HTA Core Model^® Online

Health problem and current use of technology (CUR)

According to the European Society of Cardiology, heart failure is a clinical syndrome in which patients have typical symptoms and signs resulting from an abnormality of cardiac structure or function. Although often life threatening, typical symptoms and signs resulting from an abnormality of cardiac structure or function, i.e. heart failure, leading to failure of the heart to deliver oxygen at a rate corresponding to the needs of the body are usually less dramatic than those associated with a myocardial infarction {77}.

HF is a large and global public health problem that will become more important with the aging of the world population. Up to one person in five is expected to develop HF at some point in their life in economically developed countries {70}.

Telemedicine is an approach using remote monitoring e.g. by structured telephone support of prognostic factors in order to promote an early identification of clinical deterioration in HF patients, prevent hospital readmission for acute decompensated HF, and avoid further complications {3}. Signs and symptoms reported by patients are collected by a healthcare professional who subsequently enters and stores the data into a monitoring system. The data are then reviewed by healthcare professionals, usually physicians or nurses. Appropriate action can be initiated, and deterioration can be rapidly detected, which leads to decrease in unnecessary hospital visits, a decrease in hospital (re-)admissions, an improved quality of life. {75}. The highest risk period for hospital readmission is the first few weeks after discharge {90}. Overall, telemonitoring has the potential to improve patient safety and quality of care {21}.

Substantial heterogeneity among studies was noted {119}, the content of the telemedicine interventions vary between patient groups and with regard to duration and content.

Most studies report care provided by a multidisciplinary team, but a great deal of heterogeneity regarding the professionals involved was described. Collaboration between primary care and secondary care was scarcely reported. In almost all the studies, nurses played a coordinating or leading role, but description of the specialization of clinical background were lacking. A different variation of systems for telemonitoring was found, ranging from assessment of symptoms and/or vital signs to data transmission and automatic alarms. {51}

Generally, telemedicine and telemonitoring can be seen as relatively new, currently as an adjunct to current care with the chance of more patient-self-care-involvement and improved quality of therapeutic monitoring, but without a clear unique idea where it should lead to and how it should be implemented.

Structured telephone support may not be not suitable for every patient diagnosed with HF.

Patients with cognitive impairment, a mental illness, a life expectancy less than one year, hearing impairment, language barrier or another chronic disease are often not eligible for a telemonitoring intervention such as structured telephone support {93}.

Description and technical characteristics of technology (TEC)

The non-invasive telemedicine/telemonitoring mainly contains the following aspects (seperately or combined):

• patient education
• self-care supportive strategies
• monitoring and (daily) transmission of vital parameters and weight
• telephone-follow up
• medication management (adherence),
• fluid management (adherence)
• problem solving
• exercise recommendation
• diet adeherence
• goal setting

Usual care mainly consists of

• standard post-discharge care without intensified attendance at cardiology clinics
• clinic-based CHF disease management programme
• home visiting

There is no consensus definition of the fundamental terms utilized.

Telemedicine/ telemonitoring interventions can be used in all different settings (outpatient, outpatient clinic, hospital based, home, mixed setting), they are mainly provided in outpatient organisations, the most important part ist the additional setting at the patients‘ home.

The reference values for heart failure diagnostic (- monitoring) are mainly a) mortality and b) hospitalisation (rate).

The needs for a sustainable telemonitoring include

• Qualified professionals (human resources) doing the monitoring/ statistics/emergency prioritisation
• Economic resources to provide the infrastructure for data transmission (GSM network, analogue phoneline, internet, software) and telephone support, documentation, home visits, etc.
• Transparent selection of patients who benefit best

Information to patients outside the target group and the general public should focus on the reasons and the explanation for inclusion or exclusion of people/ patients for access to structured telephone support. People should be informed that structured telephone support is not suitable for all individuals nor is it appropriate under all medical circumstances

There is also an „upcoming“ topic called mHealth meaning mobile health through mobile phones and similar devices using software applications (apps). There is increasing interest on mhealth, especially with the hope of easy and equal acces for information, tele-diagnostic or –care aspects and data collection and use for health purpose. Some major aspects are to be worked out (like network issues, data security, information quality, legal and regulatory aspects etc.) and are aim within the EU horizon 2020.

Safety (SAF)

To determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure /New York Heart Association (NYHA) I-IV, without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure/ improves clinical outcomes and quality of life, has impact on patients’ satisfaction and function, change in management or utilization of health service and patients’ and technical safety (technical reliability), in comparison with current practice, a systematic literature search according to the predefined search strategy (not limited by publication date but limited to English language), was performed according to the Cochrane methodology, in standard medical and HTA databases.  References have been included or excluded according to the overall research question, Population-Intervention-Control-Outcome (PICO)-scheme, and the predefined inclusion/exclusion criteria. One hundred full-text articles were assessed for eligibility and after the exclusion of 76 full-text articles, five high quality SRs and 19 full text published RCTs were included in our SR. Of the included RCTs, only three were judged to be of low risk of bias.

