Feasibility and cost-effectiveness of a multidisciplinary home-telehealth intervention programme to reduce falls among elderly discharged from hospital: study protocol for a randomized controlled trial.

BACKGROUND: Fall incidents are the third cause of chronic disablement in elderly according to the World Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk assessment and management programmes are effective in all older population studied. However, the application of these programmes may not be the same in all National health care setting and, consequently, needs to be evaluated by cost-effectiveness studies before to plan this intervention in regular care. In Italy structured collaboration between hospital staff and primary care is generally lacking and the role of Information and Communication Technologies (ICT) in a fall prevention programme at home has never been explored. METHODS AND DESIGN: This will be a two-group randomised controlled trial aiming to evaluate the effects of a home-based intervention programme delivered by a multidisciplinary health team. The home tele-management programme, previously adopted in our Institute for chronic patients, will be proposed to elderly people affected by chronic diseases at high risk of falling at hospital discharge. The programme will involve the hospital staff and will be managed thanks to the collaboration between hospital and primary care setting. Patients will be followed for 6 months after hospital discharge. A nurse-tutor telephone support and tele-exercise will characterize the intervention programme. People in the control group will receive usual care. The main outcome measure of the study will be the percentage of patients sustaining a fall during the 6-months follow-up period. An economic evaluation will be performed from a societal perspective and will involve calculating cost-effectiveness and cost utility ratios. DISCUSSION: To date, no adequately powered studies have investigated the effect of the Information and Communication Technologies (ICT) in a home fall prevention program. We aim the program will be feasible in terms of intensity and characteristics, but particularly in terms of patient and provider compliance. The results of the economic evaluation could provide information about the cost-effectiveness of the intervention and the effects on quality of life. In case of shown effectiveness and cost effectiveness, the program could be implemented into health services settings. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02487589 ).

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.

The SUMMA Project: a feasibility study on telemedicine in selected Italian areas.

Telemedicine is achieving relevant clinical importance in rural areas in the management of patients. The Second opinion Unificata per Medici di Medicina generAle (SUMMA) Project was designed to evaluate the feasibility of a joint telemedicine service application across general practitioners and clinical specialists in Italy. The secondary objective of the study included the comparison of telemedicine with the routine general practitioners' approach and a cost-effectiveness evaluation. One hundred and thirty-five general practitioners from Lombardy, Molise, and Valle d'Aosta were enrolled. An ad hoc questionnaire was used to evaluate the feasibility, approval, efficacy, and satisfaction of telemedicine among the general practitioners. Ninety-three general practitioners used the telemedicine consultation (responders) for a total of 1,396 calls (1,264 for cardiology, 65 for dermatology, 32 for diabetology, 22 for rheumatology, and 13 for pneumology). In cardiology, telemedicine was used to address all problems without further action in 733 cases (61%). Ninety-eight percent of responders indicate satisfaction with telemedicine. The cost of telemedicine in our study was estimated to be 25.36 Euros/contact. In conclusion, the SUMMA Project demonstrated for the first time clinically the effectiveness of second-opinion consultation by general practitioners and therefore fulfilling the actual needs in areas usually managed by the National Health System.

Wireless-accessible sensor populations for monitoring biological variables.

The current health-care infrastructure is generally considered to be inadequate to meet the needs of an increasingly older population. We have investigated the feasibility of a passive in-home monitoring system based on wireless accessible sensor populations (WASP). In an EU-funded project we have identified the system architecture and the sensors required to gather data from elderly patients by continuous monitoring. Data from biological variables (heart rate, accelerometers, body temperature and galvanic skin response) and everyday habits (body position, movements) will be transmitted to a central monitoring centre. A Body Sensor Network (worn by the patient and able to communicate with a personal mobile hub) and an Ambient Sensor Network (a number of wireless sensors incorporated into the patient's home) are envisaged. The system will be tested by using it in the telemedicine activities of the Health Telematic Network, which manages home help projects for elderly patients.

Cardiac rehabilitation in the elderly: patient selection and outcomes.

