Socioeconomic impact of informal care provided to patients with remote monitoring of pacemakers

Abstract Background The aging of the population leading patients with pacemakers to exhibit more comorbidities and, consequently, a greater need for both formal and informal care. The objective of this study was to assess personal characteristics, associated problems, workloads, time, and costs related to informal care provided to patients with pacemakers under remote monitoring (RM) vs. conventional monitoring (CM) at hospital, five years after implantation. Methods This is a controlled, non-randomised nor masked trial conducted with information obtained from the perspective of informal caregivers. The “Disability, personal autonomy, and dependency situations survey” was administered to collect information on sociodemographic characteristics, time, care difficulties, health status, professional aspects, and impact on economic, family, or leisure aspects of main caregivers providing care to patients with pacemakers. Results of the 50 patients who reported having informal caregivers, 42% belonged to the RM group. The average age was 63.14 years, 96% were women, and 72% was married. Informal caregivers lived in the homes of the patients in 70% of cases, and 88% indicated that they had to provide care six to seven days a week. The average cost per patient during the monitoring period studied was 13.17% lower in the RM group than in the CM group, and these differences were not statistically significant (p = 0.35). Conclusions This study found similar results in both groups of follow-up with respect to sociodemographic characteristics, workload, time, and problems associated with health, leisure and relatives. The costs associated with care were higher in the CM group. Key messages There are not significant differences between both groups of follow-up with respect to sociodemographic characteristics, workload, time, and problems associated with health, leisure and relatives. The average cost per patient during the monitoring period studied was 13.17% lower in the Remote Monitoring group than in the Conventional Monitoring group.

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Long-Term Socioeconomic Impact of Informal Care Provided to Patients with Pacemakers: Remote vs. Conventional Monitoring

Healthcare ◽

10.3390/healthcare8020175 ◽

2020 ◽

Vol 8 (2) ◽

pp. 175

Author(s):

Cesar Leal-Costa ◽

Antonio Lopez-Villegas ◽

Daniel Catalan-Matamoros ◽

Emilio Robles-Musso ◽

Knut Tore Lappegård ◽

...

Keyword(s):

Informal Care ◽

Remote Monitoring ◽

Personal Autonomy ◽

Informal Caregivers ◽

Personal Characteristics ◽

Socioeconomic Impact ◽

Sociodemographic Characteristics ◽

Long Term Effects ◽

The Impact

The impact of informal care immediately after pacemaker (PM) implantation has been well established; however, not much is known about its long-term effects. The present study compared personal characteristics, associated problems, workloads, time, and costs related to informal care provided to patients with PM under remote monitoring (RM) vs. conventional monitoring (CM) in the hospital, five years after implantation. The PONIENTE study was a controlled, non-randomized or masked clinical trial conducted with information obtained from the perspective of informal caregivers. Data were collected at 12 and 60 months after PM implantation. The patients in the study were assigned to two different groups: remote monitoring (RM) and conventional monitoring (CM). The “Disability, personal autonomy, and dependency situations survey” (EDAD) was administered to collect information on sociodemographic characteristics, time, care difficulties, health status, professional aspects, and impact on economic, family, or leisure aspects of the main caregivers providing care to patients with pacemakers. After five years, 55 patients completed the study (RM = 21; CM = 34). The average age was 63.14 years (SD = 14.90), 96% of them were women, and the most predominant marital status was married (72%). Informal caregivers lived in the homes of the patients in 70% of cases, and 88% indicated that they had to provide care six to seven days a week. The average cost per patient during the monitoring period studied was 13.17% lower in the RM group than in the CM group, and these differences were not statistically significant (p = 0.35). This study found similar results in the two groups under study with respect to sociodemographic characteristics, workload, time, and problems associated with health, leisure and family members. The costs associated with care were higher in the CM group; however, these differences were not statistically significant.

