Study design
This study was conducted at the First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China. Patients who visited respiratory department in the hospital and used inhaler devices were enrolled from September 2015 to June 2017. The study was conducted in accordance with the amended Declaration of Helsinki. A questionnaire was filled by the participant, including age, gender, educational status (no education, lower education, secondary education, or higher education), marital status (married or unmarried/divorced/solitary), medical insurance (yes or no), monthly income, smoking history (ever or never), drinking, diagnosis (asthma or COPD) and the type of inhaler device. The flowchart of this study was shown in Figure 1.
Inclusion criteria and exclusion criteria
Patients who meet the following criteria will be enrolled: diagnosed as asthma according to Global Initiative for Asthma (GINA) [12] or COPD according to GOLD criteria [3]; Suffering from the disease more than one month and using an inhaler device presently but did not receive any inhaler education; Aged between 18 and 75 years old; Patients could self-administer their medication and had no difficulty in communicating with Chinese; Willing to participate and accept subsequent follow-up; Did not involve in any other research. Patients who have one of the following conditions will not be enrolled: the patient is in an acute exacerbation; Using antibiotics within half a month; Bacterial infection in areas other than the respiratory system; Unstable angina pectoris or myocardial infarction occurred in the past 6 months; Suffering from severe liver or kidney dysfunction; Suffering from Coagulopathy; Suffering from connective tissue disease.
Summarization and improvement of the inhaler technique
We developed a 10-step inhaler technique according to a 7-step inhaler technique [13]. Considering the situation of inhaler usage in Chinese patients, we added three steps of sitting posture before the inhalation, cleaning and gargling after the inhalation [14]. Inhaler technique in this study was summarized into 10 simple steps according to the previous study, including sitting up, opening the device, loading drug, exhaling, biting, inhaling, holding one’s breath, repeating, cleaning and gargling [14]. The total scores of the 10-step inhaler technique were 10 scores corresponding to the 10 steps. Each correct step was defined as “1 score” and an incorrect or missed step was defined as “0 score”. Each step of the inhaler technique performed by patients was evaluated using the 10-step inhaler technique in detail, which was shown in Table 1.
Progressive pharmaceutical care model
A pharmaceutical care model was established by combining six methods to train and educate patients with asthma and COPD progressively.
Making a brochure
A brochure was created after we conducted a survey of the information that asthma and COPD patients wanted to know. The contents of the brochure included etiology and symptoms of asthma and COPD, drug classification of asthma and COPD, correct usage of inhaler devices, and the explanation of the most common problems patients encountered when using devices. The brochure was provided for asthma and COPD patients free of charge.
Making Videos based on 10-step inhaler technique
Videos based on 10-step inhaler technique named “Correct Usage methods on inhaler devices” were created and free of charge to asthma and COPD patients. The videos were uploaded to our online consultation platform. Additionally, a two-dimensional code was printed on our medication list, and patients could watch the videos via scanning it by using a China’s popular messaging app, WeChat. Patients could also watch the videos through the video APP on their mobile phone as well at any time if they want.
Setting up special drug dispensing window for asthma and COPD patients
The outpatient pharmacy of our hospital has many windows for drug dispensing, and one of these is specially designed for asthma and COPD patients. The information of patients diagnosed with asthma or COPD were automatically allocated to this drug dispensing window. The most frequently used demonstration devices of Turbuhaler, Diskus and Handihaler were provided on this window.Pharmacists used these devices to demonstrate correct inhaler technique for asthma and COPD patients. Patients could consult any questions associated with asthma and COPD on the drug dispensing window.
Face to face demonstration and evaluation
When asthma or COPD patients came to our drug dispensing window to collect their inhaler medicine, the specially trained pharmacists would educate and assess patients’ medication face to face. Patients were required to show their inhaler technique by using demonstration devices, and this process was observed by the specially trained pharmacists. Each correct step of the inhaler technique demonstrated by patients was recorded, and the incorrect steps were also recorded. Besides, the specially trained pharmacists made an initial assessment for patients, which included medication adherence, incidence of exacerbation (≥ 2 times), inhaler technique sore, rate of correct inhaler usage and belief bout medicines. After the evaluation, the same pharmacists demonstrated and explained the 10-step inhaler technique for patients by using demonstration devices, and the incorrect steps demonstrated by the patients were pointed up at the same time. This procedure continued for at least 5 minutes until no errors were made by the patients. Questions could also be asked by patients.
