervention patients received these plus a self-management workbook, a behavioral contract, inhaler training, and telephone reinforcements. The main outcome was change in Asthma Quality of Life Questionnaire (AQLQ) score at 8 weeks (a change of 1.5 is a marked clinically important difference). Secondary outcomes were repeated ED visits and change in AQLQ scores at 4, 12, and 16 weeks and 1 year. Results: Mean age of patients was 44 years, and 93% had the 8-week follow-up. Enrollment AQLQ scores were comparable and increased at 8 weeks by more than a marked clinically important difference in both groups. For controls, the change in score was 1.95 (95% confidence interval [CI] 1.74 to 2.16; P⬍.001), for intervention patients the change in score was 1.83 (95% CI 1.64 to 2.03; P⬍.001), and the difference between groups was 0.11 (95% CI – 0.17 to 0.40; P⫽.43). Patients who improved more (ie, change was above the group mean) were more likely to be high school graduates (odds ratio⫽1.9; 95% CI 1.0 to 3.8), previous or current smokers at enrollment (odds ratio⫽2.2; 95% CI 1.3 to 3.5), and to have been admitted to the hospital from the ED (odds ratio⫽1.7; 95% CI 1.0 to 2.8). Similar variables were associated with AQLQ outcomes in hierarchic analyses during 16 weeks. Repeated ED visits occurred for 12% of patients at 8 weeks and in multivariate analysis were associated with no hospitalization for the index ED visit, difficult access to outpatient care, and previous ED visits. Fewer patients (16%) had an ED visit at 12 weeks compared with a similar time before enrollment (36%). Conclusion: Patients in both groups had marked sustained improvements in clinical status 16 weeks after an ED visit for asthma. A self-management education intervention delivered in the ED and reinforced by telephone was successfully implemented, with high retention rates, but did not provide incremental benefit for quality of life and short-term repeated ED visit outcomes. [Ann Emerg Med. 2011;57:603-612.] Please see page 604 for the Editor’s Capsule Summary of this article. Provide feedback on this article at the journal’s Web site, www.annemergmed.com. A podcast for this article is available at www.annemergmed.com. 0196-0644/$-see front matter Copyright © 2010 by the American College of Emergency Physicians. doi:10.1016/j.annemergmed.2010.11.033
INTRODUCTION Background Asthma accounts for 1.1 million emergency department (ED) visits annually in the United States among patients aged 18 years and older.1 ED visits are more common among women, blacks, and those with less education and may be related to certain psychosocial characteristics, such as less asthma self-efficacy and more depressive symptoms.1-6 In addition, Volume , . : June
repeated ED visits are common and related to clinical and sociodemographic factors, such as poor medication use and lack of outpatient care.7-9 Although emergency care for asthma is necessary for some patients, for others timely recognition of symptoms and effective self-management may thwart exacerbations and decrease the need for the ED. However, many ED patients lack basic knowledge and necessary skills to effectively self-manage asthma.10,11 Annals of Emergency Medicine 603
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Editor’s Capsule Summary
What is already known on this topic Many emergency department (ED) asthma patients lack self-management skills. What question this study addressed This randomized trial of 296 patients compared 8-week Asthma Quality of Life Questionnaire (AQLQ) scores and repeated visits between controls (instruction and peak flow training) and intervention (instruction, peak flow training⫹workbook, behavioral contract, inhaler training, and telephone reinforcement). What this study adds to our knowledge This particular intervention did not incrementally increase AQLQ scores or decrease short-term repeated ED visits. How this is relevant to clinical practice Until the optimal components of an education intervention are defined, basic ED asthma instruction and peak flowmeter training should be provided.