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Cost–utility analysis of remote versus conventional monitoring of pacemakers in the Arctic Circle

European Journal of Public Health ◽

10.1093/eurpub/ckaa166.572 ◽

2020 ◽

Vol 30 (Supplement_5) ◽

Author(s):

A Lopez-Villegas ◽

D Catalan-Matamoros ◽

S Peiro ◽

K T Lappegard ◽

R Lopez-Liria

Keyword(s):

Remote Monitoring ◽

National Health System ◽

Cost Utility ◽

Cost Utility Analysis ◽

The Arctic ◽

Utility Analysis ◽

System Perspective ◽

Life Years ◽

Monitoring Group

Abstract Introduction Several studies have demonstrated that remote monitoring (RM) of pacemakers is safe, effective and cost-saving. The aim of this study was to perform an economic assessment and check whether RM offers a cost-utility alternative to conventional monitoring in hospital (CM). Methods This is a controlled, randomized, non-masked clinical trial. Fifty patients with pacemaker were assigned to receive either RM (n = 25) or CM (n = 25). Data were collected during the 12 months. A cost-utility analysis was performed in order to assess whether RM of pacemakers is cost-effective compared to CM in hospital in terms of costs per gained quality-adjusted life years (QALY). The analysis was performed from the perspectives of the Norwegian Healthcare System (NHS) and patients. Results Overall, total costs from the NHS perspective were higher in the RM group (€2,079.84 vs. €271.97; p = 0.147). The costs related to the patients perspective were higher in the RM than those in the CM group (€223.99 vs. €158.42, respectively; P = 0.429). Patients included in the CM obtained 0.04 QALYs less than those in the RM group over 12 months and the total costs per QALY comprised €1,784.10 (P = 0.175) per user with a pacemaker implant. The total number of pacemaker transmissions per patient year comprised 86.46% of minors in the CM group. Conclusions The follow-up costs were similar between both groups. Cost-utility analysis showed broad confidence intervals with ICERs ranging from potential savings to high costs for an additional QALY, with most ICERs lower than the usual NHS thresholds for coverage decisions. Key messages Total costs from the National Health System perspective were higher in the remote monitoring group, although there were not significant differences between both groups of follow-up. The costs related to the patient perspective were higher in the remote monitoring than those in the conventional monitoring group, without significant differences.

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Automatic Remote Monitoring of Implantable Cardiac Devices in Clinical Practice – The Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) Trial

European Cardiology Review ◽

10.15420/ecr.2010.6.3.87 ◽

2010 ◽

Vol 6 (3) ◽

pp. 87

Author(s):

Niraj Varma ◽

Keyword(s):

Clinical Practice ◽

Remote Monitoring ◽

Home Monitoring ◽

Implantable Devices ◽

Cardiac Device ◽

Cardiac Devices ◽

Enhance Patient Safety ◽

Implantable Cardiac Devices ◽

Post Implantation

The use of implantable electronic cardiac devices is increasing. Post-implantation follow-up is important for monitoring both device function and patient condition; however, clinical practice is inconsistent. For example, implantable cardioverter–defibrillator follow-up schedules vary from every three months to yearly according to facility and physician preference and the availability of resources. Importantly, no surveillance occurs between follow-up visits. By contrast, implantable devices with automatic remote monitoring capability provide a means for performing constant surveillance, with the ability to identify salient problems rapidly. The Lumos-T Reduces Routine Office Device Follow-up Study (TRUST) demonstrated that remote home monitoring reduced clinic burden and allowed early detection of patient and/or system problems, enabling efficient monitoring and an opportunity to enhance patient safety. The results of the trial have significant implications for the management of patients receiving all forms of implantable electronic cardiac device.

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External validation of a heart failure risk prediction model in a remote monitoring cohort submitted to cardiac resynchronization therapy

European Heart Journal ◽

10.1093/ehjci/ehaa946.0817 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

I Cardoso ◽

M Coutinho ◽

G Portugal ◽

A Valentim ◽

A.S Delgado ◽

...

