%0 Journal Article %@ 2561-1011 %I JMIR Publications %V 9 %N %P e66215 %T Patient and Clinician Perspectives on Alert-Based Remote Monitoring–First Care for Cardiovascular Implantable Electronic Devices: Semistructured Interview Study Within the Veterans Health Administration %A Kratka,Allison %A Rotering,Thomas L %A Munson,Scott %A Raitt,Merritt H %A Whooley,Mary A %A S Dhruva,Sanket %K cardiovascular implantable electronic device %K CIED %K remote monitoring %K RM %K alert-based monitoring %K remote monitoring–first care %K patient perspectives %K clinician perspectives %K veteran %K pacemaker %K implantable cardioverter-defibrillator %K mobile phone %D 2025 %7 4.4.2025 %9 %J JMIR Cardio %G English %X Background: Patients with cardiovascular implantable electronic devices (CIEDs) typically attend in-person CIED clinic visits at least annually, paired with remote monitoring (RM). As the CIED data available through in-person CIED clinic visits and RM are nearly identical, the 2023 Heart Rhythm Society expert consensus statement introduced “alert-based RM,” an RM-first approach where patients with CIEDs that are consistently and continuously connected to RM, in the absence of recent alerts and other cardiac comorbidities, could attend in-person CIED clinic visits every 24 months or ultimately only as clinically prompted by actionable events identified on RM. However, there is no published information about patient and clinician perspectives on barriers and facilitators to such an RM-first care model. Objective: We aimed to understand patient and clinician perspectives about an RM-first care model for CIED care. Methods: We interviewed 40 rural veteran patients who were experienced with RM with CIEDs and 22 CIED clinicians who were experienced in using RM regarding barriers and facilitators to an RM-first care model. We conducted a reflexive thematic analysis of interviews. Two authors familiarized themselves with the dataset and generated separate codebooks based on the interview guides and inductively coded notes. These 2 authors met and reviewed each other’s codes, sought additional author input, and resolved differences before 1 author coded the remaining interviews and developed candidate themes. These themes were refined, named, and supported with quotations. Results: Patients expressed interest in an RM-first approach, to reduce the burden of long travel times, sometimes in inclement weather, and to enable clinicians to provide care for other patients. However, many preferred routine in-person visits; reasons included a skepticism of the capabilities of RM, a sense that in-person visits provided superior care, and enjoyment of in-person patient-clinician relationships. Clinicians were interested in RM-first care, especially for stable, RM-adherent patients who were not device-dependent. Clinicians most frequently cited the benefit of reducing patient travel burden as well as optimizing clinic space and time to focus on other care such as reviewing routine RM transmissions, but also noted barriers including lack of in-person assessment, patient-perceived diminution of the patient-clinician relationship, possible loss to follow-up, and technological difficulties. Clinicians felt that an RM-first care model should be evaluated for success based on patient satisfaction and assessment of timely addressing of rhythm issues to prevent adverse outcomes. Most clinicians believed that RM-first care represented the future of CIED care. Conclusions: Both patients and CIED clinicians interviewed who were experienced in using RM were open to an RM-first care model that reduces in-person visits but reported some barriers to solely relying on RM and possible diminution of the patient-clinician relationship. Implementation of new RM recommendations will require attention to these perceptions and prioritization of patient-centered approaches. %R 10.2196/66215 %U https://cardio.jmir.org/2025/1/e66215 %U https://doi.org/10.2196/66215 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 9 %N %P e58219 %T Technology Readiness Level and Self-Reported Health in Recipients of an Implantable Cardioverter Defibrillator: Cross-Sectional Study %A Rosenmeier,Natasha %A Busk,David %A Dichman,Camilla %A Nielsen,Kim Mechta %A Kayser,Lars %A Wagner,Mette Kirstine %+ Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Copenhagen, 1353, Denmark, 45 35334448, sncb91@gmail.com %K implantable cardioverter defibrillator %K health literacy %K self-management %K ICD rehabilitation %K digital health literacy %K patient-reported outcome measure %K self-reported %K self-rated %K exploratory %K interview %K sociodemographic %K survey %K cluster analysis %K mixed method %K cross-sectional %K Denmark %D 2025 %7 6.2.2025 %9 Original Paper %J JMIR Cardio %G English %X Background: Approximately 200,000 implantable cardioverter defibrillators (ICDs) are implanted annually worldwide, with around 20% of recipients experiencing significant psychological distress. Despite this, there are no ICD guidelines addressing mental health as part of rehabilitation programs, which primarily focus on educating patients about their condition and prognosis. There is a need to include elements such as emotional distress, social interactions, and the future use of technologies like apps and virtual communication in ICD rehabilitation, without increasing the burden on health care professionals. Objective: This study aimed to demonstrate how data from the Readiness for Health Technology Index (READHY), combined with sociodemographic characteristics and exploratory interviews, can be used to construct profiles of recipients of an ICD, describing their ability to manage their condition, their need for support, and their digital health literacy. This aims to enhance health care professionals’ understanding of different patient archetypes, serving as guidance in delivering personalized services tailored to the needs, resources, and capabilities of individual recipients of ICDs. Methods: Overall, 79 recipients of an ICD participated in a survey assessing technology readiness using the READHY. The survey also collected sociodemographic data such as age, sex, and educational level. Self-reported