The opinion of experienced healthcare providers about the instruction of inhalation technique to patients with chronic obstructive pulmonary disease A qualitative, explorative study

By Hester I.H. Hoving Student id: 1740830 Drs. E.I. Metting (daily supervisor) Dr. B.M. J. Flokstra- de Blok (faculty supervisor) Department of General practice University Medical Centre Groningen, UMCG February 13, 2017

COPD

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About training sessions of healthcare providers..:

IMIS trainer: “Let’s see if you do it correct yourself.. many practice nurses

make errors with relatively simple inhalers like a turbohaler and discus.” General practitioner: “And when the

instructor already has an incorrect technique, then of course, it will be quite difficult for patients to do it

well.”

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Abstract

Introduction: COPD is a disease with a high prevalence, morbidity and mortality. Despite the fact that inhalation medication is the key stone in the treatment of COPD, research revealed that many patients have an incorrect inhaler technique. This causes, among other things, poor symptom control, more side effects and increased pressure on healthcare systems. To improve the inhaler technique of patients, proper education about inhaler technique is important. Objective: The aim of this study is to identify the opinion of experienced healthcare providers about the current instruction method for inhalation medication and to obtain ideas to improve the current instruction method. Method: This study consists of three parts, the first two parts consist of a qualitative design, the last part is a quantitative design. In the first part results of a patient study are analyzed, to explore the meaning of patients about inhaler instructions. The results are used in the second part of this study, in which a focus group is performed. In this focus group a heterogeneous group of experienced healthcare providers discussed about the instructions for inhalation medication. To validate the results of the focus group, an online questionnaire is compiled and distributed among a large group of caregivers. In this way was tested whether the results of the focus group are shared among other healthcare providers. In the focus group and the questionnaire several topics were discussed, namely the current way of instruction, training of healthcare providers, eHealth and the communication between healthcare providers. Results: A total of 9 healthcare providers participated to focus group, all experienced in inhaler technique. A total of 93 respondents reacted to the questionnaire. The research indicated patients receive a systematic instruction about inhaler technique, namely demonstration of the technique, practicing and feedback and explanation about the disease and medication. Follow-up of the inhaler technique should be more frequent, and preferably within two weeks after the initial instruction. It appeared that caregivers make errors themselves in the technique in trainings sessions. The idea came up to repeat trainings sessions more frequently and to introduce a certificate for caregivers that are trained in inhaler technique. Currently eHealth is mainly applied in the form of instruction videos and webpages. In the future video consultation will possibly make a greater contribution of the instruction. Communication between caregivers is insufficient nowadays. There is, in particular, need for communication about task division and about the errors of patients. Conclusion: There is room for improvement in the current inhaler instruction method. Two interacting components were revealed: on the one hand improvements can be made to the content of the instruction and on the other hand the organization of care.

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Samenvatting

Introductie: COPD is een aandoening met een hoge prevalentie, morbiditeit en mortaliteit. De belangrijkste behandeling van deze obstructieve longziekte bestaat uit inhalatiemedicatie. Uit onderzoek is echter gebleken dat deze medicatie vaak op een incorrecte manier wordt gebruikt, waardoor de werking van de medicatie suboptimaal is. Dit heeft gevolgen voor de patiënt, zoals een hogere ziektelast, meer ziekenhuisopnames, meer bijwerkingen en ook heeft dit hogere zorgkosten als gevolg. Het is van belang dat er een manier wordt bedacht om de inhalatie goed aan patiënten aan te leren. Om te onderzoeken wat er verbeterd kan worden aan de huidige instructiemethode, wordt de mening van zorgprofessionals over deze methode onderzocht en er wordt gekeken hoe een instructie er idealiter uit zou zien. Methode: Deze studie bestaat deels uit kwalitatief en deels uit kwantitatief onderzoek. In de eerste plaats is geholpen met de analyse van patiënten interviews, om de mening van patiënten over inhalatie instructies aan zorgverleners voor te kunnen leggen. Daarnaast is een focusgroep onderzoek voor zorgprofessionals georganiseerd, om de mening van zorgverleners over de inhalatie instructie te achterhalen. Tot slot heeft er triangulatie plaatsgevonden om de validiteit van het focusgroep onderzoek te vergroten. Hiertoe is een online vragenlijst opgesteld, waarin de uitkomsten van de focusgroep onder een grote groep zorgverleners voorgelegd zijn, om te onderzoeken of de uitkomsten gedeeld worden door andere zorgverleners. In de focusgroep en vragenlijst kwamen verschillende onderwerpen aan bod, namelijk de huidige en gewenste instructie omstandigheden, de training van zorgprofessionals, eHealth en de communicatie tussen verschillende zorgverleners. Resultaten: in totaal participeerden 9 zorgprofessionals aan het focusgroep onderzoek, allemaal gespecialiseerd in inhalatietechniek. De vragenlijst is ingevuld door 93 respondenten. Er kwam naar voren dat de instructie uit een aantal vaste onderdelen moet bestaan, namelijk demonstratie van de techniek, oefenen en feedback, uitleg over de ziekte en de medicatie. In trainingssessies maken zorgverleners zelf ook nog vaak fouten. De evaluatie van de inhalatietechniek zou vaker moeten plaatsvinden en het liefst al binnen twee weken na de eerste instructie. Ook trainingssessies zouden vaker herhaald moeten worden en gecertificeerd moeten worden. eHealth wordt nu voornamelijk toegepast in de vorm van instructievideo’s en websites, in de toekomst zou videoconsultatie een mogelijk een grotere rol gaan spelen. De communicatie tussen zorgverleners is onvoldoende. Er is vooral behoefte aan communicatie over de taakverdeling van de verschillende zorgverleners en wie er verantwoordelijk is voor de inhalatie instructie. Daarnaast kwam naar voren dat er meer communicatie zou moeten plaatsvinden over de fouten die patiënten maken in de inhalatietechniek.

Conclusie: uit het onderzoek is gebleken dat er verbeteringen nodig zijn in de instructie voor inhalatietechniek voor COPD patiënten. Deze veranderingen zullen zowel op inhoudelijk niveau, als ook op organisatorisch niveau moeten plaatsvinden.

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Index 1. Introduction

1.1 Background COPD…………………………………………………………... 7 1.2 Management of COPD………………………………………………………. 7 1.3 Inhaler technique issues……………………………………………………… 8 1.4 Reasons for poor inhaler technique………………………………………….. 9 1.5 Effective interventions to improve inhaler technique………………………... 10 1.6 Objective & research question…………………….…………………………. 11

2. Method 2.1 Part one: Patient study…………..………………………………………..….. 12 2.2 Part two: Focus group..…………….…..……………………………….……. 12 2.3 Part three: Triangulation questionnaire…..………………………………….. 14 2.4 Simultaneous examination…………..……………………………………….. 15 3. Results 3.1 Part one: Patient study………...………………………………………...……. 16 3.2.1 Part two: Participant characteristics questionnaire…………...…………….. 17 3.2.2: Part two: Focus group meeting……………………………………………. 18 3.3 Part three: Triangulation questionnaire………………………………………. 23 4. Discussion 4.1 Main results………………………………………………………………....... 26 4.2 Comparison with existing literature………………………………………….. 27 4.3 Strengths and limitations……………………………………………………... 28 4.5 Future implications…………………………………………………………… 28 4.6 Conclusion……………………………………………………………………. 29 5. References…………………………………………………………………………….. 30 6. Appendices

Appendix A – Invitation letter & informed consent…………….…………….…. 33 Appendix B – Declaration METc……………………………….……………..… 37 Appendix C – Participant characteristics questionnaire ……….………………... 38 Appendix D – Interview schedule………………………………...……………… 40 Appendix E – Triangulation questionnaire……………………….……………… 46 Appendix F – Coding tree………………………………………….…………….. 54 Appendix G – Quotes translation……………………………………..………….. 55 Appendix H – Data triangulation questionnaire…………………………………. 57

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1. Introduction

1.1 Background COPD Chronic obstructive pulmonary disease (COPD) is a complex inflammatory disease, characterized by progressive airflow limitation, which in most cases is irreversible (1). Dyspnea, first only exercise-induced, in a more serious stage also in rest, is a major symptom of the disease (2). An important risk factor for developing COPD in the western world is cigarette smoke. In developing countries the disease is often caused by air pollution (1,2). The severity of the disease is determined by exacerbations and comorbidities (3).

Epidemiology COPD is a prevalent disease and has a high association with mortality and morbidity (3,4). The disease is mainly observed in elderly and is uncommon before the age of fifty years (1,5). Because of the ageing population, the prevalence of the disease is increasing (6). In 2020 the disease will be the third leading cause of death in the world according to the World Health Organization (5). Therefore, COPD will become a major problem in healthcare. In the Netherlands, where this study will take place, 607.300 people were suffering from COPD in 2015, among them were 308.800 males and 289.500 females (7),(8). This gender difference is declining though, because more women started smoking in the last decades (5). The economic and social burden of the disease is high, mainly because of the chronic nature of the disease. In the Netherlands, €1.5 billion was spent on obstructive lung diseases in 2011, of which 34% to drugs and devices (9).

COPD diagnosis COPD will be diagnosed based on signs and symptoms (dyspnea, chronic cough or sputum production), medical and family histories, and spirometry (3,10). Currently there are two classification systems of COPD according to the GOLD guidelines. Formerly the severity of the disease only depended on spirometry (table 1). Nowadays the new classification is based on symptoms, airflow obstruction and exacerbation history (figure 1) (3).

1.2 Management of COPD COPD is not curable. The aim of the treatment is on the one hand to ease the symptoms in acute medical situations and on the other hand to slow the progression of the disease, improve the exercise capacity and quality of life (3,11,12). Smoking cessation, exercise and other lifestyle interventions next to the treatment of comorbidity, prevents progression of the disease (3,12).

Pharmacotherapy is mostly added stepwise (12). Chronic use of medication is important to achieve and maintain clinical disease control. Medical treatment at first consists of bronchodilators. With increasing severity of the disease, inhaled glucocorticoids can be added to the initial treatment (3,11-13).

Table 1. GOLD staging of severity of COPD (3) FEV1: forced expiratory volume in one second

GOLD stage

Severity Predicted spirometry (postbronchodilator)

I Mild FEV1 ≥ 80% II Moderate 50% ≤ FEV1 < 80% III Severe 30% ≤ FEV1 < 50% IV Very

Severe FEV1 < 30%

Figure 1. ABCD classification of COPD

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Inhalation medication Inhalation medication is the key stone in the treatment of COPD. Inhaled medication has advantages compared to systemic therapy, because it enables a targeted delivery to the lungs, whereby a low dose is sufficient to achieve beneficial effect and systemic adverse effects are reduced (14,15). In the 20th century, several types of inhaler systems were developed. The most commonly prescribed systems are the pressurized metered dose inhaler (pMDI) and the dry powder inhaler (DPI) (16,17). Less used devices are the soft mist inhalers and nebulizers. Also, spacers can be added to pMDIs (16). Each subgroup of the devices has its own mechanism of action and characteristics (18). Therefore, each system requires its own inhaler technique, which may result in errors (13,14). Despite the existence of many different types of inhaler systems, the guidelines are not clear about what inhaler system should be prescribed in which situation and for which patients(14).

The inhaler technique of a patient determines the amount of medication deposited in the airways, and therefore the effect of the medication on the disease. To deliver an adequate dose to the target organ, a number of steps have to be followed in a certain sequence (19). The pMDI is the most commonly prescribed device in the elderly population (17). The steps of this device are illustrated in table 2 (20).