In Western countries, the aging and improving survival of patients with coronary heart disease are responsible for an increasing number of older adults (65 years of age and older) who are eligible for cardiac rehabilitation. The elderly with coronary heart disease represent a special population with changes induced by aging and lifestyle, comorbidity, cognitive dysfunction, and high risk of disability. Although the elderly account for the majority of cardiac admissions and procedures, studies on cardiac rehabilitation have traditionally focused on younger patients. In aged experimental animals, there is evidence that exercise training is able to improve hemodynamic parameters and biologic markers. Moreover, in older patients, exercise improves functional capacity and reduces myocardial work, similar to that seen in younger patients. As for younger patients, cardiac rehabilitation requires a multidisciplinary approach, including comprehensive assessment, treatment of risk factors and comorbidity, and psychosocial assessment. Cardiac rehabilitation is safe and helpful for elderly coronary patients. Physicians must be encouraged to prescribe cardiac rehabilitation programs for the elderly following major coronary events and coronary revascularization procedures.

Chronic heart failure home-based management with a telecardiology system: a comparison between patients followed by general practitioners and by a cardiology department.

A group of patients with chronic heart failure (CHF) were followed by general practitioners (GPs) with a telecardiology system, and a second group of patients were followed by a home-based telemonitoring (HBT) protocol with medical and nursing supervision. The 212 GP patients were older than the 226 HBT patients, mostly women, with CHF secondary to chronic hypertension, less self-sufficient and with a non-optimized therapy. The mean number of telephone calls was 2.6 per patient in the GP group and 16.6 per patient in the HBT group (P<0.001). These preliminary data suggest the applicability and the efficacy of both management models for CHF patients.

Does 6-Month Home Caregiver-Supervised Physiotherapy Improve Post-Critical Care Outcomes?: A Randomized Controlled Trial.

OBJECTIVE: This study aims to determine whether a 6-month home physiotherapy program can improve outcomes in critical care survivors. DESIGN: Forty-eight consecutive patients were randomized. The treatment group underwent 2 sessions/day of breathing retraining and bronchial hygiene, physical activity (mobilization, sit-to-stand gait, limb strengthening), and exercise re-conditioning whereas controls underwent standard care. Maximum inspiratory/expiratory pressures (MIP/MEP), forced volumes, blood gases, dyspnea, respiratory rate, disability, peripheral force measurements, perceived health status (Euroquol-5D), patient adherence/satisfaction, safety, and costs were assessed. RESULTS: Outcomes of treatment versus controls: MIP 14 ± 17 vs. -0.2 ± 14 cm H2O, MEP 27 ± 27 vs. 6 ± 21 cm H2O both P < 0.03; in addition, quality of life (Euroquol-5D) (P = 0.04), FEV1 (P = 0.03), dyspnea (P = 0.002), and respiratory rate (P = 0.009) were significantly improved for treated cardiorespiratory patients only. Eighty-three percent of the treated patients were decannulated versus 14% of controls (P = 0.01). Compliance was high (74 ± 25%) and there were no side effects. The majority (87.4%) expressed satisfaction with the program. Treatment cost was 459&OV0556;/patient/month. CONCLUSIONS: Carrying over regular bronchial hygiene techniques, physical activity, and exercise into the home after long critical care stays is safe and has a beneficial effect on respiratory muscles, decannulation, pulmonary function, and quality of life.

