Effectiveness of individualized inhaler technique training on low adherence (LowAd) in ambulatory patients with COPD and asthma.

To analyze whether there is improvement in adherence to inhaled treatment in patients with COPD and asthma after an educational intervention based on the teach-to-goal method. This is a prospective, non-randomized, single-group study, with intervention and before-after evaluation. The study population included 120 patients (67 females and 53 males) diagnosed with asthma (70.8%) and COPD (29.1%). The level of adherence (low and optimal) and the noncompliance behavior pattern (erratic, deliberate and unwitting) were determined by the Test of the adherence to Inhalers (TAI). This questionnaire allows you to determine the level of adherence and the types of noncompliance. Low Adherence (LowAd) was defined as a score less than 49 points. All patients received individualized educational inhaler technique intervention (IEITI). Before the IEITI, 67.5% of the patients had LowAd. Following IEITI, on week 24, LowAd was 55% (p = 0.024). Each patient can present one or more types of noncompliance. The most frequent type was forgetting to use the inhaler (erratic), 65.8%. The other types were deliberate: 43.3%, and unwitting: 57.5%. All of them had decreased on the final visit: 51.7% (p = 0.009), 25.8% (p = 0.002), 39.2% (p = 0.002). There were no significant differences in adherence between asthma and COPD patients at the start of the study. The only predicting factor of LowAd was the female gender. An individualized educational intervention, in ambulatory patients with COPD and asthma, in real-world clinical practice conditions, improves adherence to the inhaled treatment.

Introduction

Chronic obstructive pulmonary disease (COPD) and asthma are conditions particularly prone to adherence issues due to their chronic nature and to their periods of symptom remission[1]. Incorrect adherence and inhaler technique reduces the treatment benefits and leads to concerns in the healthcare management and health-related consequences[2]. Adherence to oral or inhaler medication ranges between 41 to 57% in COPD[3,4] and, in asthma, it is 50% in children[5] and 30% in adults[6]. Adherence is associated with numerous factors such as the disease, the route of administration, access to the treatment and specific characteristics of the patient[7]. Some systematic reviews have evaluated the effectiveness of interventions to improve medication adherence, from self-management training to eHealth tools, with heterogeneous results[8,9]. Similarly, assessing medication adherence has been done using a variety of methods and has rendered heterogeneous results. There is no standard prospective methodology in COPD or asthma[10]. The stated objectives include biochemical or electronic monitoring of medication administration[11]. An example of these is the audio recording devices which simultaneously report on inhaler technique and adherence[12]. Self-reporting questionnaires overestimate adherence. Also, most of these instruments have been designed to monitor oral medication[13,14]. Recently, the Test of adherence to inhalers (TAI)[15] has been validated for asthma and COPD. It comprises two complementary 12-item questionnaires with domains for patients and for professionals. It gathers information on the degree of adherence and patterns of noncompliance. This test correlated better with adhesion measures made with electronic devices than the Morisky-Green test[15].

The inappropriate use of an inhaler is one of the most commonly associated barriers with LowAd. Even easy application devices require training[16]. The ability to successfully administer medication through an inhaler has a direct effect, not just on their deposition but also in the perception of benefits by the patient and in their willingness to maintain adherence. The training of the inhaler technique is the main factor that health professionals can modify, although the real benefits are controversial[17]. The most effective training method to teach the inhaler technique is verbal instruction combined with a physical demonstration[18,19]. The objective of the present study is to evaluate adherence to inhaled treatment using TAI[15], in real clinical practice conditions, with a cohort of ambulatory patients diagnosed with asthma and COPD; before and after an individualized educational inhaler technique intervention (IEITI).

