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Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Wearable devices can be used for continuous patient monitoring in the general ward, increasing patient safety. Little is known about the experiences and expectations of patients and health care professionals regarding continuous monitoring with these devices. OBJECTIVE:This study aimed to identify positive and negative effects as well as barriers and facilitators for the use of two wearable devices: ViSi Mobile (VM) and HealthPatch (HP). METHODS:In this randomized controlled trial, 90 patients admitted to the internal medicine and surgical wards of a university hospital in the Netherlands were randomly assigned to continuous vital sign monitoring using VM or HP and a control group. Users' experiences and expectations were addressed using semistructured interviews. Nurses, physician assistants, and medical doctors were also interviewed. Interviews were analyzed using thematic content analysis. Psychological distress was assessed using the State Trait Anxiety Inventory and the Pain Catastrophizing Scale. The System Usability Scale was used to assess the usability of both devices. RESULTS:A total of 60 patients, 20 nurses, 3 physician assistants, and 6 medical doctors were interviewed. We identified 47 positive and 30 negative effects and 19 facilitators and 36 barriers for the use of VM and HP. Frequently mentioned topics included earlier identification of clinical deterioration, increased feelings of safety, and VM lines and electrodes. No differences related to psychological distress and usability were found between randomization groups or devices. CONCLUSIONS:Both devices were well received by most patients and health care professionals, and the majority of them encouraged the idea of monitoring vital signs continuously in the general ward. This comprehensive overview of barriers and facilitators of using wireless devices may serve as a guide for future researchers, developers, and health care institutions that consider implementing continuous monitoring in the ward. TRIAL REGISTRATION:Clinicaltrials.gov NCT02933307; http://clinicaltrials.gov/ct2/show/NCT02933307.

SUBMITTER: Weenk M

PROVIDER: S-EPMC7315364 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial.

Weenk Mariska M Bredie Sebastian J SJ Koeneman Mats M Hesselink Gijs G van Goor Harry H van de Belt Tom H TH

Journal of medical Internet research 20200610 6

<h4>Background</h4>Wearable devices can be used for continuous patient monitoring in the general ward, increasing patient safety. Little is known about the experiences and expectations of patients and health care professionals regarding continuous monitoring with these devices.<h4>Objective</h4>This study aimed to identify positive and negative effects as well as barriers and facilitators for the use of two wearable devices: ViSi Mobile (VM) and HealthPatch (HP).<h4>Methods</h4>In this randomize ...[more]

PMID: 32519972

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Project description:BACKGROUND:Continuous monitoring of vital signs by using wearable wireless devices may allow for timely detection of clinical deterioration in patients in general wards in comparison to detection by standard intermittent vital signs measurements. A large number of studies on many different wearable devices have been reported in recent years, but a systematic review is not yet available to date. OBJECTIVE:The aim of this study was to provide a systematic review for health care professionals regarding the current evidence about the validation, feasibility, clinical outcomes, and costs of wearable wireless devices for continuous monitoring of vital signs. METHODS:A systematic and comprehensive search was performed using PubMed/MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials from January 2009 to September 2019 for studies that evaluated wearable wireless devices for continuous monitoring of vital signs in adults. Outcomes were structured by validation, feasibility, clinical outcomes, and costs. Risk of bias was determined by using the Mixed Methods Appraisal Tool, quality assessment of diagnostic accuracy studies 2nd edition, or quality of health economic studies tool. RESULTS:In this review, 27 studies evaluating 13 different wearable wireless devices were included. These studies predominantly evaluated the validation or the feasibility outcomes of these devices. Only a few studies reported the clinical outcomes with these devices and they did not report a significantly better clinical outcome than the standard tools used for measuring vital signs. Cost outcomes were not reported in any study. The quality of the included studies was predominantly rated as low or moderate. CONCLUSIONS:Wearable wireless continuous monitoring devices are mostly still in the clinical validation and feasibility testing phases. To date, there are no high quality large well-controlled studies of wearable wireless devices available that show a significant clinical benefit or cost-effectiveness. Such studies are needed to help health care professionals and administrators in their decision making regarding implementation of these devices on a large scale in clinical practice or in-home monitoring.