Importance Patient education is a cornerstone of asthma treatment and should be delivered during routine outpatient care.12 However, many asthma ED patients do not receive outpatient care, and the ED may be the only place where they interact with health care providers.10 Thus, the ED offers the opportunity to reach this otherwise missed population.13 However, using the hectic ED for education is challenging for clinicians and for patients, who may have difficulty assimilating new information while actively recuperating. To date, many studies addressing education during exacerbations have focused on hospitalized patients and administered interventions during several in-person sessions while patients are hospitalized.14-17 Although effective, these programs reached only the selected subset of admitted patients. Most studies that included asthma patients discharged from the ED were small or required in-person follow-up after discharge.18-22 These interventions also were effective among those who participated in the entire program, but their main limitation was high attrition rates.3 Thus, new interventions are needed that include discharged ED patients and that do not require in-person repeated contacts. This is important to meet the educational needs of this high-risk population during a teachable moment when they may be most receptive to learning how to avoid repeated ED visits.13,18,19 604 Annals of Emergency Medicine
Mancuso et al Goals of This Investigation The objective of this trial was to test an educational intervention to improve self-management by increasing asthma knowledge and self-efficacy in patients presenting to the ED for asthma. The intervention was administered at the ED visit or shortly after admission and then reinforced during weekly telephone contacts for 8 weeks. The primary goal was to assess short-term outcomes, specifically, change in asthma-related quality of life and repeated ED visits for asthma at 8 weeks. Additional assessments were made at 4, 12, and 16 weeks and 1 year.
MATERIALS AND METHODS Study Design and Setting This randomized controlled trial was approved by the institutional review boards at the Weill Cornell Medical College/New York Presbyterian Hospital in Manhattan, NY, and the New York Methodist Hospital in Brooklyn, NY, and all patients provided written informed consent. Selection of Participants Patients who were present in the ED at either hospital between 8 AM and 5 PM Monday through Friday or who had been admitted to the hospital from the ED within the previous 24 hours from April 2005 through January 2009 were screened. Patients were eligible if they were aged 18 years or older, were fluent in English, had a known diagnosis of asthma, and came to the ED because of respiratory symptoms. Patients were excluded if they refused to participate, had cognitive deficits, had pulmonary or major medical or psychiatric comorbidity, or did not have a telephone for follow-up. Patients were approached and enrolled when the treating physician deemed they were stable enough to be interviewed. Patients did not receive monetary compensation for their participation. Methods of Measurement At enrollment, patients were interviewed by study personnel with valid questionnaires measuring long-term asthma status, self-efficacy, and self-management knowledge.23-25 Knowledge questions addressed preventive strategies and use of medications. All patients were given feedback about preferred responses and why other responses were not good choices. Patients were asked whether they had outpatient physicians and how difficult was it to obtain outpatient asthma care, ranging from very difficult to very easy. Overall status of asthma (the main outcome of the trial) was measured with the original version of the 32-item Asthma Quality of Life Questionnaire (AQLQ), which assesses symptoms, limitations in activities, and emotional and environmental aspects of asthma during the past 2 weeks.26,27 Overall AQLQ scores can range from 1 to 7; higher scores indicate better status. Comorbidity was assessed with the Charlson Comorbidity Index.28 Depressive symptoms were assessed with the Geriatric Depression Scale, which is applicable to younger adults with asthma and measures mainly Volume , . : June
Mancuso et al psychological symptoms of depression.29,30 At enrollment, patients also completed pulmonary function tests with a portable spirometer and were given and taught how to use a peak flowmeter. Interventions Patients then were randomized to the control or intervention group. Thus, all baseline measurements were completed without study personnel being aware of assigned group. Controls were given 3 brochures from the American Lung Association, providing information about basic asthma pathophysiology, triggers, and use of peak flowmeters.31 Study personnel reviewed contents of the brochures with patients, which took approximately 2 minutes. During the subsequent study period, attempts were made to contact controls by telephone at 4, 8, 12, and 16 weeks and then again at 1 year. With a standard script at each follow-up, controls were asked about current asthma status, reading the brochures, and interval resource utilization. Patients again completed the AQLQ at 4, 8, and 16 weeks and 1 year. The intervention was based on social learning theory highlighting self-efficacy and was implemented through the precede-proceed model of health behavior.32-34 Social learning theory posits that behavior change occurs when the learner perceives that the new behavior will lead to certain favorable outcomes and that learning takes place by observing behaviors of credible others.33 Precede-proceed is a framework to identify