Methods

Study design and participants

The prospective, non-randomized, single-group study, with intervention and before-after evaluation, carried out between January 11, 2017 and December 21, 2018. Were included 160 ambulatory patients from a Pulmonology Department of a Public General University Hospital. The patients included were adults >18 years of age, diagnosed of bronchial asthma or COPD, who were being treated with one of the following devices: Pressurized metered-dose inhaler (pMDI)/Soft mist inhaler (SMI), Dry powder inhaler multidose (DPIm), Dry powder inhaler single dose (DPIs), and Pressurized metered-dose inhaler (pMDI) with spacer holding chamber (pMDI + spacer). The diagnosis of asthma was based on GINA criteria[20]. The diagnosis of COPD was done using GOLD criteria of airflow limitation (FEV1/FVC post-bronchodilator <0,70)[21]. In all cases, more than 6 months have passed since the initial diagnosis of COPD or asthma. Patients over 70 years old and/or with psychiatric history were evaluated for cognitive function using the Pentagon Drawing Test[22]. The patients who did not pass this test were excluded from the study and the treatment with nebulizers was recommended. Other criteria for exclusion were refusal to participate and the presence of a language barrier. The study protocol was approved by the institutional review board of the hospital, called the “Ethical Committee of Clinical Research of the General University Hospital” on 09/28/2016 (approval number: EST-30/16). All study participants provided written informed consent.

Following the recruitment phase, they were scheduled for an initial visit (IV) with a physical therapist who was not involved in the recruitment. Two Pulmonology investigators recruited patients in the consultation. The Physical therapists were trained during several sessions until they master the competence in inhalation technique training and using the TAI test. During this visit, IEITI was done and a final visit (FV) was performed on week 24. The IEITI consisted of an educational intervention based on the teach-bak model[23]. The patient received verbal instruction on the inhaler technique and then was asked to show their ability to do it. When the patient does not show an acceptable skill technique, further instructions are given until he achieved that. The patient did not show an acceptable level of skill if, after explanations followed by physiotherapy and two consecutive patient demonstrations, he could not perform the loading of the system and/or the inspiratory maneuver. The sequence of study visits is shown in Fig. 1 and the systematic training, divided into four consecutive stages, is explained in Fig. 2. The IEITI also included informational material on dosage, scheduling, and characteristics of the inhalers (Supplementary Fig. 1).

Fig. 1

Study sequence.

Fig. 2

Individualized educational inhaler technique intervention (IEITI): four stages.

Data collection

The degree of adherence to the inhaler treatment was evaluated using the ten-item TAI[15] (https://www.taitest.com/). Each item scored from 1 to 5 (where 1 was the worst possible score and 5 was the best possible score), resulting in a minimum score of 10 points and a maximum of 50 points. Three levels of adherence were established along this continuum: poor (≤45), intermediate (46–49), and good (50). For this study, we have used a composite variable that we have named Low Adherence (LowAd), which includes all patients with “intermediate” and “poor” adherence, according to the cut-off points established by the authors, with the purpose to facilitate the interpretation of the results. Therefore, LowAd patients are those with a score ≤49. Consequently, patients with Optimal Adherence (OptAd) are those with a score of 50 points. The “complete TAI” includes two additional questions (12-item TAI[15]), performed asked by the professional in order to explore nonadherence or noncompliance patterns. In item 11, 1 point is given if patients do not remember the dosage or frequency, and 2 points are given if they remember it. In item 12, 1 point indicates that the patient makes some critical error in inhaler technique whereas 2 points indicate that the patient does not make any errors when using the inhaler. Three patterns of noncompliance have been identified by dividing up the scores into three groups of questions: “erratic” <25 points (items 1–5), “deliberate” <25 points (items 6–10), and “unwitting” <4 points (items 11–12).

Individualized educational inhaler technique intervention (IEITI)

The stages of IEITI are shown in Fig. 2. An IEITI was carried out in an individual session of 30–40 min, conducted by a physical therapist. The session included the demonstration and assessment of the inhaler technique. Errors were corrected until the patient reached an acceptable technique. Prior to the intervention, the patient was asked to complete the TAI (10 items). At the beginning of the session, the therapist asks the patient to show how he uses the inhaler prescribed, before receiving any instructions for correct use. For that purpose, the patient received an identical device with a placebo. It was considered that the patient had a Deficient Inhaler Technique (DeIT) when the inspiratory flow maneuver was insufficient and/or a critical error was made. The results of the evaluation were entered on an inhaler technique evaluation card (ITEC) (Fig. 3). Next, the patient was asked about the dosage and frequency of the inhaler (item 11). If they have not made any “critical error[24]” (item 12), a graphic material of the inhaled medication is given (Supplementary Fig. 1) and the session is concluded. “Critical error” were considered if the patient showed an action or inaction that, in itself, which can lead to a detrimental impact on drug administration in the lung[24]. If the patient does not present an acceptable skill level, the physical therapist will proceed to the correct inhaler use model, correct errors, and ask the patient to show what he learned through this process. When the patient continued displaying DeIT, the therapist contacted the prescribing doctor to report that the inhaler needed to be changed.