Table 2. pMDI inhaler steps (ADMIT 2017) Do Don’t

- Take the cap off - Shake the inhaler - Hold the inhaler in vertical position - Breath out deeply - Seal lips around mouthpiece while

opening the teeth - Start to breath in slowly through the

mouth - Activate the inhaler while continuing to

breath in for at least 5 seconds - Hold your breath as long as comfortably - Breathe out - Replace the cap

- Breathe in too quickly - Activate the inhaler before breathing in - Stop breathing in when you activate the

inhaler - Stop breathing when you feel the

medicine your mouth

Healthcare organization in the Netherlands In the Netherlands, various healthcare providers take care of COPD patients. The general practitioner (GP) treats patients with mild to moderate COPD (11). Patients with more severe COPD are referred to the secondary care. Inhaler instruction can provided by GP and GP nurses, by pharmacists and pharmacy assistants and in the secondary care by pulmonologists or (specialized) nurses. COPD patients have a high demand for care, 96% consulted the GP in 2009 compared to 75% of the general population elder than fifteen years, with an average number of consultations of 7.2 towards 5.1 in the general population (21).

1.3 Inhaler technique issues Although inhalation medication is the major way of medication delivery in COPD patients, several studies show that many patients have an incorrect inhaler technique (22). The GOLD report describes that more than 67% of the patients makes at least one mistake (3). The study of Turan et al (2016) has shown that the problem is even higher in elderly (6). In their study 90.2% of the participants used an incorrect inhaler technique (6). One of the problems, for example, is the coordination between pressing the canister and inhalation (16). Another

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common mistake is insufficient breath-holding after inhalation (6,16). In addition, 65.8% of the patients forget to breath out prior to the inhalation (65.8%) (23).

Consequences of poor inhaler technique In order to get full clinical benefit from the inhalation medication, correct use of the inhaler is necessary (19). Incorrect use of the MDI, for example, reduces the medication deposition to less than 20% (15). The GOLD report state that an incorrect technique is significantly correlated with poor symptom control (3). In addition, poor inhaler technique leads to increased pressure on healthcare systems (4). Incorrect use of medication could have negative consequences for the prognosis of COPD patients (5). Consequently it can lead to a lower compliance of patients to inhalation medication (24). Patients that do not notice the efficacy of the medication, are namely less likely to use the medication (14, 24).

1.4 Reasons for poor inhaler techniques

Patient characteristics Patient characteristics seem to correlate with the amount of mistakes in the inhaler technique. Research has demonstrated that females, obese patients, patients with a low educational level and low literacy, tend to have a poorer technique (18,25). Moreover, elderly patients are more prone to make errors in the inhaler technique (3,17).

As previously mentioned, COPD becomes mostly apparent after 50 years of age. This advanced age can entail comorbidities that impede with a proper inhaler technique (26). These disabilities should be taken into account when prescribing an inhalation device. Comorbidities are for example physical changes, like reduced inspiration force, decreased muscle strength of the hands, decreased coordination and vision problems (26). On the other hand, cognitive changes play a role in decreased inhaler technique. COPD patients are often subject to depression or cognitive decline that may reduce their understanding of presented information (25). Elderly patients require more time, especially those with polypharmacy (23).

Multiple inhalers Another determinant of poor inhaler technique, especially for older COPD patients, is the use of multiple devices (3,26). The basic differences of the inhaler systems may be confusing for patients (27). Therefore, it is recommended to prescribe one type of inhaler system to a patient who needs multiple types of inhalation medication. Each inhaler type requires specific instructions for usage, which is complex for both patients and healthcare providers. The pMDI is generally the most prescribed inhaler system in the elderly population (17), while research has shown that most errors were made by patients who used a pMDI (28). International guidelines for the management of COPD do not differentiate between various devices (3).

Patient education Lack of inhaler technique instruction is also a predictor of errors in the inhaler technique (3). Training often results in a more efficient use of inhaler devices (29). This proves the importance of education of the inhaler technique. Most patients overestimate their own technique (17). Therefore, awareness of patients about errors in inhaler technique is important. Like awareness of the importance of proper education.

Follow-up In addition to a proper initial instruction, follow-up of the inhaler technique is important. Also patients with a proper inhaler technique, often lose this correct technique in time (30). Therefore, training sessions should be repeated and the inhaler technique checked at regular

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intervals (29). Patients that were not evaluated in the past year, showed a poorer technique in comparison to patients that received follow-up (18).

Healthcare professionals Research has shown that at least one third of all healthcare providers demonstrated a poor inhaler technique themselves (3,4,31). This already may cause errors at instruction level, whereby patients are misinformed. The lack of knowledge and the poor technique of healthcare providers, probably contributes to poor technique of patients (29).The fact that healthcare professionals are not able to use an inhaler device properly, implies that it is hard to use inhalers in the right way. The wide variety of inhaler systems, makes it difficult for healthcare providers to educate the patient correctly (28). Therefore, training of caregivers is essential. Uniformity of education is important according to the IMIS foundation. The recommended way patients should be educated is listed in table 3 (16).

Communication between disciplines COPD patients have to deal with multiple caregivers, e.g. general practitioners, pulmonologists, nurses in general practice and pulmonary nurses and pharmacists (21). Cooperation between the different disciplines is important to make sure patients are educated in a similar way.

1.5 Effective interventions to improve inhaler technique According to a Cochrane Review from 2016, interventions in order to improve inhaler technique can be roughly divided into a technological level and an educational level (32). This study focuses on educational interventions. This educational level consists of patient education and education of the healthcare provider.

A Dutch initiative is the Inhalation Medication Instruction School (IMIS) foundation. This foundation aims to reach national uniformity and quality of patient education and instruction material. This is done by training healthcare providers and the development of protocols and patient instruction material. For example “de zorgatlas” (figure 2) is developed, with illustrated protocols that can be used by healthcare providers to instruct patients.

eHealth is emerging in many branches of healthcare, also in the field of respiratory diseases. Research has shown eHealth can improve the inhaler technique more effectively than traditional ways of education, such as a written instruction on paper (22). Currently, many multimedia training tools are available, that demonstrate the correct inhaler technique(32). The Dutch Lung Alliance (LAN), a federated association existing of caregivers, patient associations, and insurance companies , developed a website (inhalatorgebruik.nl) where both patients and healthcare providers can watch instruction videos of all available devices and search for information about medication.

Table 3. Important steps in the inhaler instruction consultation Step Action 1 Demonstration of the clinician 2 Exercise by the patient 3 Periodic assessment of the patient’s technique 4 Positive reinforcement for correct inhaler technique

Figure 2. Illustrated inhaler protocol of IMIS

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Inhaler Research Workgroup (IRW) study This study is part of the IRW study. This workgroup, initiated in 2014, consists of a heterogeneous group, for example a behavioral scientist, human movement scientist, respiratory nurse, pharmacist and a pharmaceutical chemist. The general aim of this research group is to improve the inhaler technique of asthma and COPD patients. The study consists of four work packages. In the first work package, learning theories are explored. In the second work package, the meaning of patients and health care providers about the instruction method are explored. Eventually, a new training method will be developed, which will be tested against the current instruction method in a randomized controlled trial.

1.6 Objective & research questions The reason why inhalation medication is not administered properly, and the role of patient education in all of this, is complex. Research pointed out that education is far more important than medical treatment for successful management of chronic airway diseases (33). A proper inhaler technique is vital to attain the maximal effect of the medication, therefore it is important to improve the instruction about inhaler technique.

The aim of this study is to evaluate opinions of healthcare providers about the current way of instructions, so that we can find ways for improvement. Also, patient preferences are analyzed and presented to healthcare providers to see whether ideas of patients are implementable. The following question will be elucidated: What is the meaning of experienced healthcare providers concerning the current inhaler instruction method and how can this method be improved in their opinion? The main question is divided in several topics:

- Problems and possible solutions of the current instruction method - Training of professionals about inhaler instructions - Communication between healthcare providers - eHealth applications

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2. Methods To answer the main question, a combination of qualitative and quantitative research is applied. The study consists of three parts. In the first two parts a qualitative approach was used to explore the opinion of different participants toward inhaler instruction. In the first part data, from patient interviews was analyzed, and the results were used in the second part of the study. In the second part, also a qualitative study, the opinion of healthcare providers about inhaler instructions is examined by performing a focus group. In the last (quantitative) part of this study, triangulation of the results of the focus group took place. To achieve this, a questionnaire was compiled and distributed among a large group of healthcare providers. Below, more details of the three parts of this study are described.

Preparation Prior to this study I have taken several steps to learn more about inhaler instructions and the role of healthcare providers in all of this. A symposium about obstructive lung diseases in the UMCG was visited (organized by the allergy and asthma center of the pediatric hospital). The asthma/COPD (AC) service, an integrated care service, was visited to see how the inhaler instruction and follow-up of patients is organized. In addition, a respiratory nurse of the Martini Hospital Groningen demonstrated the way patient education is carried out and explained differences of various inhaler devices. The research meetings of the IRW group were attended. The study design was presented at the Groningen Research Institute for Asthma and COPD (GRIAC) meeting to get new input of researches of other disciplines. Also, an abstract was submitted to the CAHAG (COPD astma huisartsen advies groep) conference, were I presented the results of this study at the end of January.

2.1 Part one: Patient study Before the onset of the study with healthcare providers, I participated in the analysis of a former study. In the last two years, 35 COPD patients participated in semi-structured in-depth interviews. These patients were asked, among other things, about their experiences with the inhaler instruction they received and their opinion about this instruction.

During this study, a part of the analysis of the patient study was completed. I have assisted writing down the data of the interviews and the coding comparison procedure. The results of the patient study were of interest of the focus groups, because it is important to know whether the ideas and wishes of patients can be implemented according to healthcare providers.

2.2 Part two: Focus group

Design To investigate the opinion of healthcare providers towards inhaler instructions, a focus group was performed. A focus group is a form of qualitative research in which a group interview is performed to generate data (34,35). In this group interview, participants discuss about a certain issues to obtain new knowledge about a topic. This research method is especially useful when you are interested in peoples attitude, experiences and needs (35). To get a broad view of the current way of inhaler instructions, in this study healthcare providers of various disciplines were invited to participate. In this way the problem was illuminated from different perspectives. The opinion of healthcare providers can lead to new hypotheses about a new inhaler instruction method. The discussion went on untill saturation was reached. To increase the comprehensiveness and credibility of the study, the consolidated criteria for reporting qualitative studies (COREQ) guidelines were followed (36). This includes a checklist to consult during the preparation of qualitative research.

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Participant recruitment To expose the meaning of healthcare providers of various disciplines, a heterogeneous group of caregivers was recruited. In particular healthcare providers with high affinity on inhalation medication and/or patients with obstructive lung disease were approached. A total of 15 possible candidates were approached.

To recruit participants, healthcare providers were contacted by telephone to explain the purpose of the study. When they reacted positively, an invitation mail was sent (Appendix A). Eventually, nine healthcare providers were participating the focus group (table 5). All participants are experienced professionals, which means they are specialized in inhaler technique and inhaler instructions.

All participants gave written informed consent and signed for permission of audio and video recordings of the meeting. The study was approved by the medical ethical committee (METc) of the UMCG. The study is not covered by the Medical Research Involving Human Subjects Act (WMO) (Appendix B). Ethical approval, therefore, was not necessary.

Questionnaire participant characteristics To identify the participants’ characteristics and the background of their current way to instruct patients, the participants received an online questionnaire prior to the focus group meeting (Appendix C). A computer software program (Qualtrics, Provo, UT) was used to compile the questionnaire. The purpose of this survey was to get an idea of the current educational conditions and, therefore, save time during the focus group meeting. The data of the questionnaires will be analyzed by using SPSS, version 22.

Themes and subthemes Prior to the focus group meeting, an interview schedule (Appendix D) was developed. A brief summary of the themes that were discussed is listed in table 6. Most themes were discussed verbally. The last theme was constructed in a different way. In this part, participants had to state whether they agreed with the ideas of patients (as resulted from the patient interviews, part one of this study). Participants were asked to write down on a post-it what are advantages and disadvantages of the patient’s ideas. Post-its than were placed at a flipchart with a corresponding theme (table 6, results of patient interviews). Afterwards, the different opinions were discussed in the group. The advantage of this format is that the input of every participant is discussed.

