Impact of findings on practice

  • Regular nurse-administered asthma education with additional pharmacist counseling improves clinical symptoms for patients with asthma.

  • Asthma knowledge can be improved when the asthma patients participate in nurse administered program or receive nurse-administered program plus pharmacist counseling.

Introduction

Asthma is a chronic inflammatory disorder of the airways that remains on the rise worldwide [1]. In Taiwan, asthma is the eleventh leading cause of death and, despite advances in treatment, mortality remains high [2]. Asthma has been shown to lead to recurrent episodes of breathlessness, wheezing, coughing, and chest tightness, particularly at night or in the early morning [1]. Fluctuation of these symptoms is shown to limit physical and psychosocial activities for asthma patients [3, 4]. Since asthma is an incurable chronic condition, treatment focuses on disease management, including controlling symptoms, preventing exacerbations and controlling factors that contribute to asthma severity. Global Initiative for Asthma (GINA) [5] guidelines emphasize education as a critical component of asthma management, increasing the motivation, skills and confidence of asthma patients.

Behavioral factors shown to improve morbidity and mortality in asthma patients include patient understanding of the disease process [6], compliance with prescribed medical regimens [7] and a good relationship with healthcare providers [6]. Self-efficacy, a sense of having control over events, has also been shown to improve self-management in adolescents [8] and adults [9] with asthma. Asthma education results in reduced emergency visits, reduced medication use during hospital stays [10–13], improved symptom scores [14, 15], and improved inhalation techniques [3, 16]. Research on the effect of patient education on knowledge and health-related quality of life (HRQOL) has shown benefits of asthma education and self-management as recommended by GINA guidelines [17, 18]. Among others, Gibson and Powell [19] have shown that individualized written action plans to treat exacerbations consistently improved asthma health outcomes. Nevertheless, important questions remain about the role of pharmacists in asthma education.

GINA guidelines [1] call for national guidelines tailored to local conditions. The medical center in which the study was conducted had proposed a modified program for Asthma education, combining nurse-delivered education with pharmacist consultation. Based on the work of Diamond and Chapman [20]. and Narhi et al. [21], we sought to evaluate the efficacy of this type of intervention on self-management in asthma patients. Our goal in this study was to assess the effect on asthma knowledge, HRQOL and medication adherence in asthma patients in Taiwan of participation in a nurse-administered asthma education program with or without added pharmacist counseling.

Method

Design

Asthma patients were randomly assigned to one of three groups as described in Fig. 1. Established, previously published questionnaires were used for follow up assessment, including the Asthma Quality of Life Questionnaire (AQLQ) [22], the Chinese language version of the Asthma General Knowledge Questionnaire for Adults (AGKQA-C) [23], and the Self-Assessment of Medication Adherence questionnaire [24]. Outcomes were compared between intervention and control groups to determine the efficacy of the intervention programs. Because disease severity has been associated with quality of life [25], asthma severity was determined for each participant based on the GINA guidelines [1]. Data were collected from the three groups at three points: at enrollment (baseline, month 0), and at months 3 and 6. A standardized procedure was established to increase inter-rater reliability. Before data collection, all data collectors were trained in questionnaire content, presentation style and data collection method. The rater read the questionnaires to patients and self-reporting was supervised.

Fig. 1
figure 1

Study flow for the 91 subjects studied. In general, the pre-test and the first intervention were initiated in April 2003 (month 0), the second intervention started in May, and the third intervention and post-test were begun in June (month 3). After 3 months, the second post-test was collected from September to November 2003 (month 6)

Full size image

Patients participated in either the standard nurse-administered asthma education program, or the same education program with additional pharmacist counseling with the pharmacist. A detailed workbook prepared by chest physicians was used for each session. The asthma education program covered four topics taught in sequence in three 1-h sessions offered during monthly clinic visits (at months 1, 2 and 3). Topics covered were: (1) definition, etiology, diagnosis, disease progress, and complications of asthma; (2) instruction to monitor disease severity, especially skills needed to use the peak expiratory flow (PEF) meter and the format to record symptoms in a diary; (3) introduction on medications for asthma therapy, including protocol of a stepwise treatment plan, pharmacology of leading asthma drugs and correct inhaler techniques; and (4) guidelines for self-management, including understanding potential environmental triggers and irritant factors, environmental control and standard procedure for coping with asthma attacks. Pharmacist counseling covered information related to the action and side effects of asthma medications, treatment plans for individualized medication, and modification of medications in response to progressive asthma.

