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Effectiveness and Safety in Remote Monitoring of Patients with Pacemakers Five Years after an Implant: The Poniente Study.

ABSTRACT: Health-related quality of life (HRQoL) and functional capacity values immediately after pacemaker (PM) implantation have been well established; however, not much has been known about its long-term effects. The present study compared the long-term effectiveness and safety of remote monitoring plus a clinic visit versus clinic visits alone during follow-up of adults implanted with PMs. This study was a single-centre, controlled, non-randomised, non-blinded clinical trial. Data were collected pre-implantation and after 60 months. The patients in the PONIENTE study were assigned to two different groups: remote monitoring (RM) and conventional monitoring (CM). The EuroQol-5D (EQ-5D) questionnaire was used to assess HRQoL and Duke Activity Status Index was used for the functional capacity. After five years, 55 patients completed the study (RM = 21; CM = 34). EuroQol-5D and functional capacity values were improved; however, significant differences were observed only in the EQ5D visual analogue scale (p < 0.001). Remote monitoring was equally feasible, reliable, safe, and clinically useful as CM. The frequencies of rehospitalisations and emergency visits did not differ between the groups. RM was found to be safe and effective in early detection and treatment of medical- and device-related events and in reducing hospital visits. Improved HRQoL was described not only immediately after PM implantation but also extended over a long time.

SUBMITTER: Lopez-Liria R

PROVIDER: S-EPMC7068341 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Effectiveness and Safety in Remote Monitoring of Patients with Pacemakers Five Years after an Implant: The Poniente Study.

López-Liria Remedios R López-Villegas Antonio A Leal-Costa César C Peiró Salvador S Robles-Musso Emilio E Bautista-Mesa Rafael R Rocamora-Pérez Patricia P Lappegård Knut Tore KT Catalán-Matamoros Daniel D

International journal of environmental research and public health 20200223 4

Health-related quality of life (HRQoL) and functional capacity values immediately after pacemaker (PM) implantation have been well established; however, not much has been known about its long-term effects. The present study compared the long-term effectiveness and safety of remote monitoring plus a clinic visit versus clinic visits alone during follow-up of adults implanted with PMs. This study was a single-centre, controlled, non-randomised, non-blinded clinical trial. Data were collected pre-i ...[more]

PMID: 32102208

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Project description:Patients with pacemakers need regular follow-ups which are demanding. Telemonitoring for pacemaker can provide a new opportunity to avoid follow-up visits. On the other hand, in-person visits could help patients with pacemakers to cope better with the anxiety linked to their condition and maintain better communication with their doctors than simple remote control of their device status. Therefore, our objective was to analyze the experiences and communication comparing telemonitoring (TM) versus conventional monitoring (CM) of patients with pacemakers. A single-center, controlled, non-randomized, non-blinded clinical trial was designed. Data were collected five years after implantation in a cohort of 89 consecutive patients assigned to two different groups: TM and CM. The 'Generic Short Patient Experiences Questionnaire' (GS-PEQ) was used to assess patients' experiences, and the Healthcare Communication Questionnaire (HCCQ) was used to measure the communication of patients with healthcare professionals. Additionally, an ad-hoc survey including items from the 'Telehealth Patient Satisfaction Survey' and a 'costs survey' was used. After five years, 55 patients completed the study (TM = 21; CM = 34). Participants' mean (±SD) age was 81 (±6.47), and 31% were females. No differences in baseline characteristics between groups were found. The comparative analyses TM versus CM showed some significant differences. According to GS-PEQ, TM users received adequate information about their diagnosis or afflictions (p = .035) and the treatment was better adapted to their situation (p = .009). Both groups reported negative experiences regarding their involvement in their treatment decisions, the waiting time before admission, and perceived a low-benefit. According to HCCQ, the TM group experienced poorer consultation management by the healthcare provider (p = .041). Participants reported positive overall communication experiences. The study provides insights into the experiences and communication in PM monitoring services as well as specific areas where users reported negative experiences such as the consultation management by clinicians. Trial registration: ClinicalTrials.gov NCT02234245.

Project description:BackgroundThe concept of 'patient experience' has become central to how to improve healthcare. Remote communication with patients is today a frequent practice in healthcare services, showing similar outcomes to standard outpatient care while enabling cost reduction in both formal and informal care. The purpose of this study was to analyse the experiences of people with telemonitoring pacemakers.MethodsPatients were randomly allocated to either the telemonitoring or hospital monitoring follow-ups. Using the 'Generic Short Patient Experiences Questionnaire' (GS-PEQ), as well as an ad-hoc survey from the 'telehealth patient satisfaction survey' and 'costs survey', patients' experiences were measured six months after the pacemaker implant in a cohort of 50 consecutive patients. The mean age was 74.8 (± 11.75) years and 26 (52%) patients were male of which 1 was lost in follow-up. Finally, 24 patients were followed up with standard hospital monitoring, while 25 used the telemonitoring system. Differences in baseline characteristics between groups were not found.ResultsFindings showed overall positive and similar experiences in patients living with telemonitoring and hospital monitoring pacemakers. Significant differences were found in GS-PEQ concerning how telemonitoring patients received less information about their diagnosis/afflictions (p = 0.046). We did not find significant differences in other items such as 'confidence in the clinicians' professional skills', 'treatment perception adapted to their situation', 'involvement in decisions regarding the treatment', 'perception of hospital organisation', 'waiting before admission', 'satisfaction of help and treatment received', 'benefit received', and 'incorrect treatment'.ConclusionsThe remote communication of pacemakers was met with positive levels of patients' experiences similarly to patients in the hospital monitoring follow-up. However, telemonitoring patients received less information. Thus, improving the quality and timing of information is required in telemonitoring patients in the planning and organisation of future remote communication healthcare services for people living with a pacemaker implant.