antecedents of health behavior to develop targeted interventions to modify behaviors.34 This theory and model have been applied by other investigators to asthma education programs.34-36 In our study, these components (described in detail below) were operationalized through a personalized workbook, a behavioral contract, telephone reinforcements, and physiologic feedback. At enrollment, intervention patients were given a workbook containing 20 chapters addressing asthma knowledge and selfefficacy.37-39 Knowledge chapters are based on programs from the National Heart, Lung, and Blood Institute. Self-efficacy chapters contain vignettes describing actual patients, including recuperating ED patients, and effective techniques to manage asthma. One chapter asks patients to make a contract to adopt a behavior to improve asthma. Study personnel reviewed the workbook with patients and helped them make a contract, which took approximately 10 minutes. Patients were not asked to read the workbook in the ED. In a trial with primary care patients, the workbook was associated with increased selfefficacy and knowledge.38 Intervention patients also were taught how to use an inhaler with a teaching device that contained only air. Patients had the opportunity to practice and a checklist was used to document proficiency. During the first 8 weeks, intervention patients were contacted weekly by telephone to encourage them to persevere with their contracts and to read the workbook. During the subsequent year, intervention patients were contacted at the same points as controls and were asked about reading the workbook, interval resource utilization, and current asthma status according to the AQLQ. Volume , . : June
Asthma Education in the Emergency Department Outcome Measures All outcomes were assessed during the telephone contacts. The primary outcome was the difference in within-patient change from enrollment to 8-week AQLQ scores between randomization groups. The major secondary outcome was the difference in the proportion of patients having a repeated ED visit for asthma from enrollment to 8 weeks between randomization groups. Additional secondary outcomes were within-patient changes in AQLQ scores and repeated asthma ED visits at 4, 12, and 16 weeks. Comparison of AQLQ scores at 1 year also was a secondary outcome; however, the main reason for the 1-year follow-up was to ascertain what proportion of this difficult-to-retain population could be contacted at 1 year. The sample size calculation was based on the primary outcome. In a pilot study using similar protocols as this trial, within-patient changes in AQLQ scores were 1.5 (SD 1.3) in controls and 2.2 (SD 1.2) in intervention patients, with a difference between groups of 0.5 (SD 1.2). The authors of the AQLQ determined that a change of 0.50 points is a minimum clinically important difference.27 With an SD of 1.2 and setting ␣ at .05, 118 patients per group gave 90% power to detect a difference of 0.50 in AQLQ scores between groups. To conservatively allow for an 80% retention rate, 148 patients per group (296 total) were enrolled. The time for the main outcome was selected to be 8 weeks for 2 reasons. First, we hypothesized the intervention would have its peak effect at 8 weeks, when intervention patients had received the maximum number of telephone contacts, and second, 8 weeks is frequently reported in the literature as the period for repeated asthma ED visits. Randomization was carried out by the study statistician, using a computer program to generate assignments using blocks of various sizes stratified by ED site. Assignments were placed in numbered envelopes, which then were sealed. Once a patient was enrolled, the next envelope was opened and the assignment was linked to that patient. No envelope was reused. Randomization was verified at the conclusion of the trial. Patients and ED and inhospital physicians were blinded to randomization group. Study personnel administering the telephone follow-up were not blinded because these contacts also were used to reinforce components of the intervention. Periodically during the trial, study personnel coadministered enrollment interviews, and spot checks of telephone contacts were conducted to maximize fidelity of the protocols. Primary Data Analysis The main analysis was a t test comparison of within-patient change in enrollment to 8-week AQLQ scores between randomization groups. An intention-to-treat analysis was planned for patients who did not have the 8-week follow-up. In total, 21 patients did not have the AQLQ assessment at 8 weeks. For these patients, a score was assigned according to the mean change in score for patients who had the 8-week followup and who had enrollment scores within 1 point of the missing patient’s score. The main secondary analysis was a 2 Annals of Emergency Medicine 605