Sample

Inclusion criteria for study participants were: (1) outpatient aged 18–80 years, (2) good cognitive function, (3) able to understand Chinese, (4) confirmed diagnosis of bronchial asthma as determined by clinical features before treatment, (5) clinically stable, and (6) willing to participate. Patients with other medical conditions that could impact quality of life, including psychiatric illness or cognitive impairment, were excluded. Ethical approval for the study was granted by the administrative department of Tri-Service General Hospital. Prior to participation, all enrolled subjects signed a written consent form and were assured of the confidentiality of their responses.

Measures

Three questionnaires were used to measure participants’ knowledge, HRQOL, and medication adherence pre- and post-intervention. Acceptable validity and reliability of the instruments had been previously determined [22–24, 26–28]. Asthma patients’ quality of life was measured with the AQLQ [22], a 32-item questionnaire with four subscales of activity limitations, symptoms, emotional status, and exposure to environmental triggers. The instrument’s reliability has been validated [26] after seven years of use in clinical trials. A recent study by Abruz et al. [27]. also demonstrated acceptable validity and reliability of the instrument, with internal consistency ranging from 0.80 to 0.96 and a correlation between AQLQ and asthma disease severity. Yang et al [28]., confirmed the efficacy of this scale in a Taiwanese population. The AGKQA-C [23] has been shown to have acceptable reliability and validity to evaluate knowledge levels of education on quality of life of adult asthma patients in Taiwan [27]. Domains tested include causes of asthma, pathophysiological changes in upper respiratory tract during onset of asthma, asthma drugs, evaluation of asthma severity, symptom management, and stimulant control and movement. The Self-Assessment of Medication Adherence questionnaire [24] includes four items on specific self-management behavior in use of asthma medication within the past month.

Analysis of data

Because continuous variables, such as age and peak expiratory flow rate (PEFR), were not normally distributed, we present median scores and range for each variable. Other scores are presented as mean ± standard deviation (SD). Categorical variables, including gender, marital status, education, employment, duration of disease, smoking status, severity of disease and history of emergency visits or hospital admission are expressed as a frequency (percentage). For baseline comparisons, chi-square test and Fisher’s exact test were used to determine the difference in proportion of a categorical variable between groups. To determine statistically significant differences, age and PEFR were tested by the Kruskal–Wallis test. To determine statistically significant differences in other continuous variables, the three groups were tested by a mixed model at each time point. If significant differences were found between the three groups, the Bonferroni correction test was used to make multiple comparisons between each of two groups. The mixed model was also used to test differences between two time points within the same intervention group. Significance was defined as P < 0.05, and adjusted Bonferroni level or Cronbach α performed as appropriate. All statistics were performed using SAS version 9.1.3 (SAS Inc., Cary, NC).

Results

A total of 104 patients who met study criteria were recruited from the Pulmonary Medicine outpatient clinic, the Tri-Service General Hospital, Taipei, Taiwan. The study is a random block design. The investigator randomly assigned patients to one of three groups: 35 were assigned to the nurse-administered asthma education program (Group 1), 34 to the education program combined with pharmacist counseling (Group 2), and 35 received routine asthma care only (Control group). Nurse-administered asthma education and patient follow-up was conducted between April 1, 2003 and June 30, 2003 at monthly clinic visits. All groups received routine asthma care during their scheduled clinic visits. Data at follow-up were available in the intervention and control groups for 30, 29, and 32 patients, respectively (Fig. 1). Major reasons for loss of participants during follow up included unannounced changes in telephone number or contact address, no answer on at least three attempts to contact by telephone, disruption due to the 2003 SARS outbreak in Taiwan and other Asian countries, and inability or unwillingness to repeatedly complete questionnaires. A total of 91 patients completed the study, including 65 males and 26 females with a median age of 25.0 (range 19.0–68.0) years. Fifty-eight patients (64.9%) were single, 44 (48.4%) had more than a junior college education, 72.2% were employed, and 61.1% had never smoked. Fifty patients (58.1%) had <10 years of asthma history, 47.8% had a family history of asthma and most (75.6%) had not received prior asthma education. Patient characteristics are summarized in Tables 1 and 2. Ninety-one of 104 patients (Table 1) who met study criteria completed the study, including 30 in Group 1, 29 in Group 2, and 32 Controls. No statistically significant differences were found between the three groups at baseline (Table 1).

