Telemedicine home-based management in patients with chronic heart failure and diabetes type II: study protocol for a randomized controlled trial.

BACKGROUND: Heart failure and type 2 diabetes are prevalent public health issues in Europe. These complex chronic conditions require extensive pharmacological management, ongoing self-care, and behavioral changes. Despite the known benefits of lifestyle changes, such as regular exercise and better control of blood sugar levels, patients may need help implementing the recommended changes. This study aims to assess the effectiveness of a telemedicine program for managing heart failure and type 2 diabetes at home. The program focuses on promoting lifestyle changes. METHODS AND ANALYSIS: During scheduled outpatient cardiology evaluations, eligible patients are recruited and randomly assigned to either an intervention or control group in a 1:1 ratio. The intervention group receives support from a nursing case manager through a structured home-based teleassistance program and a trainer for daily physical activity stimulation. They also have access to teleconsultations with cardiologists and diabetes specialists as needed, telemonitoring of vital signs, and daily step tracking. An app records and monitors daily drug treatment, glycemia, blood pressure, heart rate, and other clinical parameters. Patients can also self-report symptoms and communicate via a chat and videoconference system with a Nurse Case Manager. The control group receives routine care. Data collection occurs before intervention and 6 months after baseline during a new outpatient cardiology evaluation. The primary outcome is to measure the difference in the distance walked during a 6-min walk test between baseline and after 6 months. The key secondary outcomes include improving the disease status and physical activity profile. Data will be analyzed according to the intention-to-treat principles. DISCUSSION: This study will provide evidence on the efficacy of a telemedicine home-based management model to maintain correct lifestyles in patients with both heart failure and type 2 diabetes, improving self-management, their empowerment on the diseases, and increasing their knowledge and ability to recognize symptoms early. TRIAL REGISTRATION: ClinicalTrials.gov NCT05633784. Registered on November 30, 2022.

COVID-19 teleassistance and teleconsultation: a matched case-control study (MIRATO project, Lombardy, Italy).

Background: During the COVID-19 pandemic, telemedicine has been recognised as a powerful modality to shorten the length of hospital stay and to free up beds for the sicker patients. Lombardy, and in particular the areas of Bergamo, Brescia, and Milan, was one of the regions in Europe most hit by the COVID-19 pandemic. The primary aim of the MIRATO project was to compare the incidence of severe events (hospital readmissions and mortality) in the first three months after discharge between COVID-19 patients followed by a Home-Based Teleassistance and Teleconsultation (HBTT group) program and those discharged home without Telemedicine support (non-HBTT group). Methods: The study was designed as a matched case-control study. The non-HBTT patients were matched with the HBTT patients for sex, age, presence of COVID-19 pneumonia and number of comorbidities. After discharge, the HBTT group underwent a telecare nursing and specialist teleconsultation program at home for three months, including monitoring of vital signs and symptoms. Further, in this group we analysed clinical data, patients' satisfaction with the program, and quality of life. Results: Four hundred twenty-two patients per group were identified for comparison. The median age in both groups was 70 ± 11 years (62% males). One or more comorbidities were present in 86% of the HBTT patients and 89% in the non-HBTT group (p = ns). The total number of severe events was 17 (14 hospitalizations and 3 deaths) in the HBTT group and 40 (26 hospitalizations and 16 deaths) in the non-HBTT group (p = 0.0007). The risk of hospital readmission or death after hospital discharge was significantly lower in HBTT patients (Log-rank Test p = 0.0002). In the HBTT group, during the 3-month follow-up, 5,355 teleassistance contacts (13 ± 4 per patient) were performed. The number of patients with one or more symptoms declined significantly: from 338 (78%) to 183 (45%) (p < 0.00001). Both the physical (ΔPCS12: 5.9 ± 11.4) component and the mental (ΔMCS12: 4.4 ± 12.7) component of SF-12 improved significantly (p < 0.0001). Patient satisfaction with the program was very high in all participants. Conclusions: Compared to usual care, an HBTT program can reduce severe events (hospital admissions/mortality) at 3-months from discharge and improve symptoms and quality of life. Clinical trial registration: www.ClinicalTrials.gov, NCT04898179.

Definition of a Method for the Evaluation of Telemedicine Platforms in the Italian Context.

