Simulated case management of home telemonitoring to assess the impact of different alert algorithms on work-load and clinical decisions

© 2017 The Author(s). Background: Home telemonitoring (HTM) of chronic heart failure (HF) promises to improve care by timely indications when a patient's condition is worsening. Simple rules of sudden weight change have been demonstrated to generate many alerts with poor sensitivity. Trend alert algorithms and bio-impedance (a more sensitive marker of fluid change), should produce fewer false alerts and reduce workload. However, comparisons between such approaches on the decisions made and the time spent reviewing alerts has not been studied. Methods: Using HTM data from an observational trial of 91 HF patients, a simulated telemonitoring station was created and used to present virtual caseloads to clinicians experienced with HF HTM systems. Clinicians were randomised to either a simple (i.e. an increase of 2 kg in the past 3 days) or advanced alert method (either a moving average weight algorithm or bio-impedance cumulative sum algorithm). Results: In total 16 clinicians reviewed the caseloads, 8 randomised to a simple alert method and 8 to the advanced alert methods. Total time to review the caseloads was lower in the advanced arms than the simple arm (80 ± 42 vs. 149 ± 82 min) but agreements on actions between clinicians were low (Fleiss kappa 0.33 and 0.31) and despite having high sensitivity many alerts in the bio-impedance arm were not considered to need further action. Conclusion: Advanced alerting algorithms with higher specificity are likely to reduce the time spent by clinicians and increase the percentage of time spent on changes rated as most meaningful. Work is needed to present bio-impedance alerts in a manner which is intuitive for clinicians

Novel concepts for non-invasive telemonitoring in chronic heart failure

Background: The morbidity and mortality from chronic heart failure (HF) remains alarmingly high, in part due to failure to apply substantial disease modifying strategies to halt disease progression. Telemonitoring has been proposed as a potential disease management strategy to deal with the burden posed by HF. While treatment decisions guided by invasive telemonitoring data have shown early promise, it is unclear whether non-invasively derived surrogates of haemodynamics could be reliable enough to guide therapeutic interventions.Aims: The principal aim of this thesis is to investigate whether non-invasive “smart technologies” could accurately detect and track subtle changes in surrogates of cardiovascular haemodynamics in response to challenges posed by activities of daily living and non-adherence to therapy. Methodology: A series of prospective clinical studies were conducted in stable patients with chronic heart failure, on optimum tolerated guideline directed therapy for heart failure. Studies were performed under clinically adapted conditions to mimic the patient’s own habitat.Results: Significant systemic haemodynamic perturbations were detected non-invasively with variations in environmental temperature. Additionally, music, which modulates the sympathetic tone, led to modest changes in systemic blood pressure and heart rate, although the changes did not reach statistical significance. Non-adherence to cardiovascular therapy led to striking adverse changes in systemic haemodynamics. Smart technologies demonstrated a remarkable consistency in detecting haemodynamic perturbations.Conclusion: Non-invasive detection and tracking of changes in haemodynamics is feasible with smart technologies. The results need to be validated in larger multicenter clinical trials, with particular emphasis on using the data to guide therapeutic decisions

Assessment of a primary care-based telemonitoring intervention for home care patients with heart failure and chronic lung disease. The TELBIL study

<p>Abstract</p> <p>Background</p> <p>Telemonitoring technology offers one of the most promising alternatives for the provision of health care services at the patient's home. The primary aim of this study is to evaluate the impact of a primary care-based telemonitoring intervention on the frequency of hospital admissions.</p> <p>Methods/design</p> <p>A primary care-based randomised controlled trial will be carried out to assess the impact of a telemonitoring intervention aimed at home care patients with heart failure (HF) and/or chronic lung disease (CLD). The results will be compared with those obtained with standard health care practice. The duration of the study will be of one year. Sixty patients will be recruited for the study. In-home patients, diagnosed with HF and/or CLD, aged 14 or above and with two or more hospital admissions in the previous year will be eligible.</p> <p>For the intervention group, telemonitoring will consist of daily patient self-measurements of respiratory-rate, heart-rate, blood pressure, oxygen saturation, weight and body temperature. Additionally, the patients will complete a qualitative symptom questionnaire daily using the telemonitoring system. Routine telephone contacts will be conducted every fortnight and additional telephone contacts will be carried out if the data received at the primary care centre are out of the established limits. The control group will receive usual care. The primary outcome measure is the number of hospital admissions due to any cause that occurred in a period of 12 months post-randomisation. The secondary outcome measures are: duration of hospital stay, hospital admissions due to HF or CLD, mortality rate, use of health care resources, quality of life, cost-effectiveness, compliance and patient and health care professional satisfaction with the new technology.</p> <p>Discussion</p> <p>The results of this study will shed some light on the effects of telemonitoring for the follow-up and management of chronic patients from a primary care setting. The study may contribute to enhance the understanding of alternative modes of health care provision for medically unstable elderly patients, who bear a high degree of physical and functional deterioration.</p> <p>Trial Registration</p> <p>ISRCTN: <a href="http://www.controlled-trials.com/ISRCTN89041993">ISRCTN89041993</a></p

