A non-randomized clinical trial to examine patients' experiences and communication during telemonitoring of pacemakers after five years follow-up

Daniel Catalan-Matamoros, Antonio Lopez-Villegas, Cesar Leal Costa, Rafael Bautista-Mesa, Emilio Robles-Musso, Patricia Rocamora Perez, Remedios Lopez-Liria, Daniel Catalan-Matamoros, Antonio Lopez-Villegas, Cesar Leal Costa, Rafael Bautista-Mesa, Emilio Robles-Musso, Patricia Rocamora Perez, Remedios Lopez-Liria

Abstract

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.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. CONSORT flow diagram.
Fig 1. CONSORT flow diagram.

References

    1. Townsend N, Nichols M, Scarborough P, Rayner M. Cardiovascular disease in Europe—epidemiological update 2015. Eur Heart J. 2015;36: 2696–2705. doi: 10.1093/eurheartj/ehv428
    1. Kinge JM, Modalsli JH, Øverland S, Gjessing HK, Tollånes MC, Knudsen AK, et al.. Association of Household Income With Life Expectancy and Cause-Specific Mortality in Norway, 2005–2015. JAMA. 2019;321: 1916. doi: 10.1001/jama.2019.4329
    1. Norwegian Institute of Public Health. Disease Burden in Norway 2015. Results from the Global Burden of Diseases, Injuries, and Risk Factors Study 2015. Oslo, Norway: Norwegian Institute for Public Health; 2017. Available:
    1. Wagner T, Lindstadt C, Jeon Y, Mackert M. Implantable Medical Device Website Efficacy in Informing Consumers Weighing Benefits/Risks of Health Care Options. J Health Commun. 2016;21: 121–126. doi: 10.1080/10810730.2016.1201173
    1. Carrión-Camacho MR, Marín-León I, Molina-Doñoro JM, González-López JR. Safety of Permanent Pacemaker Implantation: A Prospective Study. J Clin Med. 2019;8: 35. doi: 10.3390/jcm8010035
    1. Raatikainen MJP, Arnar DO, Merkely B, Nielsen JC, Hindricks G, Heidbuchel H, et al.. A Decade of Information on the Use of Cardiac Implantable Electronic Devices and Interventional Electrophysiological Procedures in the European Society of Cardiology Countries: 2017 Report from the European Heart Rhythm Association. EP Europace. 2017;19: ii1–ii90. doi: 10.1093/europace/eux258
    1. Lopez-Villegas A, Catalan-Matamoros D, Robles-Musso E, Peiro S. Effectiveness of pacemaker tele-monitoring on quality of life, functional capacity, event detection and workload: The PONIENTE trial: Effectiveness of pacemaker tele-monitoring. Geriatr Gerontol Int. 2016;16: 1188–1195. doi: 10.1111/ggi.12612
    1. López-Villegas A, Catalán-Matamoros D, Robles-Musso E, Peiró S. [Comparative Effectiveness of Remote Monitoring of People with Cardiac Pacemaker versus Conventional: quality of Life at the 6 Months]. Rev Esp Salud Publica. 2015;89: 149–158. doi: 10.4321/S1135-57272015000200004
    1. Lopez-Villegas A, Catalan-Matamoros D, Robles-Musso E, Bautista-Mesa R, Peiro S. Cost-utility analysis on telemonitoring of users with pacemakers: The PONIENTE study. J Telemed Telecare. 2019;25: 2014–212. doi: 10.1177/1357633X18767184
    1. Lomborg S, Langstrup H, Andersen TO. Interpretation as luxury: Heart patients living with data doubt, hope, and anxiety. Big Data Soc. 2020;7: 205395172092443. doi: 10.1177/2053951720924436
    1. Lomborg S, Thylstrup NB, Schwartz J. The temporal flows of self-tracking: Checking in, moving on, staying hooked. New Media Soc. 2018;20: 4590–4607. doi: 10.1177/1461444818778542
    1. Pink S, Lanzeni D, Horst H. Data anxieties: Finding trust in everyday digital mess. Big Data Soc. 2018;5: 205395171875668. doi: 10.1177/2053951718756685
    1. Catalan-Matamoros D, Lopez-Villegas A, Tore-Lappegard K, Lopez-Liria R. Patients’ experiences of remote communication after pacemaker implant: The NORDLAND study. Beiki O, editor. PLoS ONE. 2019;14: e0218521. doi: 10.1371/journal.pone.0218521
    1. Catalan-Matamoros D, Lopez-Villegas A, Lappegård KT, Lopez-Liria R. Assessing Communication during Remote Follow-Up of Users with Pacemakers in Norway: The NORDLAND Study, a Randomized Trial. Int J Environ Res Public Health. 2020;17: 7678. doi: 10.3390/ijerph17207678