Background: The COVID-19 outbreak led to the diffusion of several telemedicine solutions. The choice of the correct platform is crucial for ensuring the release of effective assistance. However, there is a lack of an objective method for the assessment of technical features. Objective: This study proposes a methodology for the evaluation of functional requirements of telemedicine platforms. This approach also permits the comparison of solutions in the Italian market by means of defined parameters, thus directing the choice of health care professionals. Methods: The study is divided into three phases. First, a mapping of the telemedicine platforms operating in Italy is performed. Then, the available platforms are selected based on the offered telemedicine activity. Finally, a method for evaluating the investigated platforms is defined. Results: Thirty-three (n = 33) technological systems were identified through an accurate investigation on the web and interviews with IT companies. Fifteen parameters were defined and organized into three categories: (1) usability of the telemedicine platform, (2) security, and (3) technological and organizational aspects. A score between 1 and 4 was assigned to each parameter, proportionally to the completeness of the platform. In particular, 62.96% of platforms reached an average score between 3.01 and 4 points; 33.33% of them had scores between 2.01 and 3, while the remaining 3.70% of solutions obtained a result between 1.01 and 2. Conclusions: The study provides an evaluation approach that is easily usable by health professionals to select the most suitable platform. The number of solutions and quality of information could be updated to obtain a complete tool.

Home-Based Telemanagement in Advanced COPD: Who Uses it Most? Real-Life Study in Lombardy.

Current evidence indicates that the benefits of tele-health may not be uniform across all patients. Therefore, to understand what specific variables influence use of home-based telemanagement in COPD, we conducted this retrospective study. A 6-month home-based telemanagement program (HTP) was offered to 1,074 COPD patients over a 4-year period. Multivarible linear regression analysis was used to identify predictors of HTP use/week (phone calls and specialist consultations) among all variables: clinical (body mass index, co-morbidities, HTP prescription not following an exacerbation, long-term oxygen therapy use, COPD severity, hospital readmissions, exacerbations and death), socio-demographic (sex, age, place of abode), smoking history, arterial blood gases (ABG), and specialist/general practitioner (GP) urgent need. Logistic regression was conducted to predict relapses/hospitalizations risk as well as the disease impact (COPD Assessment Test, CAT) at the end of the program. Presence of relapses (p < 0.001), ABGs (p < 0.001) and GP request (p < 0.001) were significantly associated with higher HTP-use. Smoking history (OR 1.542 [IC 95% 1.069-2.217], p = 0.020), specialist (OR 2.895 [2.144-3.910], p < 0.001) and GP consultations (OR 6.575 [4.521-9.561], p < 0.001) were the only independent risk factors for relapse. No predictor of hospitalization was found. High final CAT score was inversely related to oxygen therapy use (p = 0.001) and HTP prescription (p < 0.001), and positively related to presence of co-morbidities (p = 0.001) and baseline CAT (p < 0.001). This HTP in Lombardy shows that relapsers, people requiring several ABGs and urgent GP visits are the patient subgroup most likely to consume telemanagement services (scheduled and unscheduled). We propose a patient 'identikit' to improve prioritization for HTP prescriptions.

Is Telerehabilitation a Safe and Viable Option for Patients with COPD? A Feasibility Study.

In patients with COPD non-naïve to rehabilitation we tested the feasibility, adherence and satisfaction of a home-based reinforcement telerehabilitation program (TRP). Outcomes were compared with a standard outpatient rehabilitation program (ORP). Then 18 TRP patients underwent 28 sessions of strength exercises (60 min) and cycle training (40 min) using a satellite platform provided telemonitoring, tele-prescription, video-assistance and phone-calls, patients were equipped with an oximeter, steps-counter, bicycle, remote control and interactive TV software. 18 matched ORP, retrospectively identified from our hospital ORP database, were used as controls. At baseline and end of program, the 6-min walking test (6MWT), Medical Research Council (MRC) scale and Saint George's Respiratory Questionnaire (SGRQ) were administered. In TRP only, we assessed platform use, incremental exercise, steps walked/day and patient satisfaction. TRP patients completed all sessions without side effects, used the remote control 1,394 ± 2,329 times being in the 84% of the cases satisfied with the service. In 22% of the cases patients found the technology unfriendly. Each health-professional performed 46 ± 65 actions, 14.6 ± 2.12 phone calls and 1 ± 1.67 videoconference sessions per patient. TRP patients increased physical activity (3,412 vs. 1,863 steps/day, p = 0.0002). Both programs produced significant (all, p < 0.01) gains in 6MWT [meters, TRP +34.22 ± 50.79; ORP +33.61 ± 39.25], dyspnea [TRP - 0.72 ± 0.89; ORP - 0.94 ± 0.53] and SGRQ [TRP - 6.9 ± 9.96, ORP - 9.9 ± 12.92] without between-group differences. In conclusion, TRP is feasible and well accepted by patients, although sometimes technology was perceived as difficult. It seems to improve walking capacity, dyspnea, quality of life and daily physical activity. Future RCTs will demonstrate cost-effectiveness.

