LEAP Virtual Visit Assessment (VIVA): a structured protocol for virtual visits for patients with heart failure

Introduction

Chronic heart failure (HF) is a common progressive condition that is associated with significant clinical and economic burden and worsened quality of life.1 HF is a leading cause of hospitalization, and is further associated with high rates of mortality and morbidity.1,2 In the USA, it is estimated that almost 3% of the adult population has HF.2 Moreover, with the increase in aging of the population globally, HF will continue to be a significant clinical problem. Given this, collaborative efforts to optimize management strategies, improve clinical outcomes, and minimize the associated burden are needed.

Patients with HF are considered as a high-risk group for increased mortality.3 The coronavirus disease 2019 (COVID-19) era, during which this article was written, has led to restructuring of many hospitals and limitations of traditional medical visits, which might be associated with late recognition and treatment of episodes of decompensation and thus missed opportunities to optimize the patient's therapy.4–6 Lifestyle alterations may also have led to dietary changes, decreased physical activity, and increased consumption of alcohol that can trigger decompensation of HF.6

Efforts to overcome the limitations in management of patients with HF include greater use of telemedicine, which can be broadly described as telecommunication-based management. The use of telecommunications has been described in many areas in medicine, and its use in patients with HF is no exception.3,7–9 Telemedicine represents a potentially useful tool that can guide treatment of patients to minimize the risk of exposure in the hospital setting, while continuing to provide treatment to patients with HF and monitor for signs of new onset or worsening disease, and reduce avoidable visits to the clinic.

A number of different strategies for remote services in patients with HF have been described.3 These include home monitoring, virtual visits, forward triage, in-hospital telemedicine, and telerehabilitation.3 Home monitoring consists of remote monitoring and transmission of vital parameters (via devices, telephone, apps) to the clinic for interpretation and management, while forward triage is considered as sorting of patients in the emergency department prior to presentation to the clinic.3 Virtual visits are remote visits using an audiovisual telecommunication system or online portal.3 Lastly, telerehabilitation is the delivery of rehabilitation services remotely, in contrast to in-hospital telemedicine which consists of telemedicine in the in-hospital setting.3 Each of these strategies has different objectives, challenges, and limitations.

Although several studies have been carried out on the use of telemedicine in patients with HF, many such virtual visits are carried out on an ad hoc basis, with few strict definitions and protocols. Since 2018, a project called LEAP has been implemented in 20 centers in Italy. The LEAP project consists of the analysis of the patient's journey with HF at the 20 centers and consequent development of tools and initiatives aimed at optimizing the stakeholder experience. Given the paucity of well defined protocols for virtual visits with patients with HF, as part of the LEAP project, a structured protocol that defines all steps of virtual visits and complete with guides and support kits for both clinicians and patients was developed. Herein, the LEAP Virtual Visit protocol is presented.

Materials and methods

The structured protocol was initially developed by BIP with the support of Novartis Farma (Italy). A working group of clinicians was established which included the following hospitals: Azienda Provinciale per i Servizi Sanitari Provincia Autonoma di Trento, Ospedale Santa Chiara, Unità operativa cardiologia; Azienda Unità Sanitaria Locale di Reggio Emilia, Arcispedale S. Maria Nuova, Struttura Complessa di Cardiologia; ASST Papa Giovanni XXIII, Cardiologia 1; Azienda Ospedaliero Universitaria Ospedali Riuniti, Foggia, Cardiologia Universitaria, Utic Riabilitazione Cardiologica. The protocol was later validated by 63 additional centers through a series of workshops and sharing of protocols, training clinicians and other healthcare professionals (HCPs) involved for future implementation.

The virtual model for monitoring HF patients proposed herein was developed based on the following process:

(1) measurement and sizing of the patient flows in terms of patient profiles and type of services (emergency access, first visit, follow-up visits, etc.); (2) the flow was carefully analyzed to detect potentially critical points in terms of organizational bottlenecks; (3) next, the management processes of clinical visits were broken down to identify specific activities, players, roles, and support tools used in daily practice. Results Development of LEAP Virtual Visit protocol

The overall project consisted of four main processes: development of an organizational model; identification of the technology to be adopted; analysis of legal aspects; development of support tools.