Keyword(s):

Heart Failure ◽

Heart Rate ◽

High Risk ◽

Remote Monitoring ◽

Hospital Admissions ◽

External Validation ◽

Left Ventricular Ejection ◽

National Database ◽

Failure Risk

Abstract Background Patients (P) submitted to cardiac ressynchronization therapy (CRT) are at high risk of heart failure (HF) events during follow-up. Continuous analysis of various physiological parameters, as reported by remote monitoring (RM), can contribute to point out incident HF admissions. Tailored evaluation, including multi-parameter modelling, may further increase the accuracy of such algorithms. Purpose Independent external validation of a commercially available algorithm (“Heart Failure Risk Status” HFRS, Medtronic, MN USA) in a cohort submitted to CRT implantation in a tertiary center. Methods Consecutive P submitted to CRT implantation between January 2013 and September 2019 who had regular RM transmissions were included. The HFRS algorithm includes OptiVol (Medtronic Plc., MN, USA), patient activity, night heart rate (NHR), heart rate variability (HRV), percentage of CRT pacing, atrial tachycardia/atrial fibrillation (AT/AF) burden, ventricular rate during AT/AF (VRAF), and detected arrhythmia episodes/therapy delivered. P were classified as low, medium or high risk. Hospital admissions were systematically assessed by use of a national database (“Plataforma de Dados de Saúde”). Accuracy of the HFRS algorithm was evaluated by random effects logistic regression for the outcome of unplanned hospital admission for HF in the 30 days following each transmission episode. Results 1108 transmissions of 35 CRT P, corresponding to 94 patient-years were assessed. Mean follow-up was 2.7 yrs. At implant, age was 67.6±9.8 yrs, left ventricular ejection fraction 28±7.8%, BNP 156.6±292.8 and NYHA class >II in 46% of the P. Hospital admissions for HF were observed within 30 days in 9 transmissions. Stepwise increase in HFRS was significantly associated with higher risk of HF admission (odds ratio 12.7, CI 3.2–51.5). HFRS had good discrimination for HF events with receiving-operator curve AUC 0.812. Conclusions HFRS was significantly associated with incident HF admissions in a high-risk cohort. Prospective use of this algorithm may help guide HF therapy in CRT recipients. Funding Acknowledgement Type of funding source: None

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Implantable cardiac monitor after cryptogenic stroke: atrial fibrillation detection and predictors

European Heart Journal ◽

10.1093/ehjci/ehaa946.0382 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

E Ebrille ◽

C Amellone ◽

M.T Lucciola ◽

F Orlando ◽

M Suppo ◽

...

Keyword(s):

Atrial Fibrillation ◽

Multivariate Analysis ◽

Risk Stratification ◽

Median Time ◽

Remote Monitoring ◽

Cryptogenic Stroke ◽

Screening Process ◽

Cardiac Monitor ◽

Implantable Cardiac Monitor

Abstract Objective The main objective of our study was to analyze the incidence and predictors of atrial fibrillation (AF) in patients with cryptogenic stroke (CS) who received an implantable cardiac monitor (ICM) at our Institution. Methods From November 2013 to October 2017, a total of 133 patients who had suffered a CS were implanted with an ICM after a thorough screening process. The median time between the thromboembolic event and ICM implantation was 64 days [IQ range: 16–111]. All implanted patients were followed with remote monitoring until the first detected episode of AF or up to December 2018. Every remote monitoring transmission and related electrograms were analyzed by the dedicated Electrophysiology Nursing team and confirmed by experienced Electrophysiologists. AF was defined by any episode lasting greater than or equal to 2 minutes. Results During a median follow-up of 14.8 months [IQ range: 3.0–31.2], AF was detected in 65 out of 133 patients (48.9%). The median time from ICM implantation and AF detection was 3.5 months [IQ range: 0.9–6.7]. The prevalence of AF was 22.6%, 34.4%, 40.8% and 48.3% at 3, 6, 12 and 24 months respectively. At the multivariate analysis, high premature atrial contractions (PAC) burden and left atrium (LA) dilation were the only independent predictors of AF detection (HR 2.82, 95% CI 1.64–4.83, p<0.001 for PAC; HR 1.75, 95% CI 1.03–2.97, p=0.038 for LA dimension). Patients were dived into categories based on the probability of AF detection (low, intermediate and high risk) and a new risk stratification algorithm was implemented (Figure 1). Conclusion After a thorough screening process, AF detection in patients with CS and ILM was quite high. Having a high PAC burden and LA dilation predicted AF episodes at the multivariate analysis. A new risk stratification algorithm was developed. Figure 1 Funding Acknowledgement Type of funding source: None

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A long-term evaluation of Facebook for recruitment and retention in the ENDIA type 1 diabetes pregnancy-birth cohort study (Preprint)

10.2196/preprints.34049 ◽

2021 ◽

Author(s):

Kelly J McGorm ◽

James David Brown ◽

Rebecca Louise Thomson ◽

Helena Oakey ◽

Belinda Moore ◽

...