Asthma Education in the Emergency Department comparison of the number of repeated ED visits within 8 weeks between randomization groups. Additional analyses were multivariate models for these outcomes. We used logistic regression with the AQLQ as the dependent variable, dichotomized according to whether within-patient change in score was above or below the mean change for the entire sample. This threshold value was used because most patients had changes in scores that already exceeded the highest category of a clinically important difference; thus, categorizing patients according to the sample mean allowed us to compare within the sample. Logistic regression also was used for repeated ED visits as the dependent variable dichotomized according to whether patients did or did not have a repeated visit within 8 weeks. We chose well-established clinically relevant variables to be independent covariates in the models, specifically, age, sex, education, access to care, previous use of the ED for asthma, and smoking status. Education was dichotomized according to high school graduation. Previous use of the ED was restricted to within 3 months before the index visit to reflect relatively current utilization practices as opposed to lifetime practices. Access to care was dichotomized as very difficult/difficult versus very easy/easy/neither. Because many patients who reported that they had quit smoking also reported currently being around smokers, we dichotomized smoking status as ever smoked versus never smoked. We hypothesized that admission to the hospital for the index ED visit might have residual short-term benefits and thus included this as an additional predictor. Models were assessed with the Hosmer and Lemeshow fit statistic, for which a large P value indicates a good fit. Sensitivity Analyses Our primary analysis, ie, the difference between enrollment and 8-week AQLQ scores, did not reflect a continuum of change. Therefore, we also assessed repeated measurement of AQLQ scores at 4, 8, and 16 weeks, using a mixed-effects model with AQLQ scores from each follow-up as the dependent variable. Each patient was a random factor, and time from enrollment was a fixed time variable. All analyses were carried out in SAS (Version 5 with a significance level of 0.05, SAS Institute, Inc., Cary, NC).40
RESULTS Characteristics of Study Subjects Screening results are reported according to number of patients and not number of visits because some patients presented multiple times to the ED during the study period. In total, 521 patients were screened, 56 were ineligible, 169 were excluded, and 296 (57%) were enrolled, with 148 randomized to each group (Figure). Excluded patients were similar to enrolled patients with respect to percentage of women (70% versus 72%) but were older (mean age 51 versus 44 years). Compared with enrolled patients, the 10 patients who refused to participate were more likely to be women (90% versus 72%) but were comparable in mean age (42 versus 44 years). Patients refused because they were not interested, they thought their 606 Annals of Emergency Medicine
Mancuso et al asthma was controlled, or they thought they already knew enough to take care of their asthma. Overall, 62% (184/296) of patients were hospitalized. Compared with patients who were discharged, patients who were hospitalized were more likely to be women (odds ratio⫽2.0; 95% confidence interval [CI] 1.2 to 3.4), older than the group mean (odds ratio⫽2.7; 95% CI 1.7 to 4.4), and to have comorbidity (odds ratio⫽3.3; 95% CI 1.5 to 7.1). Comparable percentages of hospitalized and discharged patients (51% [94/184] and 48% [54/112]; odds ratio⫽0.9; 95% CI 0.6 to 1.4) were randomized to the intervention group. Of the hospitalized patients, 32% (58/184) were enrolled while still in the ED and 68% (126/184) were enrolled while on the inpatient wards; both groups had only one in-person contact with study personnel, ie, for enrollment. Neither hospital had a standard protocol for medical, nursing, or respiratory therapy staff to administer inpatient asthma education. At enrollment, randomization groups were similar with respect to most patient and clinical characteristics (Table 1). The sample was racially/ethnically diverse, approximately one third of patients had Medicaid or were uninsured, and 20% had only a high school education or less. Of the 17% with other comorbidity, the most common diagnosis was diabetes mellitus (13%). Forty-four percent were obese (body mass index ⱖ30 kg/m2), and approximately one quarter had a positive screen result for depression. Approximately 20% had no outpatient physician for asthma, and 18% reported access to outpatient asthma care was difficult or very difficult. Sixty-seven percent reported previous hospitalizations for asthma, and 36% reported being in the ED for asthma during the previous 3 months. Twenty-five percent were current smokers and an additional 21% smoked in the past. Of the past smokers, 36% reported that they currently were frequently around smokers and secondhand smoke. On discharge from the ED or hospital, 87% (129/148) of intervention patients and 82% (121/148) of controls were prescribed oral corticosteroids, and 62% in both groups were prescribed any type of asthma maintenance medication. Telephone follow-up was conducted for 91%, 93%, 91%, and 92% of patients at 4, 8, 12, and 16 weeks, respectively, with no differences between groups. Only 10 patients (8 controls, 2 intervention patients) were lost to any study-related follow-up; of these, 7 (5 controls, 2 intervention patients) were tracked through family or medical records, from which we were able to ascertain that these patients were alive and stable with respect to asthma. Between enrollment and the 8-week outcome, 89% (131/148) of controls had the scheduled 4-week telephone contact, and 98% (146/148) of intervention patients had a least 1 contact and 86% (127/148) had 5 to 7 weekly contacts. Regarding contracts made by intervention patients, the most common contracts were to use the peak flowmeter, read the workbook, and to stop smoking. At 4 and 8 weeks, 94% and 82% reported fulfilling their contracts to some degree, and 62% and 53%, respectively, reported fulfilling their contracts mostly Volume , . : June
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Asthma Education in the Emergency Department
Figure. Flow diagram of patients through the trial. Sixty-one percent of controls and 64% of intervention patients were admitted to the hospital at enrollment.