Table 4. Participants of focus group Caregiver ID number

Function Addition

1 General practitioner Specialized in COPD care 2 Nursing consultant IMIS trainer 3 Nurse practitioner IMIS trainer 4 Pediatric nurse IMIS trainer 5 GP nurse Academic general practice 6 Pharmacist Dutch Service Pharmacy 7 Pharmacist assistant Special interest pharmacy 8 Laboratory assistant A/C service 9 Laboratory assistant A/C service

Table 5. Themes discussed during focus group Theme Topic 1 Current instruction method 2 Training of healthcare providers 3 Communication between healthcare

providers 4 eHealth 5 Results of patient interviews

1. Instruction video 2. Explanation of the different steps in the

inhalation process 3. Instruction of (GP) nurse

4. Annually assessment of inhaler technique 5. Practice and feedback in every

consultation

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Setting focus group The focus group took place in November 2016, in a neutral environment outside the hospital/ healthcare center. The participants gathered in the evening. To take care of a cordial ambiance, first a meal was served. After this meal the focus group interview started. The meeting took approximately three hours with a short break in between. The data of the focus group was video and audio recorded.

Interviewer characteristics The focus groups was moderated by drs. E.I. Metting, PhD candidate. Further two medical students contributed at the focus group meeting. I performed PowerPoint presentations and participated in the discussion. The other student was present to assist the meeting.

Data analysis The data of the focus groups was analyzed by transcribing the audio recordings verbatim. After transcribing, the data analysis was conducted using the software NVivo, version 11 pro. First a coding tree was developed to categorize and abstract the data. The data of the interview was coded thematically in interview topics of the focus group. First, main codes were applied, later, the main codes were subdivided into sub nodes. To increase the scientific reliability the data was coded by two reviewers. Afterwards a coding comparison took place. To reach consensus, the differences were discussed. Hence certain parts were adjusted to other sub nodes.

2.3 Part three: Triangulation questionnaire After analyzing the data of the focus groups, triangulation took place. An online questionnaire was compiled (Appendix E) to increase the scientific validity of the focus group. The questionnaire was developed in co-operation with another medicine student, working on a similar project. The questionnaire tested whether the outcomes of the focus group were generalizable among a large group of healthcare providers. Therefore the main findings of the focus group were included in de questionnaire. Participants were asked to indicate how much they agreed with certain statements. The questionnaire is divided into three parts (table 7). The questionnaire was generated using Qualtrics software. Three slightly different questionnaires were set up, to fit with different groups of healthcare providers that were approached. The differences between the questionnaires are described in appendix E.

The goal was to recruit at least 50 respondents. The members of the IRW and the participants of the focus group helped with the distribution of the questionnaire. Furthermore the district consultant of the pharmacists association was asked to send the questionnaire to pharmacies. The University Network of Geriatrics (UNO-UMCG) distributed the survey amongst caregivers of nursing homes.

Table 6. Components of the questionnaire

Part Topic 1 Participant characteristics 2 Meaning of current instruction 3 Ideal instruction method

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The online link to the questionnaire was open for four weeks. Analysis comprised descriptive statistics for closed questions by means of SPSS version 22 and management of textual data. Because this study focuses on the opinion of experienced healthcare providers, participants that give daily or weekly inhaler instructions were included in the data analysis.

2.4 Simultaneous examination Simultaneous to this study a similar study, is carried out by another medical student. This student participated in the analysis of interviews of patients with asthma instead of COPD. The other student organized a focus group with regular healthcare providers, which means these caregivers have to deal with pulmonary patients but are not specialized in care for this target group. And, in addition, in the simultaneous study the results of the questionnaire were analyzed from participants that give rarely inhaler instructions.

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3. Results

3.1 Part one: Patient study In this section the main results of the patient interviews will be described.

Instruction content Patients want to get the ability to practice the inhaler technique in front of a healthcare professional and they want to receive feedback on their technique. Especially younger patients would like to know the reason why they have to take certain steps when inhaling their medication. They also would like to get background information about the disease. Older patients are less in favor of this extra information.

Follow-up Follow-up of the inhaler technique is important according to patients. Recent diagnosed patients did receive inhaler instruction and follow-up. Patients suffering from COPD for a longer period, often did not receive follow-up on their inhaler technique. Follow-up should be once a year according to patients. Patients prefer accessible care, close to home, like the general practice. They would rather not go to the hospital for a new appointment about inhaler instruction. Unfortunately, patients were unhappy about the instruction they received in the pharmacy.

Instruction tools Patients generally do not read the instruction package inserts at home to get information about inhaler technique. They would appreciate it, however, to get a concise manual to read it over again at home. This manual has to be clear, with pictures and easy to understand. The inhaler process should be listed step-by-step on this manual.

Group instruction With respect to younger patients, elderly patients were more positive about group instructions. This was not suggested by patients themselves. When this was mentioned by the researcher however, patients responded positively toward group education.

eHealth Most patients were not aware of the existence of instruction videos and they are in favor of a video instruction. The instruction videos of “inhalatorgebruik.nl” were clear according to the patients. While watching these videos, most patients observed new information. In comparison to younger patients, older patients would not visit a website or mobile application to search for information about the medication or the disease.

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3.2 Part two: Focus group

3.2.1 Participant characteristics questionnaire Prior to the focus group meeting, participants received an online questionnaire about the current instruction situation. The results of this questionnaire are listed in table 8. The GP and pharmacist indicated that they currently do not give inhaler instruction. The GP refers patients in need of inhaler instructions to his GP nurse. The pharmacist is currently not engaged in the pharmacy, but he is among other things engaged in the management of the IMIS foundation.

The duration of the instructions vary from less than 5 minutes up to 15 minutes. Among children the time dispersion is bigger, up to 30 minutes is spend on inhaler instructions. Different instruction tools are used in teaching inhaler technique, especially placebo’s are widely used (77.8%, n=7). Inhaler instruction always (100%, n=9) takes place in a consultation room.

Half of the participants (55.6%, n=5) always demonstrate the inhaler technique to patients. Patients get the ability to practice most of the time, participants always give feedback to patients about inhaler technique. Participants keep their knowledge about inhalation medication up to date most of all via training sessions. All the participants are trained about inhaler technique in the last five years, most of all by the IMIS foundation. Other ways to obtain knowledge is by colleagues, medical sales representatives, internet or literature.

Table 7. Characteristics healthcare providers N=9 n (%)

Participating caregivers GP

GP nurse Pharmacist

Pharmacist assistant Respiratory nurse

Pediatric nurse Laboratory assistant

1(11.1%) 1(11.1%) 1(11.1%) 1(11.1%) 2(22.2%) 1(11.1%) 2(22.2%)

Frequency of instruction Monthly Weekly

Daily No instruction

2 (22.2) 2 (22.2) 3 (33.3) 2 (22.2)

Patient category Children

Adults Elderly

7 (77.8) 8 (88.9) 6 (66.7)

Duration of instruction (minutes)

0-5 5-10

10-15 15-30

Children

3 (33.3) 2 (22.2) 1 (11.1) 1 (11.1)

Adults

3 (33.3) 2 (22.2) 3 (33.3)

0 Instruction tools

Pictures (Dutch: zorgatlas) Protocol/checklist (IMIS)

Package inserts Instruction video

Placebo No instruction tool

3 (33.3) 5 (55.6) 1 (11.1) 1 (11.1) 7 (77.8) 1 (11.1)

Demonstration inhaler technique

Always Occasionally

Never

5 (55.6) 4 (44.4)

0 Practice by the patient

Always Occasionally

Never

6 (66.7) 2 (22.2) 1 (11.1)

Ways to acquire knowledge Internet

Colleagues Literature Training

I do not acquire knowledge

3 (33.3) 6 (66.7) 4 (44.4) 7 (77.8) 1 (1.11)

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3.2.2 Part two: Focus group meeting In this section, the results of the focus group will be presented. The data of the focus groups is coded based on interview topics and this resulted in a coding tree (appendix F). The main results of the focus group are summarized and illustrated by quotes of the participants. Appendix G lists the original Dutch quotes. The following chapters are divided based on themes in the interview schedule and subdivided into the topics of the coding tree. The last theme of the interview schedule (implications of the patient study) will not be discussed separately, but as part of the corresponding topic.

Theme 1: Current and desired instruction method Different subjects will be described that are covered in the inhaler instruction as emerged in the focus group.

Demonstration, practice and feedback Most participants of the focus group demonstrate the inhaler technique and give patients the opportunity to practice the technique during the consultation. According to patients, in every consultation patients should get the ability to practice and get feedback about their inhaler technique. Participants of the focus group fully agreed with patients about this topic:

“Practicing is essential and immediate feedback provides the best results.”

The only problem could be the time factor. Funding to make time available needs to be organized by the insurance company. Group instruction would be a possible solution to cover this problem. Demonstration is an important part of the inhaler instruction, but it was mentioned that demonstration by a doctor is no instruction, because physicians are often not aware of the operation of the devices. Furthermore, physicians have less time and when time is scarce, practicing by the patient is more important than demonstrating.

Instruction tools Most participants use placebos when they instruct patients. Further, the IMIS protocols (Dutch: Zorgatlas) are being used. It would also be helpful to hand this protocol over to patients, to read it over at home. On the protocol the caregiver than can add notes to areas of concern, so that the patient is aware of potential errors. When the patient takes this protocol to the next caregiver, another caregiver is directly aware of the errors of the patient.

Explaining of the reason of different steps in the inhaler process According to the participants of the focus group, it is essential and indispensable to explain the different steps of the inhalation process. When someone knows the reason behind the different steps, they are more easy to remember and it is more likely they are executed. There was mentioned, however, time is often a limiting factor why the steps are not explained. However, when a patient understands the different steps, this probably can save time on the long term. A possible solution for the lack of time could be the development of a new kind of instruction video, in which inhalation technology is explained. Too much information during the first instruction will not benefit the knowledge of the patient. Therefore, it would be useful to watch a video at home.

Things that really make sense, like pulling off the cap, do not need further explanation. Some items, like shaking the device, body position, exhaling, holding-breath after inhaling and managing of the device, are not self-explanatory. Some participants only explain steps in the inhaler process that were incorrect.

Nurse: “I try to focus… when the patient demonstrates the technique, on the way he or she inhales [the medication] and, in particular, give additional education about incorrect steps.”

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Learning the reason behind the different steps, or in other words, learning about inhaler technology, is complicated. For an average caregiver, this takes a lot of time.

IMIS trainer: “Many instructors do not understand why certain steps need to be followed.”

Explaining the background of the disease and medication Patients receive too little information about their disease. It is important to explain the reason why medication is prescribed. When patients are aware of the importance, they will be more motivated to inhale in a correct way.

GP: “Within primary care, relatively little information is provided… And when I have no information about my medical condition, I won’t take medication myself.”

The experience is that many patients did not receive education about their disease, or they don’t remember what was told.

Pharmacy assistant: “and when you ask the patient, well…” Nurse: “they do not know.” Pharmacy assistant: “at least half of the patients aren’t aware of the disease they have.”

Duration of instruction and lack of time According to the healthcare providers of the focus group, the duration of an inhaler instruction should be about fifteen minutes in general. Nurses have generally enough time for inhaler instructions. In the pharmacy the time spend to instruction depends on the activity in the pharmacy. If it is crowded, less time is spend on inhaler instruction. Also at the A/C service little time is left for inhaler instructions. GP: “The major problem is: basically there is no time and money available for inhaler instruction. It is not included in any care program.”

Follow-up of inhaler technique The patient interviews revealed that patients would like to have an annual assessment of their inhaler technique. Healthcare providers partially agreed with this view.They believe that follow-up should occur at least once a year, but should initially be more frequent. After the first instruction, the follow-up should take place within two weeks. The feasibility in practice is doubtful, though, due to financial reasons. GP: “In many cases, the second inhaler instruction takes place one year after the first consultation.” Nurse: “There is too much time in between.” GP: “Exactly, there is too much time in between.” Pharmacist: “Repetition should actually already be done after two weeks, huh, because than errors can still be corrected.” During the focus group, it was mentioned by nurses that in their experience patients need about three consultations before they master the technique. When a patient has a correct technique, follow-up should take place annually. In the course of time, the frequency of evaluation can be adapted, depending on the inhaler technique of patients and their disease control.

