Correction: Continuous Monitoring of Vital Signs Using Wearable Devices on the General Ward: Pilot Study.

[This corrects the article DOI: 10.2196/mhealth.7208.].

Algorithms for Prediction of Clinical Deterioration on the General Wards: A Scoping Review.

OBJECTIVE: The primary objective of this scoping review was to identify and describe state-of-the-art models that use vital sign monitoring to predict clinical deterioration on the general ward. The secondary objective was to identify facilitators, barriers, and effects of implementing these models. DATA SOURCES: PubMed, Embase, and CINAHL databases until November 2020. STUDY SELECTION: We selected studies that compared vital signs-based automated real-time predictive algorithms to current track-and-trace protocols in regard to the outcome of clinical deterioration in a general ward population. DATA EXTRACTION: Study characteristics, predictive characteristics and barriers, facilitators, and effects. RESULTS: We identified 1741 publications, 21 of which were included in our review. Two of the these were clinical trials, 2 were prospective observational studies, and the remaining 17 were retrospective studies. All of the studies focused on hospitalized adult patients. The reported area under the receiver operating characteristic curves ranged between 0.65 and 0.95 for the outcome of clinical deterioration. Positive predictive value and sensitivity ranged between 0.223 and 0.773 and from 7.2% to 84.0%, respectively. Input variables differed widely, and predicted endpoints were inconsistently defined. We identified 57 facilitators and 48 barriers to the implementation of these models. We found 68 reported effects, 57 of which were positive. CONCLUSION: Predictive algorithms can detect clinical deterioration on the general ward earlier and more accurately than conventional protocols, which in one recent study led to lower mortality. Consensus is needed on input variables, predictive time horizons, and definitions of endpoints to better facilitate comparative research.

Low compliance to a vital sign safety protocol on general hospital wards: A retrospective cohort study.

BACKGROUND: Periodic vital sign monitoring is commonly used to detect clinical deterioration. Incomplete assessment of Early Warning Score (EWS) and poor protocol compliance may negatively impact nurses' responsiveness to critical situations. OBJECTIVE: This study assesses the quality of recorded EWSs and the degree of overall protocol compliance and protocol compliance in adverse event patients, in a centre that is an early adopter of an EWS safety protocol. DESIGN: Retrospective single-centre cohort study. SETTING: General hospital wards of a tertiary referral university medical centre. PARTICIPANTS: 48,864 patients admitted to general wards between 2015 and 2018. METHODS: Vital sign and Modified EWS (MEWS) data were collected from the electronic health record. MEWS completeness was evaluated by determining the proportion of missing values for each vital sign. To evaluate protocol compliance, we assessed whether the elapsed time between consecutive MEWSs was within the protocollary time as dictated by the MEWS protocol. Outcome measures were overall MEWS completeness, and both overall protocol compliance and protocol compliance specifically in the 24 h before adverse events. RESULTS: All required items to calculate a MEWS were present in 76 percent of the 1,663,743 vital sign measurements. Overall protocol compliance was 62 percent. For the low, mid-range and high MEWS groups, protocol compliances were 67, 47 and 30 percent, respectively. Time-to-next-MEWS exceeded protocol-recommended timing by up to 9 h for a substantial amount of MEWSs in the mid- and high-range MEWS groups. In patients with adverse events, compliance to the MEWS protocol during the 24 h prior to the events was 66 percent in aggregate, ranging from 80% in low MEWS groups, 74% in the mid-range, and 49% in the high MEWS groups. In the high MEWS group, improvements in protocol compliance were primarily noted in five hours immediately preceding the event. CONCLUSIONS: EWS assessments were incomplete in one-quarter of measurements. Compliance to a MEWS safety protocol was generally low, specifically when the protocol mandated more frequent MEWS assessments. Although more MEWSs were recorded in patients with adverse events, the increase in vital sign measurements' frequency mostly occurred shortly before the event manifested. This finding suggests missed opportunities to detect clinical deterioration.