Implementation of a Hospital-Based Home Palliative Care at regional level: a quantitative study of the Ospedalizzazione Domiciliare Cure Palliative Oncologiche program in Lombardy.

BACKGROUND: Home Palliative Care services can overcome trends of institutionalized dying and support higher rates of death at home. Home Palliative Care services rarely scale-up into regional health planning. This generates unwarranted variability in service provision and outcomes across patients. Lombardy Region sponsored a Hospital-Based Home Palliative Care program, which implemented a common service to oncological patients in the territory, with the purpose to align hospitals toward a target of 65% deaths at home. AIM: Our work assesses service characteristics and outcomes achieved by the regional program from 2009 to 2011. DESIGN AND SETTING: Descriptive analysis from an institutional database of service characteristics, regional expenditure, and outcomes (temporary hospitalization and patient discharge) representing 11,841 patients served by 24 providers in the period 2009-2011. RESULTS: Targets of 65% deaths at home were achieved across the Region, with temporary re-hospitalization below 4.4%. The average pathway length stood above 1 month; intensity of care stood above ministerial and regional standards, with most home visits performed by nurses and physicians. CONCLUSIONS: The implementation of the regional program revealed three strengths (prompt identification and enrollment of eligible patients, and quantity of home visits) and two weaknesses (limited enrollment from general practitioners and multi-disciplinarity). This highlights opportunities for policy-makers to invest on regional protocols of Hospital-Based Home Palliative Care to reduce trends of institutionalized dying and align providers to homogeneous results.

Cost-utility analysis of the EVOLVO study on remote monitoring for heart failure patients with implantable defibrillators: randomized controlled trial.

BACKGROUND: Heart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up. OBJECTIVE: We hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators. METHODS: Two hundred patients implanted with a wireless transmission-enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained. RESULTS: Overall, remote monitoring did not show significant annual cost savings for the health care system (€1962.78 versus €2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (€291.36 versus €381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of €888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution. CONCLUSIONS: Remote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations. TRIAL REGISTRATION: ClinicalTrials.gov NCT00873899; http://clinicaltrials.gov/show/NCT00873899 (Archived by WebCite at http://www.webcitation.org/6H0BOA29f).

Home-based telesurveillance program in chronic heart failure: effects on clinical status and implications for 1-year prognosis.

BACKGROUND: Studies focusing on the effects of telemanagement programs for chronic heart failure (CHF) on functional status are lacking, and the prognostic value of the clinical response to the programs is unknown. In the Lombardy region of Italy, a home-based telesurveillance program (HTP) including multidisciplinary management and remote telemonitoring for patients with CHF was introduced in 2000 and was formally adopted, as part of the services delivered by the regional healthcare system, in 2006. This article reports the effect of the HTP on the functional status and quality of life and describes the main outcomes observed within 1 year from the end of the program. MATERIALS AND METHODS: Six-month variations of New York Heart Association (NYHA) class, left ventricular ejection fraction (LVEF), 6-min walking distance (6MWD), and Minnesota Living with Heart Failure Questionnaire (MLHFQ) score were evaluated in 602 CHF patients. Patients showing at least two of the following conditions-NYHA class reduction, increase in LVEF ≥5%, 6MWD >30 m, and a reduction of >24 points of MLHFQ-were defined as "responders." One-year events included unplanned cardiovascular readmissions and mortality. RESULTS: A significant improvement in NYHA class, LVEF, 6MWD, and MLHFQ was observed. Clinical events occurred in 24.1% of non-responders and in 15.9% of responders (p=0.03). An unfavorable response to the program, the presence of an implantable cardioverter defibrillator, and multiple comorbidities were predictors of poor outcome. CONCLUSIONS: The HTP was effective in improving CHF patient functional status, and an unsuccessful response to the intervention seems to be an independent marker of poor prognosis.

Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study.

BACKGROUND: Heart failure patients with implantable cardioverter-defibrillators (ICDs) or an ICD for resynchronization therapy often visit the hospital for unscheduled examinations, placing a great burden on healthcare providers. We hypothesized that Internet-based remote interrogation systems could reduce emergency healthcare visits. METHODS AND RESULTS: This multicenter randomized trial involving 200 patients compared remote monitoring with standard patient management consisting of scheduled visits and patient response to audible ICD alerts. The primary end point was the rate of emergency department or urgent in-office visits for heart failure, arrhythmias, or ICD-related events. Over 16 months, such visits were 35% less frequent in the remote arm (75 versus 117; incidence density, 0.59 versus 0.93 events per year; P=0.005). A 21% difference was observed in the rates of total healthcare visits for heart failure, arrhythmias, or ICD-related events (4.40 versus 5.74 events per year; P<0.001). The time from an ICD alert condition to review of the data was reduced from 24.8 days in the standard arm to 1.4 days in the remote arm (P<0.001). The patients' clinical status, as measured by the Clinical Composite Score, was similar in the 2 groups, whereas a more favorable change in quality of life (Minnesota Living With Heart Failure Questionnaire) was observed from the baseline to the 16th month in the remote arm (P=0.026). CONCLUSIONS: Remote monitoring reduces emergency department/urgent in-office visits and, in general, total healthcare use in patients with ICD or defibrillators for resynchronization therapy. Compared with standard follow-up through in-office visits and audible ICD alerts, remote monitoring results in increased efficiency for healthcare providers and improved quality of care for patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00873899.

Healthcare continuity from hospital to territory in Lombardy: TELEMACO project.

OBJECTIVES: To verify implementation and use of TELEMACO (TELEMedicina Ai piccoli COmunilombardi; http://www.telemaco.regione.lombardia.it/), which provides specialized continuity of care with innovative healthcare services in remote areas of the Lombardy region of Italy; to design a network in the territory for sharing of continuityof- care programs; and to allow the relevant health authorities to collect cost data to establish a model for sustainable pricing for implementing these services. METHODS: TELEMACO provides home-based telemanagement services for patients with chronic heart failure and chronic obstructive pulmonary disease (COPD), as well as second-opinion teleconsultations in cardiology, dermatology, diabetology, and pulmonology for general practitioners and second-opinion teleconsultations on digital images in cases of traumatic brain injury and stroke. A total of 2 service centers, 10 cardiology and pneumology departments, 30 specialists, 176 general practitioners, 40 nurses, 2 emergency departments, and 2 consultant hospitals were involved. RESULTS: A total of 166 patients with chronic heart failure and 474 patients with COPD were enrolled. There were 4830, 51, and 44 second-opinion teleconsultations for cardiologic, dermatologic, and diabetic conditions, respectively. There were 147 second-opinion teleconsultations on digital images, 68 for stroke, and 79 for traumatic brain injury. Implementation of TELEMACO introduced innovations in working methods and provided evidence to the health authorities for allocating funds for such services. CONCLUSIONS: TELEMACO provided evidence that there is a growing need for home management of patients using telemedicine, a common and efficacious approach that can ensure care continuity, especially in chronic diseases.

Teleconsultation service to improve healthcare in rural areas: acceptance, organizational impact and appropriateness.

BACKGROUND: Nowadays, new organisational strategies should be identified to improve primary care and its link with secondary care in terms of efficacy and timeliness of interventions thus preventing unnecessary hospital accesses and costs saving for the health system. The purpose of this study is to assess the effects of the use of teleconsultation by general practitioners in rural areas. METHODS: General practitioners were provided with a teleconsultation service from 2006 to 2008 to obtain a second opinion for cardiac, dermatological and diabetic problems. Access, acceptance, organisational impact, effectiveness and economics data were collected. Clinical and access data were systematically entered in a database while acceptance and organisational data were evaluated through ad hoc questionnaires. RESULTS: There were 957 teleconsultation contacts which resulted in access to health care services for 812 symptomatic patients living in 30 rural communities. Through the teleconsultation service, 48 general practitioners improved the appropriateness of primary care and the integration with secondary care. In fact, the level of concordance between intentions and consultations for cardiac problems was equal to 9%, in 86% of the cases the service entailed a saving of resources and in 5% of the cases, it improved the timeliness. 95% of the GPs considered the overall quality positively. For a future routine use of this service, trust in specialists, duration and workload of teleconsultations and reimbursement should be taken into account. CONCLUSIONS: Managerial and policy implications emerged mainly related to the support to GPs in the provision of high quality primary care and decision-making processes in promoting similar services.