Incidence of atrial fibrillation in an Italian population followed by their GPs through a telecardiology service.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac tachyarrhythmia and is often an occasional diagnosis in the absence of known cardiac disease. The aim of this study is to describe an Italian patient population with AF followed by their General Practitioners (GPs) using a telecardiology service. METHODS: A total of 655 Italian GPs were equipped with a portable electrocardiographer. The ECG tracing of all consecutive patients (7516) received between January and September 2001 was included into the study. RESULTS: AF was detected in 719 patients (9.%) (77+/-12 years). In 448 patients, it was a known chronic condition, while in 271 patients, it was a new diagnosis. In the chronic AF, the principal reason for the teleconsultation was a routine control by the GPs, but an uncontrolled cardiac rate was present in 29% of the cases, while an antiplatelet or anticoagulation therapy was administered in only 46.2% cases. The teleconsultation alone provided a solution to the GPs' requests in 348 patients (77.6%) (154 cases (34.5%) required no further action while 194 patients (43.5%) needed therapy adjustments only), while 47 patients (10.5%) required hospitalization and 51 patients needed further diagnostic tests. In 271 cases, a first evidence of atrial fibrillation was recorded: in 259 patients, GPs requested a teleconsultation in the presence of symptoms (mainly palpitation, dyspnoea and fatigue) and in 12 for routine control; in this case, 121 patients (46.9%) needed Emergency Department (ED) admission, 113 patients (39.1%) needed therapy adjustments and, for 19 patients (7.5%), further diagnostic tests were prescribed. CONCLUSION: In Italy, many patients, in particular the elderly, with AF are followed by their GPs on a routine basis; a telecardiology service may provide a useful tool in the home management of chronic AF and in the first detection of new cases of AF.

Does growth hormone play a role in chronic heart failure?

Experimental and clinical studies have recently demonstrated that the growth hormone-insulin-like growth factor-I (GH-IGF-I) system is involved in the regulation of cardiac structure and function. Patients with acromegaly have an increased propensity of developing cardiovascular complications, such as ventricular hypertrophy with interstitial fibrosis. Conversely, patients with GH deficiency can exhibit ventricular dysfunction, increased vascular thickness, and an increased number of atheromatous plaques. In both groups of patients these abnormalities may be partially reverted by normalizing GH-IGF-I levels. In experimental or human chronic heart failure (CHF), GH administration increases ventricular mass and cardiac performance and reduces pulmonary vascular resistance. The mechanism by which this occurs is still unclear, but seems to involve calcium channels and non-endothelium-mediated vasodilatation. Randomized trials studying CHF patients contradict these results, highlighting that, in patients with heart failure, the response to GH therapy appears to be variable, and is probably influenced either by acquired GH resistance or by baseline levels of hormones. Due to the small number of patients examined to date, larger, randomized, controlled studies are needed.

Boario Home Care Project: an Italian telemedicine experience.

The use of telemedicine appears particularly promising in cardiovascular disease, because the cost/effectiveness ratio of an early, tailored intervention, in terms of life-saving and functional recovery is demonstrated. Boario Home Care project was born in 1998, with the aim of applying the new models of disease management and the new technology on the territory. In the first phase the project was to realize a telematic network for the General Practitioners in a mountain territory; In the second phase the project was extended to the regional and then national territory and the number of enrolled GPs increased. In the third phase, that is nowadays, the structure of the Service Center has been implemented with new broad band technologies (HDLS) and with an innovative teleworking model has been adopted for the professional figures involved. Four different types of services are now available: General Practitioners, Home Telenursing for chronic patients, Tele-diagnosis for palpitations and Call Center Services for hospitals. In conclusion, Boario Home Care project has reached its maturity and many results even if we can consider them preliminary in the field of Telemedicine. Boario Home Care project won e-health Awards with the honourable mention and it was presented at the "eHealth 2003: ICT for Health" in Brussels, Belgium.

[Anxiety, depression, and stressed life in patients awaiting heart transplantation: are these factors to be considered?]. / Ansia, depressione e vita stressante nel paziente in attesa di trapianto cardiaco: dimensioni da considerare?