In the most recent SR no evidence on potential harms was found on STS interventions. None of 19 included RCTs specifically mentioned adverse events (AEs) as primary or secondary outcomes. In only one RCT which specifically mentioned AEs no adverse events were reported and only one RCT provided explanation on the reason why it did not monitor AEs. Since little evidence was identified on the potential harms of STS, it was not possible to assess overall benefits and harms of STS in adults with chronic heart failure.

The sources were not sufficient to answer the questions on STS safety in patients with chronic heart failure. No evidence was found to answer technical safety.

Clinical effectiveness (EFF)

To determine whether treatment with Structured telephone support (STS) in adults with chronic heart failure /New York Heart Association (NYHA) I-IV, without implantable cardiac defibrillators (ICDs), cardiac resynchronization therapy (CRTs) or pacemakers, who have been admitted to hospital at least once for chronic heart failure/ improves clinical outcomes and quality of life, has impact on patients’ satisfaction and function, change in management or utilization of health service and patients’ and technical safety (technical reliability), in comparison with current practice, a systematic literature search according to the predefined search strategy (not limited by publication date but limited to English language), was performed according to the Cochrane methodology, in standard medical and HTA databases.  References have been included or excluded according to the overall research question, Population-Intervention-Control-Outcome (PICO)-scheme, and the predefined inclusion/exclusion criteria. One hundred full-text articles were assessed for eligibility and after the exclusion of 76 full-text articles, five high quality SRs and 19 full text published RCTs were included in our SR. Of the included RCTs, only three were judged to be of low risk of bias.

STS produced a mortality benefit and reduced HF-specific readmission rates. For the outcomes QoL and utilization the evidence was insufficient. Yet, the majority of studies presented statistically significant QoL improvements. A majority of the RCTs found no significant difference in the number of emergency room visits in either group. No evidence found to answer some assessment element questions, related on outcomes such as work ability, return to previous living conditions, activities of daily living, worthwhile of STS and willing to use STS again.

STS reduces HF-specific readmission and mortality. A majority of the studies presented statistically significant improvements in QoL. Some research gaps and transferability issues were recognized. Further research is needed on effects of STS on QoL and utilization outcomes as well as patient satisfaction during long term follow-up.

Costs and economic evaluation (ECO)

It became apparent from the results of our systematic literature search and our review of the results from other domains that the meaning of the term Structured telephone support (STS) varies quite widely across the studies. Hence, there is no explicit definition STS and, instead, the term is refers to a diverse set of approaches to care management for adults with chronic heart failure using telephonic networks.

Depending on the approach taken to STS, a range of different pieces of information can be collected by telephone from patients, and any such information can be handled and utilised by the management team or system in a large number of ways.

Therefore, one main result of the ECO domain is that variation in the nature of the intervention poses major challenges to undertaking meaningful examination of intervention costs and to undertaking economic evaluations.

If each type of STS intervention, has both different components and consequences, this has a significant effect on ability to make meaningful estimates of costs and to undertake robust economic evaluations. For this reason, we do not summarise the results of the studies per se but, instead, briefly describe those studies found.

Ethical analysis (ETH)

The current domain outlines some ethical issues arising from the use of the particular technology, i.e.  structured telephone support for adult patients suffering from CHF. Together with all the clinical efforts in the management of this devastating condition, part of the recent research has been concentrated on finding low-cost therapeutic alternatives as telemedicine and further understanding of the psychological, ethical, legal and social aspects of handling the particular technology and its impact on the patients themselves, their families and friends, the healthcare personnel and the healthcare providers as well as the society as a whole.

In compliance with the preliminarily outlined domain framework, the following issues have been considered in the text – all of them abiding by the generally accepted ethical principles: beneficence/nonmaleficence; autonomy; respect for persons and justice and equity:

• Improving patients’ quality of life;
• Challenges associated with the digital gap;
• Challenges posed by the remote interaction between a physician and a patient;
• Fair and balanced distribution of resources;
• Equal access to treatment;
• Stigmatization.

As already mentioned, on the agenda stand many ethical challenges, with the border between the benefits and harms associated with telemedicine remaining vague and fluid rather than sharply defined. This is due to the virtual environment, where electronically mediated communication replaces personal interaction and physical contact.