Keyword(s):

Social Media ◽

Type 1 Diabetes ◽

Logistic Regression ◽

Birth Cohort ◽

Multinomial Logistic Regression ◽

Sociodemographic Characteristics ◽

Recruitment And Retention

BACKGROUND Recruitment and retention of research participants is challenging. Social media, particularly Facebook, has emerged as a tool for connecting with participants due to its high uptake in the community. The Environmental Determinants of Islet Autoimmunity (ENDIA) study is an Australia-wide prospective pregnancy-birth cohort following children who have a first-degree relative with type 1 diabetes (ACTRN1261300794707). A dedicated Facebook page was established for the ENDIA study in 2013 with the aim to enhance recruitment and support participant retention. OBJECTIVE The purpose of this investigation was to evaluate the long-term impact of Facebook as a recruitment and retention tool. The hypotheses were that (1) Facebook was an important source of referral to the ENDIA study, (2) the sociodemographic characteristics of participants recruited by Facebook would be different from those of participants recruited by other means (i.e., ‘conventional recruits’), and (3) recruitment by Facebook would be associated with long-term retention. We also evaluated the most effective types of Facebook content based on post engagement. METHODS Recruitment of 1511 ENDIA participants was completed in December 2019. Characteristics of participants recruited through Facebook were compared to conventional recruits using linear, logistic, and multinomial logistic regression models. A logistic regression model was used to determine the risk of study withdrawal. Data pertaining to 794 Facebook posts over 7.5 years from June 2013 until December 2020 were extracted using the Facebook ‘Insights’ function for thematic analysis. RESULTS Facebook was the third largest source of referral to the ENDIA study (300/1511; 19.9%) behind in-person clinics (500/1511, 33.1%) and healthcare professional referrals (347/1511, 23.0%). The ENDIA Facebook page had 2337 followers at the close of recruitment. Approximately 20% of these could be identified as participating parents. Facebook recruits were more frequently Australian-born (P<.001) enrolling postnatally (P=.01) and withdrew from the study at a significantly lower rate compared to conventional recruits (4.7% vs 12.3%; P<.001) after a median of follow-up of 3.3 years. CONCLUSIONS Facebook was a valuable recruitment tool for the ENDIA study and participants recruited through Facebook were three times less likely to withdraw during long-term follow-up. The sociodemographic characteristics of Facebook recruits were different to conventional recruits, but perhaps in unintended ways. Facebook content featuring stories and images of participants received the highest engagement despite the fact that most Facebook followers were not enrolled in the study. These findings should inform social media strategies for future cohort studies involving pregnant women and young families, and for type 1 diabetes risk studies. CLINICALTRIAL Australia New Zealand Clinical Trials Registry: ACTRN1261300794707 INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1186/1471-2431-13-124

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Remote Follow-up of Self-isolating COVID-19 Patients with a Patient Portal: Protocol for a Mixed-method Pilot Study (The Opal-COVID Study) (Preprint)

10.2196/preprints.35760 ◽

2021 ◽

Author(s):

David Lessard ◽

Kim Engler ◽

Yuanchao Ma ◽

Adriana Rodriguez Cruz ◽

Serge Vicente ◽

...

Keyword(s):