or completely. Regarding the workbook and brochures, at 4 weeks, 62% of intervention patients and 50% of controls reported reading these materials (odds ratio⫽1.7; 95% CI 1.0 to 2.8; P⫽.05) and at 8 weeks 34% and 21%, respectively, reported reading these materials (odds ratio⫽2.0; 95% CI 1.1 to 3.5; P⫽.02). Main Results and Sensitivity Analysis For the entire sample, enrollment AQLQ scores were comparable and increased at 8 weeks by more than a marked clinically important difference in both groups (Table 2). For controls, the change in score was 1.95 (95% CI 1.74 to 2.16; P⬍.0001), for intervention patients the change in score was 1.83 (95% CI 1.64 to 2.03; P⬍.0001), and the difference between groups was 0.11 (95% CI – 0.17 to 0.40; P⫽.43) (Table 2). There also were no differences when stratified by Volume , . : June
discharge status, ie, among discharged patients the difference in AQLQ score between randomization groups was 0.07 (95% CI – 0.40 to 0.54; P⫽.77) and among hospitalized patients the difference was 0.18 (95% CI – 0.19 to 0.55; P⫽.34). For the entire sample, the mean change in score (1.89) exceeded the highest category of clinically important change, determined by the authors of the AQLQ to be 1.50; therefore, the sample was dichotomized and compared according to whether change in score was above or below the group mean. Patients who improved more (ie, change was greater than 1.89) were more likely to be previous or current smokers at enrollment, to be high school graduates, and to have been admitted to the hospital from the ED (Table 3). The P value for the model fit was .87, indicating a robust model. Marked improvements in AQLQ scores compared with enrollment also were observed at 4 and 16 weeks for both Annals of Emergency Medicine 607
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Table 1. Patient and clinical characteristics at enrollment.* Variables
43 (14) 77
45 (13) 66
⫺4.8 to 1.3 0.5 to 21
66 30 4 45 84 49 60
60 33 7 43 81 46 55
6 ⫺3 ⫺3 2 3 3 5
⫺5 to 17 ⫺16 to 10 ⫺10 to 4 ⫺10 to 13 ⫺8 to 14 ⫺11 to 17 ⫺9 to 19
57 6 27 10 32 (9) 25 (15) 13 (4) 35 45
59 9 24 8 32 (9) 23 (16) 12 (5) 37 47
⫺2 ⫺3 3 2 0 2 1 2 ⫺2
⫺13 to 9 ⫺9 to 3 ⫺9 to 13 ⫺5 to 9 ⫺2 to 2 ⫺1.5 to 5.5 ⫺0.03 to 2 ⫺9 to 13 ⫺14 to 9
5 22 74 59 (22) 21 77 (14) 60 (20) 16 7 (6) 20
7 28 66 55 (23) 14 73 (16) 55 (20) 18 8 (7) 26
⫺2 ⫺6 8 4 7 4 5 ⫺2 ⫺1 ⫺6
⫺8 to 4 ⫺15 to 5 ⫺2 to 18 ⫺1.1 to 9.1 ⫺2 to 16 ⫺0.6 to 7.4 0.4 to 9.6 ⫺11 to 1 ⫺2.4 to 0.5 ⫺15 to 4
Age, y, mean (SD) Women Race White Black Other Hispanic Finished high school Never married Employed (full or part time) Insurance status Private Medicare Medicaid Uninsured Body mass index, kg/m2, mean (SD) Asthma duration, y, mean (SD) ‡ Severity of Asthma Scale score, mean (SD) Had ED visit for asthma in past 3 mo Current or past smoker Current asthma medications No medications Inhaled short-acting ␤-agonists only § Any maintenance medications Forced expiratory volume in 1 s, mean (SD) Access to asthma care described as difficult or very difficult 储 KASE Asthma Self-Efficacy domain score, mean (SD) ¶ Asthma Self-Management Questionnaire score, mean (SD) Has major physical comorbidity # Geriatric Depression Scale score, mean (SD) # Positive screen for depression
*All data are percentage unless otherwise indicated. † Control group minus intervention group values. ‡ Possible score range 0 to 28; higher is more severe long-term asthma. § Includes long-acting inhaled ␤-agonists, inhaled corticosteroids, leukotriene modifiers, mast cell stabilizers, theophylline, and oral corticosteroids. 储 Knowledge, Attitude and Self-Efficacy Asthma Questionnaire, self-efficacy domain, possible score range 20 to 100; higher is more self-efficacy. ¶ Possible score range 0 to 100; higher is more knowledge. # Possible score range 0 to 30; higher is more depressive symptoms, and greater than or equal to 11 is a positive screen result for depression.