Evaluation of a Web-Based Self-Management Program for Patients With Cardiovascular Disease: Explorative Randomized Controlled Trial.

BACKGROUND: Web-based self-management programs have the potential to support patients with cardiovascular disease (CVD) in their self-management (eg, by focusing on behavior change and improving physical activity). The intervention mapping framework was used to develop a web-based program called Vascular View. The Vascular View program contained 6 modules (coping with CVD, setting boundaries, lifestyle, healthy nutrition, being physically active, interaction with health professionals) aiming to increase self-management behavior by tailoring to the perceived problems and (support) needs of patients after CVD. OBJECTIVE: The aim was to test the effectiveness of Vascular View before embarking on a full-scale randomized clinical trial (RCT) by evaluating the potential effectiveness and effect sizes of the Vascular View program and identifying outcome measures most likely to capture the potential benefits. METHODS: An explorative RCT was performed. Both control and intervention groups received care as usual and, in addition, the intervention group received 12 months of access to a web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included general patient-reported outcome measurements: Illness Perception Questionnaire (IPQ), Rand-36, Patient Activation Measure, and patient self-efficacy. Module-specific patient-reported outcome measurements were Beliefs about Medicines Questionnaire, International Physical Activity Questionnaire, Dutch Healthy Diet Index, Fagerström Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test, and Perceived Efficacy in Patient-Physician Interaction. Linear mixed models for repeated measures using intention-to-treat and per-protocol analysis were applied to study differences between the patients in the intervention and control groups. Floor and ceiling effects were explored to give insight into the outcome measures most likely to capture the potential benefits. RESULTS: A total of 105 patients in the control group and 103 patients in the intervention group participated in the study. A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND). Floor and ceiling effects were seen in the IPQ, Rand-36, and the self-efficacy questionnaire. CONCLUSIONS: No conclusion for the efficacy of the Vascular View program or selection of outcome measurements can be taken yet. A process evaluation will be conducted to gain thorough insight into the working elements of the program, patient needs in eHealth, and the use of the program by patients. This can determine for whom web-based self-management programs will work and help to adapt the program. TRIAL REGISTRATION: Dutch Trial Register NTR5412; https://www.trialregister.nl/trial/5303. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.6352.

A nurse-based intervention for improving medication adherence in cardiovascular patients: an evaluation of a randomized controlled trial.

Background: Poor medication adherence is a limitation in the secondary prevention of cardiovascular diseases (CVDs) and leads to increased morbidity, mortality, and costs. Purpose: To examine the process and effect of a nurse-led, web-based intervention based on behavioral change strategies to improve medication adherence in patients with CVD. Patients and methods: In this single-center, prospective, controlled clinical trial, cardiovascular patients were assigned to usual care, usual care plus a personalized website, or usual care plus a personalized website and personal consultations. Primary outcome was the level of adherence to cardiovascular medication. Data collection occurred between October 2011 and January 2015. Results: In total, 419 patients were randomized. Just 77 patients logged on the website and half of the invited patients attended the group consultation. Due to the limited use of the website, we combined the results of usual care and the usual care plus website group in one group (usual care) and compared these with the results of the group which received the nurse intervention (intervention group). No significant difference in adherence between the usual care group and the intervention group was observed. The adherence level in the usual care group was 93%, compared to 89% in the intervention group (p=0.08). 29% (usual care) and 31% (intervention group) of the patients showed a low adherence according to the Modified Morisky Scale® (p-value=0.94). The mean necessity concern differential was 3.8 with no differences between the two studied groups (mean 3.8 vs mean 3.9, p-value =0.86). Conclusion: Our intervention program did not show an effect. This could indicate that structured usual care provided to all cardiovascular patients already results in high medication adherence or that shortly after a cardiovascular event adherence is high. It could also indicate that the program did not have enough impact because there was not enough compliance with the intervention protocol. Trial registration: ID number NCT01449695, approved May 2011.