RATIONALE: Heart transplantation is a therapeutic procedure in which biological, psychological, social and ethical aspects play an important role, none of them has to be underestimated. It is known that the waiting period up to heart transplantation is extremely stressful for patients and their families, causing psychopathological and disadaptive reactions. Aim of the present study was to investigate psychological tract characteristics, stress reactions and quality of life in a group of patients registered for heart transplantation. METHODS: Sixty two patients (47 M, 15 F), with mean age of 53 +/- 9.9 years in NYHA class (16 class II, and 43 class III/IV) and ejection fraction 29 +/- 10 have filled in the following two questionnaires: the Cognitive Behavioural Assessment form H (CBA-H), to measure psychological functioning and/or behaviours at risk for heart disease, and the Short Form 36 (SF-36), to evaluate physical and functional health status. RESULTS: In patients awaiting heart transplantation, the presence of anxiety contributes to reduce physical activity, vitality and mental health. Depressed mood disorders negatively influence physical and mental health and vitality. Perception of stressed life limits role and physical activity, vitality, and emotional status and augments intensity of physical pain. CONCLUSIONS: Symptoms of anxiety, depression and stress influence negatively mental health and daily physical activity. These aspects may vary of intensity with progression of the disease and lengthening of waiting. The importance of an early and continuous psychological support to the patient becomes fundamental to individuate and treat these disorders to favour optimal post-transplant outcomes.

Assessment of prehospital chest pain using telecardiology.

Two hundred general practitioners were equipped with a portable electrocardiograph which could transmit a 12-lead electrocardiogram (ECG) via a telephone line. A cardiologist was available 24 h a day for an interactive teleconsultation. In a 13-month period there were 5073 calls to the telecardiology service and 952 subjects with chest pain were identified. The telecardiology service allowed the general practitioners to manage 700 cases (74%) themselves; further diagnostic tests were requested for 162 patients (17%) and 83 patients (9%) were sent to the hospital emergency department. In the last group a cardiological diagnosis was confirmed in 60 patients and refuted in 23. Seven patients in whom the telecardiology service failed to detect a cardiac problem were hospitalized in the subsequent 48 h. The telecardiology service showed a sensitivity of 97.4%, a specificity of 89.5% and a diagnostic accuracy of 86.9% for chest pain. Telemedicine could be a useful tool in the diagnosis of chest pain in primary care.

A pilot study of nurse-led, home-based telecardiology for patients with chronic heart failure.

We assessed the feasibility of home-based telecardiology for patients with chronic heart failure (CHF). Seventy-four CHF patients were enrolled into a programme of telephone follow-up and single-lead electrocardiography (ECG) monitoring. The patients transmitted their ECG data by fixed telephone line to a receiving station, where a nurse was available for an interactive teleconsultation. Patients were followed up for a mean (SD) of 307 (108) days; 1467 calls were analysed (213 ad hoc consultations and 1254 scheduled consultations). A total of 124 cardiovascular events were recorded. Modifications to therapy were suggested in response to 119 calls; hospital admissions were suggested for 13 patients, further investigations for 7 and a consultation with the patient's general practitioner for 13. No action was taken after 1330 calls. Twenty-two ECG abnormalities were recorded. In 63 patients receiving the beta-blocker carvedilol, the mean dosage increased from 36 to 42 mg. In the previous year there were 1.8 hospitalizations per patient, while in the follow-up period there were 0.2 hospitalizations per patient. Following up CHF patients using a nurse-led telecardiology programme seems to be feasible and useful.

[Cardiac event recorder yields more diagnoses than 24-hour Holter monitoring in patients with palpitations]. / Diagnostica del cardiopalmo accessuale: event recorder transtelefonico versus elettrocardiogramma dinamico secondo Holter.