The impact of community-based, nurse-supported heart failure management on self-care behaviour, psychosocial and clinical outcomes

This thesis investigated the effects of two models of community-based, nurse-led chronic heart failure (CHF) care. Study 1 evaluated a nurse practitioner-led clinic, which provided support to patients with CHF, compared with a control group. Study 2 was a randomised controlled trial of a nurse-supported telemonitoring intervention for patients with CHF. We found that community-based, nurse-led models of care improved self-managementr in patients with CHF with telemonitoring found to be a valuable adjunct to conventional CHF care

Bioimpedance-Based Heart Failure Deterioration Prediction Using a Prototype Fluid Accumulation Vest-Mobile Phone Dyad: An Observational Study

BACKGROUND: Recurrent heart failure (HF) events are common in patients discharged after acute decompensated heart failure (ADHF). New patient-centered technologies are needed to aid in detecting HF decompensation. Transthoracic bioimpedance noninvasively measures pulmonary fluid retention. OBJECTIVE: The objectives of our study were to (1) determine whether transthoracic bioimpedance can be measured daily with a novel, noninvasive, wearable fluid accumulation vest (FAV) and transmitted using a mobile phone and (2) establish whether an automated algorithm analyzing daily thoracic bioimpedance values would predict recurrent HF events. METHODS: We prospectively enrolled patients admitted for ADHF. Participants were trained to use a FAV-mobile phone dyad and asked to transmit bioimpedance measurements for 45 consecutive days. We examined the performance of an algorithm analyzing changes in transthoracic bioimpedance as a predictor of HF events (HF readmission, diuretic uptitration) over a 75-day follow-up. RESULTS: We observed 64 HF events (18 HF readmissions and 46 diuretic uptitrations) in the 106 participants (67 years; 63.2%, 67/106, male; 48.1%, 51/106, with prior HF) who completed follow-up. History of HF was the only clinical or laboratory factor related to recurrent HF events (P=.04). Among study participants with sufficient FAV data (n=57), an algorithm analyzing thoracic bioimpedance showed 87% sensitivity (95% CI 82-92), 70% specificity (95% CI 68-72), and 72% accuracy (95% CI 70-74) for identifying recurrent HF events. CONCLUSIONS: Patients discharged after ADHF can measure and transmit daily transthoracic bioimpedance using a FAV-mobile phone dyad. Algorithms analyzing thoracic bioimpedance may help identify patients at risk for recurrent HF events after hospital discharge. Sert Kuniyoshi, Joseph Rock, Theo E Meyer, David D McManus. Originally published in JMIR Cardio (http://cardio.jmir.org), 13.03.2017

Digital remote monitoring in adult congenital heart disease patients:Lessons learned and recommendations

In cardiology telemedicine is introduced for care for patients with heart failure and (possible) arrhythmia. mHealth telemonitoring might be a powerful tool for remote diagnosing and managing arrhythmias, heart failure and blood pressure. This thesis focuses on the question whether introducing digital remote patient monitoring (DRPM) by a dedicated mHealth program in the routine care management of adult congenital heart disease (ACHD) patients improves care for these patients.The project was funded with a successful crowdfunding campaign. Critical success factors contributing to this success are described. The crowdfunding campaign could have met the needs of donors, leading to enforcing of the public engagement. Appropriate patient selection for participation in mHealth contributes to an efficient use of mHealth and lower emergency care utilization. Results of a study to evaluate a mHealth telemonitoring program for managing arrhythmia, heart failure and blood pressure in symptomatic ACHD patients are presented. mHealth can be an acceptable alternative for ILR implantation in detecting arrhythmia in symptomatic ACHD patients in respect to diagnostic yield, safety and management decisions, especially in those without syncope.A narrative review is presented of scientific publications published regarding extended arrhythmia screening in ACHD patients. The number of studies found was limited. The studies found demonstrated a higher rate of arrhythmia and bradycardia detection leading to clinical care changes by extending the time of rhythm monitoring to more than 24 hours. Although several non-invasive diagnostic tools are, in symptomatic patients, a good alternative for ILRs, the optimal mode of detection is still unclear. Future directions for DRPM and key points for future DRPM research are given

Digital remote monitoring in adult congenital heart disease patients:Lessons learned and recommendations

In cardiology telemedicine is introduced for care for patients with heart failure and (possible) arrhythmia. mHealth telemonitoring might be a powerful tool for remote diagnosing and managing arrhythmias, heart failure and blood pressure. This thesis focuses on the question whether introducing digital remote patient monitoring (DRPM) by a dedicated mHealth program in the routine care management of adult congenital heart disease (ACHD) patients improves care for these patients.The project was funded with a successful crowdfunding campaign. Critical success factors contributing to this success are described. The crowdfunding campaign could have met the needs of donors, leading to enforcing of the public engagement. Appropriate patient selection for participation in mHealth contributes to an efficient use of mHealth and lower emergency care utilization. Results of a study to evaluate a mHealth telemonitoring program for managing arrhythmia, heart failure and blood pressure in symptomatic ACHD patients are presented. mHealth can be an acceptable alternative for ILR implantation in detecting arrhythmia in symptomatic ACHD patients in respect to diagnostic yield, safety and management decisions, especially in those without syncope.A narrative review is presented of scientific publications published regarding extended arrhythmia screening in ACHD patients. The number of studies found was limited. The studies found demonstrated a higher rate of arrhythmia and bradycardia detection leading to clinical care changes by extending the time of rhythm monitoring to more than 24 hours. Although several non-invasive diagnostic tools are, in symptomatic patients, a good alternative for ILRs, the optimal mode of detection is still unclear. Future directions for DRPM and key points for future DRPM research are given

