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Telehealth for heart failure management: patient empowered self-care or surveillance by the nanny state?

“...as telehealth becomes more sophisticated and perhaps the only economic option for the delivery of chronic disease management, might we see a shift from self-management to one of surveillance by the state?” Kevin M Goode* The UK, with its increasing older population, worsening diet, inactive lifestyles and the consequent burden of chronic disease; faces a crisis of increasing healthcare demands set against a backdrop of drastic fiscal cuts. How can the government reconcile these two problems? At least for now, telehealth is seen as just one of the many care choices for patients with heart failure (HF). However, as telehealth becomes more sophisticated and perhaps the only economic option for the delivery of chronic disease management, might we see a shift from self-management to one of surveillance by the state? If a patient continually fails to adhere to dietary, lifestyle and medication advice, might the information that telehealth provides, lead to the possibility of a withdrawal of free healthcare services for the noncompliant? Society is embarking on a bold social experiment with the wider scale introduction of telehealth (or home telemonitoring) for the management of chronic conditions such as HF. In the UK, we are witnessing the transition from largescale randomized controlled trials (RCTs) of tele­ health (such as the Whole System Demonstrator program [1,2]) ; to the mainstream delivery of healthcare using telehealth [3] .

Telehealth makes use of simple daily vital sign monitoring (e.g., weight, blood pressure and heart rate) combined with symptom questionnaires. This information can now easily be collected in the home environment and sent via the internet or mobile communications network to a clinician. Using this information the clinician can identify any deterioration in health status and provide proactive and timely intervention. There is now good evidence that telehealth for the management of patients with HF reduces mortality, HF-related hospitalizations and length of stay [4–7] . What is not so clear is the mechanism by which it achieves this benefit; although frequency of measurement (>once per week) and speed of response (within 1 day) have been shown to improve patient outcomes [8] . Advocates of telehealth often refer to the benefits of patient-empowered self-care; arguing that daily monitoring facilitates a better understanding of a patient’s own condition and the triggers that precipitate physiological decline. This, they assert, leads to the positive reinforcement of good habits, which ultimately leads to better self-management and, by implication, better patient outcomes. However, despite two recent systematic

KEYWORDS

• adherence • heart failure • home telemonitoring • self-care • surveillance • telehealth

*Department of Health Technology & Perioperative Practice, Aire Building, Faculty of Health & Social Care, University of Hull, Cottingham Road, Hull, HU6 7RX, UK; Tel.: +44 (0)1482 464608; [email protected]

10.2217/FCA.14.5 © 2014 Future Medicine Ltd

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“Indeed, given the societal costs of nonadherence, what responsibility does the state have to ensure that patients comply with their medication?”

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reviews, there is insufficient evidence to support this position [9,10] . This is due to the high heterogeneity between the studies, poor study quality and a significant risk of confirmation bias. Early RCTs of telehealth were actually designed with a surveillance model in mind; with the monitoring clinician keeping track of a patient’s health status. Yet despite this rather paternalistic model, the majority of studies have demonstrated improved outcomes. We cannot rule out a complex interaction between surveillance and self-care, but as yet there is no evidence to support this. Whatever the mechanism of action, it seems reasonable to expect that the improved outcomes are a result of better adherence to medication and life-style changes. In the TEHAF study, patients in the telehealth arm had a greater understanding of the importance of medication adherence by 6 months than those receiving usual care [11] ; although no difference in self-reported medication adherence was observed. However, self-reported adherence is considered an unreliable measurement instrument. The WHO has estimated that in the developed world only 50% of those who suffer from a chronic disease adhere to their medication [12] . In elderly patients with HF, estimates of medication adherence range from 10 to 98%, depending on the measurement instrument used [13] . Given the millions of pounds invested in the development of safe and effective treatments for HF, it makes sense to tackle the issue of poor medication adherence. Indeed it has been estimated that medication nonadherence costs the EU approximately €125 billion and the USA approximately $289 billion annually. Good adherence to medication is associated with better mortality [14] and patients with HF who do adhere to their medication have less emergency department visits [15] . The reasons why a patient fails to adhere to evidence-based medication are likely to be multifactorial [16,17] . It may be that the patient does not understand why they are being prescribed a medication (often as a result of poor communication by clinicians), they may simply forget to take it, have poor dexterity due to arthritis or are put off by unpleasant side effects. Socioeconomic factors and the costs of medication can have unexpected consequences such as prescription sharing or self-restriction [18] and cultural norms can negatively impact on attitudes towards medicine [12] .

