Remote monitoring of CIEDs: How important is the organisational model and what can be achieved?

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Renato Ricci

Renato P Ricci (Rome, Italy) writes about the HomeGuide organisational model, a strategy aimed to improve the effectiveness of remote monitoring of cardiac implantable electronic devices (CIEDs) with low resource consumption. The strategy focuses on the joint work of expert allied professionals with a coordinating physician.

Remote monitoring is currently the standard of care for the follow-up of patients with cardiac implantable electronic devices (CIEDs), as stated by the recently delivered Heart Rhythm Society Expert Consensus Statement on Remote Interrogation and Monitoring for Cardiovascular Electronic Implantable Devices;1 despite this, adoption in daily clinical practice remains slow.

Remote monitoring is currently offered only to less than 50% of potential candidates in the USA and much less in Europe. Possible explanations for this include: reluctance accepting new technology, concern for legal issues, reimbursement issues (in Europe) and concern for increased work burden in the transition phase.

As a matter of fact, the greatest challenge in implementing remote monitoring in standard practice is the need to develop new organisational models. Different from face-to-face visits, more actors are involved in the telemedicine scenario, playing different roles. Standard organisational models applied by early adopters failed in appropriate planning of regular transmission and alert reviewing by the physician and in defining early reaction strategies to life-threatening alerts.

Effective organisational strategies should include strict definition of roles and responsibilities, early reaction ability, high reliability and safety, traceability, keeping continuity of care, low resource consumption, high patient acceptance and satisfaction, maintaining human relationship with the patient.


The HomeGuide organisational model: Primary Nursing

First tested in a single-site pilot experience, the HomeGuide organisational model was then evaluated in a large Italian multicentre registry. It is based on the Primary Nursing model in which each patient is univocally assigned to an expert reference nurse under supervision of a responsible physician. Both have specific tasks and responsibilities related to remote monitoring.

Two distinctive features characterise the HomeGuide organisational model: i) the key role of the reference nurse to filter remote monitoring data and ii) the assignment of a patient to one nurse responsible for continuity of care in order to reinforce patients’ feeling of being under constant professional observation and to increase the degree of customisation of the patient-to-clinic relationship. To this purpose, the initial patient training is critical in order to ensure that both patients and relatives actually understand what the objectives of remote monitoring are, how it works, how to manage the transmitter unit, whom to address any question or further issues. Remote monitoring transmissions have to be reviewed by the reference nurse within two working days, upon remote monitoring alert of critical events flagged for attention.

Critical or controversial reports have to be submitted to the responsible physician for medical decision. Automatic alerts are also programmed to notify connectivity interruptions. Even in case of no alerts, the reference nurse has to check all patient data at least every three months. Alerts are individually programmed. Written protocols are established in order to guide nurse reaction to findings and alerts. After clinical evaluation, the reference nurse is responsible for checking patient compliance and therapy benefits. In case of symptoms or device sound or vibration alerts, the patient is encouraged to contact himself the reference nurse for clinical assistance. If the case, a manual transmission may be asked to the patient. Bidirectional communication between the patient and the reference nurse is critical for the continuity of care. At enrolment, the responsible physician focuses patient attention on clinical aspects, suggesting behaviour rules to be followed in different circumstances. In particular, he stresses that remote monitoring currently does not represent an emergency system. The patient is appropriately informed about the service and he has to sign a legally binding informed consent document. Further duties of the responsible physician are alert update and overview of the full process. In the Figure 1,3 the organisational model workflow with action items and responsibilities is detailed2.

The HomeGuide registry3,4

The aim of the HomeGuide registry was to estimate the effectiveness of device remote monitoring in clinical event detection and management and to analyse the associated outpatient clinic workload and impact on resource consumption by applying the previously described organisational model. An extensive training programme was performed before starting to promote the HomeGuide organisational model and to get centres familiar with it. Remote monitoring was accomplished with the Home Monitoring system (Biotronik). From March 2008 to September 2011, 1,650 patients were enrolled in 75 Italian centres.

During a 20-month follow-up, generalised estimating equation (GEE)-adjusted sensitivity and positive predictive value of remote monitoring in detecting 2,471 independently adjudicated events were 84.3% and 97.4%, respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during remote monitoring sessions. Median reaction time was three days. GEE-adjusted incremental utility, calculated according to four properties of major clinical interest (remote monitoring-witnessed; correct initial diagnosis; asymptomatic events; actionability), was significantly in favour of the Home Monitoring sessions (+0.56). Looking at source consumption, 76% of Home Monitoring sessions were performed by the nurse, who submitted to the physician only 15% of the reports for clinical evaluation. The physician planned unscheduled face-to-face visits in 12% of revised transmissions. Overall, with the HomeGuide model workflow, remote monitoring required a median manpower of 55.5 minutes x health personnel per month every 100 patients.


Patient acceptance and satisfaction

Data from the registry demonstrated a high rate of patient satisfaction for different aspects such as the patient’s perceived relationship with their healthcare providers, ease of use, psychological impact, and the ability to maintain follow-up compliance. Only a minority of patients did not accept remote monitoring, for reasons that include privacy concerns, fear of technology, and concern about the risk of losing human contact with nurses and physicians. Clear explanations of what data are transmitted, where they are transmitted to, under what circumstances, and how the data are to be used often assuage patients’ privacy concerns. To this regard, in the Primary Nursing model personal knowledge of the allied professionals who actually call the patient in case of trouble can considerably strengthen the human relationship and improve patient compliance.


Conclusion

Time is right to offer remote monitoring to all patients with implantable devices. The suggested model involving expert allied professionals with a coordinating physician combines effectiveness with low resource consumption. It may represent the key to extensively implement remote monitoring in standard practice.


References

  1. David Slotwiner et al: HRS Expert Consensus Statement on Remote Interrogation and Monitoring for Cardiovascular Electronic Implantable Devices, HeartRhythm, https://dx.doi.org/10.1016/j.hrthm.2015.05.008.
  2. Ricci RP, Morichelli L: Workflow, time, patient satisfaction from the perspective of home monitoring. Europace 2013;15:i49–i53.
  3. Ricci RP, Morichelli L, D’Onofrio A, Calò L, Vaccari D, Zanotto G, Curnis A, Buja G, Rovai N, Gargaro A: Effectiveness of remote monitoring of cardiac implantable electronic devices in detection and treatment of clinical and device-related cardiovascular events in daily practice. The HomeGuide Registry. Europace 2013;15(7): 970-977.
  4. Ricci RP, Morichelli L, D’Onofrio A, Calò L, Vaccari D, Zanotto G, Curnis A, Buja G, Rovai N, Gargaro A. Manpower and outpatient clinic workload for remote monitoring of patients with cardiac implantable electronic devices: Data from the HomeGuide registry. J Cardiovasc Electrophysiol. 2014 Nov;25(11):1216-23.


Renato P Ricci is with the Department of Cardiology, San Filippo Neri Hospital, Rome, Italy. He has received  minor consultancy fees from Medtronic and Biotronik.

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