Online consultation
Various menu items were created in our WeChat Subscription, and one of which was used for online consultation for patients with asthma and COPD. If patients had confusion about the diseases of asthma and COPD or inhaler technique, they could consult our pharmacists by using this platform. Besides, popular science articles related with asthma and COPD were offered regularly in our WeChat Subscription for patients to acquire popular science knowledge.
Follow-up and re-evaluation
Telephone follow-up was made to all the participants once a month by the specially trained pharmacists, and the follow-up was conducted three times. Each telephone conversation time was less than 5 minutes. The pharmacists re-educated patients if they still operated the inhaler devices incorrectly during the first two follow-up. Additionally, patients could also ask questions if they had confusion. During the third telephone follow-up, the pharmacists re-evaluated the patients by talking to them over the phone. The assessment included the rate of clinical effective, the incidence of exacerbation (≥ 2 times), medication adherence, inhaler technique score, the rate of correct inhaler usage and belief about medicines. Patient satisfaction in the intervention group participants was also investigated.
Outcome measures
Rate of clinical effective
Disease control was assessed by Asthma Control Test (ACT) score [15] or COPD Assessment Test (CAT) score [16]. The total ACT scores are 25 points, and asthma patients have an ACT score ≥20 indicates effective in clinical treatment. The total CAT scores are 40 points. Patients with COPD with a variation in CAT score by 2 points or more indicates effective in clinical treatment [16]. The rate of clinical effective is considered as the number of patients who acquired complete and partial control accounts for the number of total patients in the intervention group or control group. The rate of clinical effective was assessed after 3 months’ intervention
Incidence of exacerbation (≥ 2 times)
The incidence of exacerbation (≥ 2 times) is considered as the number of exacerbations (≥ 2 times) accounts for the number of total patients in the intervention group or control group. The incidence of exacerbation (≥ 2 times) before and after 3 months’ intervention was evaluated.
Medication adherence
The medication adherence of patients was evaluated according to the MMAS-8 [17]. The MMAS-8 contains 8 questions. The answer “no” is defined as “1 score” and “yes” is defined as “0 score” corresponding with the item 1 to 4, and 6 to 7. The item 5 is reverse scored, and the answer “yes” is defined as “1 score” and “no” is defined as “0 score”. The question-8 is scored based on a 5-point Likert scale, and the answer “never/almost never” is defined as “4 scores”, and the answer “always” is defined as “0 score”. The total scores are the sum of the scores of the 8 questions, and the highest score is 11 scores. The total score that below 6 is considered low adherence, and between 6 and 7 is considered medium adherence, and above 8 is considered high adherence. The MMAS-8 score was evaluated before and after 3 months’ intervention.
Inhaler technique score
Patients’ inhaler usage was evaluated and re-educated based on the 10-step inhaler technique when
the monthly follow-up was conducted. After 3 months’ intervention, patients’ inhaler technique was scored on the last telephone follow-up, and the result was compared to the inhaler technique score result before intervention.
Rate of correct inhaler usage
The rate of correct inhaler usage was defined as the percentage of patients who use the inhaler devices correctly. The rate of correct inhaler usage of each individual step was evaluated before and after 3 months’ intervention.
Belief bout medicines
Patients’ belief about medicines was assessed according to the questionnaire on belief about medicine (BMQ) [18]. The BMQ is a 9-item questionnaire. The answer “yes” is defined as “1 score” and “no” is defined as “0 score”. The total score is the sum of the scores of all items. A higher total score indicates a stronger negative belief in drug. The BMQ score was evaluated before and after 3 months’ intervention.
Patient satisfaction
A satisfaction questionnaire was designed according to a previous research [19] and the properties of the present study population. The satisfaction questionnaire consisted of 8 questions. The response option for the question 1-7 was “yes” or “no”. The answer “yes” is defined as “1 score” and “no” is defined as “0 score”. The answer for the eighth question was optional. Patient satisfaction was evaluated in the intervention group after 3 months’ intervention.
Data Analysis
Data was analyzed by using the Statistical Package for Social Science (SPSS) software (version 19, SPSS, Chicago, Illinois), and was presented as the mean ± standard deviation (sd) or percentages. T test and χ2 test were used for the comparison between the intervention group and control group. Differences with P<0.05 were considered statistically significant.