groups, with no differences between randomization groups (Table 2). In a mixed-effects model during 16 weeks, variables associated with greater improvement in AQLQ scores were higher enrollment AQLQ score (estimate 0.26), being a previous or current smoker at enrollment (estimate 0.22), and being a high school graduate (estimate 0.36). During the first 8 weeks, 33 patients had at least 1 asthma ED visit, with no difference between groups (13% controls, 11% intervention patients), and 14 patients were hospitalized for asthma (10 controls, 4 intervention patients). In multivariate analysis, variables associated with having an asthma ED visit within 8 weeks were not being admitted to the hospital for the enrollment ED visit, very difficult/difficult access to outpatient care, and having had an asthma ED visit in the 3 months before enrollment (Table 4). The P value for the model fit was .50, indicating a robust model. During the first 12 weeks, 42 patients (21 controls, 21 intervention patients) had at least 1 608 Annals of Emergency Medicine
asthma ED visit; this was less than the percentages who reported an asthma ED visit in the 3 months before enrollment (16% [21/135] versus 35% [52/148] for controls and 15% [21/136] versus 37% [54/148] for intervention patients). Overall, 197 patients (68% [100/148] controls, 66% [97/ 148] intervention patients) were contacted at 1 year. Patients were more likely to have had the 1-year contact if they were older than the group mean (odds ratio⫽2.0; 95% CI 1.2 to 3.2) and were high school graduates (odds ratio⫽2.6; 95% CI 1.4 to 4.8). For these 197 patients, AQLQ scores at 1 year remained stable compared with 8-week scores, with no difference between groups. Specifically, for controls the change in score was 0.18 (95% CI ⫺0.08 to 0.44), for intervention patients the change in score was ⫺0.04 (95% CI ⫺0.31 to 0.24), and the difference between groups was 0.22 (95% CI ⫺0.15 to 0.60). At each telephone follow-up, patients were asked about adverse events, considered to be ED visits or hospitalizations for Volume , . : June
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Table 2. AQLQ and resource utilization outcomes. Had Repeated ED Visit for Asthma, %
AQLQ Scores* Variables Enrollment Number of patients Score, mean (SD) 4 wk, % Number of patients Score, mean (SD) ‡ Change in score, mean (SD) 8 wk, % § Number of patients Score, mean (SD) ‡ Change in score, mean (SD) 12 wk, % 储 Number of patients 16 wk, % Number of patients Score, mean (SD) ‡ Change in score, mean (SD)
148 3.55 (1.10)
148 3.51 (0.91)
131 5.17 (1.16) 1.69 (1.33)
139 5.32 (1.03) 1.79 (1.27)
148 5.50 (1.00) 1.95 (1.28)
148 5.34 (1.12) 1.83 (1.22)
135 5.40 (1.08) 1.90 (1.27)
137 5.49 (1.10) 1.96 (1.30)
Difference Between Groups † (95% CI)
16 135 19 140
15 136 21 141
0.04 (⫺0.19 to 0.28)
⫺0.15 (⫺0.42 to 0.11) ⫺0.10 (⫺0.41 to 0.21)
0.16 (⫺0.09 to 0.40) 0.11 (⫺0.17 to 0.40)
⫺0.09 (⫺0.35 to 0.17) ⫺0.06 (⫺0.37 to 0.25)
*Possible score range 1 to 7; higher is better status. † Difference between groups, ie, control group score minus intervention group score. ‡ Follow-up score minus enrollment score; for all within-group comparisons P⬍.0001; greater than or equal to 1.5 is a marked clinically important difference. § All patients for AQLQ, based on intention to treat. 储 AQLQ not measured at 12 weeks.