BACKGROUND: Palpitations are a common symptom that sometimes results from a substantial cardiac arrhythmia. A 24-hour Holter monitoring is usually used, but the yield of this instrument is low in patients whose symptoms occur infrequently. The aim of this study was to compare the diagnostic yield and the cost-effectiveness of transtelephonic event recorder (TER) with those of Holter monitoring in patients with intermittent palpitations. METHODS: Three hundred and ten patients with intermittent palpitations were allocated to the study and randomly assigned to receive a TER or 24-hour Holter monitoring. TER was given to patients until recording was obtained while symptoms occurred or was used at most for 7 days. At enrollment, a basal trace was recorded. Patients with palpitations recorded the one lead ECG trace and sent it by phone (fixed or mobile) to the telemedicine call center where a trained nurse compared the trace with the basal one and checked the patient's symptoms. The cardiologist reported "on-line" all the traces sent in the presence of an arrhythmic event and "stored and forwarded" all the other traces. Standard methods were used for Holter recording and reading. RESULTS: Patients with palpitations during the examination were 119 (76.8%) in the group of TER and 74 (47.8%) in the Holter group (p < 0.000) with an efficacy increase of 29% for TER. In symptomatic patients there were no differences between the two groups about the presence or absence of arrhythmias checked in the ECG traces; the time necessary to make a presence/absence diagnosis of arrhythmias was 2.97 +/- 2.74 days with the event recorder. The total cost of 155 tests made with Holter was altogether 9605.35 Euro (costs per test 61.97 Euro), while the one of TER was 6019.2 Euro (cost par test 38.83 Euro). The cost-effectiveness analysis was 129.80 Euro for Holter and 50.57 Euro for TER, with a saving of 79.23 Euro for every diagnosis made. CONCLUSIONS: TER allows to detect intermittent palpitations in real time; it is more useful and effective than Holter; moreover this effectiveness was also confirmed by the cost analysis in which TER resulted less expensive.

In COPD patients on prolonged mechanical ventilation heart rate variability during the T-piece trial is better after pressure support plus PEEP: a pilot physiological study.

OBJECTIVES: To evaluate heart rate variability (HRV), hemodynamics, mechanics, dyspnea and blood gases following different mechanical ventilation (MV) settings. BACKGROUND: No study has evaluated physiological changes during T-piece trials following different MV settings. METHODS: In 8 COPD patients on prolonged MV we applied in random order two MV settings: i) pressure support (PS) 20 cm H2O + positive end-expiratory pressure (PEEP) 0 cm H2O (setting-1) and ii) PS 15 cm H2O + PEEP 5 cm H2O (setting-2), each followed by a 30 min T-piece trial. RESULTS: Setting-1 induced greater minute ventilation, tidal volume/inspiratory time and lower pulmonary artery occlusion pressure; setting-2 reduced intrinsic PEEP. Mechanics and hemodynamics data did not differ, but all HRV time domain indices were reduced only after setting-1, suggesting a decreased parasympathetic and increased sympathetic cardiac modulation. CONCLUSIONS: The T-piece trial following setting-2 seems less stressful on neural control of HRV. Future studies on T-piece trials should consider the residual effect of the MV setting.

Effects of a multidisciplinary care program on disability, autonomy, and nursing needs in subjects recovering from acute respiratory failure in a chronic ventilator facility.

BACKGROUND: The aim of this study was to analyze the effects of a multidisciplinary program carried out in a chronic ventilator facility on disability, autonomy, and nursing needs of patients after a prolonged ICU stay. Secondary outcome measures were survival, weaning rate, chronic ventilator facility stay, and discharge destination. METHODS: Multidisciplinary assessment, clinical stabilization, weaning attempts, and a new Disabled Patients Autonomy Planning tool to assess daily care needs were investigated in 240 subjects in a chronic ventilator facility (52 subjects after cardiovascular surgery, 60 subjects with acute respiratory failure, 71 subjects with COPD, and 57 subjects with neurological disease). RESULTS: At admission, nursing needs, disability, and autonomy differed according to diagnosis (P < .001); weaned subjects had greater nursing needs (P < .001) and disability (P = .0014) than unweaned subjects. During the stay, 13.8% of the subjects died irrespective of diagnosis (P = .12); 47% (P < .001) were weaned with significant differences (P <.007) by diagnosis. In the 207 surviving subjects, nursing needs increased as disability increased (r = 0.59, P < .001) and autonomy decreased (r = -0.66, P < .001); disability and autonomy were inter-related (r = 0.61, P < .001). Oxygen saturation, hypercapnia, dyspnea, disability, autonomy, and nursing needs significantly improved (all, P < .001). Fifty-nine percent of the subjects were discharged home. Subjects discharged to nursing homes presented mainly neurological diseases, being more disabled and less autonomous, with higher nursing needs (all, P < .04). Mechanical ventilation use and tracheostomy increased the probability of being discharged to a nursing home (odds ratio [OR] of 1.84, P = .04; OR 2.47, P = .003, respectively). Mortality was higher in subjects who were ventilated (OR 8.44, P < .001), male (OR 2.64, P = .01), elderly (P < .001), or malnourished (P = .01) and in subjects with low autonomy (P < .001), greater nursing needs (P = .002), and more severe disabilities (P = .04). CONCLUSIONS: A specialized tailored multidisciplinary program in subjects after an ICU stay contributed to recovery from disability, autonomy, and fewer nursing needs irrespective of diagnosis. Subjects discharged to a nursing home were the most severely disabled.