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The use of spot urine tests in patients recruited to a RCT of ramipril for patients with diabetes (the DIABHYCAR study [19]) revealed that despite being randomized to the active medication, 27% were not taking it at follow-up. What is surprising about this result is that the patients understood that they were in a clinical trial and that they would be subject to a urine test to look at levels of medication. Despite this, more than a quarter stopped taking ramipril altogether. Of course medication adherence is only part of the problem. Patients with HF often have multiple cardiovascular risk factors such as diabetes, chronic obstructive pulmonary disease, pre-existing coronary artery disease, atrial fibrillation, obesity, smoking, high alcohol use, a sedentary life style and advancing age. They need to not only adhere to medications to manage HF, but also those medications needed to manage their comorbidities. Furthermore, they also need to adhere to lifestyle changes such as exercise, improved diet, smoking cessation, reduced alcohol consumption and fluid and salt restriction (although there is little or no evidence to support the latter). How can we reinforce the importance of medication adherence? Maybe one solution is to see adherence as not only the responsibility of the patient, but also that of the clinician, family, friends and possibly even neighbours. Indeed, given the societal costs of nonadherence, what responsibility does the state have to ensure that patients comply with their medication? Is telehealth the tool the state can use to ensure better medication and lifestyle adherence in patients with HF? Consider a not too distant future where patients with HF have to use wearable or implantable vital sign monitoring devices; where their urine is tested via a smart toilet. The toilet knows who is using it by an RFID tag in their monitoring device. If the patient fails to take their medication or is not following diet recommendations then this will be detected via a sample of their urine. If they are too inactive this will be detected by accelerometers in their wearable/ implantable device. They will be sent reminders. If they persist in noncompliance they will be fined or given the choice to take part in an online educational session. If they persist in their noncompliance then access to free healthcare would be removed. If this sounds draconian and a little farfetched, consider how quickly we have accepted punitive measures for those who do not wear seat

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Telehealth for heart failure management: patient empowered self-care or surveillance by the nanny state?  belts while they are driving, despite any clear evidence that it reduces death or serious injury [20] . The same is now true of using mobile phones whilst driving and tachometers are required to ensure long-distance lorry drivers do not exceed speed limits or drive for too long. In the UK, if a driver is caught speeding they can mitigate the points on their license by opting for a safety awareness course; however if they repeat offend they lose their license to drive. The evidence for the negative effects of nonadherence to medication and/or lifestyle is much more compelling and yet as a society we seem frightened to apply similar principles to healthcare. Is it important to uphold the principles of patient choice; the right to choose whether to take all, some or none of the medication that healthcare professionals recommend for us? May we have to accept that by consciously deciding not to take our medication we have to forfeit our right to be given care when our health deteriorates more seriously? Worse still, if we agree to take our medication but telehealth can demonstrate we are not being entirely truthful, we may have to face punitive consequences? Future telehealth may provide a cost-effective mechanism for healthcare delivery that maximizes the benefits of medication and lifestyle interventions while rewarding those who follow them by giving them continued access to medical services whatever the ultimate progression of their disease. For those who won’t comply (rather than can’t) they will not retain these benefits.

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Bower P, Cartwright M, Hirani SP et al. A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial. BMC Health Serv. Res. 11, 184 (2011). Steventon A, Bardsley M, Billings J et al. Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial. Brit. Med. J. 344, e3874 (2012).

3

Appello Telehealth Ltd. White Paper - 3 million lives; which 3 million lives? (2012). www.telehealthforum.org/wp-content/ uploads/2012/05/Salix-Appello-White-PaperFINAL.pdf.

4

Polisena J, Tran K, Cimon K et al. Home telemonitoring for congestive heart failure:

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As the system currently stands, I am probably one of the last people who might want to accept any technology to monitor a long-term condition should I be unfortunate enough to acquire one. Like Neo in The Matrix I would probably choose the ‘red’ pill rather than continue to accept an ordered and prescribed reality. Of course, faced with a chronic illness and a new-world-order of conditional care, I may find it more palatable to take the ‘blue’ pill. Disclaimer The opinions expressed in this opinion article are those of the author and do not necessarily reflect the views of Future Medicine Ltd.

Acknowledgements KM Goode would like to acknowledge the assistance of Amanda Crundall-Goode for proofreading of the final article.

Financial & competing interests disclosure KM Goode has previously received consultancy fees in relation to telehealth projects from Philips Research and Merke Sharp & Dohme (UK) and is in receipt of grant funding from the UK Engineering and Physical Sciences Research Council for a project on telehealth. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript. a systematic review and meta-analysis. J. Telemed. Telecare 16(2), 68–76 (2010).

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Marre M, Chatellier G. Assessment of patients’ and physicians’ compliance to an ACE inhibitor treatment based on urinary N-acetyl Ser-Asp-Lys-Pro determination in the noninsulin-dependent diabetes, hypertension, microalbuminuria, proteinuria, cardiovascular events, and ramipril (DIABHYCAR) study. Diabetes Care 29(6), 1331–1336 (2006). 20 McCarthy M. The benefit of seat-belt

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Telehealth for heart failure management: patient empowered self-care or surveillance by the nanny state?

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