Service development project to pilot a digital technology innovation for video direct observation of therapy in adult patients with asthma

Introduction

Asthma affects approximately 262 million people worldwide.1 Adherence to pharmacotherapy, including inhaler therapies, is a central part of asthma management. Use of an inhaler at the dosage prescribed and correct inhaler technique is crucial to ensuring that the medicine is deposited deep within the lungs. However, poor adherence to prescribed therapy is common, that is, the patient can fail to use inhaler(s) at the frequency prescribed. Furthermore, many studies have reported that the majority of patients (50%–80%) fail to use effective inhaler technique.2 Poor adherence to inhaled therapies and/or incorrect inhaler use are major causes of uncontrolled asthma and increased healthcare utilisation.3

Adherence to medication can be complex and multifactorial. Interventions to promote adherence must focus on issues important to the patient. From the perspective of the person with asthma, adherence to prescribed therapy can relate to poor understanding of the need for treatment, lack of involvement in decision-making about their inhaler device and low motivation to change behaviour.4 From the clinician’s perspective, there can also be barriers to facilitating good adherence practices including difficulty in scheduling, treatment by different healthcare providers and time constraints.5 There is a need for a feasible method of monitoring and supervising therapy, which supports the delivery of standard care which includes provision of advice, education and empowerment of patients in the self-management of their condition. Approaches to enhance patient motivation can include thorough patient and caregiver education and more frequent patient contact.6 Digital devices offer the potential to support the delivery of best practices, optimise adherence and direct decision-making in asthma, thereby helping clinicians and empowering patients

Direct observation of therapy (DOT) is the viewing by a clinician of a patient’s medication administration, to ensure adherence (medicine is used as prescribed) and effective technique (medicine is administered appropriately).7 In tuberculosis (TB), there is strong evidence that DOT allows assessment of correct self-administration of medication and course completion.8 As a result, DOT has been promoted by the World Health Organisation (WHO) to enhance medication adherence in patients with TB.9 However, DOT can be labour intensive and inconvenient to both patients and healthcare workers, making it difficult for healthcare services to sustain.10 The use of video DOT (v-DOT) or remote DOT, where patients submit ‘selfie’ videos of their administration of medicines for assessment by a healthcare professional, has the potential to increase flexibility and reduce the costs associated with traditional DOT while meeting patient-specific needs for treatment. Significantly, v-DOT has been shown to be effective in patients with TB in whom good medication adherence is imperative.11 Emerging evidence from feasibility studies in children with asthma have demonstrated high levels of acceptability and improvement in inhaler technique using v-DOT.5 12 13 The effect of v-DOT in the adult asthma service has not yet been explored. There are significant differences in the type of therapies and the method of therapy administration in adults compared with children.

Aims and objectives

The aim of this service development project was to explore the use of the v-DOT platform to monitor inhaler technique and adherence to inhaler treatment in patients in an adult asthma outpatient service in a tertiary hospital in the Western Health and Social Care Trust, Northern Ireland.

The primary objective was to explore the utility and the feasibility of using the v-DOT platform to monitor inhaler technique and adherence to inhaler treatment in adult outpatients and to explore patient and clinician ease of use and satisfaction with the v-DOT platform.

A secondary objective was to explore if treatment improvement had been achieved as measured using patient clinical markers (lung function and asthma control test scores).

Methodology

Results

Patient engagement with the V-DOT platform

The median (IQR) length of time that patients used the technology was 7 (6-7) weeks. An equal number of patients (5/10; 50%) used the v-DOT platform with 1 or 2 asthma inhalers. The devices monitored were dry powder inhalers (DPIs) (73%), Softmist inhalers (20%) and pressurised metered-dose inhalers (7%).

Each individual had an expected number of videos to be uploaded (according to their individual inhaler treatment regimen and number of monitored days). Over each individual’s duration of time using the technology, the proportion of the actual number of videos uploaded/expected number of videos uploaded was as summarised in figure 1. The median (IQR) proportion of videos submitted over a median 7-week period was 78% (66%–92%). Two patients requested to continue using the technology after the 6-week project period, as they found the reminder function on the v-DOT platform useful (platform sent a text message reminder to use their inhalers).

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Figure 1

The proportion of actual number of videos/expected number of videos uploaded to video direct observation of therapy platform for each patient.