Fig. 3

Inhaler technique evaluation card (ITEC).

Clinical variables and outcome measure

Data was gathered on sociodemographic, clinical, and spirometric information, type of inhaler evaluated, and the results of the inhaler technique skill level of the patient (optimal or poor inhaler technique). The primary and secondary variables were analysed at the baseline and after the intervention (IEITI). The main variable was the decrease in the percentage of patients with LowAd in the final visit. Secondary variables were: types of noncompliance: erratic unwitting and deliberate, and percentage of patients with poor Inhaler Technique and critical errors. The differences between patients diagnosed with asthma and COPD were also analysed as part of the study variables. To minimize measurement bias, the evaluation of the last visit, in week 24, was performed by a nurse previously trained in conducting the questionnaire TAI, blinded to the results of the initial questionnaire and who has not participated in the initial training.

Statistical analysis

The sample size was calculated in bilateral contrast factoring in a 5% alpha risk and 0.1 beta risk (90% statistical power). A sample of 130 participants is necessary assuming that the initial rate of LAd would be 45% and the final rate 25%[25-27]. The rate of patient loss to follow-up was estimated at 8%. Quantitative variables are shown as averages ± standard deviation (interquartile range: first and third quartile). Comparisons between groups were performed with the Fisher exact test. Categorical variables were expressed as absolute and relative frequencies, and comparisons between them were made using the Pearson Chi2 test or Fisher’s test. Quantitative variables were expressed as mean ± standard deviation and the comparisons were made between independent groups using the Student’s t-test or the Mann–Whitney test if the variable did not present a normal distribution. When the variables have been measured at different points, the McNemar test was used for their comparison and the paired samples t-test or Wilcoxon test depending on whether or not the distribution of the quantitative variables.

A multivariate logistic regression analysis was performed to evaluate associated factors with LowAd, calculating the odds ratios (ORs) and 95% confidence intervals (CI). The independent variables considered were: age, sex, deficient inhaler technique (initial visit), smokers status, previous training, the severity level of disease (COPD/Asthma), type of disease (COPD/asthma), and types of inhalers evaluated (initial visit). First, a univariate analysis of each variable was performed, and then, the variables whose univariate test had a p value <0.3 were included in the multivariate logistic regression model. The goodness-of-fit of the multivariate model was evaluated with the Hosmer–Lemeshow test. Odds ratio (OR) values were calculated with 95% confidence intervals (CI 95% CI). All analyses were performed “two tails”, and a p value of less than 0.05 was considered significant. All analyses were performed with the SPSS statistical software program (SPSS version 25.0; IBM®, Armonk, NY) and Stata [StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP]. A blinded researcher carried out the data analysis.

Table 1

Baseline characteristics of patients in the initial visit (n = 120).

Characteristic		N = 120	%
Female, n (%)		67	55,8
Age, years, mean ± SD		60,8 ± 16.6
Asthma diagnosis	Mild-intermittent	54	63,8
	Moderate-severe	31	36,5
COPD Diagnosis	Mild-moderate	20	57,1
	Severe-very severe	15	52,9
Smokers status, n (%)		25	20,8
Previous training*, n (%)		54	45
Number drugs /patient**, mean ± SD		2 (1,5)
Number inhalers/patient***, mean ± SD		2 (2,2)
No studies or primary, n (%)		83	69,2

SD standard deviation, FEV1 forced expiratory volume in 1 second, COPD chronic obstructive pulmonary disease.

*some form of “unstructured” instruction, **excluded inhalers, ***were evaluated 430 inhalers.

Table 2

Types of inhalers evaluated in the study visits.

