Research Team of Prof. Richard Reilly at the Trinity Centre for BioEngineering; developers of the Inhaler Compliance Assessment (INCA) device for inhaler monitoring in asthma and COPD.
Identify the human factors that influence patient adherence to medication and recommend an improved feedback mechanism that may be used in conjunction with the INCA device and that improves adherence levels in patients with poor adherence to medication.
In the cases of diseases or conditions that require a high degree of self-management, i.e., long-term conditions, we identified the need for better integration of patient medical data into the patient narrative. This integration does not necessarily have to be related to increasing the medical knowledge of the patient, but be directed towards overcoming of the psychological factors that affect adherence to medication.
A simple visual concept to bridge the gap between the patient and interpretation of data and graphs without context. This visualisation helps to create a simple narrative for the patient whereby they have a frame to manage and process information from their inhaler device and their medical care team.
Note: There are three terms used to describe medication-taking among patients: compliance, adherence and concordance. Modern opinion suggests that "compliance" should not be used because of its harsh, uncompromising connotations. "Adherence" is most commonly used as it implies a certain level of responsibility and need for self-management on the patient's part. The psychological factors discussed in this case study may help provide an understanding as to why these subtle distinctions in language are important. For the purposes of this case study, I use the terms compliance and adherence interchangeably.
1.1 The Inhaler Compliance Assessment device (INCA) device
The INCA study was designed to test the hypothesis that the acoustic features of an inhalation could be used to quantify aerosol drug delivery. The INCA device provided integrated acoustic analysis for inhalers and reporting of the key parameters from the point-of-use back to the clinician. The device was mounted onto the GlaxoSmithKline (GSK) dry powder inhaler (DPI), the Diskus (shown below in Figure 1). The operation of the INCA device was simple: when the inhaler is open, the INCA device begins recording, and when the user is finished and closes the device, the INCA device ceases recording. The file is then saved with the date and time and then goes into sleep mode until it is used again. The full set of audio files obtained from the recording device are then processed by an algorithm that outputs the time and date of the inhaler event, the classification of technique error (e.g., did the patient exhale into the inhaler at any point) and a classification of flow rate.
1.2 Standard Feedback to Patient from the INCA device
The standard feedback to the patient attempted to address four issues. It aims to encourage the patient to:
Be more compliant in taking their two inhaler doses daily.
Maintain a consistent interval between each dose.
Improve any technique areas.
Achieve required inspiratory flow rates and duration.
The following are examples of the feedback given from the nurse to the patient.
From the perspective of the clinician, the feedback graphs gave a good indication of patient compliance over a certain period of time. However, representation of the data in this manner had no real meaning to the patient themselves. While this feedback may be effective in identifying incidences of non-compliance, it does not consider the patient as a self-manager of their condition or disease.
1.2 Adherence to Prescribed Medication - Why is it difficult?
As you might expect, good adherence to medication and treatment is strongly associated with better health status, less frequent exacerbations and hence less frequent hospitalizations due to exacerbations . There are two main types of non-compliance: unintentional non-compliance and intentional non-compliance. In the case of unintentional non-compliance, the patient is unaware that they are not compliant. This may be a result of misunderstanding of the treatment or incorrect technique when taking the inhaler. It was here that the INCA device was intended to have a positive impact by identifying incorrect technique.
Intentional non-compliance refers to the scenario whereby the patient makes a conscious decision to reject their treatment or even the diagnosis. Intentionally non-compliant patients tend to reduce the frequency of their doses or number of medications to be taken to a level that they deem appropriate or necessary. Some patients may also discontinue therapies that they believe to be ineffective, unnecessary or dangerous . Patient psychology is a complex area and in this scenario the patient creates a narrative that suits their identity and lifestyle independent of medical advice or direction. L. M. Osman identifies a number of issues that have a significant influence on shaping the patients’ attitudes towards their disease and treatment and thus their level of compliance .
Positive and negative feelings about medication: the patient’s dilemma.
Why don’t patients believe what their doctors tell them about medication?
Delivery method and type of medication: do these influence attitudes?
Attitudes and personal styles of medication management: chaos or control?
Can doctors change patient attitudes? Must attitudes change before behaviour changes?
From a patient point of view, self-management of their condition or disease is an important part of everyday life. Translating the issues identified by Osman into patient terms, we targeted the following areas to guide our research:
Understanding / Education of the patient
Knowledge of the underlying cause(s) of disease
How the disease affects the patient
How the treatment affects the patient
2. Research Areas
2.1 Technique and Associated Errors
Adequate instruction of the patient is extremely important and many studies concerning instruction of the DPI usage have been published. In order to determine the correct technique, we analysed the instructional video “Demonstration of How to Use a Diskus Inhaler” available on the Asthma Society of Ireland website and spoke to a respiratory nurse at Beaumont hospital Dublin. Correct inhalation technique is crucial for the effective use of the inhaler device. We decomposed this information into the steps required to take the inhaler correctly and developed a cognitive task analysis.