For those videos not uploaded by the patient, the reasons given included technical issues (video would not upload, app not working), patient issues (trial run, patient forgot, patient did not upload video of adequate quality for review) or unknown (no reason given). 5 out of the 10 (50%) patients reported a technical issue at some stage during the usage period, causing a barrier to video upload. Delays in accessing the videos (due to barriers to video upload) to evaluate the quality of inhaler technique were reported by the clinician in 4 out of 10 (40%) of cases.

In the instances where there were technical issues uploading or accessing the videos by the patient and/or the clinician, the v-DOT platform vendor technical support was accessed to troubleshoot and resolve the matter (table 2).

Table 2

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Feasibility and utility of the v-DOT platform across the project lifespan

Of the videos submitted to the v-DOT platform, each received a quality rating on the patient’s inhaler technique by the clinician (figure 2). Overall, the majority of the patient videos submitted across the total time period were rated as demonstrating ‘good’ quality inhaler technique (96%).

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Figure 2

Inhaler technique quality rating by clinician of submitted videos.

This result indicated that when videos were uploaded, the clinician was able to determine that patients were adherent to their prescribed medication (used inhaler) and could also assess inhaler technique (technique evaluated using visual and audio aspects of the uploaded videos). In only a few cases was the inhaler technique judged partially effective and in no cases was the technique judged poor. In a very few cases, the videos were not of sufficient quality to judge inhaler technique (no rating category).

Table 2 summarises the technical and/or feasibility issues raised during the pilot and the action required to resolve. Issues related mainly to technical troubleshooting on the patient and clinician interfaces of the v-DOT platform.

Lung function and asthma control

Over the course of using the v-DOT technology, 7/10 patients had an increase in FEV₁% predicted, 4/10 patients had an increase in FVC % predicted and 9/10 patients had an increase in FEV₁/FVC % predicted. 3 out of 10 patients had a decrease in FeNO and 8/10 patients had an increase in their asthma control test. Individual level changes are presented in figure 3 (A–E).

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Figure 3

(A) FEV1 % predicted individual level changes from start to end. (B) FVC % predicted individual level changes from start to end. (C) FEV1/FVC % predicted individual level changes from start to end. (D) FENO (ppm) individual level changes from start to end. (E) Asthma Control Test individual level changes from start to end. FeNO, fractional exhaled nitric oxide; FEV₁, forced expiratory volume in one second; FVC, forced vital capacity.

Discussion

Inhaled medication is a commonly prescribed pharmacotherapy in asthma. Adherence to prescribed pharmacotherapy and use of the correct inhaler technique are considered important basic principles of asthma management. However, poor adherence to prescribed therapy and incorrect inhaler technique are common. There is a need for a feasible method of monitoring and supervising therapy that supports the delivery of standard care.

This project indicated that it was feasible for a proportion of patients with asthma managed in this outpatient setting to use v-DOT technology to take and upload videos of themselves using their inhaler therapy over a median 7-week period, 78% of the time. Furthermore, it was feasible for the clinicians in this setting to quality rate the inhaler technique and provide feedback to patients based on their video uploads. In this project, there was agreement that shorter periods or ‘bursts’ of using the technology to promote adherence and good inhaler technique when needed would be the most useful application of the technology for clinicians and patients.

All patients and clinicians involved reported that they found the technology easy to use and were satisfied with the technology. A range of positive impacts with the v-DOT technology were reported by patients and clinicians including corrected and optimised inhaler technique, increased patient confidence and understanding, benefit of reminders and benefits of monitoring and data collection for patient management. However, it was clear that time, resource and clear communication channels to detect and resolve potential technical issues at all stages were essential, as half of patients experienced technical issues at some time over the 6-week monitoring period. By the end of the pilot, the majority of the technical matters had been resolved for this patient group, however, some technical challenges remained. Some patients continued to have intermittent problems uploading video and further improvements in the layout and format of the clinician viewing page, on-boarding of patients to the app and the troubleshooting process to resolve technical issues would be required in order for the innovation to be assimilated more easily in future.