health was measured using a Likert scale. Cluster analysis categorized participants into profiles based on their READHY scores. Correlations between READHY scores and self-reported health were examined. In addition, qualitative interviews with representatives from different readiness profiles provided deeper insights. Results: Four technology readiness profiles were found: (1) profile 1 (low digital health literacy, insufficient on 5 dimensions), (2) profile 2 (sufficient on all dimensions), (3) profile 3 (consistently sufficient readiness on all dimensions), and (4) profile 4 (insufficient readiness on 9 dimensions). Participants in profile 4, characterized by the lowest readiness levels, were significantly younger (P=.03) and had lower self-reported health (P<.001) than those in profile 3. A correlation analysis revealed that higher READHY scores were associated with better self-reported health across all dimensions. Qualitative interviews highlighted differences in self-management approaches and the experience of support between profiles, emphasizing the essential role of social support toward the rehabilitation journeys of recipients of an ICD. Two patient vignettes were created based on the characteristics from the highest and lowest profiles. Conclusions: Using the READHY instrument to create patient profiles demonstrates how it can be used to make health care professionals aware of specific needs within the group of recipients of an ICD. %M 39913910 %R 10.2196/58219 %U https://cardio.jmir.org/2025/1/e58219 %U https://doi.org/10.2196/58219 %U http://www.ncbi.nlm.nih.gov/pubmed/39913910 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50009 %T Using Topic Modeling to Understand Patients’ and Caregivers’ Perspectives About Left Ventricular Assist Device: Thematic Analysis %A Melnikov,Semyon %A Klein,Stav %A Shahar,Moni %A Guy,David %+ Nursing Department, Steyer School of Health Professions, Faculty of Medical & Health Sciences, Tel Aviv University, Haim Levanon 55, Tel Aviv, 6997801, Israel, 972 36405456, melniko@tauex.tau.ac.il %K left ventricular assist device %K LVAD %K topic modeling %K health care forum %K heart disease %K cardiovascular condition %K medical devices %K devices for heart %K latent Dirichlet allocation %K cardiovascular %K device %K visualization tool %K tool %K heart %K caregiver %K monitoring %K management %K care %K users %K communication %K heart failure %D 2024 %7 13.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Heart failure (HF) is a significant global clinical and public health challenge, impacting 64.3 million individuals worldwide. To address the scarcity of donor organs, left ventricular assist device (LVAD) implantation has become a crucial intervention for managing end-stage HF, serving as a bridge to heart transplantation or as a destination therapy. Web-based health forums, such as MyLVAD.com, play a vital role as trusted sources of information for individuals with HF symptoms and their caregivers. Objective: We aim to uncover the latent topics within the posts shared by users on the MyLVAD.com website. Methods: Using the latent Dirichlet allocation algorithm and a visualization tool, our objective was to uncover latent topics within the posts shared on the MyLVAD.com website. Through the application of topic modeling techniques, we analyzed 459 posts authored by recipients of LVAD and their family members from 2015 to 2023. Results: This study unveiled 5 prominent themes of concern among patients with LVAD and their family members. These themes included family support (39.5% weight value), encompassing subthemes such as family caregiving roles and emotional or practical support; clothing (23.9% weight value), with subthemes related to comfort, normalcy, and functionality; infection (18.2% weight value), covering driveline infections, prevention, and care; power (12% weight value), involving challenges associated with power dependency; and self-care maintenance, monitoring, and management (6.3% weight value), which included subthemes such as blood tests, monitoring, alarms, and device management. Conclusions: These findings contribute to a better understanding of the experiences and needs of patients implanted with LVAD, providing valuable insights for health care professionals to offer tailored support and care. By using latent Dirichlet allocation to analyze posts from the MyLVAD.com forum, this study sheds light on key topics discussed by users, facilitating improved patient care and enhanced patient-provider communication. %M 39137408 %R 10.2196/50009 %U https://www.jmir.org/2024/1/e50009 %U https://doi.org/10.2196/50009 %U http://www.ncbi.nlm.nih.gov/pubmed/39137408 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e47616 %T Investigating the Cost-Effectiveness of Telemonitoring Patients With Cardiac Implantable Electronic Devices: Systematic Review %A Raes,Sarah %A Prezzi,Andrea %A Willems,Rik %A Heidbuchel,Hein %A Annemans,Lieven %+ Department of Public Health and Primary Care, Ghent University, Corneel Heymanslaan 10, Gent, 9000, Belgium, 32 9 332 83 59, Sarah.Raes@UGent.be %K systematic review %K cost-effectiveness %K telemonitoring %K cardiac device %K implantable cardioverter-defibrillator %K ICD %K pacemaker %K monitoring %K patient management %K effectiveness %K cost %K quality of life %K cardiac implantable electronic device %K cardiac %D 2024 %7 19.4.2024 %9 Review %J J Med Internet Res %G English %X Background: Telemonitoring patients with cardiac implantable electronic devices (CIEDs) can improve their care management. However, the results of cost-effectiveness studies are heterogeneous. Therefore, it is still a matter of debate whether telemonitoring is worth the investment. Objective: This systematic review aims to investigate the cost-effectiveness of telemonitoring patients with CIEDs, focusing on its key drivers, and the impact of the varying perspectives. Methods: A systematic review was performed in PubMed, Web of Science, Embase, and EconLit. The search was completed on July 7, 2022. Studies were included if they fulfilled the following criteria: patients had a CIED, comparison with standard care, and inclusion of health economic evaluations (eg, cost-effectiveness analyses and cost-utility analyses). Only complete and peer-reviewed studies were included, and no year limits were applied. The exclusion criteria included studies with partial economic evaluations, systematic reviews or reports, and studies without standard care as a control group. Besides general study characteristics, the following outcome measures were extracted: impact on total cost or income, cost or income drivers, cost or income drivers per patient, cost or income drivers as a percentage of the total cost impact, incremental cost-effectiveness ratios, or cost-utility ratios. Quality was assessed using the Consensus Health Economic Criteria checklist. Results: Overall, 15 cost-effectiveness analyses were included. All studies were performed in Western countries, mainly Europe, and had primarily a male participant population. Of the 15 studies, 3 (20%) calculated the incremental cost-effectiveness ratio, 1 (7%) the cost-utility ratio, and 11 (73%) the health and cost impact of telemonitoring. In total, 73% (11/15) of the studies indicated that telemonitoring of patients with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy ICDs was cost-effective and cost-saving, both from a health care and patient perspective. Cost-effectiveness results for telemonitoring of patients with pacemakers were inconclusive. The key drivers for cost reduction from a health care perspective were hospitalizations and scheduled in-office visits. Hospitalization costs were reduced by up to US $912 per patient per year. Scheduled in-office visits included up to 61% of the total cost reduction. Key drivers for cost reduction from a patient perspective were loss of income, cost for scheduled in-office visits and transport. Finally, of the 15 studies, 8 (52%) reported improved quality of life, with statistically significance in only 1 (13%) study (P=.03). Conclusions: From a health care and patient perspective, telemonitoring of patients with an ICD or a cardiac resynchronization therapy ICD is a cost-effective and cost-saving alternative to standard care. Inconclusive results were found for patients with pacemakers. However, telemonitoring can lead to a decrease in providers’ income, mainly due to a lack of reimbursement. Introducing appropriate reimbursement could make telemonitoring sustainable for providers while still being cost-effective from a health care payer perspective. Trial Registration: PROSPERO CRD42022322334; https://tinyurl.com/puunapdr %M 38640471 %R 10.2196/47616 %U https://www.jmir.org/2024/1/e47616 %U https://doi.org/10.2196/47616 %U http://www.ncbi.nlm.nih.gov/pubmed/38640471 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e51399 %T Physical Activity, Heart Rate Variability, and Ventricular Arrhythmia During the COVID-19 Lockdown: Retrospective Cohort Study %A Texiwala,Sikander Z %A de Souza,Russell J %A Turner,Suzette %A Singh,Sheldon M %+ Schulich Heart Center, Sunnybrook Health Sciences, Room A222, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada, 1 416 480 6100 ext 86359, sheldon.singh@sunnybrook.ca %K implantable cardioverter defibrillator %K heart rate variability %K physical activity %K lockdown %K ICD %K ventricular arrhythmias %K defibrillator %K implementation %D 2024 %7 5.2.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: Ventricular arrhythmias (VAs) increase with stress and national disasters. Prior research has reported that VA did not increase during the onset of the COVID-19 lockdown in March 2020, and the mechanism for this is unknown. Objective: This study aimed to report the presence of VA and changes in 2 factors associated with VA (physical activity and heart rate variability [HRV]) at the onset of COVID-19 lockdown measures in Ontario, Canada. Methods: Patients with implantable cardioverter defibrillator (ICD) followed at a regional cardiac center in Ontario, Canada with data available for both HRV and physical activity between March 1 and 31, 2020, were included. HRV, physical activity, and the presence of VA were determined during the pre- (March 1-10, 2020) and immediate postlockdown (March 11-31) period. When available, these data were determined for the same period in 2019. Results: In total, 68 patients had complete data for 2020, and 40 patients had complete data for 2019. Three (7.5%) patients had VA in March 2019, whereas none had VA in March 2020 (P=.048). Physical activity was reduced during the postlockdown period (mean 2.3, SD 1.6 hours vs mean 2.1, SD 1.6 hours; P=.003). HRV was unchanged during the pre- and postlockdown period (mean 91, SD 30 ms vs mean 92, SD 28 ms; P=.84). Conclusions: VA was infrequent during the COVID-19 pandemic. A reduction in physical activity with lockdown maneuvers may explain this observation. %M 38315512 %R 10.2196/51399 %U https://cardio.jmir.org/2024/1/e51399 %U https://doi.org/10.2196/51399 %U http://www.ncbi.nlm.nih.gov/pubmed/38315512 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 7 %N %P e50973 %T Barriers and Facilitators Associated With Remote Monitoring Adherence Among Veterans With Pacemakers and Implantable Cardioverter-Defibrillators: Qualitative Cross-Sectional Study %A Dhruva,Sanket S %A Raitt,Merritt H %A Munson,Scott %A Moore,Hans J %A Steele,Pamela %A Rosman,Lindsey %A Whooley,Mary A %+ San Francisco Veterans Affairs Medical Center, 4150 Clement St, Building 203, 111C, San Francisco, CA, 94121, United States, 1 4152214810, sanket.dhruva@ucsf.edu %K cardiac implantable electronic device %K electrophysiology %K pacemaker %K remote monitoring %K veterans %K adherence %D 2023 %7 21.11.2023 %9 Original Paper %J JMIR Cardio %G English %X Background: The Heart Rhythm Society strongly recommends remote monitoring (RM) of cardiovascular implantable electronic devices (CIEDs) because of the clinical outcome benefits to patients. However, many patients do not adhere to RM and, thus, do not achieve these benefits. There has been limited study of patient-level barriers and facilitators to RM adherence; understanding patient perspectives is essential to developing solutions to improve adherence. Objective: We sought to identify barriers and facilitators associated with adherence to RM among veterans with CIEDs