The role of non-invasive devices for the telemonitoring of heart failure patients

Heart failure (HF) patients represent one of the most prevalent as well as one of the most fragile population encountered in the cardiology and internal medicine departments nowadays. Estimated to account for around 26 million people worldwide, diagnosed patients present a poor prognosis and quality of life with a clinical history accompanied by repeated hospital admissions caused by an exacerbation of their chronic condition. The frequent hospitalizations and the extended hospital stays mean an extremely high economic burden for healthcare institutions. Meanwhile, the number of chronically diseased and elderly patients is continuously rising, and a lack of specialized physicians is evident. To cope with this health emergency, more efficient strategies for patient management, more accurate diagnostic tools, and more efficient preventive plans are needed. In recent years, telemonitoring has been introduced as the potential answer to solve such needs. Different methodologies and devices have been progressively investigated for effective home monitoring of cardiologic patients. Invasive hemodynamic devices, such as CardioMEMS™, have been demonstrated to be reducing hospitalizations and mortality, but their use is however restricted to limited cases. The role of external non-invasive devices for remote patient monitoring, instead, is yet to be clarified. In this review, we summarized the most relevant studies and devices that, by utilizing non-invasive telemonitoring, demonstrated whether beneficial effects in the management of HF patients were effective

Technology-driven heart failure management system : changes in functional capacity and quality of life.

Background . Heart failure treatment guidelines emphasize the importance of daily weight monitoring. To support this practice, the Health Care Financing Administration Heart Failure Demonstration Project (2000) was designed to evaluate the effect of technology driven monitoring of daily weight and symptoms in elderly HF patients (NYHA class II to IV). This sub-study is conducted to assess the effect of a technology driven HF monitoring system on clinically meaningful change in functional capacity and quality of life (QOL). Methods . This is a randomized, multi-centered, controlled clinical trial in which Medicare beneficiaries with a history of hospitalization within one year were randomized to standard care or standard care + a technology driven heart failure monitoring system. Primary end points were clinically meaningful change in functional capacity [6-minute walk distance (6MWD) or 6-minute work (6MW)] and QOL [Minnesota Living with Heart Failure Questionnaire (MLHF)] after 6-months of follow-up. Regression to the mean effects were estimated and adjusted according to the Edwards-Nunnally (EN) method. Clinically meaningful change is then defined in terms of the standard error of measurement (SEM) criterion. Results . Two hundred eighty four patients from three centers in USA were randomized. Mean age was 74 +/- 9 yrs, 58% were male, 82% were Caucasians, and New York Heart Association class II (31%), III (59%), and IV (10%). The change in functional capacity in terms of 6WD was 42 m, by 6MW was 3668 kg/m of work, and change in QOL in terms of MLHF total score by 6.0, physical dimension score by 4.0, and emotional dimension score by 2.0 from baseline. Body mass index, Left ventricular Ejection Fraction, beta-blocker usage and intra-cardiac device (ICD) implantation were the best clinically relevant predictors of change in functional capacity. Technology driven heart failure management did not result in a clinically meaningful incremental benefit in functional capacity or in QOL. Conclusions . There is no significant clinically meaningful benefit in functional capacity or in QOL from technology driven HF monitoring system in NYHA class II-IV elderly HF patients. Further, monitoring HF patients increased outpatient care resource utilization and costs, and was associated with a significantly poorer QOL

Exploring the potential of virtual hospital care

Healthcare expenditures in the Netherlands have been rising for decades, predominantly driven by demographic and technological developments. Due to the aging population, the prevalence of chronic diseases and multimorbidity is increasing, causing the demand for healthcare to rise. In addition to the rising healthcare costs, there is also a labor market shortage in the healthcare sector, particularly a shortage of nurses. It is expected that this shortage will grow substantially, meaning that healthcare systems will have to provide care for an increasing number of patients, with less personnel. To answer these challenges, virtual care is expected to have to play an important part. This dissertation had two main aims. The first aim was to explore the extent to which virtual hospital care could lead to cost savings or increases in capacity. The second aim of this dissertation was to assess the feasibility of remote continuous monitoring of vital signs.This dissertation shows that virtual hospital care, in general, tends to reduce the number of (re)admissions and the length of hospital stay. These reductions can be expected to mainly have an impact on capacity. Expected cost savings are limited relative to the national healthcare budget, even in an optimistic scenario. This dissertation also shows that there is a need for further development of the technology, for example with regard to the reliability of data transmission, evidence that clinical deterioration can be detected with continuous monitoring of (a limited set of) vital signs, ease of use, and compatibility with existing work processes.<br/