Since the issues discussed are highly controversial, the current text does not pretend to be a detailed or comprehensive analysis but provides some thoughts and reflections. Instead of giving certain prescriptions, the authors aim at providing a balance between norms and values through the consideration of social, political, cultural, legal, religious and economic aspects arising from the opposition to the generally accepted environmental values, healthcare system goals and the application of new technologies.

A particular problem that could affect the quality and nature of the conclusions in the text stems from the fact that, like many other innovations in the healthcare field, almost all of the studies from the available literature, assessing the positive and negative impact of telemedicine, focus primarily on the purely economic, technical and clinical parameters, particularly emphasizing on cost reduction and technological efficiency but ignoring the ethical considerations at the same time.

Generally, scientific literature demonstrates that the effect of telemedicine on patient-centered care varies more or less. Some studies see the negatives, but most find neutral or positive effects. In view of all these and acknowledging some of the literature gaps already mentioned, the authors may conclude that the basis of empirical studies is still too poor to allow any solid conclusions at this stage.

Organisational aspects (ORG)

When planning the introduction of a TM intervention in general, there are several questions that need to be addressed concerning: the choice of patients targeted by these programmes; the parameters that will be monitored; the more efficient way to monitor them; the training of patients and healthcare personnel; how to organize the response of the health care professionals to data obtained from monitoring to optimize patient care. Possibly management will need to deal with (de)employment of new resources, new information systems, new equipment for STS provisions, new administrative leadership and new group culture that promotes quality improvement.

STS can be carried out in very different settings, from primary care to tertiary care. There is little information in the studies on the changes of the workflow – usually for the STS an additional nurse was used who had access to patient data, carried out the STS, monitored the patient, recorded the symptoms and data and reinforced and adapted the plan of care for the patient.

In STS the most important thing is training and education of nurses and patients and communication. The STS support starts being planned while the patient is in hospital through education and meeting with the HF nurse. Education and practising with the technology follows and the materials are given to the patients as well as explained to the relatives. At the point of discharge the timing of the first call is agreed. The frequency of calls varies greatly among the studies but in common the calls are weekly at least first two weeks after discharge and then get biweekly until two months after discharge. After that they become monthly. The number of telephone contacts per week should not be too high, not even in the first week as this may affect adherence. Adherence is reported from 55,1% to 84% across the studies, adaptation to the technology to 90% or higher, more than 90% of patietns are statisfied with the use of technology.

 It is not clear how long the intervention should last: there are different periods, going from 3 months up to 2 years after the discharge. It is not clear when the effect is biggest, possibly within first 3 months. A published communication strategy is important, including patient support strategy, communication between patient: nurse, patient: medical doctor, patient: pharmacist, the brochures, diaries to record daily control measurements, web pages with disease information and with instructions, instructions for family members  to share a best practise. In general, STS provides greater access to care in geographical terms and no specific problems were mentioned regarding financial accessibility.

In spite of various methods of costs calculation, which makes them highly incomparable, it is posisble to establish that the average costs of intervention across the studies amounted from $23,6 to $443, the reported savings amounted from $30,9 to $536 per patient per month. None of the studies analyzed a shift of cost, from specialits to HF nurse to GP.

Eligibility to new technology depends on an assessment of the general practitioner of a patient’s condition and the patient's willingness and ability to participate. Access to new technologies depends on support of healthcare providers as they are rarely reimbursed.

Social aspects (SOC)

The aspects related to patients’ quality of life and satisfaction with STS, patients’ views, perceptions and probable improvements in self care allowed by the use of this intervention, are an important part of the success of this technology.

In the studies where quality of life (QoL) is measured with standardised instruments, there is a significant improvement of QoL in the intervention group or no difference between the usual care and the intervention. Pandor’s systematic review shows that 4 studies which had quality of life as a secondary outcome and where about STS, reported improvements in QoL, with significant improvements in physical [Angermann, 2011] and overall [Barth, 2001, Wakefiled, 2008] measures, but one study found no significant differences between the groups [Riegel, 2006]. Oher (primary) studies we selected gave scattered results. Dunagan et al. 2005 found that nurse-administered, telephone-based disease management intervention had some impact on functional status and quality of life. Piotrowicz et al. 2015 found that the in the intervention group there was a similar improvement in total QoL index as in the control group. Patients who underwent home-based tele rehabilitation observed an improvement mainly in the mental categories. On the other hand Ramachandran et al, 2007 found and increase in quality of life, as a whole and in many dimensions the intervention group that persisted over time. For Jerant 2003 telenursing at least did not have any large negative impact on patient satisfaction or health status. In the study by Boyne et al. 2014 authors conclusions says that tailored telemonitoring was found to educate patients with HF and to improve their self-care abilities and sense of self-efficacy. Domingues and collegues state that in thier study (2011) the educational nursing intervention performed during the hospitalization period brought improved knowledge of HF and self-care in all patients regardless of telephone contac.