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Who is responsible The patient interviews revealed that some patients had a bad experience with the instruction they received in the pharmacy. Some received inhaler instruction over the counter in the pharmacy. Patients indicated therefore that they would like to be instructed by a GP nurse or respiratory nurse. Healthcare professionals do not fully agree. They believe that although it is convenient that nurses give inhaler instruction, they think the pharmacy is an important link in the process as well. Every caregiver that has to do with pulmonary patients should be able to give inhaler instructions, and should be well educated.

Different devices The selection of a correct device is customization. When patients receive several types of medication and therefore need multiple devices, it is important these devices fit together. Prescribers often do not know the devices and combine devices that do not match. Respiratory nurses are more aware of the suitability of a device for a patient than physicians.

Issues related to inhaler instruction and inhalation medication It was mentioned that GPs and other healthcare providers assume that patients get inhaler instruction at the pharmacy at medication dispensing. The pharmacy assistant, however, explained that the instruction in the pharmacy is not organized properly. For example, when it is busy in the pharmacy and patients are waiting in line, the inhaler instruction will be rushed.

A solution could be to schedule appointments with patients that require inhaler instruction and on the other hand to designate an employee in the pharmacy with expertise of inhalation medication that is responsible for the education of patients.

Nurse: “It would be a good solution to appoint a nurse in the pharmacy who is responsible for inhaler instruction.”

Patients should not receive more than one inhaler, because this will not benefit the inhaler technique. Different inhaler devices have different ways to handle the device. This is confusing for patients and errors will be made more easy.

Insurance companies & preference policy It often happens that caregivers have given instructions about a device prescribed by the physician but then another device is dispensed in the pharmacy. The active substance is the same, but the device by which the medication is administered, is different. Patients return to the caregiver with complaints. They were converted to another device in the pharmacy, but did not receive instructions. This problem is partly due to the pharmacy, that get discount on certain devices, but also by insurance companies that apply the preference policy. This is very frustrating for both patients and caregivers. Besides, it may actually increase the economic burden of the disease, e.g. by hospitalization of a formerly stable patient. Moreover, this is counterproductive. Insurance companies invest in inhaler instruction and as a result of their preference policy, more instructions are needed.

Nurse: “The insurance companies determine in the end which device the patient receives, while you choose this very carefully.”

Theme 2: Training and retraining of healthcare professionals During the focus group meeting the importance of well trained professionals was discussed.

Opinion about content and ideas for improvement During retraining, various topics have to be incorporated according to the different healthcare providers in the focus group. Too many new topics should be avoided. The purpose of

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retraining is to refresh knowledge about inhaler technique. Because many caregivers have an incorrect inhaler technique themselves, it is important they get the opportunity to practice at the retraining. To transfer the information to the patients, they have to master the technique themselves.

IMIS trainer: “Therefore, I say: keep practicing at the IMIS training. Practice, practice, practice!”

Transparency of the caregivers is important at trainings. They must feel free to admit mistakes and the lack of knowledge and should be open for criticism.

IMIS trainer: “What you see in patients is what you see in practice nurses and I suppose respiratory nurses as well: they think they know”

GP: “If the instructor already has a poor technique.. then it is quite difficult, of course, for patients to get it right.” Furthermore, it is important that healthcare providers know the reason of the different steps of the inhaler technique and the technology of the device. Learning to recognize incorrect inhaler technique. Also, it was mentioned that it is important for patients to get a uniform instruction from different healthcare providers. Patients should get the same explanation in the pharmacy and at the general practice.

Frequency of training Nowadays, there is no obligation to repeat the IMIS training sessions. During the focus group, it was mentioned that annual training of professionals is preferred. Besides, it was suggested that a certificate should be introduced for trained professionals who have sufficient experience with inhaler instructions. General practices where qualified professionals are employed should get a quality mark.

Pharmacy According to the pharmacy assistant, new employees in the pharmacy are not trained about inhaler instructions, but the way to instruct patients is explained by colleagues. She told us that patient instructions in the pharmacy are not uniform and of poor quality. This, while most other healthcare providers, such as the GP and the GP nurse, assume that proper explanation is given in the pharmacy. Pharmacy assistant: “Training in the pharmacy could be better”. Respiratory nurse: “Is it poor?” Pharmacy assistant: “Yes, it is really poor.”

Theme 3: Communication between healthcare providers The focus group has revealed that there is little communication between healthcare providers about patients concerning their inhaler technique. In the general practice, for example, the GP and GP nurse assume that at the first medication dispensing inhaler instruction is given in the pharmacy. There is no communication whether this really has happened. Also, laboratory assistants of the AC service report when patients have an incorrect inhaler technique. This information, together with spirometry results, is sent to the pulmonologist and afterwards to the GP. With regard to the information of the inhaler technique, the GP told that this information is not addressed in the GP.

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GP: “Yes, than the administrative processing is arranged well, and that is very nice, but the patient will not benefit from this.” Laboratory assistant: “Why not?” GP: “Well.. because, then it is noted in the computer…” Nurse: “Not in an action list” A possible solution for the communication problem professionals suggested to develop a collective system to score findings. Different caregivers have to make better arrangements about who does the assessment and when.

Theme 4: eHealth The participants of the focus group believe that COPD patients are not a group of patients that are in favor of eHealth, because of their age. This will probably emerge in the future, because the use of internet among elderly is rising. Furthermore, it was mentioned that the group of COPD patients is getting younger. Apps & games Participants of the focus group think apps will be used in the instruction in the future. Younger patients are more willing to use apps or games. Pharmacists develop apps, but it is difficult for caregivers to evaluate the quality of these apps. Nurse: “I do not know a proper app to recommend to my patients.”

Instruction videos & webpages Patients appreciated to watch a video instruction during the consultation. Healthcare providers have a different opinion about this. They think it is a waste of time to watch videos during the consultation. The base of the instruction should be face-to-face education. Video instruction can be added when enough time is available, but not instead of face-to-face instruction. The webpages: inhalatorgebruik.nl and thuisarts.nl are often recommended to patients. Another option was mailing a link to patients to access a suitable video, provided the webpage is reliable. The task of the caregiver is to draw the patient’s attention to the existence of websites, but the GP emphasized that patients have an individual responsibility to visit these websites.

GP: “I think, in fact we have to guide people, by saying: you just have to look on the internet... At the moment this is too open-ended. It is too easy to get an inhaler instruction and, ehh, just sit back and do nothing, patients also have their own responsibility.”

Video consultation Video consultation, whereby the inhaler technique of a patient itself is being filmed, could also be a future solution, to make follow-up more accessible. This should also lower the number of visits of the patient. Also, the consultation can be recorded on the smartphone, making it possible for patients to listen it again at home. Video consultation could be supplementary to face to face instruction. It is important, though, that the initial instruction is face to face. Follow-up appointments can eventually be scheduled by means of video consultation. This might also work for patients who get their medication delivered at home. However, the downside is that these patients are often ill patients. This is a group of patients that needs special attention.

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11%

60%

11%

10% 8%

Regular nurse

Respiratory nurse

Pediatric nurse

Specialized nurse

GP nurse

Figure 4. Subdivision of different nurses N=72

3.3 Part 3 - Results Triangulation questionnaire Out of 235 respondents that answered the questionnaire, 93 were experienced in inhaler instructions, which means they give daily (51.6%, n=48) or weekly (51.6%,n=52) inhaler instructions. Table 10 lists the demographic characteristics of the respondents. Nurses, a group that makes up the majority of respondents, can be subdivided according to function (figure 4). Most respondents (93.5%, n=87) are trained to give inhaler instructions. The majority is trained by the IMIS foundation, other respondents are trained during their education, also the Foundation of Specific Education for Nurses (SSSV) was mentioned. 47.2% (n=34) of the nurses that responded is connected to the IMIS foundation to train other caregivers.

Current and desired way of instruction In the following section, the most important results of the questionnaire are summarized. A more detailed overview of the results is listed in appendix H.

In 80.7% (n=75) of the cases inhaler instruction takes 5-15 minutes. The majority (64.5%, n=60) is satisfied with the time available for instructions. Half of the respondents (49.5%, n=46) always demonstrate the inhaler technique to patients, 98.9% (n=91) indicates demonstration is significant. Patients get the ability to practice in 86% of the cases (n=80) and receive feedback during the consultation in 95.7% of the time (n=89), 100% of the respondents (n=92) indicates that instruction is significant.

Moreover, practicing by the patient and feedback on inhaler technique, is indicated as significant by even more participants, both 92.4%. The same applies to explanation about the different steps in the inhaler process, 89.1 of the respondents thinks this is important. Watching an instruction video is considered to be less important, 53.3% of the respondents marked this point as potential necessary.

Follow-up of inhaler technique More than half of the respondents (51.1%, n=47) agrees that there is too much time in between the first instruction and the follow-up of the inhaler technique. 77.2% of the respondents (n=71) agree that the first assessment should take place within two weeks after the instruction.

Table 8. Demographic characteristics of the participants

Characteristic N (%) Sex Male Female

11 (11.8) 82 (88.2)

Age (years) < 30 30-40 40-50 50-60 >60

2 (2.2)

10 (10.8) 32 (34.4) 42 (45.2)

7 (7.5) Function GP Pulmonologist Nurse Pharmacist Pharmacy assistant Laboratory assistant Nursing home assistant

1 (1.1) 2 (2.2)

72 (77.4) 5 (5.4) 5 (5.4) 7 (7.5) 1 (1.1)

Organization General practice Hospital Asthma/COPD service Pharmacy Nursing home Home care Other

15 (16.1) 43 (46.2)

6 (6.5) 10 (10.8)

1 (1.1) 9 (9.7) 9 (9.7)

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Pharmacy The pharmacists received a different questionnaire than the other caregivers. The following part is only answered by the pharmacists/ pharmacy assistants, therefore, the sample size is small (N=9). The majority of the respondents (88.9%, n=8) agreed that it should be possible that patients make an appointment in the pharmacy to get inhaler instructions. None of the respondents agrees with the idea to appoint a practice nurse in the pharmacy that is responsible for inhaler instruction.

Training of healthcare providers To the statement that training should be mandatory among healthcare providers 95.6% (n=86) of the respondents agree, 76.7% (n=69) think the trained professionals should be rewarded with a certificate. Also, 85.6% (n=77) agree with annual repetition of the training. The questionnaire revealed that most participants (82.2%,n=74)) would like to get information about inhalation technology of the devices during the training session. Repetition of elder devices they prefer less (38.9%,n=35). In the questionnaire was room for additions about desired content of training. This pointed out that participants would like to learn about insurance policies. Communication with other caregivers and patients would also be an idea of training. Furthermore, ways to promote medication adherence and common mistakes in the inhaler technique per device, should be featured during the training.

Communication between healthcare providers Because the focus groups pointed out that the participants were dissatisfied about the communication between healthcare providers, this topic was considered again in the questionnaire. The questionnaire showed that respondents are moderately satisfied about the communication among caregivers. 88.4% (n=76) of the respondents agreed with the statement that there has to be more communication between different healthcare providers about asthma and COPD patients. Dissatisfaction is the highest about communication of medication adherence (41.3%, n=38) and the possibility to alert each other about errors (40.2%, n=37).

Respondents would like to communicate with other caregivers about medication adherence (90%, n=81) and the effect of the medication (81.1%, n=73), the suitability of the device for the patient (87.8%, n=81) and whether assessment of the patients inhaler technique took place (84.4%, n=76) and what kind of errors were made by the patient (77.8%, n=70).

eHealth eHealth is used by 66.7% (n=62) of the respondents when instructing patients. Instruction videos and websites are the most applied forms of eHealth in practice (90.3%, n= 56 respectively 80.6%, n=50). Apps are not widely used and games are not used at all.

