Tele-monitoring of ventilator-dependent patients: a European Respiratory Society Statement

Introduction

The reported, although probably underestimated, prevalence of patients with chronic respiratory failure (CRF) requiring home mechanical ventilation (HMV) in Europe is 6.6 per 100 000 people [1]. There are challenges when providing HMV, including patients and caregiver training, adequacy of respiratory care, reimbursement policy, and need of patient/family cooperation [2]. Furthermore, factors such as patients' chronic diseases and their exacerbations, need of technology and lack of professional supervision make the management of ventilator dependent individuals (VDI) by family and non-professional caregivers a difficult task. Supervision by external companies has many limitations, such as lack of standardisation, lack of regular feedback to the prescribing centres [3], costs and logistical problems. The need to reduce healthcare costs and to improve safety has prompted the development of tele-monitoring for VDIs.

Information and communication technologies (ICT) applied to health and healthcare systems have been considered able to increase their efficiency, improve quality of life and unlock innovation in health markets. However, the EU considers this promise as still largely unfulfilled [4]. There is some confusion about the terms used to define tele-health, as well as tele-medicine versus tele-monitoring. Home mechanical ventilators are sometimes equipped with remote monitoring tools in order to improve supervision on the delivered treatment and adapt settings to the patient's need and comfort accordingly [5]. The economic issues of home tele-monitoring are crucial for its rapid transfer to healthcare systems both in terms of cost/benefit ratio and in term of reimbursing rules [6]. An assessment of the costs associated to such an innovative application should be investigated in detail, together with regulatory (legal, insurance and reimbursement) issues. Other relevant issues may include [7]: indications, modalities of follow-up, team expertise and composition, technologies, outcome, adherence and compliance measures, tele-rehabilitation programmes. The aim of this European Respiratory Society (ERS) task force was to provide a statement describing commonly accepted indications, follow-up schedules, equipment and facilities, legal issues (if any). This may be useful to: 1) Promote common standards of clinical criteria, data transmission, management pathways, equipment, facilities, and regulations of tele-monitoring systems in countries where these tools are already in use. 2) Describe models for countries developing new HMV systems of care. 3) Design clinical studies in the field for HMV. Definitions regarding terminology referred to in this report are given in box 1⇓.

Clinical scenarios

Equipment and technology

The components of the technological dimensions can be grouped into four variables: synchronicity, network design/configuration, connectivity and inter-operability [19].

Follow-up

There is poor exchange of information and feedback among the centres prescribing HMV and the external companies performing the ventilator servicing, with the frequency of communication ranging from 3–12 months [3, 15]. Tele-monitoring may play a major role in improving HMV quality control, by remotely monitoring ventilation variables and facilitating exchange of information on quality control among partners involved in HMV. Some programmes used weekly [42] or 3-month [43] phone calls as “store and-forward necessity”. Vitacca et al. [14, 18] proposed an interactive online system: continuous on-call service was available 24/7 and arterial oxygen saturation measured by pulse oximetry (S_pO2) was accessible for check-point analysis [14, 18].

Timing of evaluation of compliance to continuous positive airway pressure (CPAP) devices and feed-back has been defined in the setting of obstructive sleep apnoea (OSA) management [44]; downloaded information every week day morning (except holidays) and contacts to the patient, if any, of the following were present: mask leak >40 L·min⁻¹ or >30% of the night, <4 h use for two consecutive nights, machine measured apnoea–hypopnoea index (AHI) >10 events·h⁻¹, and 90th percentile of pressure >16 cmH₂O. The research coordinator called the patient and inquired about symptoms/side effects [44].

In a pilot study published as an abstract [45], of titration and surveillance of HMV initiation, authors used a ventilator connected with oximetry and Global System for Mobile Communications (GSM) modules and Encore Anywhere software (Koninklijke Philips N.V., Amsterdam, the Netherlands). Compliance data were downloaded on the 4th day and the 2nd month, while nocturnal oximetry (under HMV) was performed on the 7th day and the 1st month. If efficacy of ventilation criteria were not fulfilled, remote titration of ventilator settings were based on compliance/oximetry downloads (COD). At COD assessments phone calls were made by the homecare provider in order to check performance of the study protocol [45]. Bertini et al. [22], were able to avoid emergency visits in 62.5% of cases with once a week and on-demand nocturnal monitoring, using a Digital multiparametric recorder that included ventilator parameters and S_pO2 coupled with a telephone counselling.