followed by the Veterans Health Administration. Methods: We interviewed 40 veterans with CIEDs regarding their experiences with RM. Veterans were stratified into 3 groups based on their adherence to scheduled RM transmissions over the past 2 years: 6 fully adherent (≥95%), 25 partially adherent (≥65% but <95%), and 9 nonadherent (<65%). As the focus was to understand challenges with RM adherence, partially adherent and nonadherent veterans were preferentially weighted for selection. Veterans were mailed a letter stating they would be called to understand their experiences and perspectives of RM and possible barriers, and then contacted beginning 1 week after the letter was mailed. Interviews were structured (some questions allowing for open-ended responses to dive deeper into themes) and focused on 4 predetermined domains: knowledge of RM, satisfaction with RM, reasons for nonadherence, and preferences for health care engagement. Results: Of the 44 veterans contacted, 40 (91%) agreed to participate. The mean veteran age was 75.3 (SD 7.6) years, and 98% (39/40) were men. Veterans had been implanted with their current CIED for an average of 4.4 (SD 2.8) years. A total of 58% (23/40) of veterans recalled a discussion of home monitoring, and 45% (18/40) reported a good understanding of RM; however, when asked to describe RM, their understanding was sometimes incomplete or not correct. Among the 31 fully or partially adherent veterans, nearly all were satisfied with RM. Approximately one-third recalled ever being told the results of a remote transmission. Among partially or nonadherent veterans, only one-fourth reported being contacted by a Department of Veterans Affairs health care professional regarding not having sent a remote transmission; among those who had troubleshooted to ensure they could send remote transmissions, they often relied on the CIED manufacturer for help (this experience was nearly always positive). Most nonadherent veterans felt more comfortable engaging in RM if they received more information or education. Most veterans were interested in being notified of a successful remote transmission and learning the results of their remote transmissions. Conclusions: Veterans with CIEDs often had limited knowledge about RM and did not recall being contacted about nonadherence. When they were contacted and troubleshooted, the experience was positive. These findings provide opportunities to optimize strategies for educating and engaging patients in RM. %M 37988153 %R 10.2196/50973 %U https://cardio.jmir.org/2023/1/e50973 %U https://doi.org/10.2196/50973 %U http://www.ncbi.nlm.nih.gov/pubmed/37988153 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 8 %N 4 %P e26964 %T Clinician Preimplementation Perspectives of a Decision-Support Tool for the Prediction of Cardiac Arrhythmia Based on Machine Learning: Near-Live Feasibility and Qualitative Study %A Matthiesen,Stina %A Diederichsen,Søren Zöga %A Hansen,Mikkel Klitzing Hartmann %A Villumsen,Christina %A Lassen,Mats Christian Højbjerg %A Jacobsen,Peter Karl %A Risum,Niels %A Winkel,Bo Gregers %A Philbert,Berit T %A Svendsen,Jesper Hastrup %A Andersen,Tariq Osman %+ Department of Computer Science, Faculty of Science, University of Copenhagen, Universitetsparken 5, Copenhagen, 2100, Denmark, 45 21231008, matthiesen@di.ku.dk %K cardiac arrhythmia %K short-term prediction %K clinical decision support systems %K machine learning %K artificial intelligence %K preimplementation %K qualitative study %K implantable cardioverter defibrillator %K remote follow-up %K sociotechnical %D 2021 %7 26.11.2021 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Artificial intelligence (AI), such as machine learning (ML), shows great promise for improving clinical decision-making in cardiac diseases by outperforming statistical-based models. However, few AI-based tools have been implemented in cardiology clinics because of the sociotechnical challenges during transitioning from algorithm development to real-world implementation. Objective: This study explored how an ML-based tool for predicting ventricular tachycardia and ventricular fibrillation (VT/VF) could support clinical decision-making in the remote monitoring of patients with an implantable cardioverter defibrillator (ICD). Methods: Seven experienced electrophysiologists participated in a near-live feasibility and qualitative study, which included walkthroughs of 5 blinded retrospective patient cases, use of the prediction tool, and questionnaires and interview questions. All sessions were video recorded, and sessions evaluating the prediction tool were transcribed verbatim. Data were analyzed through an inductive qualitative approach based on grounded theory. Results: The prediction tool was found to have potential for supporting decision-making in ICD remote monitoring by providing reassurance, increasing confidence, acting as a second opinion, reducing information search time, and enabling delegation of decisions to nurses and technicians. However, the prediction tool did not lead to changes in clinical action and was found less useful in cases where the quality of data was poor or when VT/VF predictions were found to be irrelevant for evaluating the patient. Conclusions: When transitioning from AI development to testing its feasibility for clinical implementation, we need to consider the following: expectations must be aligned with the intended use of AI; trust in the prediction tool is likely to emerge from real-world use; and AI accuracy is relational and dependent on available information and local workflows. Addressing the sociotechnical gap between the development and implementation of clinical decision-support tools based on ML in cardiac care is essential for succeeding with adoption. It is suggested to include clinical end-users, clinical contexts, and workflows throughout the overall iterative approach to design, development, and implementation. %M 34842528 %R 10.2196/26964 %U https://humanfactors.jmir.org/2021/4/e26964 %U https://doi.org/10.2196/26964 %U http://www.ncbi.nlm.nih.gov/pubmed/34842528 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 5 %N 2 %P e27720 %T Clinic Time Required for Remote and In-Person