Respondents were asked via an open ended question whether they had new ideas for eHealth applications that could benefit the inhaler instruction. Video consultation was mentioned several times, with the advantage that the patient does not have to travel to the hospital and the accessibility of professionals increases. Also apps for patients who do not speak the Dutch language was suggested. It was also stated that the quality of the instruction videos need to be improved and the various videos have to be unambiguously. A frequent desire was the developing of a counting system on the device coupled to an app, which gives patients a sign when the device is empty. Another idea was to show videos in the waiting room or at the bedside of the patient. The combination of eHealth with patient portals was another option. In spite of the advantages of eHealth, it was mentioned that personal communication between a healthcare provider and a patient remains crucial.

Financial aspects of inhaler instruction Respondents were asked how often they have to deal with certain situations concerning the financial aspect involved in inhalation medication. The preference policy is causing regularly

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that patients receive another device than prescribed in 75% of the respondents (n=66). This hinders the patients specific choice for a device frequently in 76.1% of the cases (n=67). How often the financial situation of the patient is taken into account while selecting a device, is more widespread. Patients rarely refuse a device because of their financial situation.

Monitoring in the primary care The contribution of the primary care in the monitoring of inhaler technique should be extended according to 72.5%, n=66) of the respondents. The respondents indicated that training of healthcare providers in primary care than should be improved. Now, knowledge is insufficient and they are not aware of the national protocols. There should be more communication between the general practice and the pharmacy.

Suggestions of respondents Finally, an open ended question was asked, in which participants could give suggestions for improving the inhaler instruction method. In this paragraph these answers will be summarized. Many ideas of the respondents were already discussed in the other result section, these ideas are not mentioned again.

It was suggested that it would be better if placebo devices do not contain gas or powder at all. Some caregivers cannot demonstrate the inhaler technique to patients, because they get airway symptoms by demonstration the placebos to patients.

A protocol should be generated in order to facilitate the selection of a device. The pharmaceutical industry have to be convinced that each device needs a counting system.

In the pharmacy the assistant has to give inhaler instruction at every medication dispensing, also at repeat prescription. The pharmacy should have a prominent role in the care of asthma and COPD patients. Data showed, however, that the instruction in the pharmacy is inadequate. Therefore, pharmacy assistants should be trained in giving inhaler instruction. It should be better when inhaler instruction is not covered by the ‘own risk’, because then patients are more open to receive instruction. The pharmacy should communicate to the caregiver when the patients receives another device than prescribed.

Finally, perhaps eHealth can be used to improve communication between different caregivers.

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4. Discussion

4.1 Main findings The aim of this study is to find out more about the opinion of healthcare providers concerning the instructions of inhaler technique, in order to form hypotheses to improve the current instruction method. In this section the main results are summarized.

The duration of the inhaler instruction is mostly 5 to 15 minutes. Most caregivers are satisfied with the available time. The participants of the questionnaire agreed with the participants of the focus group that above all practicing of the inhaler technique and feedback is the most important during the inhaler instruction. In addition, explanation about the different steps in the inhalation process is important. Demonstration of the technique is less important according to the respondents of the questionnaire. The respondents of the questionnaire agreed that there two weeks between the initial instruction and the first evaluation of the technique. Furthermore, the frequency of the evaluation should be adapted to the patient’s needs, but even patients with a correct technique should be evaluated once a year. Instruction of various caregivers should be uniform.

The questionnaire showed that most caregivers are trained to give inhaler instruction. However, there is no obligation to repeat this training. The respondents of the questionnaire agreed with the participants of the focus group that training should be mandatory and repeated annually. Also, the respondents agreed about the idea to introduce a certificate for trained caregivers. The participants of the focus group think that the training should be a course to refresh knowledge about devices and practice inhaler technique. The respondents of the questionnaire, on the other hand, would especially like to be trained about new devices, and repetition is in their opinion less important.

The most applied types of eHealth are instruction videos and websites. The respondents of the questionnaire are satisfied with the quality and accessibility of instruction videos and websites. Although the fact that the amount of apps is expanding, apps and games are not widely used. This could probably be because caregivers have no clue about which apps are suitable. Therefore it is necessary that apps are developed by an approved authority. Apps and games will probably play a more important role in the future.

Improvements can be made in the communication between healthcare providers. Respondents of the questionnaire were dissatisfied with the communication between different caregivers about inhaler technique. They desire more communication about medication adherence, whether the device fits the patient, whether evaluation of the technique found place, and about the inhaler technique of the patient. A possible solution for the communication issue would be to develop an electronic patient file that is accessible by both the pharmacist as the GP. Also the roles of the various caregivers should be discussed during the pharmacotherapeutic consultation (FTO).

A common problem is that patients are instructed about a particular device, but receive another device in the pharmacy because of the preference policy. This regularly interferes with the patient specific choice for a device also emerged from the questionnaire. Prescribers should be more aware about the preference policy in order to obviate this problem.

The employees of the pharmacy agreed with the idea that patients should make an appointment to receive inhaler instructions in the pharmacy. There was less consensus about the idea to appoint a nurse in the pharmacy responsible for the inhaler instruction. Most of the respondents agreed that more time should be provided for inhaler instruction in the pharmacy. The respondents agreed that clear agreements in FTO’s are necessary about who is responsible for the inhaler instruction.

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4.2 Comparison with existing literature As far as we know, this is the first study in which the opinion of healthcare providers about inhaler instructions is explored. It will be described whether the outcomes of the study are comparable with previous research.

It has emerged from our investigation that systematic education is needed to improve inhaler technique of patients. First came forward that the caregiver has to demonstrate the technique. Previous research has indeed expelled that the demonstration by the caregiver is more effective than written/verbal advice (37). According to the participants of our study, practicing and feedback is even more important than demonstration of the technique. Our study also indicated that it is important that patients receive information about the disease and background information about the medication. A randomized controlled trial performed in a Dutch general practice, pointed out that patients that where informed by a GP assistant had a significant better inhaler technique than patients that where only informed about their disease by the GP, because they received more information (38). Moreover, when patients understand the reason why they need to take the medication and they know what to expect about the benefits and potential adverse effects, this will benefit the acceptance of the device (25).

The healthcare providers in this study agreed that instruction by different caregivers should be uniform. A previous study showed that patients treated in a group practice made more mistakes while inhaling the medication (39). The researchers reason that the patients received different explanations. This emphasizes the importance of a uniform instruction. When instructors are all trained in a similar way and follow guidelines, uniform instruction will be reached and this will benefit the technique of patients. Continuity of care is very important, especially in chronic diseases, such as COPD (40).

In our study, healthcare providers agreed that the inhaler technique should be evaluated annually, even for patients with a proper technique. These findings are consistent with previous studies that showed the inhaler technique should be repeated in follow-up visits (41). This is because some patients forget the proper technique in the course of time and new errors are introduced (41).

This study revealed that the evaluation of the technique should be more soon after the initial instruction. Former research showed that three days after successful instruction, more than one-third of patients no longer use their DPI correctly (29). In addition this research showed that patients that received inhaler instructions at least once more after the initial instruction have better inhaler technique compared with those who received a single inhaler instruction at the time of prescription (29).

Nurses that were present during the focus group indicated that, on average, they need three instruction sessions to reach an errorless inhaler technique in their patients. This is confirmed by prior research that indicated that only 24% of the patients achieved an errorless technique after one education session and 97% of the patients had a proper technique after three sessions (37). This emphasizes the importance of multiple instruction sessions.

IMIS trainers in the focus group indicated that they often see caregivers with incorrect inhaler techniques in training sessions. Research confirms that at least a third and in some cases all caregivers have an incorrect inhaler technique (3,31). Education of healthcare professionals significantly improves the inhaler technique of patients (29). General textbooks used during the education of caregivers, often fail to include basic information about how to use inhaler devices (25). This emphasizes the importance of additional training sessions.

Our study revealed that healthcare providers have the opinion that patients should only use a single design of device. Also, other studies have revealed that simultaneous use of different types of devices is predictive of errors in inhaler technique (42). In addition, patients with multiple inhalers have a lower adherence (42).

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4.3 Strengths and limitations A strength of this study is that different instruments were used to answer the main question. First, the general ideas of healthcare providers about inhaler instruction were explored, later, these ideas were presented to 93 caregivers to explore if they agreed with these results. The results of the questionnaire corresponded with the results of the focus group. Therefore the expectation is that the results are generalizable among caregivers in the Netherlands.

By including healthcare providers of various disciplines, the opinions of a representative of caregivers involved in care for COPD patients could be explored. This gave a broad view to the main topic. Moreover, the focus group meeting offered the opportunity for caregivers of different disciplines to communicate with each other about the problems they face in practice and to gain insight in the activities of colleagues working in other disciplines.

The professionals that were present during the focus group and answered the questionnaire were experienced healthcare providers, specialized in inhaler technique and instructions. Therefore it is possible that the perspective of some caregivers are not covered in this study. Meanwhile, all participants were well-informed about important topics concerning the care of COPD patients and it can be assumed that they gave a reasoned reply.

No pilot focus group meeting was organized about this topic. The moderator of the focus group is experienced, though. She moderated several other focus groups and knows how to deal with group discussions.

4.4 Future questions and implications This study proved that there is room for improvement in multiple problems that patients and caregivers face with the instructions of inhaler technique. Improvements can be made in the content of the instruction itself and in the organization of the instructions. Caregivers should follow guidelines if instructing patients, to make sure there is uniformity in the instruction. It would be helpful when more clear guidelines were developed about the content of the inhaler instruction. In addition, it would be a good idea to develop a certificate for caregivers that follow annual trainings sessions. In the most ideal situation, follow-up should be within two weeks after the inhaler instruction. In the future, follow-up can be realized by means of video consultation. It might be beneficial when an inhaler technology video is developed. This video can be viewed by patients in their home situation. This has to advantages, it is important on the one hand that patients do not receive too much information during consultation. On the other hand, it could save time during the consultation. More communication between caregivers is essential. In primary care, this would be realized by means of FTO’s. Between the primary and secondary care more correspondence about COPD patients might be beneficial. In the future, this problem can be obviated by developing a shared electronic patient file. It might be helpful when physicians receive information about the preference policy, to make sure patients receive a device in which they are trained. Furthermore, insurance companies need to be aware of the importance of a proper inhaler instruction. It is important that more money will be devoted to inhaler instruction.

The findings from this study will inform the next phase of the research process. Once a unified instruction method is developed, the effectiveness can be evaluated, by a randomized controlled trial (RCT). In this RCT one group receives the current way of instruction and the other group receives the new instruction method. The inhaler technique of the patients can be analyzed to see whether the new instruction method improves the technique of patients. Further, the effect on the medical condition could be examined.

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4.5 Conclusion This study explored the meaning of experienced healthcare providers about the instruction of inhaler technique in order to generate hypotheses about ways to improve instructions and thereby inhaler technique of patients. It became clear that many improvements can be made in the current instruction method. Improvements on the one hand can be made regarding the instruction content. On the other hand, a large part of the problem is organizational. Uniformity in instruction is important, to avoid confusion of patients. Certain topics should be incorporated in the instruction, namely, demonstration of the technique, practicing and feedback about the technique and explanation about the disease and the medication. In the future the expectation is that eHealth will play a more important role in the educational process. It is important, however, that reliable videos and apps are developed and that healthcare providers are aware of the existence of reliable webpages and apps.

Healthcare providers that provide inhaler instructions should be trained annually and certificated for this training. This will help to reach uniformity. Prescribers must be trained about the preference policy in order to prevent that patients receive a device in which they are not instructed. Follow-up and evaluation of the inhaler technique should be within two weeks after the instruction. When the patient masters the technique, monitoring of the technique should be performed annually. Video consultation can play a role in the follow-up. More communication between healthcare providers about patients with COPD and their inhaler technique is important. This could be by means of multidisciplinary meetings and in the future by developing a shared electronic patient file, accessible by multiple caregivers.

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(6) Turan O, Turan PA, Mirici A. Parameters affecting inhalation therapy adherence in elderly patients with chronic obstructive lung disease and asthma. Geriatr Gerontol Int 2016 Jul 18.