Table 3. Variables associated with increase in AQLQ scores above group mean score at 8 weeks. Bivariate Variables Intervention group Women Age* Previous or current smoker High school graduate Admitted to the hospital from the ED
Table 4. Variables associated with repeated ED visit within first 8 weeks after enrollment visit.
1.0 1.7 1.0 2.0 1.9 1.8
0.7–1.6 1.0–2.8 0.7–1.3 1.3–3.2 1.0–3.6 1.1–2.9
1.1 1.6 0.9 2.2 1.9 1.7
0.7–1.7 0.9–2.8 0.6–1.2 1.3–3.5 1.0–3.8 1.0–2.8
Intervention group Not admitted from enrollment ED visit Access to outpatient care difficult or very difficult Had ED visit for asthma during 3 mo before enrollment
any reason. Overall, 63 patients were treated in the ED and 34 patients were hospitalized for any reason during the entire trial, with no differences between groups; none of the events was associated with this trial. There was 1 death in the control group at 15 weeks because of asthma, and this was not attributed to the trial. At 8 weeks, all patients were asked how participation in this trial affected their asthma; 80% of controls and 89% of intervention patients (P⫽.06) reported that it made their asthma better, the remaining patients reported it had no effect, and none reported that it made their asthma worse.
LIMITATIONS There are several limitations to this study. First, study personnel were not in the ED at all times, and patients presenting during off hours may have had more barriers to Volume , . : June
outpatient care. Second, this study included only Englishspeaking urban dwellers and may not be generalizable to other populations. We enrolled only fluent English speakers because our goal was to first determine whether the intervention was effective before we addressed the multilingual and multicultural issues of our diverse population. Third, to parallel clinical practice, asthma treatment was based on individual practice preferences of treating emergency and inhospital physicians. A resulting limitation was the lack of a standard treatment approach for all patients. Fourth, we did not reassess knowledge and self-efficacy during telephone contacts to minimize response burden. Therefore, we cannot comment on what particular effects the intervention may have had on knowledge and selfefficacy. Fifth, our study included both hospitalized and discharged patients, and although both groups received the same attention from study personnel, differences in provider criteria Annals of Emergency Medicine 609
Asthma Education in the Emergency Department for admission may have affected the outcomes we considered. We also cannot conclude why hospitalized patients had better outcomes. Although inpatients may have received additional education from health care providers, it is likely that this was minimal, given that there were no formal hospital-based asthma education protocols and there was little time for informal instruction because length of stay was relatively short for most patients. Other possible reasons for better outcomes among admitted patients may be that more treatment with nebulizers and intravenous corticosteroids resulted in longer-lasting effects and removal from possible environmental and psychosocial triggers helped to arrest the exacerbation.