Management of Patients With Cardiac Devices: Time and Motion Workflow Evaluation %A Seiler,Amber %A Biundo,Eliana %A Di Bacco,Marco %A Rosemas,Sarah %A Nicolle,Emmanuelle %A Lanctin,David %A Hennion,Juliette %A de Melis,Mirko %A Van Heel,Laura %+ Medtronic, 8200 Coral Sea Ct NE, Mounds View, MN, 55112, United States, 1 800 633 8766, david.lanctin@medtronic.com %K cardiac implantable electronic devices %K remote monitoring %K patient management %K clinic efficiency %K digital health %K mobile phone %D 2021 %7 15.10.2021 %9 Original Paper %J JMIR Cardio %G English %X Background: The number of patients with cardiac implantable electronic device (CIED) is increasing, creating a substantial workload for device clinics. Objective: This study aims to characterize the workflow and quantify clinic staff time requirements for managing patients with CIEDs. Methods: A time and motion workflow evaluation was performed in 11 US and European CIEDs clinics. Workflow tasks were repeatedly timed during 1 business week of observation at each clinic; these observations included all device models and manufacturers. The mean cumulative staff time required to review a remote device transmission and an in-person clinic visit were calculated, including all necessary clinical and administrative tasks. The annual staff time to manage a patient with a CIED was modeled using CIED transmission volumes, clinical guidelines, and the published literature. Results: A total of 276 in-person clinic visits and 2173 remote monitoring activities were observed. Mean staff time required per remote transmission ranged from 9.4 to 13.5 minutes for therapeutic devices (pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy) and from 11.3 to 12.9 minutes for diagnostic devices such as insertable cardiac monitors (ICMs). Mean staff time per in-person visit ranged from 37.8 to 51.0 and from 39.9 to 45.8 minutes for therapeutic devices and ICMs, respectively. Including all remote and in-person follow-ups, the estimated annual time to manage a patient with a CIED ranged from 1.6 to 2.4 hours for therapeutic devices and from 7.7 to 9.3 hours for ICMs. Conclusions: The CIED patient management workflow is complex and requires significant staff time. Understanding process steps and time requirements informs the implementation of efficiency improvements, including remote solutions. Future research should examine heterogeneity in patient management processes to identify the most efficient workflow. %M 34156344 %R 10.2196/27720 %U https://cardio.jmir.org/2021/2/e27720 %U https://doi.org/10.2196/27720 %U http://www.ncbi.nlm.nih.gov/pubmed/34156344 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 9 %P e19550 %T Patients' and Nurses’ Experiences and Perceptions of Remote Monitoring of Implantable Cardiac Defibrillators in Heart Failure: Cross-Sectional, Descriptive, Mixed Methods Study %A Liljeroos,Maria %A Thylén,Ingela %A Strömberg,Anna %+ Department of Health, Medicine and Caring Sciences, Linköping University, Campus US, Linköping, 581 83, Sweden, 46 703728329, maria.liljeroos@liu.se %K heart failure %K remote patient monitoring %K implantable cardioverter-defibrillator %D 2020 %7 28.9.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The new generation of implantable cardioverter-defibrillators (ICDs) supports wireless technology, which enables remote patient monitoring (RPM) of the device. In Sweden, it is mainly registered nurses with advanced education and training in ICD devices who handle the arrhythmias and technical issues of the remote transmissions. Previous studies have largely focused on the perceptions of physicians, and it has not been explored how the patients’ and nurses’ experiences of RPM correspond to each other. Objective: Our objective is to describe, explore, and compare the experiences and perceptions, concerning RPM of ICD, of patients with heart failure (HF) and nurses performing ICD follow-up. Methods: This study has a cross-sectional, descriptive, mixed methods design. All patients with HF and an ICD with RPM from one region in Sweden, who had transitioned from office-based visits to implementing RPM, and ICD nurses from all ICD clinics in Sweden were invited to complete a purpose-designed, 8-item questionnaire to assess experiences of RPM. The questionnaire started with a neutral question: “What are your experiences of RPM in general?” This was followed by one positive subscale with three questions (score range 3-12), with higher scores reflecting more positive experiences, and one negative subscale with three questions (score range 3-12), with lower scores reflecting more negative experiences. One open-ended question was analyzed with qualitative content analysis. Results: The sample consisted of 175 patients (response rate 98.9%) and 30 ICD nurses (response rate 60%). The majority of patients (154/175, 88.0%) and nurses (23/30, 77%) experienced RPM as very good; however, the nurses noted more downsides than did the patients. The mean scores of the negative experiences subscale were 11.5 (SD 1.1) for the patients and 10.7 (SD 0.9) for the nurses (P=.08). The mean scores of the positive experiences subscale were 11.1 (SD 1.6) for the patients and 8.5 (SD 1.9) for the nurses (P=.04). A total of 11 out of 175 patients (6.3%) were worried or anxious about what the RPM entailed, while 15 out of 30 nurses (50%) felt distressed by the responsibility that accompanied their work with RPM (P=.04). Patients found that RPM increased their own (173/175, 98.9%) and their relatives’ (169/175, 96.6%) security, and all nurses (30/30, 100%) answered that they found RPM to be necessary from a safety perspective. Most patients found it to be an advantage with fewer office-based visits. Nurses found it difficult to handle different systems with different platforms, especially for smaller clinics with few patients. Another difficulty was to set the correct number of alarms for the individual patient. This caused a high number of transmissions and a risk to miss important information. Conclusions: Both patients and nurses found that RPM increased assurance, reliance, and safety. Few patients were anxious about what the RPM entailed, while about half of the nurses felt distressed by the responsibility that accompanied their work with RPM. To increase nurses’ sense of security, it seems important to adjust organizational routines and reimbursement systems and to balance the workload. %M 32985997 %R 10.2196/19550 %U http://www.jmir.org/2020/9/e19550/ %U https://doi.org/10.2196/19550 %U http://www.ncbi.nlm.nih.gov/pubmed/32985997 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e15873 %T Experiences With Wearable Activity Data During Self-Care by Chronic Heart Patients: Qualitative Study %A Andersen,Tariq Osman %A Langstrup,Henriette %A Lomborg,Stine %+ Department of Computer Science, University of Copenhagen, Universitetsparken 5, Copenhagen, 2100, Denmark, 45 26149169, tariq@di.ku.dk %K consumer health information %K wearable electronic devices %K self-care %K chronic illness %K patient experiences %D 2020 %7 20.