Impact Assessment of an Innovative Integrated Care Model for Older Complex Patients with Multimorbidity: The CareWell Project.

OBJECTIVES: To evaluate the impact in terms of use of health services, clinical outcomes, functional status, and patient's satisfaction of an integrated care program, the CareWell program, for complex patients with multimorbidity, supported by information and communication technology platforms in six European regions. DATA SOURCES: Primary data were used and the follow-up period ranged between 8 and 12 months. STUDY DESIGN: A quasi-experimental study, targeting chronic patients aged 65 or older, with 2 or more conditions - one of them necessarily being diabetes, congestive heart failure or congestive obstructive pulmonary disease. The intervention group received the integrated care program and the control group received usual care. Generalized mixed regression models were used. DATA COLLECTION: Data were obtained from individual interviews and electronic clinical records. PRINCIPAL FINDINGS: Overall, 856 patients were recruited (475 intervention and 381 control). In the intervention group, the number of visits to emergency rooms was significantly lower, and the number of visits to the general practitioners and primary care nurses was higher than in the control group. CONCLUSION: The CareWell program resulted in improvements in the use of health services, strengthening the role of PC as the cornerstone of care provision for complex patients with multimorbidity.

The effectiveness of remote monitoring of elderly patients after hospitalisation for heart failure: The renewing health European project.

Background: The effectiveness of remote monitoring (RM) in the management of the elderly after hospitalisation for heart failure (HF) is uncertain. Methods and results: Randomized trial (2:1 design) comparing RM with usual care (UC) in patients >65 years old, hospitalised in the previous 3 months for HF with left ventricular ejection fraction <40% or >40% plus BNP > 400 (or NT-proBNP >1500); the primary end-point (PE) was the combined 12-month incidence of death by any cause or at least one hospital readmission for HF. Overall, 229 and 110 pts were enrolled in the RM and UC group, respectively; in the intention-to-treat analysis, the PE was reached in 101 (44.1%) and 51 (46.4%) patients in the RM and UC group respectively (p = 0.78), with no difference in mortality (24.0% vs 21.8%, p = 0.097) or in the proportion of patients with at least one rehospitalisation for HF (34.5% vs 39.1%, p = 0.48). Quality of life, secondary end-point measured by SF36v2 scores, was significantly improved in the RM group, both in physical (2.63 score difference, p < 0.0001) and mental (1.69 score difference, p = 0.04) components. In the on-treatment analysis comparing 190 patients that ultimately received RM with the 149 remaining patients, the primary end-point was reached in 40.0% vs 51.0% (p = 0.055), respectively. Conclusion: In the intention-to-treat analysis, during the 12-month follow up of elderly patients hospitalised for HF, remote monitoring had no impact on the primary end-point but it significantly improved patients' quality of life. In the on-treatment analysis a trend for improving the PE was observed in the RM group.

Telemonitoring of Type 2 Diabetes Mellitus in Italy.

BACKGROUND: Type 2 diabetes mellitus (DM) affects 382 million people worldwide. INTRODUCTION: This study aimed at assessing whether telemonitoring (TM) of DM patients improves health-related quality of life (HRQoL). MATERIALS AND METHODS: As part of the RENEWING HEALTH project, 299 DM patients with HbA1c >7.0% were enrolled in a randomized controlled trial, with 208 patients in the TM group and 91 patients in the usual-care group. TM electronically transmitted glucose measurements to physicians during a 12-month follow-up. The SF-36v2 questionnaire was used to assess HRQoL. RESULTS: In a total of 243 patients analyzed, the study did not identify any clinically important improvement in HRQoL, our primary endpoint. There was no statistically significant difference in HbA1c between the two groups; however, outpatient visits and planned hospitalizations were significantly reduced in the TM group (p < 0.0001 and p = 0.02). DISCUSSION: The results regarding HRQoL might be, at least in part, an artifact stemming from the criteria used to select patients. TM reduced ambulatory visits and planned hospital admissions, an important result that plausibly reflects the fact that clinicians can strictly monitor their patients' health status without face-to-face contacts. CONCLUSIONS: Enhancement of HRQoL should represent the most critical goal of DM healthcare delivery. Effects of TM on HRQoL of diabetic patients should be studied further.

Home telemonitoring for patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial.