Patient Outcomes ◽

Mixed Method ◽

Healthcare Professionals ◽

Qualitative Interviews ◽

Sociodemographic Characteristics ◽

Patient Portal ◽

Implementation Outcomes ◽

Service Outcomes ◽

Qualitative Analyses

BACKGROUND Individuals diagnosed with COVID-19 are instructed to self-isolate at home. However, during self-isolation, they may experience anxiety and insufficient care. Some patient portals can allow patients to self-monitor and share their health status with healthcare professionals for remote follow-up, but little data is available on the feasibility of their use. OBJECTIVE This manuscript presents the protocol of the Opal-COVID Study which has four objectives: 1) assess the implementation of using the Opal patient portal for distance monitoring of COVID-19 patients self-isolating at home; 2) identify influences on the intervention’s implementation; and describe 3) service and 4) patient outcomes of this intervention. METHODS This mixed-method pilot study aims to recruit 50 COVID-19 patient participants tested at the McGill University Health Centre (MUHC, Montreal, Canada) for 14 days of remote follow-up. With access to questionnaires through the Opal patient portal smartphone app, configured for this study, patients will complete a daily self-assessment of symptoms, vital signs, and mental health, monitored by a nurse, and receive subsequent teleconsultations, as needed. Study questionnaires will be administered to collect data on sociodemographic characteristics, medical background, implementation outcomes (acceptability, usability, and respondent burden) and patient satisfaction. Coordinator logbook entries will inform on feasibility outcomes, namely, recruitment/retention rates and fidelity, as well as on the frequency and nature of contacts with healthcare professionals via Opal. The statistical analyses for Objectives 1 (implementation outcomes), 3 (service outcomes), and 4 (patient outcomes) will evaluate the effects of time and sociodemographic characteristics on the outcomes. For Objectives 1 (implementation outcomes) and 4 (patient outcomes), the statistical analyses will also examine the attainment of predefined success thresholds. As to the qualitative analyses, for Objective 2 (influences on implementation), semi-structured qualitative interviews will be conducted with four groups of stakeholders (i.e., patient participants, healthcare professionals, technology developers and study administrators) and submitted to content analysis, guided by the Consolidated Framework for Implementation Research to help identify barriers and facilitators of implementation. For Objective 3 (service outcomes), reasons for contacting healthcare professionals through Opal will also be submitted to content analysis. RESULTS Between December 2020 and March 2021, 51 patient-participants were recruited. Qualitative interviews were conducted with 39 involved stakeholders, from April to September 2021. Delays in the study process were experienced due to implemented measures at the MUHC to address COVID-19 but the quantitative and qualitative analyses are currently underway. CONCLUSIONS This protocol is designed to generate multidisciplinary knowledge on the implementation of a patient portal-based COVID-19 care intervention and will lead to a comprehensive understanding of feasibility, stakeholder experience, and influences on implementation that may prove useful for scaling up similar interventions. CLINICALTRIAL ClinicalTrials.gov identifier NCT04978233.

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Canadian Registry of Electronic Device Outcomes: remote monitoring outcomes in the Abbott battery performance alert—a multicentre cohort

EP Europace ◽

10.1093/europace/euab025 ◽

2021 ◽

Author(s):

Sharath Kumar ◽

Jason Davis ◽

Bernard Thibault ◽

Iqwal Mangat ◽

Benoit Coutu ◽

...

Keyword(s):

Remote Monitoring ◽

Primary Outcome ◽

Electronic Device ◽

Electronic Devices ◽

Cardiac Resynchronization ◽

Device Performance ◽

Cardiac Implantable Electronic Devices ◽

All Cause Mortality ◽

Multicentre Cohort

Abstract Aims Cardiac implantable electronic devices with device advisories have the potential of device malfunction. Remote monitoring (RM) of devices has been suggested to allow the identification of abnormal device performance and permit early intervention. We sought to describe the outcomes of patients with and without RM in devices subject to the Abbott Premature Battery Depletion (PBD) advisory with data from a Canadian registry. Methods and results Patients with an Abbott device subject to the PBD advisory from nine implantable cardioverter defibrillator (ICD) implanting centres in Canada were included in the registry. The use of RM was identified from baseline and follow-up data in the registry. The primary outcome was detection of PBD and all-cause mortality. A total of 2666 patients were identified with a device subject to the advisory. In all, 1687 patients (63.2%) had RM at baseline. There were 487 deaths during follow-up. At a mean follow-up of 5.7 ± 0.7 years, mortality was higher in those without a remote monitor compared with RM at baseline (24.7% vs. 14.5%; P < 0.001). Pre-mature battery depletion was identified in 36 patients (2.1%) with RM vs. 7 (0.7%) without RM (P = 0.004). Time to battery replacement was significantly reduced in patients on RM (median 5 vs. 13 days, P = 0.001). Conclusion The use of RM in patients with ICD and cardiac resynchronization therapy under advisory improved detection of PBD, time to device replacement, and was associated with a reduction in all-cause mortality. The factors influencing the association with mortality are unknown and deserve further study.

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