(7) Nationaal Kompas Volksgezondheid. Trend aantal nieuwe gevallen COPD in de huisartsenpraktijk. 2016; Available at: https://www.volksgezondheidenzorg.info/onderwerp/copd/cijfers-context/trends#node-trend-aantal-nieuw-gevallen-copd-huisartsenpraktijk. Accessed December 20, 2016.

(8) Long Alliantie Nederland L. Zorgstandaard COPD. 2016; Available at: http://www.longalliantie.nl/files/9014/5578/9160/LAN_Zorgstandaard_COPD-2016-2.pdf. Accessed Accessed, October 18, 2016.

(9) RIVM. Kosten van de zorg voor astma en COPD. 2013; Available at: https://www.volksgezondheidenzorg.info/onderwerp/copd/kosten/kosten#node-kosten-van-zorg-voor-astma-en-copd. Accessed 01/13, 2017.

(10) King Han M, Dransfield MT, Martinez FJ. Chronic obstructive pulmonary disease: Definition, clinical manifestations, diagnosis, and staging. 2016; Available at: https://www.uptodate.com/contents/chronic-obstructive-pulmonary-disease-definition-clinical-manifestations-diagnosis-and-staging?source=see_link. Accessed 12/22, 2016.

(11) Snoeck-Stroband JB, Schermer TB, Van Schayck CP, Muris JW, Van der Molen T, In 't Veen JCCM, et al. NHG-Standaard COPD (derde herziening). Huisarts Wet 2015;58(4):198-211.

(12) Ferguson G, Make B. Management of stable chronic obstructive pulmonary disease. 2016; Available at: https://www.uptodate.com/contents/management-of-stable-chronic-obstructive-pulmonary-disease?source=search_result&search=copd&selectedTitle=2~150. Accessed 1/5, 2017.

(13) van der Molen T, Willemse BW, Schokker S, ten Hacken NH, Postma DS, Juniper EF. Development, validity and responsiveness of the Clinical COPD Questionnaire. Health Qual Life Outcomes 2003 Apr 28;1:13.

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(14) Hagedoorn P, Klemmeier T. Inhalatie technologie & instructie. 1st ed. Beuningen: Esculaap Media bv; 2014.

(15) Zambelli-Simoes L, Martins MC, Possari JC, Carvalho GB, Coelho AC, Cipriano SL, et al. Validation of scores of use of inhalation devices: valoration of errors. J Bras Pneumol 2015 Jul-Aug;41(4):313-322.

(16) Bailey W, Hess D. The use of inhaler devices in adults. 2016; Available at: https://www.uptodate.com/contents/the-use-of-inhaler-devices-in-adults?source=see_link. Accessed 1/5, 2017.

(17) Micallef JA. A review of the metered dose inhaler technique in asthmatic and COPD patients. Malta Medical Journal 2015;27(01):22-28.

(18) Westerik JA, Carter V, Chrystyn H, Burden A, Thompson SL, Ryan D, et al. Characteristics of patients making serious inhaler errors with a dry powder inhaler and association with asthma-related events in a primary care setting. J Asthma 2016;53(3):321-329.

(19) Basheti IA, Armour CL, Bosnic-Anticevich SZ, Reddel HK. Evaluation of a novel educational strategy, including inhaler-based reminder labels, to improve asthma inhaler technique. Patient Educ Couns 2008 Jul;72(1):26-33.

(20) Aerosol Drug Management Improvement Team. The ADMIT webpage. 2017; Available at: http://www.admit-online.info/en/. Accessed 7/2, 2017.

(21) Van Houtem L, Van Spreeuwenberg P, Heijmans M. Zorgsituatie van mensen met COPD. 2010; Available at: http://www.nivel.nl/sites/default/files/bestanden/rapport-zorgsituatie-met-methode-copd-2010.pdf. Accessed 09-05, 2011.

(22) Crompton GK, Barnes PJ, Broeders M, Corrigan C, Corbetta L, Dekhuijzen R, et al. The need to improve inhalation technique in Europe: a report from the Aerosol Drug Management Improvement Team. Respir Med 2006 Sep;100(9):1479-1494.

(23) Restrepo RD, Alvarez MT, Wittnebel LD, Sorenson H, Wettstein R, Vines DL, et al. Medication adherence issues in patients treated for COPD. Int J Chron Obstruct Pulmon Dis 2008;3(3):371-384.

(24) Hesso I, Gebara SN, Kayyali R. Impact of community pharmacists in COPD management: Inhalation technique and medication adherence. Respir Med 2016 Sep;118:22-30.

(25) Fink JB, Rubin BK. Problems with inhaler use: a call for improved clinician and patient education. Respir Care 2005 Oct;50(10):1360-74; discussion 1374-5.

(26) Kreemer F, Bischoff E, Heijdra Y, Dekhuijzen P. COPD bij ouderen succesvol medicamenteus behandelen: 10 tips. Ned Tijdschr Geneeskd 2016;160(D500):2016/10/18.

(27) van der Palen J, Klein JJ, van Herwaarden CL, Zielhuis GA, Seydel ER. Multiple inhalers confuse asthma patients. Eur Respir J 1999 Nov;14(5):1034-1037.

(28) Pothirat C, Chaiwong W, Phetsuk N, Pisalthanapuna S, Chetsadaphan N, Choomuang W. Evaluating inhaler use technique in COPD patients. Int J Chron Obstruct Pulmon Dis 2015 Jul 8;10:1291-1298.

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(29) Lavorini F, Magnan A, Dubus JC, Voshaar T, Corbetta L, Broeders M, et al. Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD. Respir Med 2008 Apr;102(4):593-604.

(30) Braido F, Chrystyn H, Baiardini I, Bosnic-Anticevich S, van der Molen T, Dandurand RJ, et al. "Trying, But Failing" - The Role of Inhaler Technique and Mode of Delivery in Respiratory Medication Adherence. J Allergy Clin Immunol Pract 2016 Sep-Oct;4(5):823-832.

(31) Hanania NA, Wittman R, Kesten S, Chapman KR. Medical personnel's knowledge of and ability to use inhaling devices. Metered-dose inhalers, spacing chambers, and breath-actuated dry powder inhalers. Chest 1994 Jan;105(1):111-116.

(32) Normansell R, Kew K. Interventions to improve inhaler technique for people with asthma (Protocol). The Cochrane Collaboration 2016(7).

(33) Fink JB. Inhalers in asthma management: is demonstration the key to compliance? Respir Care 2005 May;50(5):598-600.

(34) Ketelaar P, Hentenaar F, Kooter M. Groepen in focus: In vier stappen naar toegepast focusgroeponderzoek. 1st ed. Den Haag: Boom Lemma Uitgevers; 2011.

(35) Kitzinger J. Qualitative Research - Introducing focus groups. British Medical Journal 1995;311:299-302.

(36) Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 2007 Dec;19(6):349-357.

(37) Jolly GP, Mohan A, Guleria R, Poulose R, George J. Evaluation of Metered Dose Inhaler Use Technique and Response to Educational Training. Indian J Chest Dis Allied Sci 2015 Jan-Mar;57(1):17-20.

(38) Hesselink AE, Penninx BW, van der Windt DA, van Duin BJ, de Vries P, Twisk JW, et al. Effectiveness of an education programme by a general practice assistant for asthma and COPD patients: results from a randomised controlled trial. Patient Educ Couns 2004 Oct;55(1):121-128.

(39) Hesselink AE, Penninx BW, Wijnhoven HA, Kriegsman DM, van Eijk JT. Determinants of an incorrect inhalation technique in patients with asthma or COPD. Scand J Prim Health Care 2001 Dec;19(4):255-260.

(40) Alazri M, Heywood P, Neal RD, Leese B. Continuity of Care: Literature review and implications. Sultan Qaboos Univ Med J 2007 Dec;7(3):197-206.

(41) Broeders ME, Sanchis J, Levy ML, Crompton GK, Dekhuijzen PN, ADMIT Working Group. The ADMIT series--issues in inhalation therapy. 2. Improving technique and clinical effectiveness. Prim Care Respir J 2009 Jun;18(2):76-82.

(42) Levy ML, Dekhuijzen PN, Barnes PJ, Broeders M, Corrigan CJ, Chawes BL, et al. Inhaler technique: facts and fantasies. A view from the Aerosol Drug Management Improvement Team (ADMIT). NPJ Prim Care Respir Med 2016 Apr 21;26:16017.

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Appendix A: Invitation letter & informed consent

Geachte (naam deelnemer),

Graag willen wij u uitnodigen om deel te nemen aan een focusgroep bijeenkomst om te discussiëren over de instructie voor inhalatietechniek. Xxx adviseerde ons om u te benaderen voor dit onderzoek omdat u een geschikte kandidaat bent om aan ons onderzoek deel te nemen.

Deze focusgroep wordt georganiseerd door de Inhaler Research Workgroup (IRW), een onderzoeksgroep met als doel het verbeteren van de inhalatietechniek instructie voor astma en COPD patiënten. Uit onderzoek is gebleken dat veel astma en COPD patiënten moeite hebben met het correct gebruiken van hun inhalatiemedicatie. Dit heeft u mogelijk in de praktijk ook gemerkt. Ook patiënten die een goede instructie hebben gehad blijken dit moeilijk te kunnen onthouden. Een slechte inhalatietechniek kan de uiteindelijke ziektelast verergeren. Wij denken dat de inhalatietechniek verbeterd kan worden door patiënten op een andere manier te instrueren. Binnen de IRW werken experts op het gebied van de geneeskunde, farmacie, psychologie en onderwijskunde samen om een nieuwe instructiemethode te ontwikkelen. We vragen u om ons daarbij te helpen. Het doel van de focusgroep bijeenkomsten We willen onderzoeken wat de beste instructiemethode is om de inhalatietechniek op patiënten over te brengen. Deze informatie helpt ons bij het ontwikkelen van de nieuwe instructiemethode. In dit focusgroep onderzoek zullen verschillende professionals (o.a. POH-ers, artsen, apothekers en apothekersassistenten, longverpleegkundigen en longfunctie laboranten) hierover met elkaar in gesprek gaan. Wat kunt u verwachten? U werkt mee aan het ontwikkelen van een nieuwe instructiemethode en kunt ervaringen uit wisselen met

vakgenoten De bijeenkomst duurt ongeveer 2 uur en vindt plaats op een goed bereikbare plaats in Groningen De bijeenkomst zal in november worden georganiseerd vanaf 18.00uur. Voorafgaand aan de bijeenkomst

zullen soep en broodjes worden geserveerd Wij kunnen u een kleine vergoeding voor uw deelname aanbieden in de vorm van een VVV-bon Wilt u meedoen? In de bijlage is extra informatie over het onderzoek toegevoegd. Bent u geïnteresseerd en wilt u ons helpen door mee te doen? Mail dan het ingevulde opgaveformulier naar focusgroep.irw@gmail.com. We zullen een datumprikker rondsturen om de definitieve datum te bepalen. Als u meedoet wordt u gevraagd om vooraf een korte inventariserende online vragenlijst in te vullen. Heeft u naar aanleiding van deze brief nog vragen of opmerkingen? Dan horen wij dat graag via e-mail (zie boven) of telefoon: 06-256 470 87. Met vriendelijke groeten, Vera Otermann & Hester Hoving, studenten geneeskunde Namens de IRW groep, T. van der Molen, E.I. Metting, P. Hagedoorn, T. Klemmeier, S. Schokker, E. van Heijst, M.R. Rodríguez, I. Tsiligianni

www.IRWstudy.com

Improving inhaler technique in asthma and COPD patients by combining the knowledge and experience of patients, scientists and health care professionals

An international multidisciplinary study, performed in: the Netherlands - Spain - Greece

Bijlagen: 1. Achtergrond informatie onderzoek 2. Opgaveformulier/informed consent