Project description:BACKGROUND:With an ageing population and widening indications for pacemakers implantation, the number of persons carrying an implant is steadily increasing. The routine follow-up is thus a heavy burden for the respective NHS as well as for the patients and their relatives. Most of them of the studies have been performed in densely populated areas and nearby to the hospital. It is thus unknown whether these results could be applied also in rural areas such as Northern Norway with a more scattered population. The aim of this study was to assess the effectiveness of tele-monitoring (TM) in patients with pacemakers regarding reliability, safety and health-related quality of life, compared to traditional follow-up in outpatient clinic in a setting where geographical effects could possible influence the results. METHODS:The NORDLAND study is a controlled, randomized, non-masked clinical trial in pacemaker patients, with data collection carried out during the pre-implant stage and after 6 months. Between August of 2014 and November of 2015, 50 patients were assigned to either a tele-monitoring group (n =?25) or a conventional hospital monitoring (HM) group (n =?25). The EuroQol-5D (EQ-5D) utilities and visual analogue scale (VAS) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) were used to measure Health-Related Quality of Life. Baseline characteristics and number of hospital visits were also analyzed. RESULTS:The baseline characteristics of the two study groups were similar for EQ-5D utilities (TM:0.81; HM:0.76; p =?0.47), EQ-5D VAS (TM: 64.00; HM:64.88; p =?0.86) and the MLHFQ (TM:20.20; HM:28.96; p =?0.07). At the 6 month follow-up, there were no significant differences between the groups in EQ-5D utilities (TM: 0.81; HM: 0.76; p =?0.54) and EQ-5D VAS scores (TM: 72.71; HM: 59.79; p =?0.08). The MLHFQ score was improved in both groups (TM: -4.40; HM: -15.13; p <? 0.001). The number of in-office visits was similar in both groups (TM: 1.24 vs HM: 1.12; P = 0.30). CONCLUSIONS:The NORDLAND trial shows that HRQoL is improved after implant in both groups. Without significant differences with regards to effectiveness and safety. In addition, provides a scientifically rigorous method to the field of HRQoL evaluations in patients with pacemakers. TRIAL REGISTRATION:ClinicalTrials.gov NCT02237404 , September 11, 2014.

Project description:BackgroundVirtual care for patients with coronavirus disease 2019 (COVID-19) allows providers to monitor COVID-19-positive patients with variable trajectories while reducing the risk of transmission to others and ensuring health care capacity in acute care facilities. The objective of this descriptive analysis was to assess the initial adoption, feasibility and safety of a family medicine-led remote monitoring program, COVIDCare@Home, to manage the care of patients with COVID-19 in the community.MethodsCOVIDCare@Home is a multifaceted, interprofessional team-based remote monitoring program developed at an ambulatory academic centre, the Women's College Hospital in Toronto. A descriptive analysis of the first cohort of patients admitted from Apr. 8 to May 11, 2020, was conducted. Lessons from the implementation of the program are described, focusing on measure of adoption (number of visits per patient total, with a physician or with a nurse; length of follow-up), feasibility (received an oximeter or thermometer; consultation with general internal medicine, social work or mental health, pharmacy or acute ambulatory care unit) and safety (hospitalizations, mortality and emergency department visits).ResultsThe COVIDCare@Home program cared for a first cohort of 97 patients (median age 41 yr, 67% female) with 415 recorded virtual visits. Patients had a median time from positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to first appointment of 3 (interquartile range [IQR] 2-4) days, with a median virtual follow-up time of 8 (IQR 5-10) days. A total of 4 (4%) had an emergency department visit, with no patients requiring hospitalization and no deaths; 16 (16%) of patients required support with mental and social health needs.InterpretationA family medicine-led, team-based remote monitoring program can safely manage the care of outpatients diagnosed with COVID-19. Virtual care approaches, particularly those that support patients with more complex health and social needs, may be an important part of ongoing health system efforts to manage subsequent waves of COVID-19 and other diseases.

Dataset Information

Effectiveness and Safety in Remote Monitoring of Patients with Pacemakers Five Years after an Implant: The Poniente Study.

Publications

Effectiveness and Safety in Remote Monitoring of Patients with Pacemakers Five Years after an Implant: The Poniente Study.

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