Feasibility of a New Cuffless Device for Ambulatory Blood Pressure Measurement in Patients With Hypertension: Mixed Methods Study.

BACKGROUND: Frequent home blood pressure (BP) measurements result in a better estimation of the true BP. However, traditional cuff-based BP measurements are troublesome for patients. OBJECTIVE: This study aimed to evaluate the feasibility of a cuffless device for ambulatory systolic blood pressure (SBP) measurement. METHODS: This was a mixed method feasibility study in patients with hypertension. Performance of ambulatory SBPs with the device was analyzed quantitatively by intrauser reproducibility and comparability to a classic home BP monitor. Correct use by the patients was checked with video, and user-friendliness was assessed using a validated questionnaire, the System Usability Scale (SUS). Patient experiences were assessed using qualitative interviews. RESULTS: A total of 1020 SBP measurements were performed using the Checkme monitor in 11 patients with hypertension. Duplicate SBPs showed a high intrauser correlation (R=0.86, P<.001). SBPs measured by the Checkme monitor did not correlate well with those of the different home monitors (R=0.47, P=.007). However, the mean SBPs measured by the Checkme and home monitors over the 3-week follow-up were strongly correlated (R=0.75, P=.008). In addition, 36.4% (n=4) of the participants performed the Checkme measurements without any mistakes. The mean SUS score was 86.4 (SD 8.3). The most important facilitator was the ease of using the Checkme monitor. Most important barriers included the absence of diastolic BP and the incidental difficulties in obtaining an SBP result. CONCLUSIONS: Given the good intrauser reproducibility, user-friendliness, and patient experience, all of which facilitate patients to perform frequent measurements, cuffless BP monitoring may change the way patients measure their BP at home in the context of ambulant hypertension management.

Mobile Apps for Blood Pressure Monitoring: Systematic Search in App Stores and Content Analysis.

BACKGROUND: Using a mobile app for self-management could make it easier for patients to get insight into their blood pressure patterns. However, little is known about the availability, quality, and features of mobile apps targeting blood pressure. OBJECTIVE: The goal of the research was to determine the availability, functionality, and quality of mobile apps that could be used for blood pressure monitoring purposes. METHODS: A systematic app search was performed based on the standards for systematic reviews. We searched the Dutch official app stores for Android and iOS platforms using predefined keywords and included all English and Dutch mobile apps targeting blood pressure. Two independent assessors determined eligibility and quality of the apps using the 5-point Mobile App Rating Scale (MARS). Quality scores of the apps with and without 17 a priori selected characteristics were compared using independent sample t tests. RESULTS: A total of 184 apps (104 Android, 80 iOS) met the inclusion criteria. The mean overall MARS score was 2.63 (95% CI 2.55-2.71) for Android and 2.64 (95% CI 2.56-2.71) for iOS. The apps Bloeddruk (4.1) and AMICOMED BP (3.6) had the highest quality scores on the Android and iOS platforms, respectively. Of the app characteristics recorded, only pricing, in-app advertisements, and local data storage were not associated with the quality scores. In only 3.8% (7/184) of the apps, involvement of medical experts in its development was mentioned, whereas none of the apps was formally evaluated with results published in a peer-reviewed journal. CONCLUSIONS: This study provides an overview of the best apps currently available in the app stores and important key features for self-management that can be used by health care providers and patients with hypertension to identify a suitable app targeting blood pressure monitoring. However, the majority of the apps targeting blood pressure monitoring were of poor quality. Therefore, it is important to involve medical experts in the developmental stage of health-related mobile apps to improve the quality of these apps.

A Cloud-Based Virtual Outpatient Clinic for Patient-Centered Care: Proof-of-Concept Study.