Table 1 Demographical characteristics of study patients (n = 91)
Full size table
Table 2 Asthma-related characteristics of study patients (n = 91)
Full size table

Table 3 shows the comparison of outcome indicators by group at each time point. Knowledge scores among the three groups differed significantly at month 3 (23.03 vs. 20.22, P = 0.007) and month 6 (24.83 vs. 21.03, P < 0.001). Compared with controls, knowledge scores for Group 1 were significantly increased at month 3 (23.03 vs. 20.22) and 6 (20.79 vs. 21.03, all P < 0.0167), and knowledge scores for Group 2 were significantly increased at month 6 (23.57 vs. 21.03, P < 0.0167). Compared with baseline, knowledge scores for both intervention groups (Groups 1 and 2) significantly increased (19.13–24.83 and 16.86–23.57, respectively, all P < 0.0167) with time, but not in the control group. However, mixed model analysis indicated that the overall time trend for asthma knowledge scores was significant (P < 0.001) (Fig. 2).

Table 3 Comparison of asthma knowledgea and asthma medication adherenceb between groups by time point
Full size table
Fig. 2
figure 2

Time trend for score of asthma knowledge. Data are presented as mean ± standard deviation (SD). There were 32 subjects in the control group, 30 subjects in experimental group 1 (education), and 29 subjects in experimental group 2 (education + pharmacist)

Full size image

No significant differences were found in medication adherence scores among the three groups at each time point, even though medication adherence scores for all three groups increased significantly with time (9.19–12.6 for control group, 10.27–13.40 for Group 1, and 9.52–13.62 for Group 2, all P < 0.0167) (Table 3). Results of mixed model analysis also indicated that the overall time trend for medication adherence scores was significant (P < 0.001) (Fig. 3).

Fig. 3
figure 3

Time trend for score of asthma medication adherence. Data are presented as mean ± standard deviation (SD). There were 32 subjects in the control group, 30 subjects in experimental group 1 (education), and 29 subjects in experimental group 2 (education + pharmacist)

Full size image

Four subscales (activity limitations, symptoms, emotional status and exposure to environmental triggers) were used to assess HRQOL in study subjects. No significant differences were found in HRQOL scores among the three groups at any time point (Table 4). In terms of time-effect, overall HRQOL scores increased with time, but results were not significant (P = 0.070). Differences in scores by subscale among the three groups were not significant except for symptoms (Table 4). Symptom scores increased significantly between baseline (month 0) and month 6 for experimental Group 2 (4.99 vs. 4.21, P = 0.008) (Table 4), indicating symptom improvement. All four scores increased with time, but results were not significant.

Table 4 Quality of life questionnaire scores between groups by time point
Full size table

Discussion

The major findings in this study were that knowledge scores increased significantly at month 3 in asthma patients receiving a nurse-administered education program and the same program with pharmacist intervention compared to controls. Asthma knowledge significantly increased in both intervention groups with increased follow-up. No significant differences were seen between groups in medication adherence, suggesting that patients complied with asthma therapy and medication, with or without nurse-based or pharmacist-based intervention.

No significant differences were seen in overall quality of life between the three groups. However, we observed significant symptom improvement at month 6 for patients receiving asthma education with pharmacist counseling (P < 0.0167) (Table 4). This change was consistent with a difference in symptoms on the AQLQ [22], which measures the intrusion of asthma symptoms into normal daily functioning, including sleep (data not shown). Unlike the Asthma Control Test [29], which measures asthma controlled over four weeks, the AQLQ asks patients to recall symptoms over the past two weeks. While the AQLQ is self-reported, its validity has been confirmed in a number of studies [26, 30–35].

Although knowledge of asthma did not differ significantly between the three groups at baseline, the significant improvement in asthma knowledge scores were maintained from 3 to 6 months. These findings strongly indicate that both nurse-administered asthma education alone and nurse-administered asthma education plus pharmacist counseling result in increasing patients’ knowledge about asthma, agreeing with previous studies of increased knowledge associated with asthma education [5, 10, 12, 14–17].