While the operation of the Diskus inhaler is explained well, no reasons are given as to why the patient should:
a) Exhale fully before breathing in.
b) Take a deep breath and for how long.
c) Hold their breath for ten seconds.
A number of studies have been carried out in order to investigate inhaler misuse. Incorrect technique is certainly a contributing factor to inefficient delivery of medication. All errors associated with the Diskus inhaler can be classified under the three areas listed above (a) to (c). Patient education is also a major contributing factor. The current education of patient for the inhalation technique is most of the time verbal. Thus, we identified our first opportunity for improvement in highlighting the importance of the steps (a) to (c) in the first instance and reinforcing those steps in the second instance.
2.2 Inspiratory Flow Rate
In order to ensure that the dose emitted from the dry powder inhaler (DPI) contains drug particles that have the greatest potential to be delivered to the conducting airways, the patient must generate an adequate inspiratory flow rate. The Total Emitted Dose (TED) is the term given to the amount of drug released during a single actuation . Within TED, therapeutic benefit is derived from the mass of the drug particles that are small enough to reach the airways during inhalation. This parameter is defined as fine particle fraction (FPF) or fine particle mass (FPM). It refers to the mass of particles released that have an aerodynamic diameter of less than 5 micrometers. These particles have the greatest potential to be deposited on the required airways during inhalation. Particles larger than this tend to deposit on the oropharynx and are swallowed.
The level of research surrounding inspiratory flow rates is quite high. These studies highlight the importance of the inspiratory flow rate. Design of the inhaler has a part to play here and in the case of some types of medication, a nebuliser may be required to deliver the medication effectively. In the case of inhalers, the patient must perform the inhalation process correctly in order to receive the right dose of drug. The flow rate is a consistent factor that can outline if the patient inhales appropriately or not.
2.3 Psychological Factors
2.3.1 Poor adherence to medication is a natural reaction
A study carried out by Hansson Scherman and Löwhagen aimed to describe the patients’ experiences of medication . It was based on the assumption that the patient has good reasons for being non-compliant in accordance with their experiences of the medication. A series of interviews were carried out and questions were divided into three categories with one category having four subcategories:
(A) Access to medication is important to relieve discomfort and to avoid fear.
(B) Medicine damages your body and your identity without curing the illness.
(B1) You can become immune or addicted.
(B2) The ability of your body to heal itself is weakened.
(B3) Your body’s own signals are camouflaged.
(B4) You become stigmatized.
(C) Production and distribution of medicine is a profit-seeking commercial undertaking, which is not primarily aimed at curing the patient.
The answers provided to these questions highlighted a number of attitudes, fears and misconceptions that the constitute the patient narratives relating to their disease and treatment. Different attitudes are shown to shape the patients’ view on medication. This study highlights how different experiences will shape the patients’ perception of medication. Patient answers that were categorized in (A) represented the view that access to medication is important to improve the patient’s sense of security and avoid fear of illness. There is an underlying positive attitude here. In some cases, the respondent gave answers that fell into more than one category. However, it was determined that the dominant experience was the one that shaped the patients’ attitude towards their medication and treatment. For example, one patient gave answers that came under (A) and (B). However, their fear of illness (A) was greater than their fear of the medication damaging their body (B). Therefore, their level of compliance was quite good. It is important to recognise that non-compliance is not an act of disobedience but a rational act based on the person’s perception of their disease and the treatment involved. Additionally, different patients will respond in different ways to medication and treatments and this fact needs to be taken into consideration.
2.3.2 Patient Personas
A study carried out by Adams et al., attempted to explain the reasons for the variation in the way people diagnosed with asthma use their prescribed medication and develop various attitudes towards their diagnosis . They carried out in-depth interviews with the respondents. The respondents were then split into three groups:
Deniers and Distancers
Deniers and Distancers accounted for half of the respondents. The people in this group were reluctant to admit that they suffered from asthma or at least “proper asthma”. Several of the respondents claimed that their doctor did not specifically tell them that they had asthma. Based on the responses, it seemed that they focused on certain words or phrasing used by the doctor in order to tell themselves that they did not have asthma. This could be seen as a coping mechanism. The misconceptions relating to asthma was also investigated, which might explain the reason why these respondents were so adamant to not be associated with this condition. Many of the respondents had negative images of what asthma is and what people suffering from the condition were like. People suffering from asthma were seen as being weak and being severely debilitated. Thus there was a fear of being stigmatised and a desire to live a “normal” life and so the main coping strategy was avoidance of treatment and denial of diagnosis.
Acceptors made up the second largest group. While they shared many of the same notions and opinions, their coping strategies differed enormously. Rather than avoid their treatment and deny their diagnosis in order to live a normal life, they chose to adhere to their medical treatment. An important finding was that the patients’ had attempted to reduce their treatment and take as little medication as possible. They had experimented and judged the therapeutic efficacy of their medication against specific outcomes. However, each respondent then returned to his or her prescribed treatment. Pragmatists made up the rest of the respondents could be described as being somewhere in between accepters and deniers, but closer to accepters. They acknowledged that they had asthma. However, they differed from the accepters in that some would not take their medication in accordance with how it was prescribed. One participant described his approach as taking his reliever medication when he was “in trouble” and taking in the following days in order to make sure it was “gone until next time”.