Legal issues

The legal problems associated with tele-medicine are still controversial. Despite many processes of tele-consultation are unique, the legal principles applying to conventional, face-to-face, doctor–patient relationships may be equally as valid in the context of the practice of medicine at a distance [51, 52]. In tele-medicine, three roles can be held legally liable for the delivered performance [52]:

• 1) The person who transmits the data. Any application of tele-medicine is considered a medical act. The relationship between the person using the service (especially when he/she is the patient) and other stakeholders, must be governed by “informed consent”. This preliminary action allows the patient to be adequately informed about the characteristics of the service, the potential risks, the precautions to reduce them and to ensure the confidentiality of the information [51].

• 2) The person who receives data. The person who conducts the remote health service: he/she is the medical user of the service and the medical consultant [51].

• 3) The service provider(s). The quality and confidentiality of the transmitted and received data must be ensured by service providers [51].

The use of tele-monitoring carries several risks [52–54]: tele-consultation may fail to reach standard of care; equipment or system may fail; electronic data can be manipulated; the electronic record may be subject to abuse; the network may suffer from poor data protection (poor confidentiality, authenticity, data report, procedure certification, security and privacy); the network may show difficulty to ascertain responsibilities and potential obligations of health professionals.

Important system precautions need to be used by e-Health users [55, 56].

Economic considerations

The proportion of the elderly (aged >65 years and <80 years) and older (aged ≥80 years) EU population is expected to rise from 17.4% in 2010 to 30.0% in 2060 and from 4.7% in 2010 to 12.1% in 2060, respectively. Patients often suffer from acute exacerbations of their chronic diseases resulting in frequent hospitalisations in intensive care units (ICUs) or emergency room admissions, as well as general practitioner (GP) visits. As a result, the EU average health expenditure rose from 5.9% in 1990 to 7.2% of gross domestic product (GDP) in 2010, and the projections show that it may further grow to 8.5% GDP in 2060, due to the ageing population and other socio-economic and cultural factors. In addition, the long-term care expenditure projection would on average almost double over this period. The impact of these changes is already being perceived and is worsened by increased pressure on public budgets, progressive decline in the number of health personnel, and growing demands and expectations from citizens for higher quality services and social care [58–62].

Challenges and opportunities

Tele-monitoring can be considered as both a challenge and an opportunity for health services [63]. Particular attention is given to dimensions such as safety, usability, and quality of patients' knowledge of their disease as the key factor of an effective self-management [64]. As a consequence, HMV requires a big amount of human and financial resources [67]. Some studies have evaluated and compared the costs associated to home and institutional or hospital setting alternative solutions. An early paper from Fields et al. [66] on the cost-effectiveness of homecare technology for respiratory technology–dependent children, reports a mean annual homecare cost >$100 000 USA for ventilator-dependent children, and >$60 000 for oxygen-dependent tracheotomised patients, respectively. This corresponds to ∼$79 000 and $83 000 per patient saving, respectively, compared to alternative institutional cares. Another study [67] on ventilator dependent children showed that health costs were 70% less than hospitalisation-related costs, while the average costs for homecare were 87% less than a hospital setting care. In the UK, Noyes et al. [68] compared the costs of service for ventilator dependent children and young people at home and in hospital settings. They found that living at home for children not needing employed carers was always cheaper than living in the hospital. However, for children needing 24 h care by qualified nurses, the homecare package was ∼1.5 time more expensive than for children treated in the hospital setting. Also a recent literature review [61] outlines that HMV is a more cost-effective therapy compared to in-patient care in ICUs reporting a cost reduction ranging from 62% to 74% in general. Furthermore, invasive HMV has a higher cost compared to home NIV, principally due to the care equipment and partially due to the need for 24-h care by highly qualified personnel. Available comparisons of institutional and at home solutions in VDI may underestimate the importance of comparing at home alternatives such as: 1) tele-monitoring versus formal caregiver monitoring in VDI's homecare, to highlight the savings associated to tele-monitoring when compared to high intensity labour home activities; and 2) quality-of-life comparison in patients using home and hospital care solutions.

Table 3 shows the few studies reporting the cost-effectiveness of remote monitoring in VDIs. For example, the study by Vitacca et al. [23] concluded that tele-monitoring was cost-effective in case of severe and frail patients when LTOT and/or either NIV ventilator or invasive mechanical ventilation are needed, considering activation and healthcare service provision costs. Constant costs were mainly based on the number of calls, and savings in healthcare services costs were mainly due to the prevented hospitalisations. Per patient costs were ∼33% less than for usual outpatient follow-up, whereas per COPD patients tele-monitoring costs were about 50% less than for usual outpatient follow-up. Despite these preliminary studies have shown an advantage in applying tele-health systems, recent research casts some doubts that these systems are more effective and less expensive than usual care [70–72].