DISCUSSION In this randomized controlled trial, we were able to provide a self-management educational intervention to patients presenting to the ED for asthma and to have excellent retention rates through 16 weeks. Patients in both groups had marked improvements in quality of life, measured from 4 to 16 weeks, with no differences between groups. There also were no differences in the rates of repeated asthma ED visits; however, rates were lower for both groups after enrollment compared with a similar period before enrollment. There are several possible reasons why the intervention was not more effective than the control state. First, the intervention was designed to be administered during one in-person session with telephone contacts to maximize participation. This may not have constituted a large enough dose to provide incremental benefit over and above the medical care received by all patients. The natural course of a treated exacerbation is to improve, particularly in patients who are treated in the ED or hospital, where they are required to meet certain thresholds of pulmonary function before discharge.20 Thus, the intervention may not have been powerful enough to provide additional benefit above what was provided by standard care. Second, the version of the AQLQ we used has been used mostly in stable outpatients and may not be able to distinguish among nuances of marked improvement after an exacerbation. Third, although we also measured the AQLQ at 4 weeks, it is possible that a difference between groups occurred earlier and was missed. Fourth, only half of intervention patients were fulfilling their contracts at 8 weeks; thus, better ways to encourage use of the contract may have been needed. In addition, the contracts might have been more effective if patients had chosen goals that are known to be associated with improved outcomes, such as taking medications and keeping outpatient appointments. Fifth, through the selfmanagement questionnaire administered at enrollment, both groups were given patient-specific feedback about their asthma knowledge and how to manage triggers and medications; this may have been a cointervention received by both groups. Similar to results of other reports, several independent variables were found to predict outcomes in our study. For example, current and past smokers, many of whom reported exposure to secondhand smoke, had improvements in AQLQ scores at follow-up, most likely because of increased motivation 610 Annals of Emergency Medicine
Mancuso et al to stop smoking and to avoid smokers after the ED visit. This explanation is consistent with outcomes of other reports that showed better quality of life and fewer ED visits for patients who stopped smoking and decreased exposure to environmental smoke.41,42 Regarding the repeated ED outcome, our results confirm results of other studies that reported greater prevalence of ED visits among patients with previous ED visits and lack of medical follow-up; the latter issue was approximated in our study by self-reported difficult access to outpatient care.4,6,8,43,44 However, unlike other researchers we did not find that hospitalization for asthma was associated with more subsequent ED visits. We attribute this to the relatively short-term followup period in our study, during which we hypothesize patients continued to derive benefit from their hospital care, compared with the longer follow-up periods considered in other reports. This trial raises important issues for future research, such as how intense interventions should be to be effective and whether interventions should be customized to specific patient characteristics. For example, interventions might be directed at specific gaps in patients’ knowledge and at helping patients choose behavioral contracts that are associated with better outcomes, such as taking medications and keeping outpatient appointments. In addition, boosters are well known to foster persistent behavior change45 and may be necessary for conditions such as asthma, in which exacerbations may be discouraging and result in abandonment of proactive behaviors. The current trial also highlights the importance of choosing salient outcomes and determining how and when they should be measured. For example, timely return to necessary patientspecific activities may be a better goal for ED patients compared with improvement in overall quality of life. Finally, ultrashort follow-up (ie, days) may be necessary for certain outcomes such as return to work, resumption of childcare responsibilities, and comanagement of other chronic diseases. In conclusion, this randomized controlled trial addressed a challenging clinical problem in a population that is difficult to study longitudinally. The trial was novel in its attempt to administer an intervention focusing on clinical and psychosocial aspects of self-management while patients were receiving care for an exacerbation. The trial demonstrated that patients were receptive to education in the ED and could be retained for telephone follow-up several weeks after discharge. Additional research in self-management education in this population should address the content of interventions and the selection of pertinent outcomes. Supervising editor: Amy H. Kaji, MD, PhD Author contributions: CAM, MGEP, TJG, JLF, and JPA conceived the study, designed the trial, and obtained research funding. CAM, TJG, JLF, RHB, and LAM supervised the conduct of the trial and data collection. CAM, TJG, JLF, RHB, and LAM undertook recruitment of participating centers and patients and managed the data, including quality control. CAM and Volume , . : June
Mancuso et al MGEP provided statistical advice and analyzed the data. JPA provided the behavioral model and framework for components of the intervention. CAM coordinated the oversight of an external data and safety monitoring board, and all authors participated in board meetings. CAM and MGEP drafted the article, and all authors contributed substantially to its revision. CAM takes responsibility for the paper as a whole. Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). Supported by R01 HL075893 from the National Heart, Lung, and Blood Institute. Publication dates: Received for publication August 11, 2010. Revisions received November 9, 2010, and November 16, 2010. Accepted for publication November 24, 2010. Available online January 12, 2011.
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Reprints not available from the authors. Address for correspondence: Carol A. Mancuso, MD, Hospital for Special Surgery, 535 East 70th St, New York, NY 10021; 212-774-7508, fax 212-249-2373; E-mail [email protected]
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