2.3.3 Providing context to the medication-taking process
While the work of Adams et al allows us to define three patient persons, the work of J. Bajcar allows us to put these personas in context. Bajcar devised a detailed task analysis of how patients take their medication on the basis of a number of in-depth interviews . The study focused on aspects of the medication-taking practice and how these influenced the amount of information that the patient required regarding their medication. A number of major categories were identified that describe and characterize the tasks associated with the practice of taking medication for individual patients. The categories included:
Making sense of medication.
Making sense of medication was identified as the core category. This refers to the patients’ process in trying to determine how the disease affects them and how the medication and treatment will affect their daily lives. For all of the participants, this process was an on-going process and was both a cognitive and emotional process. Three primary modes were identified within this category. The patient was said to be in non-problematic mode if the medication-process made sense to them. It was found that when the information supplied to the patient externally was consistent with their experience of the medication. Essentially, in order to make sense of the medication- taking process, the patient first requires information that allows them to make sense of the disease and diagnosis. This then provides the context for them to interpret the information relating to the medication.
When the patient was unable to make sense of their medication-taking process, they were said to be in either problematic mode or stunned mode. Patients’ in problematic mode felt that they did not have all the necessary information. Consequently, they had some doubts relating to the efficacy of their medication. In this case if information from an external source (e.g., doctor) contradicted information obtained from the patient’s own experiences, the patient tended to form a negative attitude (e.g., feelings of anxiety) towards their medication. Patients in the problematic mode also had a tendency to try and gather information on their own. In many cases, they desired extensive discussions about their medication with their doctor or health care provider, but most of the participants in this study felt that they could not have satisfactory discussions. Stunned mode was most common in situations where the patient had only found out about their disease very recently. Patients’ in this mode could not even begin to make sense of their illness or medication and felt “stunned or paralysed”. Bajcar states that:
“While in the stunned mode, an individual is limited in his or her ability or willingness to receive and interpret new information. An individual in this mode is not in a position to learn and thus will not develop or add to his or her understanding of the illness or medications, no matter how well the health care provider provides the education.”
The patient’s attitude towards their medication and treatment is directly affected by their relationship with their medical care team. If there is a strong level of trust between the two, then the patient tends to not require as much information regarding the drug. However, if the level of trust is low, e.g., a new doctor, the patient may require a lot more information to ensure that the doctor knows the needs of the patient.
2.4 Visual Perception
The area of visual perception is very important in the recommendation of any visual feedback.
Visual communication can be used to communicate information. It includes graphs, sketches, videos, icons, etc. Aldous Huxley is highly regarded as one of the most prominent explorers of visual communication and sight-related theories. Becoming near blind in his teen years as the result of an illness set the stage for what would make him one of the most intellectual people to have ever explored visual communication. His work includes important novels on the dehumanising aspects of scientific progress, most famously Brave New World and The Art of Seeing. He described "seeing" as being the sum of sensing, selecting, and perceiving.
Studies find that the human brain deciphers image elements simultaneously, while language is decoded in a linear, sequential manner taking more time to process. Our minds react differently to visual stimuli. Also a multi-modal feedback system enhances our ability to create narratives for understanding as we can contextualise the data that we are processing easier. Below is a visual representation of the areas of the brain that become active when analysing data versus the experience of a story.
Initial ideas for this project included the addition of physical components to the INCA device such as an alarm to signal incorrect technique or a mobile application whereby the data and graphs could be transmitted directly to the patient's phone. However, as the research progressed, we came to the realisation that a solution that was focused more on the psychological factors around medication-taking would have a higher impact on patient adherence.
From our research we defined a number of inputs to guide our recommendations. Thus we generated a goal statement:
In relation to technique, the feedback should highlight the importance of exhaling fully before inhaling, taking a deep breath and holding your breath for 10 seconds. The feedback should be designed for the Deniers and Distancers patient persona and target this persona in "Problematic mode", specifically by constructing a narrative around the act of medication-taking.
We recommended that a simple balloon model be used to visually represent the lungs. With this model, key technique areas can be visualised rather than being considered as a step towards task completion. Exhaling fully can now be visualised as emptying the balloon so that it can be filled again with air containing the drug. The deep breath can be visualised as filling the balloon as much as possible and the breath hold for 10 seconds can be visualised as allowing the drug particles to settle. Depending of the patient's experience of interpreted graphs, visual feedback in the graphical form could potentially make the patient feel excluded from their treatment pushing them into the Deniers and Distancers persona. Visual feedback in the form of a balloon model is simple, intuitive and normal. The colours green, yellow and red would represent good flow rate and duration, adequate flow rate and duration and poor flow rate and duration, respectively.
This new visual element combined with the audio recordings of the INCA device form a multi-modal solution. The patient can now unconsciously connect the narrative of medication-taking with the act of taking their inhaler. The graphs used by the clinician can be thought of as an added layer of understanding accessible to the patient if they choose.
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