The organisational differences among the variuos STS interventions in the selected studies (programs offering exercise, education and behavioral interventions on patients’ psychological outcomes, or monitoring systems of vital signs led by nurses or physician etc.) can help to explain those differences in findings and results and make trasferability and comparability of them difficoult.

To have a deeper understanding about how patients experience the care when it is moved outside of the hospital to their homes with  the support of STS, we also selected qualitative studies which allow to highlight perceptions of patients about complex interventions. From this perspective selected qualitative studies show that there can be positive and negative aspects in using telemedicine and its application such as STS. Lynga et al. 2013 interviews to patients who used the intervention showed, that  the technology was easy to perform, made patients active in their own care, and increased their self-care activities. However, there were concerns of potential deterioration: transmission of body weight reminded patients of illness, deterioration in their health, increase of diuretic dose (inconvenience in the patient’s daily life) and some experienced also a perception of fear that affected their psychological well being.

As regard tro the barriers to the use of the technology, digital divide related to the age or socio-economical status which could avoid patients to use the facilities related to the intervention, we could not retrive definitive and conclusive studies. The qualitative literature that gave an answer to this reaserch question would show digital divide due to age as not being a relevant problem. Seto et al. shows that relatives of those not technology-accustomed would be able to provide support to patient [Seto 2012]. Bond, 2014 finds that most people found the telehealth system easy to use and in the study of Prescher, 2013 most of the patients reported an easy and robust handling of the devices. Nontheless more quantitative studies about the influence of age, gender etc. on the use of STS should be developed to better understand implications of thoses macrosocial variables on the use of STS.

Legal aspects (LEG)

For the implementation of telemonitoring one has to look at least for existing property rights on the used system, the implemented software, existing patents, and to secure/regulate the permission for use.

For structured telephone support as a telemonitoring approach for patients with chronic heart failure there is a need of patient-cooperation which implies the will of the patient to take this kind of healthcare.

Data networks and data communication between providers of tele-healthcare and patients have to secure and protect data sources according to legal data protection regulations.

In any case the data protection should be on awareness, especially with low-level support via usual telephone or cell phone line. The informed consent with the patient and the (written) agreement are necessary.

Limited access to structured telephone support as a telemonitoring service for special persons have to be based on the balance between evidence of best outcome rates, economic calculations for the costs and reduction of possible disadvantages due to i.e. lack of compliance. The decision for inclusion/ exclusion into a structured telephone support service  has to be transparent.

Usually there is no health care tourism expected for structured telephone support for chronic heart failure patients. In case of (emergency) treatment abroad and re-transfer into the home-country the appropriate information and continuity of care has to be guaranteed. The routine provision of structured telephone support across borders (in our outside Europe) is expected to be limited by language.

There seem to be no major differences in product safety aspects comparing structured telephone support with usual care. The product safety and responsibility duties have to be followed in both settings. If telemonitoring/ stuctured telephone support is newly implemented there should be appropriate awareness for the safety structure to be equal/similar (or better) as in ”usual care”

Within structured telephone support provided by a physical person (like a nurse) and/or a group of professionals evaluating deterioration from the collected data by STS, the guarantee for quality can be given via the professional licencing regulations as it is handled within hospitals.

The Directive on public contracting assures price control of servies in case of contracting the whole STS service or in case of material purchasing for HF patients at home. Pricining within reimbursement system for STS (like DRG) is subject to national legislation. The pricing within DRG system must therefore take into account all national legislation and regulation, like national policy on wages or depreciation. However,  when the material costs are built into DRG, again the procedures for the public contracting is important, in case of STS it oculd apply to the telephone lines and various equipment that is given to HF patients to monitor their health status at home  (scales, meters for circumference of ankles etc).

Within medical services and/or medical devices advertising is regulated by local governments to prevent misinterpretation about the device or service.

There is still legal uncertainty within the provision of structured telephone support for patients with chronic heart failure in terms of

• Cross border healthcare services
• Funding aspects
• Reimbursement
• Procurement
• Sustainable business models
• Data protection via telephone line
• Provider responsibilities

For the provision of telemedical services/ STS several different legal regulations have to be followed, like:

• Occupational laws
• Hospital legislations
• Good clinical practice
• Health telematic law
• Data protection law
• E-government law
• Consumer protection law
• Signature law
• E-commerce-law
• Telecommunication law
• Copyright/ patent protection
• Media law

(list not exhaustive)