To evaluate the real cost/effectiveness of new methods such as remote monitoring in this population it is important to understand what “standard therapy” and “usual therapy” mean in the papers published until now. It is clear that the superiority (if any) of this new method of care must be compared to a “gold standard” of homecare that is very variable among the European countries and within each European country [57].

Alternatively, tele-monitoring may represent an opportunity for health services. Despite the economic crisis, the potential e-health market is strong. The global tele-medicine market has grown from $9.8 billion in 2010 to $11.6 billion in 2011, and is expected to continue to grow to $27.3 billion in 2016, representing a compound 18.6% annual growth rate [4]. The health market enabled by digital technologies (mobile applications, devices) is rapidly growing. The convergence between wireless communication technologies and healthcare devices and between health and social care is creating new businesses [4].

Tele-rehabilitation to support VDIs

As a whole there is a lack of research on the effectiveness of tele-rehabilitation in VDIs. Mandatory items for rehabilitation in VDIs are: education, change in lifestyle, physical activity, muscle training, airway clearance, nutrition [73]. Tele-rehabilitation can be defined as the provision of services to support functional status using technologies [74] according to four models of service delivery: 1) “face to face” standard model used for interactive video conferencing; 2) “tele-homecare” with a nurse coordinating a service named “tele-support”; 3) tele-monitoring with possible interactive tele-evaluation; and 4) tele-care where the patient “plays” or performs exercises under home tele-monitoring and therapist may remotely change settings.

Tele-rehabilitation was promoted through phone calls, and messages, email, video phones, websites or mobile phones, video-conferencing; biological electronic sensors able to send data; medical devices able to be programmed at distance; dedicated Internet software. Timing of application occurred after an hospital discharge or to maintain benefits such as functional independence, education, participation, physical change, early detection of relapses, adherence, airway clearance, exercise training. Among different technologies, video-conferencing can vastly increase the provision of patients (particularly those in rural/remote areas) with previously difficult access to services [75, 76]. An on-demand tele-consult and mechanical insuflator-exsuflator device access programme avoided hospitalisations due to severe airway encumbrance for patients with ALS with significant cost savings [69].

Age, education, experience in technology, home environment, cognitive deficits, motor and visual ability, phonation and speech play an important role in the patient's ability to use technology during tele-rehabilitation [77]. The training to the use of technology and the structure of the programme should be directed to caregivers in order to make them able to act in accordance with predefined protocols [78]. Whether these positive experiences mostly coming from non VDIs patients can be widely extended to those patients must be confirmed by future research.

Role of tele-monitoring in sleep-related breathing disorders

Sleep-related breathing disorders are characterised by abnormalities of the respiratory pattern during sleep. The most important are OSA and hypoventilation syndromes, central or ventilatory pump disorders or obesity hypoventilation. CPAP and NIV may benefit these patients [81–81]. With the aim of improving compliance as well as finding new diagnostic strategies, some studies investigated the role of tele-monitoring in the management sleep disorders [81–86].

Although CPAP and NIV may reverse events and can improve survival and quality of life in hypoventilation and nocturnal desaturation in NMD, and in patients with hypoventilation syndromes [79, 87], abnormalities may occur at night, such as air leaks, ventilator–patient asynchrony, central events, and glottic closure leading to desaturations, arousals, impaired sleep architecture, and poor adherence. Polysomnography using conventionally available parameters is an important tool for accurately establishing the device setting avoiding these abnormalities.

Unlike the well-established titration procedure of CPAP in OSA, the approach to follow-up patients with hypoventilation syndromes under NIV is still unclear [88, 89]. In addition, nocturnal monitoring is complex and unforeseen problems arise for many reasons, such as: 1) physiological variations of different variables, 2) clinical problems (pain and secretions, among others) or 3) sleep disturbances. Finally, almost all ventilator types are different, and knowing the algorithms operating in most of them is impossible, which may generate difficulties or even mistakes. Marked differences can occur in ventilator performance, mode of triggering, pressurisation slope and type of exhalation. In addition, leaks and upper airway resistance variations may modify these patterns [88, 89].

According to the American Academy of Sleep Medicine recommendations, titration based on polysomnography using conventionally available parameters is an important tool for accurately establishing devices settings, to avoid abnormalities in most of the patients and to achieve optimal treatment and maximal clinical improvement [90]. The potential of tele-monitoring in hypoventilation syndrome has been less studied and no clear recommendations exist in clinical protocols [39, 87, 91–96] or procedures [91, 97]. Indeed, ICT seems to have a great potential in this field. For example, in many cases one night and follow-up visits in the sleep laboratory are not enough to adequately set the ventilator, ICT can support the home refinement of the titration of these patients [98]. Tele-consultations can also positively contribute to OSA management [99]. A recent multicentre randomised controlled trial provided evidence that a strategy based on a web platform and tele-consultations, for the CPAP follow-up of OSA patients is as effective as the face-to-face approach at lower costs [87]. Caution is needed because data transmitted by commercial devices come from different manufacturer strategies. Standardisation and homogenisation of these data collection and transmission should be regulated by the relevant scientific societies involved [100].