While studies of asthma education often involve nurses or doctors (shown to be equally effective [36]), many have shown the efficacy of using pharmacists in the community setting [37–49]. A recent study by Petkova [37] reported on a 4-month educational intervention based in community pharmacies. Those supplied information by the pharmacists had better clinical outcomes (PEFR rate, wheezing, breathlessness, hospitalizations, and doctor visits) than controls. Similarly, Kritikos et al. [38] demonstrated that a pharmacist outreach educational program in rural Australia increased both asthma knowledge and requests for additional information. In the present study, implementing nurse-administered asthma education with pharmacist counseling resulted in improved asthma knowledge scores, enabling patients to monitor, control, and manage their disease through the study period while following an asthma workbook. Study findings indicated increases in knowledge of control group patients, believed to result from heightened awareness and improved understanding of asthma when asthmatic patients are questioned about their asthma condition.

A major finding of this study was significant improvement in symptoms scores 6 months after nurse-administered asthma education with additional pharmacist counseling. This result suggests that pharmacy-based programs may be key in improving clinical outcomes when implemented as an adjunct to nurse-administered education programs in the clinical setting. Diamond and Chapman [20] evaluated the impact of a pharmacy-based educational intervention on self-management behavior and symptom control of asthma patients. Results obtained 30 days after the educational intervention showed that patients experienced significant decreases in the frequency of daytime asthma symptoms, nocturnal symptoms, and medication use. Armour et al. [50] examined the impact of a community pharmacy-based education and monitoring program in 50 pharmacies throughout Australia. Patients who received community pharmacist intervention (assessment, goal setting, monitoring and review) had improved symptoms, better medication adherence, less use of reliever medication, improved quality of life, more asthma knowledge and better asthma control [50].

Our Pharmacy Department is currently conducting a pharmacists counseling system for asthmatic patients which includes pharmacists counseling by phone. These results therefore provide an important benchmark to practices in different parts of the world. These outcomes reinforce other findings that pharmacists, who already interact with patients as they fill their prescriptions, are well suited not only to provide regular education and counseling, but also to help correct patients’ misconceptions about their condition and medications, thereby encouraging self-management practices that support better outcomes [37–49]. Thus, arranging regular and repeated guidance by pharmacists through outpatient services would be valuable for asthma patients. While pharmacist interventions are not without costs, the economic costs of asthma are rising [51], and increased costs are associated with poor symptom control [52, 53]. McLean et al. [48] found that pharmaceutical care is more cost-effective than usual care in controlling most direct and indirect costs in asthma patients.

The present study failed to demonstrate that a nurse-administered asthma education program improved overall scores of HRQOL and four subscales. In a recent study, Kheir et al. [54] tested the AQOL against another quality of life instrument in a community pharmacy setting. The AQOL Environmental stimuli domain was less sensitive in reporting change in patients. In our study, patients improved in all domains, but the results did not achieve statistical significance. Patients may generally require more than 6 months to assimilate new information from the education program and adopt new techniques to influence their HRQOL. Studies with longer follow-up periods may be needed.

Although the nurse-administered asthma education program was shown to be effective, bias may exist in data interpretation due to the relatively small sample size and differences in patients’ asthma status. While outcomes did not differ by disease severity, this factor has been associated in adolescents with low educational attainment, use of medication, passive smoking, and being employed, suggesting potential impact on outcomes [25]. Although distribution of family history of asthma was different for experimental and control groups, the difference was not significant (P = 0.28). However, larger studies should certainly control for family history. In addition to the limitation of small sample size, the numbers of sessions in the program were also limited, the period of follow-up was relatively brief, and quality of intervention among instructors may have varied. Additional research is needed to demonstrate more effective models for integrating pharmacist counseling into the nurse-administered asthma education program, and better administration systems for encouraging pharmacists to work with nurses in the program. Finally, long-term studies may also be needed to determine the cost and benefit of nurse-administered asthma education combined with pharmacist counseling.

Conclusion

Our results indicate that pharmacist counseling, as an adjunct to nurse-administered asthma education, significantly increased patients’ knowledge of asthma and improved asthma symptoms.