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Achtergrondinformatie Zowel astma als COPD zijn chronisch obstructieve longziekten welke veel voorkomen binnen de Nederlandse bevolking. Beide ziekten hebben een grote sociale en economische impact en komen steeds vaker voor.1 Een juiste tijdige behandeling is daarom van groot belang. De hoofdzakelijke behandeling van beide ziekten bestaat uit het gebruik van inhalatiemedicatie. Door het juiste gebruik van inhalatoren komt deze voornamelijk in de longen terecht.2 Het uiteindelijke effect van deze therapie is erg afhankelijk van de gebruikte techniek van inhalatie.3,4 Uit eerdere onderzoeken blijkt dat 4-94% van de patiënten fouten maakt bij inhalatie, afhankelijk van het pufje dat ze gebruiken.5,6,7 De meest voorkomende fouten die gemaakt worden zijn fouten in coördinatie, snelheid en diepte van inspiratie, niet volledige expiratie voor inhalatie en het niet vasthouden van de ademhaling na inhalatie.6

Gevolgen Als een verkeerde inhalatietechniek gebruikt wordt, vermindert het effect van de medicatie. Hierdoor ervaren patiënten een grotere ziektelast en hebben zij een verhoogde kans op een ziekenhuisopname.8 Aangezien het aantal patiënten met COPD en astma in Nederland welke inhalatiemedicatie gebruiken aanzienlijk is, is het zeer relevant om de inhalatietechniek bij deze patiënten te verbeteren.9

Richtlijnen Op dit moment geven de richtlijnen aan dat het belangrijk is instructies te geven voor het gebruik van inhalatiemedicatie, echter, op welke manier de instructies het beste gegeven kunnen worden is nog niet geheel duidelijk. Het wordt gezien als een taak van de huisarts, apotheker, praktijkondersteuner, apothekersassistente, longarts en longverpleegkundige. Tevens wordt geadviseerd de inhalatietechniek later te controleren, maar in hoeverre dit daadwerkelijk gebeurd valt volgens patiënten tegen.10,11 Stichting IMIS heeft als doelstelling om landelijk een eenduidige instructiemethode op te stellen en is bezig hiervoor protocollen te ontwikkelen. Een recent gepubliceerd artikel van de Aerosol Drug Management Improvement Team laat echter duidelijk zien dat er een gebrek is aan bewijs voor de huidige overtuigingen wat betreft het juiste gebruik van inhalatiemedicatie en verder onderzoek hiernaar noodzakelijk is.12

Inhaler Research workgroup Al met al valt uit bovenstaande te concluderen dat het juiste gebruik van inhalatiemedicatie door COPD en astma patiënten sterk verbeterd kan worden. De Inhaler Research Workgroup (IRW) study focust zich hierop en heeft als doel de inhalatietechniek bij astma en COPD patiënten te verbeteren door kennis en ervaringen van patiënten, zorgprofessionals en deskundigen uit verschillende vakgebieden te combineren. Hiervoor zijn eerder onder andere al diepte-interviews afgenomen bij COPD en astma patiënten. In dit onderzoek zal er gericht gekeken worden naar de mening van zorgprofessionals. Het doel van dit onderzoek is dan ook om te onderzoeken wat de mening en ervaringen zijn van zorgprofessionals met de huidige instructie voor inhalatietechniek bij longpatiënten en hoe deze verbeterd kan worden. Focusgroep Om dit te onderzoeken wordt gebruik gemaakt van een focusgroep onderzoek. Een focusgroep bestaat uit een groep van 6-10 personen die met elkaar in gesprek gaan over bepaalde onderwerpen om zo tot nieuwe ideeën en de gedachten van de groep te komen. De bijeenkomst zal ongeveer twee uur in beslag nemen en voorafgegaan worden door een kleine maaltijd. De bijeenkomst zal begeleidt worden door een gespreksleider, welke tevens de te bespreken onderwerpen aanbod zal brengen. In dit focusgroep onderzoek zullen verschillende professionals (o.a. POH-ers, artsen, longverpleegkundigen en longfunctie laboranten) met elkaar in gesprek gaan. Privacy Deelname aan het onderzoek is geheel vrijwillig en u heeft het recht ten alle tijden te stoppen met het onderzoek. Het is mogelijk reiskosten vergoeding te ontvangen. Tijdens het onderzoek zullen video- en audio-opnames gemaakt worden welke later geanalyseerd zullen worden door de onderzoekers. Alle informatie zal anoniem verwerkt worden en alleen door de onderzoekers worden bekeken en/of beluisterd en niet aan derden worden verstrekt.

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Referenties 1. Kumar P, Clark M. Clinical Medicine. Eighth edition. Elsevier Saunders; 2012. 2. Christopher H Fanta, MD, Robert A Wood, MD, Bruce S Bochner, MD, Helen Hollingsworth, MD. An overview of asthma management. UptoDate. May 31, 2016. Beschikbaar via: http://www.uptodate.com.proxy-ub.rug.nl/contents/an-overview-of-asthma-management?source=search_result&search=astma&selectedTitle=1%7E150. Geraadpleegd op: 2 juli 2016. 3. Melani, A.S. et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir. Med. 105, 930–988 (2011). 4. Levy ML, Hardwell A, McKnigth E, Holmes J. Asthma patients’ inability to use a pressurised metered-dose inhaler (pMDI) correctly correlates with poor asthma control as defined by the global initiative for asthma (GINA) strategy: a retrospective analysis. Prim Care Respir J. 2013 Dec;22(4):406-11. doi: 10.4104/pcrj.2013.00084. 5. Pothirat C, Chaiwong W, Phetsuk N, Pisalthanapuna S, Chetsadaphan N, Choomuang W. Evaluating inhaler use technique in COPD patients. Int J Chron Obstruct Pulmon Dis. 2015. 6. Sanchis J, Gich I, Pedersen S. Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest. 2016. 7. Lavorini F, Magnan A, Dubus JC, Voshaar T, Corbetta L, Broeders M, et al. Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD. Respir Med 2008 Apr;102(4):593-604. 8. Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med 2011 Jun;105(6):930-938. 9. Suijkerbuijk AWM, Hoogeveen RT, de Wit GA, Wijga AH, Hoogendoorn EJI, Rutten-van Mölken MPMH, Feenstra TL. Maatschappelijke kosten voor astma, COPD en respiratoire allergie (2012), RIVM Rapport 260544001. 10. Snoeck-Stroband JB, Schermer TRJ, Van Schayck CP, Muris JW, Van der Molen T, In ’t Veen JCCM, Chavannes NH, Broekhuizen BDL, Barnhoorn MJM, Smeele I, Geijer RMM, Tuut MK. NHG-Standaard COPD (Derde herziening). Huisarts Wet 2015;58(4):198-211. 11. Smeele I, Barnhoorn MJM, Broekhuizen BDL, Chavannes NH, In ’t Veen JCCM, Van der Molen T, Muris JW, Van Schayck O, Schermer TRJ, Snoeck-Stroband JB, Geijer RMM, Tuut MK. NHG-Standaard Astma bij volwassenen (derde herziening).Huisarts Wet 2007;50(11):537-51. 12. ML Levey, PNR Dekhuijzen, PJ Barnes, M Broeders, CJ Corrigan, BL Chawes, L Corbetta, JC Dubus, Th Hausen, F Lavorini, N Roche, J Sanchis, Omar s Usmani, J Viejo, W Vincken, Th Voshaar, GK Crompton, Soren Pedersen. Inhaler technique: facts and fantasies. A view from the Aerosol Drug Management Improvement Team (ADMIT). NPJ Primary Care Respiratory Medicine 2016, 26.

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Opgave formulier/Informed consent Deelname formulier focusgroep bijeenkomst Samenvatting _______ Wat: Focusgroep bijeenkomst inhalatie instructie bij astma en COPD patiënten Hoe: De bijeenkomsten worden opgenomen met een video- en audiorecorder Wanneer: Avond in november Hoe laat: 18.00 – 21.30 met van te voren soep met broodjes Waar: Een nader te bepalen goed bereikbare locatie in/rondom Groningen Aantal deelnemers: 6-10 Vergoeding: VVV-cadeau bon + reiskostenvergoeding Vrijwillige deelname Deelname aan dit onderzoek is geheel vrijwillig. U heeft het recht ten alle tijden met het onderzoek te stoppen. Ik heb het bovenstaande gelezen en ik neem vrijwillig deel aan het onderzoek: Naam: …………………………………………………………………………………………………………… Adres: …………………………………………………………………………………………………………… Postcode & woonplaats: …………………………………………………………………………………………………………… Telefoonnummer: …………………………………………………………………………………………………………… E-mailadres: …………………………………………………………………………………………………………… Datum: Handtekening deelnemer:

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Appendix B: Declaration METc

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Appendix C: Participant characteristics questionnaire

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Appendix D: Interview schedule

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Appendix E: Triangulation questionnaire

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Differences between questionnaires

Three different questionnaires have been developed. One questionnaire for employees in the pharmacy, one for healthcare providers in general, and one for employees of the home care. Above the questions are listed in the way they are send to the general healthcare providers.

In the pharmacy questionnaire an extra question is added about the situation in the pharmacy:

Question 7 (Are you an IMIS trainer?) is absent in the questionnaire send to the pharmacy, because no IMIS trainers are active in the pharmacy. The question about the occasion in which the inhaler technique of the patient is controlled consists of different answer possibilities in the (table..)

Table 9. Differences between questionnaires Wat are the occasions that you check the inhaler technique of patients? General healthcare providers Pharmacy Never Never When prescribing the medication At first medication dispensing With medication change When patients receive medication At every follow up moment Otherwise, namely… Otherwise, namely… In the home care questionnaire the question about the preference policy (Q24) is missing, because in the home care nurses have nothing to do with the prescription of medication. In the pharmacy questionnaire the following question is added: “in the pharmacy the patient refuses instructions for financial reasons”. And the following question is missing: “The selection of a the device by the physician is affected by the financial situation of the patient.” In Question 32: “Which caregiver is most appropriate to give inhaler instructions” the home care nurse is added as an answer option in the questionnaire for home care nurses. Q34 about the different devices, one answer option is missing in the home care questionnaire: “prescribers must be more aware about the preference policy”

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Appendix F: Coding tree

Inhaler instruction

Content

Demonstration

Practise & feedback

Instruction tools

Inhaler device

Disease & medication

Purpose

Issues related to inhaler

instruction

Time

Duration

Lack of time

Follow up

First follow up

Frequency

Content

eHealth

App

Instruction video

Website

Games

Video consultation

Healthcare structure

Who gives the instruction

Primary and secundary care

Monitoring in primary care

Communication healthcare providers

Pharmacy

Training & retraining

Content

Opinion

Ideas for improvement

Frequency

Patient characteristics

Children

Adults

Elderly

Medication

Inhaler technique

Adherence

Device prescription

Various inhalers

Finance

Insurance companies

Preference policy

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Appendix G: Quotes translation

“Practicing is essential and immediate feedback provides the best results.” “Oefenen is essentieel en direct feedback geeft het beste resultaat”

“I try to focus… when the patient demonstrates the technique, on the way he or she inhales [the medication] and, in particular, give additional education about incorrect steps.” “Ik probeer altijd wel te focussen op, als ik de patiënt het voor laat doen hoe die inhaleert en

juist extra uitleg te geven over dat deel wat niet goed gaat.” “Many instructors do not understand why certain steps need to be followed.” “Heel veel instructeurs snappen niet zo goed waarom er bepaalde stappen worden genomen”

“Within primary care, relatively little information is provided… And when I have no information about my medical condition, I won’t take medication myself.” “Binnen de eerste lijn.. wordt er relatief weinig informatie gegeven. En als ik te weinig weet

van mijn aandoening, dan zou ik zelf ook geen medicijnen innemen.” Pharmacy assistant: “and when you ask the patient, well…” Nurse: “They do not know.” Pharmacy assistant: “at least half of the patients aren’t aware of the disease they have.” Apothekersassistente: “en als je het aan de patiënt vraagt, nou..”

Verpleegkundige: “Weten ze het niet.” Apothekersassistente: “… zeker de helft weet gewoon niet wat ie heeft.”

GP: “The major problem is: basically there is no time and money available to the inhalation instruction. It is not included in any care program.” “En het grote probleem is dus dat eigenlijk geen tijd en geld is ingeruimd voor die inhalatie

instructie. Er is geen enkel zorgprogramma waar dat in zit.” GP: “In many cases, the second inhalation instruction takes place one year after the first consultation.” Nurse: “Yes, there is too much time in between.” GP: “Exactly, there is too much time in between.” Huisarts: “In heel veel gevallen krijgen ze dat pas na een jaar, komt dan de tweede instructie.”