In developing the organizational model, the type of visit along with previsit activities, duration of the visit, and actions needed post-visit were taken into consideration. The different players were identified (clinician, nurse, patient, caregiver). In the protocol developed, sections were included on patient eligibility, exams and supportive tools, and practical organizational aspects. IT requirements were also considered and the most widely used teleconference platforms were compared according to features that were considered to be priority for virtual visits (e.g. data protection, document sharing, user experience). Protocols and support kits were developed for both clinicians and patients (see text file, Supplemental Digital Content 1, https://links.lww.com/JCM/A475, which includes this material). These include the following:

(1) a clinical guide that provides all the information necessary to set up and implement the virtual visit service (e.g. how to enroll patients and the activities to conduct during the visit), ensuring standardized patient management; (2) two questionnaires to assess the level of satisfaction of both clinicians and patients after the virtual visit; (3) a patient guide to ensure the patient is fully onboarded and prepared to properly manage the visit remotely (in terms of procedures and technology); (4) a patient diary to collect clinical parameters (e.g. weight, heart rate, blood pressure, fluid intake) and patient-reported outcomes (difficulties at walking, sleeping etc.) that can be used by the clinician to evaluate the patient's condition; (5) disease progression brochure to increase the patient's awareness of HF and its management (e.g. symptoms, lifestyle); (6) register of activities and monitoring template of key performance indicators to identify possible corrective actions during the test phase. Description of the protocol

The phases include an enrolment phase, document sharing phase, pre-evaluation phase, the virtual visit itself, and the post-visit phase. The overall protocol developed is shown in Fig. 1. The protocol for the virtual visit was divided into eight steps to be sequentially carried out between the clinic and patient/caregiver. The process is started by the clinic who explains the process to the patient/caregiver during a physical visit or by telephone.

F1Fig. 1:

Flow chart for virtual visit.

Patients eligible for a virtual visit can be identified among those already treated by the clinic, considering a set of criteria that refer both to their clinical condition and digital readiness. The patient then expresses his/her desire to participate by signing the consent form, which was generally done during the first face-to-face visit. The starter kit is then handed to the patient or shared through the selected platform along with the date and time of the virtual visit. The patient then obtains/performs the documentation/exams requested and sends them to the center through the indicated channel prior to the virtual visit (Fig. 2).

F2Fig. 2:

Detail of pre-visit and virtual visit.

The following were considered essential information to be collected through the patient's diary: weight, blood pressure, heart rate, and daily activity, while SpO2 was considered optional. Depending on the organization of the clinic, the systematization of collecting patient data can be supported by nurses or specialist physician trainees to let the specialists focus exclusively on clinical evaluation and patient interaction.

During the visit the clinician and patient review the clinical parameters and evaluate pharmacotherapy. The therapy is confirmed or changed as needed, and any additional exams are requested. Clinical reports and prescriptions (exams or therapies) are shared with patients according to the different hospital protocols, either by secured encrypted mail or via a traditional paper copy to be collected at the hospital at the patient/caregiver's convenience. A checklist for the clinician (Table 1) is provided to support a structured approach to the virtual visit and ensure that all key activities (from discussion of clinical parameters to the scheduling of the next appointment) are carried out.

T1Table 1:

Virtual visit activities checklist for patients with heart failure

Discussion

The protocol described herein can be expected to have a number of benefits for the patient, clinic, and healthcare structure as shown in Table 2. For the patient, benefits are possible in terms of simplification of the logistics involved in the visit, while minimizing the risk associated with the exposure in the hospital setting to potential infections or contagious diseases, with possibly reduced direct and indirect costs. For clinicians, a virtual follow-up visit allows the patient to be under continuous care and be efficiently managed, even at a distance, therefore contributing to reducing the visit backlog. Furthermore, adoption of this model reduces the number of informal interactions through channels that may not guarantee the protection of patient personal and clinical data (e.g. instant messaging) according to the provisions of the General Data Protection Regulation (GDPR). The protocol is also perceived to have benefits for the healthcare structure by increasing the volume of patients under care with potentially increased cost savings.