BACKGROUND: Most electronic health (eHealth) interventions offered to patients serve a single purpose and lack integration with other tools or systems. This is problematic because the majority of patients experience comorbidity and chronic disease, see multiple specialists, and therefore have different needs regarding access to patient data, communication with peers or providers, and self-monitoring of vital signs. A multicomponent digital health cloud service that integrates data sharing, collection, and communication could facilitate patient-centered care in combination with a hospital patient portal and care professionals. OBJECTIVE: This study aimed to assess the feasibility and functionality of a new cloud-based and multicomponent outpatient clinic, the "Virtual Outpatient Clinic" (VOC). METHODS: The VOC consists of 6 digital tools that facilitate self-monitoring (blood pressure, weight, and pain) and communication with peers and providers (chat and videoconferencing) connected to a cloud-based platform and the hospital patient portal to facilitate access to (self-collected) medical data. In this proof-of-concept study, 10 patients from both Departments of Internal Medicine and Dermatology (N=20) used all options of the VOC for 6 weeks. An eNurse offered support to participants during the study. We assessed the feasibility, usage statistics, content, adherence, and identified technical issues. Moreover, we conducted qualitative interviews with all participants by following a standard interview guide to identify user experiences, including barriers, facilitators, and potential effects. RESULTS: Most participants successfully used all options of the VOC and were positive about different tools and apps and the integral availability of their information. The adherence was 37% (7/19) for weight scale, 58% (11/19) for blood pressure monitor, and 70% (14/20) and 85% (17/20) for pain score and daily questions, respectively. The adherence for personal health record was 65% (13/20) and 60% (12/20) for the patient portal system. Qualitative data showed that performance and effort expectancy scored high among participants, indicating that using the VOC is convenient, easy, and time-saving. CONCLUSIONS: The VOC is a promising integrated Web-based technology that combines self-management, data sharing, and communication between patients and professionals. The system can be personalized by connecting various numbers of components, which could make it a relevant tool for other patient groups. Before a system, such as the VOC, can be implemented in daily practice, prospective studies focused on evaluating outcomes, costs, and patient-centeredness are needed.

Continuous Monitoring of Vital Signs Using Wearable Devices on the General Ward: Pilot Study.

BACKGROUND: Measurement of vital signs in hospitalized patients is necessary to assess the clinical situation of the patient. Early warning scores (EWS), such as the modified early warning score (MEWS), are generally calculated 3 times a day, but these may not capture early deterioration. A delay in diagnosing deterioration is associated with increased mortality. Continuous monitoring with wearable devices might detect clinical deterioration at an earlier stage, which allows clinicians to take corrective actions. OBJECTIVE: In this pilot study, the feasibility of continuous monitoring using the ViSi Mobile (VM; Sotera Wireless) and HealthPatch (HP; Vital Connect) was tested, and the experiences of patients and nurses were collected. METHODS: In this feasibility study, 20 patients at the internal medicine and surgical ward were monitored with VM and HP simultaneously for 2 to 3 days. Technical problems were analyzed. Vital sign measurements by nurses were taken as reference and compared with vital signs measured by both devices. Patient and nurse experiences were obtained by semistructured interviews. RESULTS: In total, 86 out of 120 MEWS measurements were used for the analysis. Vital sign measurements by VM and HP were generally consistent with nurse measurements. In 15% (N=13) and 27% (N=23) of the VM and HP cases respectively, clinically relevant differences in MEWS were found based on inconsistent respiratory rate registrations. Connection failure was recognized as a predominant VM artifact (70%). Over 50% of all HP artifacts had an unknown cause, were self-limiting, and never took longer than 1 hour. The majority of patients, relatives, and nurses were positive about VM and HP. CONCLUSIONS: Both VM and HP are promising for continuously monitoring vital signs in hospitalized patients, if the frequency and duration of artifacts are reduced. The devices were well received and comfortable for most patients.

Self-Management Support Program for Patients With Cardiovascular Diseases: User-Centered Development of the Tailored, Web-Based Program Vascular View.