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Most commercial activity trackers are developed as consumer devices and not as clinical devices. The aim is to monitor and motivate sport activities, healthy living, and similar wellness purposes, and the devices are not designed to support care management in a clinical context. There are great expectations for using wearable sensor devices in health care settings, and the separate realms of wellness tracking and disease self-monitoring are increasingly becoming blurred. However, patients’ experiences with activity tracking technologies designed for use outside the clinical context have received little academic attention. Objective: This study aimed to contribute to understanding how patients with a chronic disease experience activity data from consumer self-tracking devices related to self-care and their chronic illness. Our research question was: “How do patients with heart disease experience activity data in relation to self-care and chronic illness?” Methods: We conducted a qualitative interview study with patients with chronic heart disease (n=27) who had an implanted cardioverter-defibrillator. Patients were invited to wear a FitBit Alta HR wearable activity tracker for 3-12 months and provide their perspectives on their experiences with step, sleep, and heart rate data. The average age was 57.2 years (25 men and 2 women), and patients used the tracker for 4-49 weeks (mean 26.1 weeks). Semistructured interviews (n=66) were conducted with patients 2–3 times and were analyzed iteratively in workshops using thematic analysis and abductive reasoning logic. Results: Of the 27 patients, 18 related the heart rate, sleep, and step count data directly to their heart disease. Wearable activity trackers actualized patients’ experiences across 3 dimensions with a spectrum of contrasting experiences: (1) knowing, which spanned gaining insight and evoking doubts; (2) feeling, which spanned being reassured and becoming anxious; and (3) evaluating, which spanned promoting improvements and exposing failure. Conclusions: Patients’ experiences could reside more on one end of the spectrum, could reside across all 3 dimensions, or could combine contrasting positions and even move across the spectrum over time. Activity data from wearable devices may be a resource for self-care; however, the data may simultaneously constrain and create uncertainty, fear, and anxiety. By showing how patients experience self-tracking data across dimensions of knowing, feeling, and evaluating, we point toward the richness and complexity of these data experiences in the context of chronic illness and self-care. %M 32706663 %R 10.2196/15873 %U https://www.jmir.org/2020/7/e15873 %U https://doi.org/10.2196/15873 %U http://www.ncbi.nlm.nih.gov/pubmed/32706663 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 3 %N 2 %P e9815 %T Outsourcing the Remote Management of Cardiac Implantable Electronic Devices: Medical Care Quality Improvement Project %A Giannola,Gabriele %A Torcivia,Riccardo %A Airò Farulla,Riccardo %A Cipolla,Tommaso %+ Ospedale San Raffaele Giglio, Contrada Pietra Pollastra, Cefalù, 90015, Italy, 39 0921 920111, cardiologia@hsrgiglio.it %K remote monitoring %K telemonitoring %K cardiac implantable electronic devices %K implantable defibrillators %K pacemaker %K implantable cardioverter defibrillator %K triage outsourcing %K follow-up %D 2019 %7 18.12.2019 %9 Original Paper %J JMIR Cardio %G English %X Background: Remote management is partially replacing routine follow-up in patients implanted with cardiac implantable electronic devices (CIEDs). Although it reduces clinical staff time compared with standard in-office follow-up, a new definition of roles and responsibilities may be needed to review remote transmissions in an effective, efficient, and timely manner. Whether remote triage may be outsourced to an external remote monitoring center (ERMC) is still unclear. Objective: The aim of this health care quality improvement project was to evaluate the feasibility of outsourcing remote triage to an ERMC to improve patient care and health care resource utilization. Methods: Patients (N=153) with implanted CIEDs were followed up for 8 months. An ERMC composed of nurses and physicians reviewed remote transmissions daily following a specific remote monitoring (RM) protocol. A 6-month benchmarking phase where patients’ transmissions were managed directly by hospital staff was evaluated as a term of comparison. Results: A total of 654 transmissions were recorded in the RM system and managed by the ERMC team within 2 working days, showing a significant time reduction compared with standard RM management (100% vs 11%, respectively, within 2 days; P<.001). A total of 84.3% (551/654) of the transmissions did not include a prioritized event and did not require escalation to the hospital clinician. High priority was assigned to 2.3% (15/654) of transmissions, which were communicated to the hospital team by email within 1 working day. Nonurgent device status events occurred in 88 cases and were communicated to the hospital within 2 working days. Of these, 11% (10/88) were followed by a hospitalization. Conclusions: The outsourcing of RM management to an ERMC safely provides efficacy and efficiency gains in patients’ care compared with a standard in-hospital