Assessment and analysis of territorial experiences in digital tele-echocardiography.

Nowadays digital ultrasound-cardiovascular devices are able to send out directly digital images and films. Thanks to the large adoption of such devices, the echocardiographic world is facing new ways of exchanging images and collaborating. What we present in this paper is a review of the experimental projects carried in Lombardy, meant to support the work of specialists by means of second opinion and telemedicine services. On the medical point of view echocardiography is a widely used activity where operators are perfectly accustomed to do repetitive operations and steps. Tele-echocardiography (T-E) introduces new methods and technologies into stable and everyday medical practice, causing disruptions either on the side of the specialists' way of working or on the new opportunities and service. Introducing such a service means to properly model it in order to reduce the changes in the operators' way of working while maximizing the benefits. A proper method of modelling the operators' needs is then a key factor which must be correctly addressed. This paper will present some successful projects and the assessment procedure but it will also discuss a possible service modelling method, which has been adopted for the described experiences.

A web based health technology assessment in tele-echocardiography: the experience within an Italian project.

Due to major advances in the information technology, telemedicine applications are ready for a widespread use. Nonetheless, to allow their diffusion in National Health Care Systems (NHCSs) specific methodologies of health technology assessment (HTA) should be used to assess the standardization, the overall quality, the interoperability, the addressing to legal, economic and cost benefit aspects. One of the limits to the diffusion of the digital tele-echocardiography (T-E) applications in the NHCS lacking of a specific methodology for the HTA. In the present study, a solution offering a structured HTA of T-E products was designed. The methodology assured also the definition of standardized quality levels for the application. The first level represents the minimum level of acceptance; the other levels are accessory levels useful for a more accurate assessment of the product. The methodology showed to be useful to rationalize the process of standardization and has received a high degree of acceptance by the subjects involved in the study.

[The homecare management of chronic heart failure followed up by hospital cardiologists: a pilot study]. / Gestione integrata ospedale-territorio nello scompenso cardiaco cronico: progetto pilota di fattibilità.

BACKGROUND: The management of patients with chronic heart failure turns to new diagnostic and therapeutic approaches, focusing on an integrated network among general practitioners and cardiologists. METHODS: In order to improve heart failure patient care, we developed a pilot study to assess the feasibility of a homecare program including visits performed by hospital cardiologists on request of general practitioners. RESULTS: This pilot study confirmed the feasibility of the collaborative project among general practitioners and cardiologists and the suitability of home visits performed on request. In 80/96 visits (85%) the cardiologist confirmed that home visit could be shared. Preliminary epidemiological data showed an elderly population (mean age 82 years) with prevalence of females (60%); hypertension in 46%, diabetes in 27%, and infrequent access to outpatient visits. CONCLUSIONS: This integrated management showed good results in terms of an improvement of cooperation among general practitioners and cardiologists, and allowed to verify a very high level of diagnostic accuracy of general practitioners.

Service level web monitoring in the field management of emergencies.

Cardiologic Emergency Project is based on a hospital network in Milan, Italy, in order to provide patients with more efficient first aid immediately after the occurrence of an Acute Coronary Syndrome. The Project includes ECG transmission from running ambulances to the 118 telephone central help desk, and from there to the suitable hospital. Since the maximum total transfer time should stay within a few tens of minutes, and given that a number of different factors may cause very dangerous delays, the effective coordination of several healthcare systems, devices and organizations is critical. Monitoring of the activities on each component is a must. Cardiologic Emergency Project uses a Web application devoted to the monitoring and evaluation of the service levels. Web applications allow the quantitative monitoring of the durations of extra-hospital operations. Several types of tables and graphics are automatically filled for the best care of the patient. For example, given a lengthy total time request by a satisfactory full ECG transmission, the system allows analysis of the ECG machine, of the cellular phone partial-only coverage along the ambulance pathway, of the transfer time in rush hours, etc., to determine which elements in the process can be improved to avoid future delays.