Heart failure. Optimal postdischarge management of chronic HF.

Not all strategies for the management of chronic heart failure have been shown to be equally effective in improving outcomes, and the ideal programme has yet to be defined. The WHICH? trial sheds some light on whether a clinical, in-hospital or a home-based strategy of care is superior and cost-effective.

Home-based versus in-hospital cardiac rehabilitation after cardiac surgery: a nonrandomized controlled study.

BACKGROUND: Exercise rehabilitation after cardiac surgery has beneficial effects, especially on a long-term basis. Rehabilitative programs with telemedicine plus appropriate technology might satisfy the needs of performing rehabilitation at home. OBJECTIVE: The purpose of this study was to compare exercise capacity after home-based cardiac rehabilitation (HBCR) or in-hospital rehabilitation in patients at low to medium risk for early mortality (EuroSCORE 0-5) following cardiac surgery. DESIGN: A quasi-experimental study was conducted. METHODS: At hospital discharge, patients were given the option to decide whether to enroll in the HBCR program. Clinical examinations (electrocardiography, cardiac echo color Doppler, chest radiography, blood samples) of patients in the HBCR group were collected during 4 weeks of rehabilitation, and exercise capacity (assessed using the Six-Minute Walk Test [6MWT]) was assessed before and after rehabilitation. A group of patients admitted to the in-hospital rehabilitation program was used as a comparison group. Patients in the HBCR group were supervised at home by a medical doctor and telemonitored daily by a nurse and physical therapist by video conference. Periodic home visits by health staff also were performed. RESULTS: One hundred patients were recruited into the HBCR group. An equal number of patients was selected for the comparison group. At the end of the 4-week study, the 2 groups showed improvement from their respective baseline values only in the 6MWT. No difference was found in time × group interaction. LIMITATIONS: Because patients self-selected to enroll in the HBCR program and because they were enrolled from a single clinical center, the results of the study cannot be generalized. CONCLUSIONS: In patients who self-selected HBCR, the program was found to be effective and comparable to the standard in-hospital rehabilitative approach, indicating that rehabilitation following cardiac surgery can be implemented effectively at home when coadministered with an integrated telemedicine service.

Home-based telemanagement in chronic heart failure: an 8-year single-site experience.

During an eight-year period, 358 patients with chronic heart failure (CHF) were enrolled in a six-month home-based telemanagement (HBT) programme. The efficacy of the programme was evaluated in two four-year periods, based on changes in clinical, functional, Quality of Life (QoL) status and rate of hospital readmission. The New York Heart Association (NYHA) class and the number of patients with comorbidities increased significantly in the second period, while the number of patients with beta-blockers decreased significantly (P < 0.01). Following the HBT programme, non-cardiovascular hospital readmission rate and all-cause readmission rate increased by 11% (P < 0.03) and 13% (P < 0.05), respectively. On re-evaluation after six months (238 patients) there was a general improvement in clinical, functional and QoL status and a significant increase in the mean daily dosage of beta-blockers prescribed. Our experience confirms that HBT for patients with CHF is associated with favourable effects on hospital readmission for cardiovascular reasons and on QoL. However, a more comprehensive multidisciplinary approach will probably be required to obtain favourable effects on total morbidity.