management. Moreover, the externalization of RM management could be a key tool for saving dedicated staff and facility time with possible positive economic impact. Trial Registration: ClinicalTrials.gov NCT01007474; http://clinicaltrials.gov/ct2/show/NCT01007474 %M 31845898 %R 10.2196/cardio.9815 %U https://cardio.jmir.org/2019/2/e9815 %U https://doi.org/10.2196/cardio.9815 %U http://www.ncbi.nlm.nih.gov/pubmed/31845898 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 2 %N 2 %P e10499 %T Implantable Cardioverter Defibrillator mHealth App for Physician Referrals and eHealth Education: ICD-TEACH Pilot Study %A Gandhi,Sumeet %A Morillo,Carlos A %A Schwalm,Jon-David %+ Population Health Research Institute, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada, 1 9055771423, sumeet.gandhi@medportal.ca %K mHealth %K smartphone app %K implantable defibrillator cardioverter %K ICD %K physician decision %K eHealth %K mobile phone %D 2018 %7 05.11.2018 %9 Original Paper %J JMIR Cardio %G English %X Background: Mobile health (mHealth) decision tools for implantable cardioverter defibrillator may increase physician knowledge and overall patient care. Objective: The goals of the ICD-TEACH pilot study were to design a smartphone app or mHealth technology with a novel physician decision support algorithm, implement a direct referral mechanism for device implantation from the app, and assess its overall usability and feasibility with physicians involved in the care of patients with an implantable cardioverter defibrillator. Methods: The initial design and development of the mHealth or smartphone app included strategic collaboration from an information technology company and key stakeholders including arrhythmia specialists (electrophysiologists), general cardiologists, and key members of the hospital administrative team. A convenience sampling method was used to recruit general internists or cardiologists that refer to our local tertiary care center. Physicians were asked to incorporate the mHealth app in daily clinical practice and avail the decision support algorithm and direct referral feature to the arrhythmia clinic. Feasibility assessment, in the form of a physician survey, was conducted after initial mHealth app use (within 3 months) addressing the physicians’ overall satisfaction with the app, compliance, and reason for noncompliance; usability assessment of the mHealth app was addressed in the physician survey for technical or hardware problems encountered while using the app and suggestions on improvement. Results: A total of 17 physicians agreed to participate in the pilot study with 100% poststudy survey response rate. Physicians worked in an academic practice, which included both inpatient and ambulatory care. System Usability Scale was applied with an average score of 77 including the 17 participants (>68 points is above average). Regarding the novel physician decision support algorithm for implantable cardioverter defibrillator referral, 11% (1/9) strongly agreed and 78% (7/9) agreed that the algorithm for device eligibility was easy to use. Only 1 patient was referred through the direct referral system via the mHealth app during the pilot study of 3 months. Feasibility assessment showed that 46% (5/11) strongly agreed and 55% (6/11) agreed that the mHealth app would be utilized if integrated into an electronic medical record (EMR) where data are automatically sent to the referring arrhythmia clinic. Conclusions: The ICD-TEACH pilot study revealed high usability features of a physician decision support algorithm; however, we received only 1 direct referral through our app despite supportive feedback. A specific reason from our physician survey included the lack of integration into an EMR. Future studies should continue to systematically evaluate smartphone apps in cardiology to assess usability, feasibility, and strategies to integrate into daily workflow. %M 31758779 %R 10.2196/10499 %U http://cardio.jmir.org/2018/2/e10499/ %U https://doi.org/10.2196/10499 %U http://www.ncbi.nlm.nih.gov/pubmed/31758779 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 2 %N 1 %P e5 %T Monitoring Patients With Implantable Cardioverter Defibrillators Using Mobile Phone Electrocardiogram: Case Study %A Kropp,Caley %A Ellis,Jordan %A Nekkanti,Rajasekhar %A Sears,Samuel %+ Department of Psychology, East Carolina University, 104 Rawl Building, East 5th Street, Greenville, NC, 27858, United States, 1 252 328 1828, kroppc15@students.ecu.edu %K atrial fibrillation %K ICD %K ECG %K mobile phone monitoring %K mobile health %K electrophysiology %D 2018 %7 21.02.2018 %9 Original Paper %J JMIR Cardio %G English %X Background: Preventable poor health outcomes associated with atrial fibrillation continue to make early detection a priority. A one-lead mobile electrocardiogram (mECG) device given to patients with an implantable cardioverter defibrillator (ICD) allowed users to receive real-time ECG readings in 30 seconds. Objective: Three cases were selected from an institutional review board-approved clinical trial aimed at assessing mECG device usage and satisfaction, patient engagement, quality of life (QoL), and cardiac anxiety. These three specific cases were selected to examine a variety of possible patient presentations and user experiences. Methods: Three ICD patients with mobile phones who were being seen in an adult device clinic were asked to participate. The participants chosen represented individuals with varying degrees of reported education and patient engagement. Participants were instructed to use the mECG device at least once per day for 30 days. Positive ECGs for atrial fibrillation were evaluated in clinic. At follow-up, information was collected regarding their frequency of use of the mECG device and three psychological outcomes in the domains of patient engagement, QoL, and cardiac anxiety. Results: Each patient used the technology approximately daily or every other day as prescribed. At the 30-day follow-up, usage reports indicated an average of 32 readings per month per participant. At 90-day follow-up, usage reports indicated an average of 34 readings per month per participant. Two of the three participants self-reported