Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design

Chronic illness is the leading cause of disability and death worldwide [1], accounting for the majority of healthcare expenditures. Care for the chronically ill requires a multiplicity of providers, often resulting in fragmentation at multiple locations. Care coordination becomes an important issue since significant proportions of the population are affected. In the nephrology setting, Patients with chronic kidney disease (CKD) may remain asymptomatic at the early stages of the disease, leading to suboptimal care [2‐4]. It is well documented that coordination of care between healthcare providers and multidisciplinary care teams is associated with earlier nephrology referral and reduced morbidity, mortality, overall cost and number of consultations [5]. Many countries have searched for ways to improve care coordination. Multidisciplinary care clinics have incited much interest while another possibility, telemedicine, has received relatively little attention [6]. French legislators have nevertheless recognised the potential of five telemedicine applications: teleconsultation, tele-expertise, telemonitoring, tele-assistance and coordination of medical response [7].

One promising application is home telemonitoring, a solution where active patient participation is a central component. Communication is facilitated between the patient and healthcare professionals as is interaction between healthcare providers. The characteristic feature of this mode of intervention is its capacity to strengthen patient follow-up, allowing rapid detection of early symptoms signalling potential deterioration of the patient’s health status. Theoretically, better control of chronic illness would have a significant impact on overall healthcare, limiting expenditures and reducing the need for acute care and hospitalisation. Several studies have demonstrated that telemonitoring enables better control of blood pressure, blood glucose, and asthma symptoms [8]. Telemonitoring would also improve patient autonomy by helping patients to a better understanding and control of their chronic disease and disease-related symptoms, an important incentive for treatment adherence.

Telemedicine has been evaluated in the nephrology setting for the follow-up of home dialysis patients. A clinical benefit has been demonstrated for patients on peritoneal dialysis and haemodialysis in satellite outpatient dialysis units, with a reduction in the number of hospitalisations [9‐11]. For renal transplantation, data are scarce in the literature [12] and no telemedicine data are available for CKD stage 3-4 patients.

Very few studies have explored the cost-effectiveness of telemedicine for the management of chronic disease [13]. One study conducted in the United States among patients with chronic obstructive pulmonary disease and heart failure demonstrated a 4.3% reduction in mortality and a 9.8% reduction in cost [14]. To date no study has addressed the question for CKD patients.

The French national investments in the future programme initiated in 2010 included a tender designed to stimulate the development of economic models in the eHealth field (esante.gouv.fr/actus/politique-publique/). Specifically, healthcare providers were encouraged to perform studies in cooperation with industrial partners to demonstrate the usefulness of large-scale programmes offering complete service packages. Designed in this framework, eNephro was selected with its industrial promoter, Pharmagest Interactive (http://​www.​pharmagest.​com). This background has provided a unique opportunity to evaluate the cost-effectiveness of a novel technique for home telemonitoring incorporating an expert system and centred on the active participation of CKD patients before and after renal replacement therapy.

There have been very few assessments of the medicoeconomic interest of home telemonitoring for chronic diseases, and the quality of evidence has often been weakened by methodological flaws. Therefore, it is difficult to compare home telemonitoring with usual care for the chronic diseases studied [25]. eNephro is the first medicoeconomic study designed to evaluate the benefits of home telemonitoring for CKD patients at different stages. The implementation of telemedicine applications differs from other health interventions, such as the use of medications or devices, in that these applications contain several interacting components and have effects that are highly dependent on the local context in which they take place. Evaluating such interventions, qualified as complex interventions [26], raises practical and methodological issues that researchers have to take into account. Guidance for developing and evaluating complex interventions was published by the Medical Research Council in 2008 [26]. Later, national and international templates for the specific evaluation of telemedicine projects, integrating general recommendations about the assessment of complex interventions, were published in 2012-13 (HAS [27], MAST [28]). All templates emphasize the need for a comparative design [29], but acknowledge the trade-off between methodological requirements to ensure internal validity and the necessity to permit a degree of flexibility or tailoring of the assessed intervention. Ensuring strict fidelity to a protocol (e.g. medications trials) may be inappropriate as the intervention may work better if adaptation to the local setting is allowed. The choice of a pragmatic trial for our evaluation combines the methodological requirements (comparative design and randomisation) and the necessary flexibility in the implementation of the intervention. Templates also underscore the usefulness of multiple outcomes and the integration of patients’ and professionals’ points of view, important aspects included in the eNephro evaluation. Moreover, the effects of telemedicine on patient health – clinical parameters, morbidity, mortality, health-related quality-of-life – are evaluated and all resources used are considered in the cost evaluation, according to the above-mentioned recommendations. The French health insurance database (SNIIRAM) appears to offer the best way to estimate medical expenditures incurred for a given patient during a given period. SNIIRAM records data for all healthcare beneficiaries in France, and includes the reimbursed costs of all out-of-hospital healthcare consumptions, as well as all hospital stays and consultations in public or private institutions [30]. Finally, the acceptability of the telemedicine system and satisfaction with its use are assessed, as recommended, for all stakeholders, i.e. patients randomised to intervention groups and health professionals involved in the home telemonitoring.