Project description:ObjectiveTo determine feasibility, in terms of acceptability and system fidelity, of continuous vital signs monitoring in abdominal surgery patients on a general ward.DesignObservational cohort study.SettingTertiary teaching hospital.ParticipantsPostoperative abdominal surgical patients (n=30) and nurses (n=23).InterventionsPatients were continuously monitored with the SensiumVitals wearable device until discharge in addition to usual care, which is intermittent Modified Early Warning Score measurements. Heart rate, respiratory rate and axillary temperature were monitored every 2?min. Values and trends were visualised and alerts sent to the nurses.OutcomesSystem fidelity was measured by analysis of the monitoring data. Acceptability by patients and nurses was assessed using questionnaires.ResultsThirty patients were monitored for a median duration of 81?hours (IQR 47-143) per patient, resulting in 115?217 measurements per parameter. In total, 19% (n=21?311) of heart rate, 51% (n=59?184) of respiratory rate and 9% of temperature measurements showed artefacts (n=10?269). The system algorithm sent 972 alerts (median alert rate of 4.5 per patient per day), of which 90.3% (n=878) were system alerts and 9.7% (n=94) were vital sign alerts. 35% (n=33) of vital sign alerts were true positives. 93% (n=25) of patients rated the patch as comfortable, 67% (n=18) felt safer and 89% (n=24) would like to wear it next time in the hospital. Nurses were neutral about usefulness, with a median score of 3.5 (IQR 3.1-4) on a 7-point Likert scale, ease of use 3.7 (IQR 3.2-4.8) and satisfaction 3.7 (IQR 3.2-4.8), but agreed on ease of learning at 5.0 (IQR 4.0-5.8). Neutral scores were mostly related to the perceived limited fidelity of the system.ConclusionsContinuous monitoring of vital signs with a wearable device was well accepted by patients. Nurses' ratings were highly variable, resulting in on average neutral attitude towards remote monitoring. Our results suggest it is feasible to monitor vital signs continuously on general wards, although acceptability of the device among nurses needs further improvement.

Project description:BackgroundContinuous monitoring of vital signs (CMVS) using wearable wireless sensors is increasingly available to patients in general wards and can improve outcomes and reduce nurse workload. To assess the potential impact of such systems, successful implementation is important. We developed a CMVS intervention and implementation strategy and evaluated its success in 2 general wards.ObjectiveWe aimed to assess and compare intervention fidelity in 2 wards (internal medicine and general surgery) of a large teaching hospital.MethodsA mixed methods sequential explanatory design was used. After thorough training and preparation, CMVS was implemented-in parallel with the standard intermittent manual measurements-and executed for 6 months in each ward. Heart rate and respiratory rate were measured using a chest-worn wearable sensor, and vital sign trends were visualized on a digital platform. Trends were routinely assessed and reported each nursing shift without automated alarms. The primary outcome was intervention fidelity, defined as the proportion of written reports and related nurse activities in case of deviating trends comparing early (months 1-2), mid- (months 3-4), and late (months 5-6) implementation periods. Explanatory interviews with nurses were conducted.ResultsThe implementation strategy was executed as planned. A total of 358 patients were included, resulting in 45,113 monitored hours during 6142 nurse shifts. In total, 10.3% (37/358) of the sensors were replaced prematurely because of technical failure. Mean intervention fidelity was 70.7% (SD 20.4%) and higher in the surgical ward (73.6%, SD 18.1% vs 64.1%, SD 23.7%; P<.001). Fidelity decreased over the implementation period in the internal medicine ward (76%, 57%, and 48% at early, mid-, and late implementation, respectively; P<.001) but not significantly in the surgical ward (76% at early implementation vs 74% at midimplementation [P=.56] vs 70.7% at late implementation [P=.07]). No nursing activities were needed based on vital sign trends for 68.7% (246/358) of the patients. In 174 reports of 31.3% (112/358) of the patients, observed deviating trends led to 101 additional bedside assessments of patients and 73 consultations by physicians. The main themes that emerged during interviews (n=21) included the relative priority of CMVS in nurse work, the importance of nursing assessment, the relatively limited perceived benefits for patient care, and experienced mediocre usability of the technology.ConclusionsWe successfully implemented a system for CMVS at scale in 2 hospital wards, but our results show that intervention fidelity decreased over time, more in the internal medicine ward than in the surgical ward. This decrease appeared to depend on multiple ward-specific factors. Nurses' perceptions regarding the value and benefits of the intervention varied. Implications for optimal implementation of CMVS include engaging nurses early, seamless integration into electronic health records, and sophisticated decision support tools for vital sign trend interpretation.