Nurse: “ Ja, daar zit teveel tijd tussen.” Huisarts: “ja precies, teveel tijd tussen.”

Pharmacist: “Repetition should actually already be done after two weeks, huh, because than errors can still be corrected.” “(…)dat je na 2 weken eigenlijk moet herhalen, hè, want dan kunnen fouten die erin geslopen

zijn toch nog hersteld worden.” “The insurances companies determine in the end which device the patient receives, while you choose this very carefully.” “maar dan bepaalt eigenlijk de zorgverzekeraar, die bepaalt dus uiteindelijk het device, terwijl

je dat heel zorgvuldig aan het uitzoeken bent.” “Therefore, I say: keep practicing at the IMIS training. Practice, practice, practice!” “Dus vandaar uit, zeg ik ook blijf op herhaling bij de IMIS training, oefenen, oefenen,

oefenen..” “What you see in patients is what you see in practice nurses and I suppose respiratory nurses as well: they think they know”

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“Wat je bij patiënten ziet, zie je bij nou ja bij praktijkondersteuners, ik neem aan longverpleegkundigen ook, is dat ze denken dat ze het weten.”

“If the instructor already has a poor technique.. then it is quite difficult, of course, for patients to get it right.” “En dan zie je dus als dan de instructeur het al niet goed doet.. dan wordt het natuurlijk best

lastig dat patiënten het goed gaan doen.” Pharmacy assistant: “Training in the pharmacy could be better”. Respiratory nurse: “Is it poor?” Pharmacy assistant: “Yes, it is really poor.” Apothekersassistente: “Maar ik denk het stukje scholing, dat dat in de apotheek beter zou

kunnen.” Longverpleegkundige: “Hangt het er een beetje bij?”

Apothekersassistente: “Ja dat hangt er echt bij.” GP: “Yes, than the administrative processing is arranged well, and that is very nice, but the patient will not benefit from this.” Laboratory assistant: “Why not, because…?” GP: “Well.. because, then it is noted in the computer…” Nurse: “Not in an action list” Huisarts: “ja, nee, dan is het administratief goed verwerkt en dat is dan ook heel mooi, maar de

patiënt heeft daar niet zoveel aan.” Laborante: “in welke zin niet? Want wat…”

Huisarts: “nou omdat.. dan staat het in de computer en welke vervolgactie wordt daaraan gekoppeld?”

Verpleegkundige: “niet in de actielijst ofzo” “I do not now a proper app to recommend to my patients.” “Ik weet niet wat een goeie app is om een patiënt te adviseren.”

“I think, in fact we have to guide people, by saying: you just have to look on the internet... At the moment this is too open-ended. It is too easy to get an inhaler instruction and, ehh, just sit back and do nothing, patients also have their own responsibility.” “Eigenlijk vind ik dat je toch mensen meer moet sturen om te zeggen u moet gewoon op

internet kijken. Om het daar ook nog eens een keer eh te doen he, dat is nou ook wel wat vrijblijvend. […] Het is ook wel heel erg gemakkelijk om een keer inhalatie instructie te krijgen en eh, nou verder achterover te gaan leunen, eh ik vind dat patiënten er zelf ook wel wat voor mogen doen.”

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Appendix H: Data triangulation questionnaire

Table 10. Current instruction conditions N=93 n (%)

I received training about inhalation medication Yes No

I do not know

87 (93.5)

4 (4.3) 2 (2.2)

I received retraining (N=89) Yes No

84 (94.4)

5 (5.6) Instruction experience I give daily instructions

I give weekly instructions

48 (51.6) 45 (48.4)

Duration of instruction (minutes) < 5

5-10 10-15

>15

9 (9.7)

38 (40.9) 37 (39.8)

9 (9.7) Demonstration of inhaler technique

Never Occasionally

Always

4 (4.3)

43 (46.2) 46 (49.5)

Practice by the patient Never

Occasionally Always

3 (3.2)

10 (10.8) 80 (86.0)

Feedback on inhaler technique Never

Occasionally Always

2 (2.2) 2 (2.2)

89 (95.7)

Table 11. Level of satisfaction about current instruction conditions Question Unsatisfied Neutral Satisfied

What is the meaning of participants about…

n (%) n (%) n (%)

Available time for inhaler instruction

16 (17.2)

17 (18.3)

60 (64.5)

The amount of time between the first instruction and the first evaluation

20 (21.5)

33 (35.5)

40 (43.0)

The frequency of assessment 30 (32.3) 24 (25.8) 39 (41.9) The extent to which patient receive

background about COPD

9 (9.7)

23 (24.7)

61 (65.6) Location of instruction 4 (4.3) 12 (12.9) 77 (82.8)

The availability of placebo’s 11 (11.83) 17 (18.3) 65 (69.9) The availability of instruction material 12 (12.9) 10 (10.8) 71 (76.3)

The quality of instruction material 5 (5.38) 19 (20.4) 69 (74.2)

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Table 12. Which subjects should be incorporated in the inhaler instruction? N=92 Unnecessary/

Unimportant Potentially significant

Significiant, if sufficient time

Necessary/ Significant

n (%) n (%) n (%) n (%) Demonstration by caregiver 1 (1.1) 15 (16.3) 20 (21.7) 56 (60.9) Practice by patient 0 1 (1.1) 6 (6.5) 85 (92.4) Feedback on technique 0 2 (1.2) 5 (5.4) 85 (92.4) Instruction video 1 (1.1) 49 (53.3) 35 (38.0) 7 (7.6) Instruction pictures 2 (2.2) 28 (30.4) 28 (30.4) 34 (37.0) Anatomical models 5 (5.4) 37 (40.2) 21 (22.8) 28 (31.5) Explaining different steps 0 3 (3.3) 7 (7.6) 82 (89.1)

Table13. Goal of the inhaler instruction N=92 Disagree Neutral Agree

n(%) n(%) n(%) Practice until error-less technique 6 (6.5) 8 (8.7) 78 (84.8)

Error-less inhaler technique is not feasible 60 (65.2) 17(18.5) 15 (16.3)

Table 14. Follow-up: frequency and content Disagree Neutral Agree

Frequency (N=92) n (%) n (%) n (%) There is too much time between instruction and evaluation of inhaler technique

23 (25) 22 (23.9) 47 (51.1)

The first evaluation should take place within 2 weeks after instruction

8 (8.7) 13 (14.1) 71 (77.2)

The follow-up frequency is patient dependent 8 (8.7) 14 (15.2) 70 (76.1) Also a patient with an error-less technique requires annual evaluation

5 (5.4) 4 (4.3) 83 (90.2)

Content (N=91) The content of the evaluation should be the same as the initial instruction

18 (19.8) 28 (30.8) 45 (49.5)

Evaluation should be by the same caregiver as the initial instruction

53 (58.2) 26 (28.6) 12 (13.2)

Sufficient time is essential for a proper inhaler instruction

2 (2.2) 1 (1.1) 88 (96.7)

Table 15. The use and opinion of eHealth N=61 Unsatisfied n (%) Neutral n (%) Satisfied n (%) I don’t use it n (%) Instruction video Quality Accessibility

3 (4.9) 4 (6.6)

16 (26.2) 7 (11.5)

45 (65.9) 49 (80.3)

0

1 (1.6) App Quality Accessibility

3 (4.9) 3 (4.9)

17 (27.9) 18 (29.5)

6 (9.8) 4 (5.6)

35 (57.4) 36 (59.0)

Website Quality Accessibility

4 (6.6) 1 (1.6)

12 (19.7) 13 (21.3)

45 (73.8) 47 (77.1)

0 0

Games Quality Accessibility

1 (1.6) 2 (3.3)

16 (26.2) 15 (24.6)

0 0

44 (77.1) 44 (77.1)

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Table 16. Desirability of eHealth according to respondents that do not use eHealth N=31 Undesirable Neutral Desirable

n (%) n (%) n (%) Instruction video 0 3 (9.7) 28 (90.3) Information video about asthma/COPD 0 6 (19.4) 25 (80.6) App for children 0 8 (25.8) 23 (74.2) App for adults 1 (3.2) 11 (35.5) 19 (61.3) App for elderly 3 (9.7) 18 (58.1) 10 (32.3)

Table17. Training of healthcare providers Disagree Neutral Agree n (%) n (%) n (%) Training of caregivers should be mandatory 1 (1.1) 3 (3.3) 86 (95.6) Training should be repeated annually 3 (3.3) 10 (11.1) 77 (85.6) Trained caregivers should receive a certificate 5 (5.6) 16 (17.8) 69 (76.7) To prescribe a proper device, physicians should be trained about the various devices

2 (2.2) 14 (15.6) 74 (82.2)

Desired training topics: n (%) Inhalation technology of new devices 74 (82.2) Inhalation technology repetition 35 (38.9) Inhaler instruction method 65 (72.2) eHealth 69 (76.7) Information about asthma/COPD 27 (30) Information about medication 60 (66.7)

Table 18. Satisfaction and desirability of communication between healthcare providers Dissatisfied Neutral Satisfied Satisfaction of current communication topics n (%) n (%) n (%) Inhaler instruction 34 (37.0) 29 (31.5) 29 (31.5) Device selection 29 (31.5) 35 (38.0) 28 (30.4) Medication adherence 38 (41.3) 34 (37.0) 20 (21.7) Alert each other about errors 37 (40.2) 40 (43.5) 15 (16.3) Desired communication topics n (%) Medication adherence 81 (90.0) Who is responsible 57 (63.3) Whether evaluation took place 76 (84.4) The kind of errors the patient made 70 (77.8) The effect of the medication 73 (81.1) Whether the device fits the patient 79 (87.8) Communication is not relevant 6 (6.7)

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Table 19. Frequency in which financial aspect affect the inhaler selection Never Rarely Regular Often Always n (%) n (%) n (%) n (%) n (%) Because of the preference policy patients receive another device than prescribed (N=88)

1 (1.1) 14 (15.9) 66 (75.0) 6 (6.8) 1 (1.1)

The preference policy hinders the patient's specific device selection (N=88)

1 (1.1) 17 (19.3) 50 (56.8) 17 (19.3) 3 (3.4)

Selection of a device is determined by the patients financial situation (N=88)

16 (18.2) 33 (37.5) 35 (39.8) 4 (4.5) 0

The patients financial situation plays a role in the selection of a device by a physician (N=79)

23 (29.1) 33 (41.8) 23 (29.1) 0 0

In the pharmacy patients refuse particular devices because of their financial situation (N=9)

3 (33.3) 4 (44.4) 1 (1.11) 1 (1.11) 0

Table 20. Device selection and issues Disagree Neutral Agree Total n (%) n (%) n (%) N

The device should fit the patient 0 0 90 (100) 90 There should be a quicker change of device when patients have an incorrect inhaler technique

17 (18.9) 32 (35.6) 41 (45.6) 90

Patients should use one kind of device 6 (6.7) 17 (18.9) 67 (74.4) 90 Prescribers should be more aware of the preference policy

8 (9.1) 14 (15.9) 66 (75) 88

Table 21. Desired situation in the pharmacy Disagree Neutral Agree

n (%) n (%) n (%) Patients should make an appointment to receive inhalation instruction

1 (11.1) 0 8 (88.9)

Evaluation of the technique only at first medication dispensing 0 0 9 (100) When it comes to inhaler instruction, the pharmacy must act more proactive

2 (22.2) 1 (11.1) 6 (66.7)

When medication is delivered at home, patients should receive instruction

0 0 9 (100)

There should be more time available for inhaler instruction 1 (11.1) 3 (33.3) 5 (55.6) At FTO’s agreements should be made about whom is responsible for the instruction

0 1 (11.1) 8 (88.9)

In the pharmacy a practice nurse should be appointed that is responsible for inhaler instruction

5 (55.6) 4 (44.4) 0