Many types of results are expected to come forward. For patients with stage 3B/4 CKD, eNephro home telemonitoring should allow enhanced follow-up since clinical and biological information will be recorded regularly by the data platform. It is also expected that the expert systems identifies early situations where patients risk for decompensation and/or deterioration of their health status, even before the development of clinical symptoms prompt them to seek medical assistance. This should enable more rapid medical intervention and a lower rate of hospitalisation. Better control of blood pressure and proteinuria should delay the need for more aggressive care with replacement therapy. For patients on home and out centre dialysis (haemodialysis or peritoneal dialysis), regular transmission of data issuing from various sources (patient, health practitioners, medical devices, medical laboratories) should lead to earlier and more rapid care for complications, with a reduction in the need for hospitalisation, an important source of medical expenditure in this population. It has been demonstrated that an expert system evaluating the state of hydration of patients on peritoneal dialysis enables a considerable reduction in the number of hospitalisations for acute pulmonary oedema [19]. Furthermore, knowing one is under telesurveillance and that important health data can be transmitted quickly is reassuring. For patients on haemodialysis, the transmission of data issuing from the generator during the dialysis session improves the detection of problems involving a malaise [31] or the vascular access [18]. Transplant recipients should also benefit from telesurveillance facilitated by a specifically designed expert system [12], and the number of visits to the transplantation centre may be limited when clinical and biological parameters remain within target ranges.

Use of a home telemonitoring system affects medical routine practices, implying to adapt and reorganise the physicians work schedule. It’s necessary to fix daily time slots for monitoring alerts, communicating with patients, or adapting treatments. As the mass of data generated by the system is significant, a telemedicine coordinator (e.g. a coordinating nurse) seems to be necessary to deal with all information transmitted. The reduction in the need for in-centre visits undoubtedly releases time for this new allotment. The acceptability of a telemedicine system by physicians depends heavily upon the capacity for optimal reorganisation, and the realisation that home telemonitoring activity is not simply an added work load. The clinical situations requiring management should be less complicated, and thus less time demanding since detected earlier by the expert system. Home telemonitoring also facilitates communication and cooperation between specialists, disciplines, and referral levels (nephrology – 2^nd line referral, general medicine – 1^st line referral), undoubtedly leading to improved patient-centred care. All of these elements join together to facilitate the delivery of higher quality care, a common goal for patients, professionals and healthcare systems.

For the healthcare system, home telemonitoring also contributes to cost containment by limiting the need for patient transportation, by reducing the number of in-centre visits, hospitalisations and by favouring early care for deteriorated health status and by preventing complications. In the eNephro study, it is expected that the costs generated by the telemedicine system are counterbalanced by lower overall healthcare costs. In this case, the results would be an important argument favouring reimbursement of home telemonitoring costs by the national health insurance fund.

This study can be expected to identify barriers and facilitators for implementing a home telemonitoring system as well as profiles of patients most likely to benefit from this new care system.

The first patient was enrolled in the eNephro study on November 27, 2015. At the time this article was submitted, a total of 259 patients (127 telemedicine patients; 132 control patients) had been enrolled.