Table 2 - Potential benefits of virtual follow-up visits of patients with HF using the protocol devised Benefit Patient Clinic Healthcare structure Simplification of logistics • Minimize risk of contagion • • Potential time savings for clinical staff • Continuity in care • • • Streamline patient visits • Use of innovative solutions for management • • • Increase in volume of patients seen • Reinforcement of physician–patient contact • Reduction in direct and indirect costs • •

The use of telemedicine has become of pressing concern. In fact, given the initial guidance from the Italian Ministry of Health on 13 April 2020 recommending the adoption of telemedicine, 14 of 21 regions have, to date, regulated the use of telemedicine. The use of telemedicine must obviously be tailored to the individual condition and diagnostic and follow-up exams needed. The LEAP structured virtual management protocol described herein is an important step in that direction. The LEAP Virtual Visit protocol describes all the steps and exams to adopt that can be easily tailored to the needs of the individual center and patient.

The minimal tests required at each virtual visit are broadly similar to the recent proposal by Orso et al. for outpatient telephone monitoring.10 Those authors devised a 23-item questionnaire to obtain a score that assigns patients to progressively increasing risk score groups: green, yellow, and red. We feel that a virtual visit adds important information to telephone monitoring alone, since it allows the clinician to see the patient and interact with him/her.

Telemedicine has been widely proposed and studied even before the COVID-19 pandemic,11 although the benefits have been somewhat controversial.12 A meta-analysis of telemedicine in 2015 concluded that a program of structured telephone support and telemonitoring significantly decreased the number of both deaths [odds ratio (OR) 0.53] and hospitalization for HF (HHF; OR 0.69) versus usual care. An updated analysis of randomized controlled trials in 2017 confirmed that telemedicine is associated with reduced all-cause mortality (OR 0.68) and HHF (OR 0.61).13 Similar results were also seen in a meta-analysis of 29 randomized trials involving almost 11 000 patients [all-cause mortality (OR 0.75) and HHF (OR 0.74)].14 Although limited information is available on virtual visits, similar or better outcomes can be expected. Current analyses thus highlight the need for additional studies using defined protocols such as LEAP Virtual Visit to better define the clinical benefits of telemedicine, and will be the object of future study.

While telemedicine may have many potential advantages, there are obviously practical considerations that limit its implementation in routine practice.3 These include the hardware needed (i.e. computer, smartphone, tablet) and internet access. In fact, some patients may be unable to use the devices needed or participate in a telemedicine session without assistance because of old age, hearing loss, and cognitive dysfunction. Moreover, some patients may prefer in-person visits over virtual visits,15 although satisfaction with telemedicine can be considered high overall.16 Overcoming the barriers to telemedicine obviously requires further evidence and focused changes in policy.17 In addition, the important role of the caregiver must be taken into consideration in patients with HF as they have a key function in the care of many patients.18 Indeed, considering that caregivers play a major role in HF self-care and that 59% of patients present to physical clinical visits with their caregiver, clinicians can hypothesize that the caregiver will still be the point of reference during virtual visits for 48% of patients.

Notwithstanding these limitations, it is clear that health technology solutions are needed to improve on gaps in care.19 Implementation of a priority system and telemedicine are now being actively discussed, and it is certain that telemedicine will play an increasing role in the future, even in the post-COVID-19 era.20

Acknowledgements

The authors thank Patrick Moore, PhD for medical writing assistance on behalf of Health Publishing & Services srl, which was funded by Novartis Farma, Origgio, Italy in accordance with Good Publication Practice (GPP3) guidelines.

Conflicts of interest

M.S. declares consultancy for Novartis, Abbott, Merck, Bayer, Vifor, Astrazeneca, Boehringer. J.M.F. and M.V. are employees of BIP Life Sciences. G.L.D. and L.P. are employees of Novartis. The other authors declare that they have no conflict of interest.

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