Type inhaler	Initial visit	Final visit
	N = 120 (%)	N = 120 (%)
pMDI	12 (10)	18 (15)
pMDI + chamber spacer	31 (25,8)	24 (20)
Soft mist inhaler	12 (10)	19 (15,8)
MDPI	52 (43,3)	48 (40)
UDPI	13 (10,8)	11 (9,1)

pMDI metered-dose inhaler pressurized, MDPI inhaler dry powder multidose, UDPI inhaler dry powder unidose.

Table 3

Changes in adherence, type of noncompliance and critical errors in initial an final visit.

	Initial visit	Final visit	P
Adherence (items 1–10 TAI)	n (%)	n (%)
Low adherence (≤49 points)	81 (67,5)	66 (55)	0.024
Optimal adherence (=50 points)	39 (32,5)	54 (45)
Types noncompliance (items 1–12 TAI)
Erratic noncompliance (items 1–5)	79 (65,8)	62 (51,7%)	0.009
Ignorant noncompliance (items 11–12)	69 (57,5)	47 (39,2%)	0.002
Deliberate noncompliance (items 6–10)	52 (43,3)	31 (25,8%)	0.002
Critical errors (Item 12 TAI)	21 (16,3%)	3 (2,5%)	0.461
Evaluations with poor inhalation technique*	69 (57,5%)	22 (11,2%)	0.002

TAI test of the adherence to inhalers, DeIT deficient inhaler technique.

*Deficient inhaler technique (DeIT).

Table 4

Changes in adherence, type of noncompliance, and critical errors between COPD and asthma.

	COPD	ASTHMA
	n (%)	n (%)	P
Adherence (items 1–10 TAI)
Low adherence (≤49 points)	20 (57,1)	61 (71,8)	0.120
Types noncompliance (items 1–12 TAI)
Erratic noncompliance (items 1–5)	20 (57,1)	59 (69,4)	0.198
Unwitting noncompliance (items 11–12)	20 (57,1)	49 (57,5)	0.095
Deliberate noncompliance (items 6–10)	11 (31,4)	41 (48,2)	0.091
Critical errors (item 12 TAI)	4 (11,4)	14 (16,5)	0.482
Inhalation technique*	24 (68,6)	45 (52,9)	0.115
Evaluations with por
inhalation technique*	24 (68,6)	45 (52,9)	0.115

TAI test of the adherence to inhalers, COPD chronic obstructive pulmonary disease, DeIT deficient inhaler technique.

*Deficient inhaler technique (DeIT).

Table 5

Relation of the low and optimal adherence and baseline characteristics of the patients with COPD and asthma.

Characteristics		Low adherence	Optimal adherence	P
		45 (69.7)	22 (38.9)	0.001
Females		58.9 ± 16.7
		80.7 ± 23.7	70.9 ± 20.1	0.073
Asthma diagnosis	Mild-intermittent	31 (62)	23 (65.7)	*0.726
	Moderate-severe	19 (38)	12 (34.3)
COPD diagnosis	Mild-moderate	9 (56.3)	11(57.9)	*0.922
	Severe-very severe	7 (43.8)	8 (42.1)
Smoker		16 (24.2)	9 (16.7)	0.429
Previous inhaler technique training **		30 (45.5)	24 (44.4)	0.912
Medications /patient excluding inhalers		2 ± 1.5	2 (0.5)	0.746
Inhalers/patient		2 ± 2.2	2 (0.5)	0.456
No formal or basic education		44 (66.7)	39 (72.2)	0.512

The dates show n (%) or average ± standard deviation.

COPD chronic obstructive pulmonary disease.

*P result severity of asthma and COPD, ** some form of “unstructured” instruction.

Table 6

Logistic regression model.

Variable	OR	IC-95% OR	p value
Age >70	0.591	0.252–1.394	0.231
Female	2.394	1.039–5.518	0.04
Asthma diagnosis	1.384	0.573–3.341	0.469

The variables identified as predictors of low adherence on univariate analysis: age, gender and asthma or COPD diagnosis, were included. For this model, the Hosmer–Lemeshow test showed a p value = 0.699.

OR odds ratio, IC interval confidence, COPD chronic obstructive pulmonary disease.