Despite these encouraging results, the penetration of these technological advances in the clinical practice is still slow, especially when compared with other respiratory chronic diseases or others pathologies [98, 99, 101–103]. Furthermore recently published results questioned the validity of this technology as a method to delivery healthcare for all populations [104]. Consequently, it appears crucial to carefully select proper outcomes and most receptive target patients' groups. We believe that it should be critical to assess the role of ICTs in potentially suitable populations, such as patients on CPAP or NIV. At present, two major topics concerning the hypoventilation and sleep should be considered: 1) Clinical procedures: indication of treatment, device titration, and quality control [105], follow-up strategies as well as new approaches to obtain daytime and night-time adequate ventilation and finally treatment compliance. 2) The required innovation: cost-effectiveness analysis, improvement in procedures as well as in technology, specifically by implementing and validating tele-monitoring applications. 3) We lack RCT evaluating the real impact of tele-monitoring on survival in these patients.

Tele-monitoring in palliative care and at the end of life

Tele-hospice, the use of technologies to provide palliative services to patients with severe chronic disease or living with and dying from advanced illness, may offer an innovative solution to the challenges of providing high-quality, cost-effective end-of-life care. Specifically, the technology used for tele-hospice was video contacts and videophones [32, 106–108] resulting to be both feasible and satisfactory. Most studies were not conducted in VDIs. A 24-h telephone consultation service was proposed to fulfil GPs need dealing with daily dilemmas in palliative care treatment for cancer patients [119]. Tele-hospice interventions may be more readily accepted by nursing and administrative staff members, while those employees who address primarily psychosocial issues may be reluctant to use such technology [110]. Using tele-medicine, it is possible to reduce the number of in-person visits, thereby significantly decreasing the cost of providing hospice care [111]. The use of videophone technology gave providers, patients, and family members' new means to communicate [106]. However, it has been emphasised that it must be considered as an additional tool and not a substitute for actual visits [112]. Patients are usually satisfied with tele-hospice and often express frustration that nurses do not use those pieces of equipment more frequently [113]. Tele-hospice was able to decrease spiritual and medical burden, improving quality of life and symptom management for veterans and families coping with end of life [114]. Home tele-health consultations are a feasible and acceptable means of facilitating a palliative care consultation reducing the burden on families also in paediatric patients [115, 116].

We identified only a feasibility study [117], showing the impact in severe CRF patients (13 on HMV) discharged home at the end of their life. The programme consisted of scheduled phone calls, S_pO2 recording, 24 h call centre, and specialised nurse and physician second opinion. This nurse-centred programme improved communication between hospital staff and the patients' relatives, optimised pain and respiratory symptoms management, improved healthcare assistance and the healthcare needs [117].

Conclusion: problems and future directions

Due to paucity of literature the style of this document is very anecdotal and it could not provide a systematic analysis of the core problems of tele-monitoring. Nevertheless some conclusions can be made.

• 1) Variable models of care exist for VDIs [118].

• 2) Despite the hopes in tele-monitoring as a means to face these problems, much more research is needed before considering tele-monitoring a real improvement in the management of these patients.

• 3) Tele-monitoring might be a key element in HMV but it is difficult to assess without considering other services received by patients (homecare, access to hospital, social care). Considering the overall care received by the patient, tele-monitoring should be included in the full potential set of  “care package” [7].

Major barriers hamper the wider diffusion of tele-monitoring. Solutions of these barriers are areas to be solved for the future [4].

• 1) Lack of awareness of, and confidence in e-Health solutions among patients, citizens and healthcare professionals.

• 2) Lack of interoperability between e-Health solutions.

• 3) Limited large-scale evidence of the cost-effectiveness.

• 4) Lack of legal clarity.

• 5) Lack of transparency of utilisation of data collected by such applications.

• 6) Inadequate or fragmented legal frameworks including the lack of reimbursement schemes.

• 7) High start-up costs involved in setting up.

• 8) Regional differences in accessing ICT services, limited access in deprived areas.

Areas of future research may be effects of tele-monitoring on.

• 1) Physiological mechanism involved in HMV.

• 2) Outcomes (survival, quality of life, daily living activities, social interaction, autonomy, self-management, care-giver burden).

• 3) Health services (phone calls, technical home visits).

• 4) Resources use (emergency visits, admissions, out-patient visits).