BACKGROUND: In addition to medical intervention and counseling, patients with cardiovascular disease (CVD) need to manage their disease and its consequences by themselves in daily life. OBJECTIVE: The aim of this paper is to describe the development of "Vascular View," a comprehensive, multi-component, tailored, Web-based, self-management support program for patients with CVD, and how this program will be tested in an early randomized controlled trial (RCT). METHODS: The Vascular View program was systematically developed in collaboration with an expert group of 6 patients, and separately with a group of 6 health professionals (medical, nursing, and allied health care professionals), according to the following steps of the intervention mapping (IM) framework: (1) conducting a needs assessment; (2) creating matrices of change objectives; (3) selecting theory-based intervention methods and practical applications; (4) organizing methods and applications into an intervention program; (5) planning the adaption, implementation, and sustainability of the program, and (6) generating an evaluation plan. RESULTS: The needs assessment (Step 1) identified 9 general health problems and 8 determinants (knowledge, awareness, attitude, self-efficacy, subjective norm, intention, risk perception, and habits) of self-managing CVD. By defining performance and change objectives (Step 2), 6 topics were distinguished and incorporated into the courses included in Vascular View (Steps 3 and 4): (1) Coping With CVD and its Consequences; (2) Setting Boundaries in Daily Life; (3) Lifestyle (general and tobacco and harmful alcohol use); (4) Healthy Nutrition; (5) Being Physically Active in a Healthy Way; and (6) Interaction With Health Professionals. These courses were based on behavioral change techniques (BCTs) (eg, self-monitoring of behavior, modeling, re-evaluation of outcomes), which were incorporated in the courses through general written information: quotes from and videos of patients with CVD as role models and personalized feedback, diaries, and exercises. The adoption and implementation plan (Step 5) was set up in collaboration with the members of the two expert groups and consisted of a written and digital instruction manual, a flyer, bimonthly newsletters, and reminders by email and telephone to (re-)visit the program. The potential effectiveness of Vascular View will be evaluated (Step 6) in an early RCT to gain insight into relevant outcome variables and related effect sizes, and a process evaluation to identify intervention fidelity, potential working mechanisms, user statistics, and/or satisfaction. CONCLUSION: A comprehensive, multi-component, tailored, Web-based, self-management support program and an early RCT were developed in order to empower patients to self-manage their CVD. TRIAL REGISTRATION: Nederlands Trial Register NTR5412; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5412 (Archived by WebCite at http://www.webcitation.org/6jeUFVj40).

A Multifaceted Nurse- and Web-Based Intervention for Improving Adherence to Treatment in Patients With Cardiovascular Disease: Rationale and Design of the MIRROR Trial.

BACKGROUND: Poor adherence to medication is one of the limitations in the treatment of cardiovascular diseases, thereby increasing the risk of premature death, hospital admissions, and related costs. There is a need for simple and easy-to-implement interventions that are based on patients' perspectives, beliefs, and perceptions of their illness and medication. OBJECTIVE: The objective is to test the effectivity of this intervention to improve medication adherence in patients with established cardiovascular disease, that is, in secondary prevention. METHODS: In this study the effect of a personalized visualization of cardiovascular risk levels through a website aiming at supporting self management in combination with a group consultation and communication intervention by a nurse on adherence to treatment in 600 patients with manifest cardiovascular diseases will be assessed. The health belief model was chosen as main theoretical model for the intervention. RESULTS: Primary outcome is adherence to treatment calculated by refill data. Secondary outcomes include the Beliefs about Medication Questionnaire and the Modified Morisky Scale. Patients are followed for one year. Results are expected by 2015. CONCLUSIONS: This study assesses adherence to treatment in a high-risk cardiovascular population by applying an intervention that addresses patients' capacity and practical barriers as well as patients' beliefs and perceptions of their illness and medication. CLINICALTRIAL: ClinicalTrials.gov NCT01449695; https://clinicaltrials.gov/ct2/show/NCT01449695 (Archived by WebCite at http://www.webcitation.org/6kCzkIKH3).