When used correctly and consistently, inhaled asthma medications are designed to alleviate the symptoms by controlling inflammation and minimising exacerbations. The increase in lung function and asthma control test scores observed with some patients in this small patient group align with these clinical aims. There was, however, a median 6 ppm increase in FeNO levels. Elevated FeNO levels may be explained by the presence of other respiratory comorbidities, for example, nasal disease. While clinicians in this setting agreed that using the technology was beneficial to their service and would like to have continued access to the technology, information gathered from screening patients (for participation and feedback) indicated that it may not be a useful tool for all patients. For example, the older population was more reluctant to engage with the video recording aspect of the technology. Adherence to medication is a complex issue, influenced by multiple treatment, clinician and patient-related barriers. v-DOT in this outpatient asthma service was considered one of the ‘tools’ in the ‘toolkit’ in addressing non-adherence and poor inhaler technique. Digital modes of delivering care may support, rather than replace, patient facing strategies.

A recent scoping review evaluating 121 studies of digital interventions in asthma reported on how study outcomes related to the level of interactivity with the patient. The review concluded that there was evidence of improvement in both adherence and impairment due to asthma with interactive interventions involving two-way responsive patient communication.14 The review highlighted that the ability to personalise a digital intervention in asthma care is important for its success. This v-DOT platform facilitated interaction between clinician and patient in relation to feedback, as required, on inhaler technique. The feedback from some patients and clinicians (eg, inclusion of a chat function, shorter duration of time for some patients) may be important aspects of personalisation in ongoing development of v-DOT technology to promote correct inhaler technique and adherence.

Further scale up and adoption of any technology in the National Health Service (NHS) requires evaluation of the available evidence and decisions on commissioning or purchasing. Digital health technologies evidence frameworks and guidelines15 16 on the use of digital technologies within the NHS outline a range of standard categories against which technology should be evaluated to assess proposed digital health technologies. These categories include design factors, describing value, demonstrating performance, delivering value and deployment considerations. This project provides information on feasibility and acceptability of the v-DOT approach among a small group of patients and clinicians in an asthma outpatient service in a tertiary hospital in Northern Ireland. Obtaining a fuller understanding of the impact of the technology on clinical outcomes in this patient group would require a robust research methodology. In the evidence framework,15 the ‘demonstrating performance’ category includes a standard to provide evidence of the technology effectiveness to support its claimed benefits. In order for the new digital health technology to claim an impact on clinically relevant outcomes, high-quality interventional studies are advised. While the framework outlines that randomised controlled trials would be preferable (where this study design is appropriate), high quality, comparative real-world study designs may also be acceptable.

In the case of v-DOT, however, it may be argued that this is not a new digital technology, but rather simply an approach that harnesses a patient’s mobile phone to allow a more efficient delivery of the established DOT approach. Current clinical guidelines for DOT as part of the management of respiratory populations include National Institute for Health and Care Excellence (NICE) clinical guideline 33 on TB (NG33), which recommends DOT as part of enhanced case management for certain at-risk groups (eg, evidence of non-adherence to treatment, history of homelessness, multidrug resistant TB) and the children of these at-risk groups.17 The American Thoracic Society (ATS)/Centers for Disease Control and Prevention (CDC)/Infectious Diseases Society of America (IDSA) guideline and the Singapore guideline also recommend DOT for TB.18 19 Specifically linked to v-DOT, the WHO guideline recommends using v-DOT to replace DOT where the technology is available (a conditional recommendation based on evidence with low-certainty in the findings).20 This demonstrates that a level of evidence to support the use of DOT and v-DOT interventions currently exists. Furthermore, the use of v-DOT internationally in TB management adds to that evidence on a daily basis.17 The decision to use available v-DOT technology may therefore come down to aspects of access, utility and implementation, that is, the delivering value and deployment aspects as outlined by digital health technologies evidence frameworks and guidelines.15 16 A next step to expedite general adoption of such an innovation within the NHS setting may be to implement further service development pilots, with the ongoing collection of implementation and cost-effectiveness data, as guided by the digital technology frameworks.

Conclusion

The v-DOT technology was shown to be a feasible method of assessing inhaler technique and monitoring adherence to prescribed inhaler use in a small group of outpatient adult patients with asthma who engaged with the technology (n=10; 53% of those invited to join the project). A range of positive impacts for participating patients and clinicians were reported. Not all eligible patients invited to join the project agreed to participate and engage with using the technology, highlighting that in this setting, digital modes of delivering care provide only one of the approaches in the necessary ‘tool kit’ for clinicians and patients. Furthermore, v-DOT may be useful at certain points and/or for limited periods in the clinical pathway and may not be needed continuously. Although all participating patients reported that v-DOT was very easy or easy to use, technical issues were experienced by 5 out of the 10 participating patients and time, resource and clear communication channels were required to detect and resolve these.