Project description:BackgroundVital signs monitoring is a universal tool for the detection of postoperative complications; however, unwell patients can be missed between traditional observation rounds. New remote monitoring technologies promise to convey the benefits of continuous monitoring to patients in general wards.ObjectiveThe aim of this pilot study was to evaluate whether continuous remote vital signs monitoring is a practical and acceptable way of monitoring surgical patients and to optimize the delivery of a definitive trial.MethodsWe performed a prospective, cluster-randomized, parallel-group, unblinded, controlled pilot study. Patients admitted to 2 surgical wards at a large tertiary hospital received either continuous and intermittent vital signs monitoring or intermittent monitoring alone using an early warning score system. Continuous monitoring was provided by a wireless patch, worn on the patient's chest, with data transmitted wirelessly every 2 minutes to a central monitoring station or a mobile device carried by the patient's nurse. The primary outcome measure was time to administration of antibiotics in sepsis. The secondary outcome measures included the length of hospital stay, 30-day readmission rate, mortality, and patient acceptability.ResultsOverall, 226 patients were randomized between January and June 2017. Of 226 patients, 140 were randomized to continuous remote monitoring and 86 to intermittent monitoring alone. On average, patients receiving continuous monitoring were administered antibiotics faster after evidence of sepsis (626 minutes, n=22, 95% CI 431.7-820.3 minutes vs 1012.8 minutes, n=12, 95% CI 425.0-1600.6 minutes), had a shorter average length of hospital stay (13.3 days, 95% CI 11.3-15.3 days vs 14.6 days, 95% CI 11.5-17.7 days), and were less likely to require readmission within 30 days of discharge (11.4%, 95% CI 6.16-16.7 vs 20.9%, 95% CI 12.3-29.5). Wide CIs suggest these differences are not statistically significant. Patients found the monitoring device to be acceptable in terms of comfort and perceived an enhanced sense of safety, despite 24% discontinuing the intervention early.ConclusionsRemote continuous vital signs monitoring on surgical wards is practical and acceptable to patients. Large, well-controlled studies in high-risk populations are required to determine whether the observed trends translate into a significant benefit for continuous over intermittent monitoring.Trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN60999823; http://www.isrctn.com /ISRCTN60999823 (Archived by WebCite at http://www.webcitation.org/73ikP6OQz).

Project description:Rationale: Monitoring patients’ vital signs is done to detect clinical deterioration. For this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is used. Although the MEWS provides relevant data on patients’ health status, the interval measurements may not capture early deterioration of vital signs, especially during the night. As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac arrhythmias, which are known to complicate postoperative course. Besides, this way of measuring vital signs may be stressful for patients and disturbs patients’ sleep. New technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of vital signs using wearable devices transmitting relevant data to nurses and clinicians. With this, the investigators think that clinical deterioration may be detected in an early phase and reduce nurse work load and patient distress. Objective: to investigate the feasibility of wearable devices on the general ward. Study design: feasibility study. Study population: adult patients hospitalized on the internal medicine ward and adult postoperative patients on the surgical ward. Intervention: patients in the intervention groups will be randomized in one of the two groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements take place at usual time points. Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side effects of devices, STAI scores, and PCS scores will be documented. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will wear one device for at least three days. Devices can be uncomfortable by being heavy or the patches can start itching. More measurements by nurses can take place when indicated, for example after alarms. The participating patients will fill out the STAI on daily basis and the PCS on the last day of hospitalization. Both questionnaires will take a few minutes to complete. Patients could benefit from early detection of clinical deterioration and early corrective interventions or ICU admissions.

Project description:In recent years, noncontact measurements of vital signs using cameras received a great amount of interest. However, some questions are unanswered: (i) Which vital sign is monitored using what type of camera? (ii) What is the performance and which factors affect it? (iii) Which health issues are addressed by camera-based techniques? Following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement, we conduct a systematic review of continuous camera-based vital sign monitoring using Scopus, PubMed, and the Association for Computing Machinery (ACM) databases. We consider articles that were published between January 2018 and April 2021 in the English language. We include five vital signs: heart rate (HR), respiratory rate (RR), blood pressure (BP), body skin temperature (BST), and oxygen saturation (SpO2). In total, we retrieve 905 articles and screened them regarding title, abstract, and full text. One hundred and four articles remained: 60, 20, 6, 2, and 1 of the articles focus on HR, RR, BP, BST, and SpO2, respectively, and 15 on multiple vital signs. HR and RR can be measured using red, green, and blue (RGB) and near-infrared (NIR) as well as far-infrared (FIR) cameras. So far, BP and SpO2 are monitored with RGB cameras only, whereas BST is derived from FIR cameras only. Under ideal conditions, the root mean squared error is around 2.60 bpm, 2.22 cpm, 6.91 mm Hg, 4.88 mm Hg, and 0.86 °C for HR, RR, systolic BP, diastolic BP, and BST, respectively. The estimated error for SpO2 is less than 1%, but it increases with movements of the subject and the camera-subject distance. Camera-based remote monitoring mainly explores intensive care, post-anaesthesia care, and sleep monitoring, but also explores special diseases such as heart failure. The monitored targets are newborn and pediatric patients, geriatric patients, athletes (e.g., exercising, cycling), and vehicle drivers. Camera-based techniques monitor HR, RR, and BST in static conditions within acceptable ranges for certain applications. The research gaps are large and heterogeneous populations, real-time scenarios, moving subjects, and accuracy of BP and SpO2 monitoring.

Dataset Information

Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial.

Publications

Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial.

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