a significant improvement in their physical QoL from baseline to completion, while simultaneously self-reporting a significant decrease in their mental QoL. All three participants reported high levels of device acceptance and technology satisfaction. Conclusions: This case study demonstrates that ICD patients with varying degrees of education and patient engagement were relatively active in their use of mECGs. All three participants using the mECG technology reported high technology satisfaction and device acceptance. High sensitivity, specificity, and accuracy of mECG technology may allow routine atrial fibrillation screening at lower costs, in addition to improving patient outcomes. %M 31758776 %R 10.2196/cardio.8710 %U http://cardio.jmir.org/2018/1/e5/ %U https://doi.org/10.2196/cardio.8710 %U http://www.ncbi.nlm.nih.gov/pubmed/31758776 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 2 %P e52 %T Attrition and Adherence in a Web-Based Distress Management Program for Implantable Cardioverter Defibrillator Patients (WEBCARE): Randomized Controlled Trial %A Habibović,Mirela %A Cuijpers,Pim %A Alings,Marco %A van der Voort,Pepijn %A Theuns,Dominic %A Bouwels,Leon %A Herrman,Jean-Paul %A Valk,Suzanne %A Pedersen,Susanne %+ Department of Psychology, University of Southern Denmark, Campusvej 55, Odense M, 5230, Denmark, 45 6550 7992, sspedersen@health.sdu.dk %K implantable cardioverter defibrillator %K Web-based interventions %K adherence %K dropout %K attrition %D 2014 %7 28.02.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: WEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients (WEBCARE) is a Web-based randomized controlled trial, designed to improve psychological well-being in patients with an implantable cardioverter defibrillator (ICD). As in other Web-based trials, we encountered problems with attrition and adherence. Objective: In the current study, we focus on the patient characteristics, reasons, and motivation of (1) completers, (2) those who quit the intervention, and (3) those who quit the intervention and the study in the treatment arm of WEBCARE. Methods: Consecutive first-time ICD patients from six Dutch referral hospitals were approached for participation. After signing consent and filling in baseline measures, patients were randomized to either the WEBCARE group or the Usual Care group. Results: The treatment arm of WEBCARE contained 146 patients. Of these 146, 34 (23.3%) completed the treatment, 88 (60.3%) dropped out of treatment but completed follow-up, and 24 (16.4%) dropped out of treatment and study. Results show no systematic differences in baseline demographic, clinical, or psychological characteristics between groups. A gradual increase in dropout was observed with 83.5% (122/146) completing the first lesson, while only 23.3% (34/146) eventually completed the whole treatment. Reasons most often given by patients for dropout were technical problems with the computer, time constraints, feeling fine, and not needing additional support. Conclusions: Current findings underline the importance of focusing on adherence and dropout, as this remains a significant problem in behavioral Web-based trials. Examining possibilities to address barriers indicated by patients might enhance treatment engagement and improve patient outcomes. Trial Registration: Clinicaltrials.gov: NCT00895700; http://www.clinicaltrials.gov/ct2/show/NCT00895700 (Archived by WebCite at http://www.webcitation.org/6NCop6Htz). %M 24583632 %R 10.2196/jmir.2809 %U http://www.jmir.org/2014/2/e52/ %U https://doi.org/10.2196/jmir.2809 %U http://www.ncbi.nlm.nih.gov/pubmed/24583632 %0 Journal Article %@ 1929-073X %I JMIR Publications Inc. %V 2 %N 2 %P e27 %T Remote Monitoring for Implantable Defibrillators: A Nationwide Survey in Italy %A Luzi,Mario %A De Simone,Antonio %A Leoni,Loira %A Amellone,Claudia %A Pisanò,Ennio %A Favale,Stefano %A Iacoviello,Massimo %A Luise,Raffaele %A Bongiorni,Maria Grazia %A Stabile,Giuseppe %A La Rocca,Vincenzo %A Folino,Franco %A Capucci,Alessandro %A D'Onofrio,Antonio %A Accardi,Francesco %A Valsecchi,Sergio %A Buia,Gianfranco %+ Azienda Ospedaliero Universitaria Ospedali Riuniti, Cardiology Clinic, Via Conca, 71, Ancona, 60126, Italy, 39 338 7893860, marioluzi@virgilio.it %K implantable defibrillator %K remote monitoring %K follow-up %D 2013 %7 20.09.2013 %9 Original Paper %J Interact J Med Res %G English %X Background: Remote monitoring (RM) permits home interrogation of implantable cardioverter defibrillator (ICD) and provides an alternative option to frequent in-person visits. Objective: The Italia-RM survey aimed to investigate the current practice of ICD follow-up in Italy and to evaluate the adoption and routine use of RM. Methods: An ad hoc questionnaire on RM adoption and resource use during in-clinic and remote follow-up sessions was completed in 206 Italian implanting centers. Results: The frequency of routine in-clinic ICD visits was 2 per year in 158/206 (76.7%) centers, 3 per year in 37/206 (18.0%) centers, and 4 per year in 10/206 (4.9%) centers. Follow-up examinations were performed by a cardiologist in 203/206 (98.5%) centers, and by more than one health care worker in 184/206 (89.3%) centers. There were 137/206 (66.5%) responding centers that had already adopted an RM system, the proportion of ICD patients remotely monitored being 15% for single- and dual-chamber ICD and 20% for cardiac resynchronization therapy ICD. Remote ICD interrogations were scheduled every 3 months, and were performed by a cardiologist in 124/137 (90.5%) centers. After the adoption of RM, the mean time between in-clinic visits increased from 5 (SD 1) to 8 (SD 3) months (P<.001). Conclusions: In current clinical practice, in-clinic ICD follow-up visits consume a large amount of health care resources. The results of this survey show that RM has only partially been adopted in Italy and, although many centers have begun to implement RM in their clinical practice, the majority of their patients continue to be routinely followed-up by means of in-clinic visits. %M 24055720 %R 10.2196/ijmr.2824 %U http://www.i-jmr.org/2013/2/e27/ %U https://doi.org/10.2196/ijmr.2824 %U http://www.ncbi.nlm.nih.gov/pubmed/24055720