BACKGROUND: Although a number of studies have suggested that the use of Telemonitoring (TM) in patients with Chronic Obstructive Pulmonary Disease (COPD) can be useful and efficacious, its real utility in detecting Acute Exacerbation (AE) signaling the need for prompt treatment is not entirely clear. The current study aimed to investigate the benefits of a TM system in managing AE in advanced-stage COPD patients to improve their Health-Related Quality of Life (HRQL) and to reduce utilization of healthcare services. METHODS: A 12-month Randomised Controlled Trial (RCT) was conducted in the Veneto region (Italy). Adult patients diagnosed with Class III-IV COPD in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification were recruited and provided a TM system to alert the clinical staff via a trained operator whenever variations in respiratory parameters fell beyond the individual's normal range. The study's primary endpoint was HRQL, measured by the Italian version of the two Short Form 36-item Health Survey (SF36v2). Its secondary endpoints were: scores on the Hospital Anxiety and Depression Scale (HADS); the number and duration of hospitalizations; the number of readmissions; the number of appointments with a pulmonary specialist; the number of visits to the emergency department; and the number of deaths. RESULTS: Three hundred thirty-four patients were enrolled and randomized into two groups for a 1 year period. At its conclusion, changes in the SF36 Physical and Mental Component Summary scores did not significantly differ between the TM and control groups [(-2.07 (8.98) vs -1.91 (7.75); p = 0.889 and -1.08 (11.30) vs -1.92 (10.92); p = 0.5754, respectively]. Variations in HADS were not significantly different between the two groups [0.85 (3.68) vs 0.62 (3.6); p = 0.65 and 0.50 (4.3) vs 0.72 (4.5); p = 0.71]. The hospitalization rate for AECOPD and/or for any cause was not significantly different in the two groups [IRR = 0.89 (95% CI 0.79-1,04); p = 0.16 and IRR = 0.91 (95% CI 0,75 - 1.04); p = 0.16, respectively]. The readmission rate for AECOPD and/or any cause was, however, significantly lower in the TM group with respect to the control one [IRR = 0.43 (95% CI 0.19-0.98); p = 0.01 and 0.46 (95% CI 0.24-0.89); p = 0.01, respectively]. CONCLUSION: Study results showed that in areas where medical services are well established, TM does not significantly improve HRQL in patients with COPD who develop AE. Although not effective in reducing hospitalizations, TM can nevertheless facilitate continuity of care during hospital-to-home transition by reducing the need for early readmission. TRIAL REGISTRATION: Retrospectively registered on January 2012, ClinicalTrials.gov Identifier: NCT01513980 .

Assessment of Patients' Perception of Telemedicine Services Using the Service User Technology Acceptability Questionnaire.

INTRODUCTION: The purpose of this paper is to assess if similar telemedicine services integrated in the management of different chronic diseases are acceptable and well perceived by patients or if there are any negative perceptions. THEORY AND METHODS: Participants suffering from different chronic diseases were enrolled in Veneto Region and gathered into clusters. Each cluster received a similar telemedicine service equipped with different disease-specific measuring devices. Participants were patients with diabetes (n = 163), chronic obstructive pulmonary disease (n = 180), congestive heart failure (n = 140) and Cardiac Implantable Electronic Devices (n = 1635). The Service User Technology Acceptability Questionnaire (SUTAQ) was initially translated, culturally adapted and pretested and subsequently used to assess patients' perception of telemedicine. Data were collected after 3 months and after 12 months from the beginning of the intervention. Data for patients with implantable devices was collected only at 12 months. RESULTS: Results at 12 months for all clusters are similar and assessed a positive perception of telemedicine. The SUTAQ results for clusters 2 (diabetes), 5 (COPD) and 7 (CHF) after 3 months of intervention were confirmed after 12 months. CONCLUSIONS: Telemedicine was perceived as a viable addition to usual care. A positive perception for telemedicine services isn't a transitory effect, but extends over the course of time.

Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation.

BACKGROUND: Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3-12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach. OBJECTIVE: The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a "real world" context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency. METHODS: A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months. RESULTS: In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM) and 0.37 (ICD) real clinical events per patient per year were detected within a mean (SD) time of 1.18 (2.08) days. Mean time spent by physicians to treat a patient was lower in the I-group compared to the U-group (-4.1 minutes PM; -13.7 minutes ICD). Organizational analysis showed that remote monitoring implementation was rather haphazard and fragmented. From a health care system perspective, the economic analysis showed statistically significant gains (P<.001) for the I-group using PM. CONCLUSIONS: This study contributes to build solid evidence regarding the usefulness of RM in detecting and managing clinical and technical events with limited use of manpower and other health care resources. To fully gain the benefits of RM of PM/ICD, it is vital that organizational processes be streamlined and standardized within an overarching strategy.

Integration of telehealth and telecare: the implementation model for chronic disease management in the veneto region.

The integration of health and social care is the latest dogma for improving the quality of care for chronic and frail patients. In the Veneto Region, a unique platform has been developed for the provision of both telecare and telehealth to chronic patients that are equipped at home with a personal health system for real time detection of emergencies situations and to measure their clinical parameters according to a plan scheduled by their clinician. The integrated service is centrally managed by a regional eHealth center that represents the point of intermediation between the patient and the health and social care professionals.