    1. Andersen TO, Nielsen KD, Moll J, Svendsen JH. Unpacking telemonitoring work: Workload and telephone calls to patients in implanted cardiac device care. Int J Med Inf. 2019;129: 381–387. doi: 10.1016/j.ijmedinf.2019.06.021
    1. Andersen TO, Bansler JP, Kensing F, Moll J, Mønsted T, Nielsen KD, et al.. Aligning Concerns in Telecare: Three Concepts to Guide the Design of Patient-Centred E-Health. Comput Supported Coop Work. 2018;27: 1181–1214. doi: 10.1007/s10606-018-9309-1
    1. Epstein AE, DiMarco JP, Ellenbogen KA, Estes NAM, Freedman RA, Gettes LS, et al.. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008;51: e1–62. doi: 10.1016/j.jacc.2008.02.032
    1. Wilkoff BL, Auricchio A, Brugada J, Cowie M, Ellenbogen KA, Gillis AM, et al.. HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations: Developed in partnership with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA); and in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), the European Society of Cardiology (ESC), the Heart Failure Association of ESC (HFA), and the Heart Failure Society of America (HFSA). Endorsed by the Heart Rhythm Society, the European Heart Rhythm Association (a registered branch of the ESC), the American College of Cardiology, the American Heart Association. Europace. 2008;10: 707–725. doi: 10.1093/europace/eun122
    1. Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, et al.. A randomized trial of long-term remote monitoring of pacemaker recipients (The COMPAS trial). Eur Heart J. 2012;33: 1105–1111. doi: 10.1093/eurheartj/ehr419
    1. Petersen JH, Blomquist SD. A qualitative innovation of digital healthcare for remotemonitoring pacemaker patients. Master Thesis, Aalborg University. 2018. Available:
    1. Skov MB, Johansen PG, Skov CS, Lauberg A. No News is Good News: Remote Monitoring of Implantable Cardioverter-Defibrillator Patients. Proceedings of the 33rd Annual ACM Conference on Human Factors in Computing Systems—CHI ‘15. Seoul, Republic of Korea: ACM Press; 2015. pp. 827–836. doi: 10.1145/2702123.2702192
    1. Petersen HH, Larsen MCJ, Nielsen OW, Kensing F, Svendsen JH. Patient satisfaction and suggestions for improvement of remote ICD monitoring. J Interv Card Electrophysiol. 2012;34: 317–324. doi: 10.1007/s10840-012-9675-4
    1. Leal-Costa C, Lopez-Villegas A, Catalan-Matamoros D, Robles-Musso E, Lappegård KT, Bautista-Mesa RJ, et al.. Long-Term Socioeconomic Impact of Informal Care Provided to Patients with Pacemakers: Remote vs. Conventional Monitoring. Healthcare. 2020;8: 175. doi: 10.3390/healthcare8020175
    1. López-Liria R, López-Villegas A, Leal-Costa C, Peiró S, Robles-Musso E, Bautista-Mesa R, et al.. Effectiveness and Safety in Remote Monitoring of Patients with Pacemakers Five Years after an Implant: The Poniente Study. Int J Environ Res Public Health. 2020;17: 1431. doi: 10.3390/ijerph17041431
    1. Sjetne IS, Bjertnaes OA, Olsen RV, Iversen HH, Bukholm G. The Generic Short Patient Experiences Questionnaire (GS-PEQ): identification of core items from a survey in Norway. BMC Health Serv. Res. 2011;11. doi: 10.1186/1472-6963-11-88
    1. Gremigni P, Sommaruga M, Peltenburg M. Validation of the Health Care Communication Questionnaire (HCCQ) to measure outpatients’ experience of communication with hospital staff. Patient Educ Couns. 2008;71: 57–64. doi: 10.1016/j.pec.2007.12.008
    1. Abrams DJ, Geier MR. A comparison of patient satisfaction with telehealth and on-site consultations: a pilot study for prenatal genetic counseling. J Genet Couns. 2006;15: 199–205. doi: 10.1007/s10897-006-9020-0
    1. Bas Villaobos M. Propuesta de un sistema de monitorización remota de dispositivos implantados en pacientes cardiológicos: Consideraciones económicas, organizativas y de calidad percibida. Tesis Doctoral, Universidad Politécnica de Madrid. 2010. Available:
    1. López-Villegas A, Catalán-Matamoros D, Robles-Musso E, Peiró S. Workload, time and costs of the informal cares in patients with tele-monitoring of pacemakers: the PONIENTE study. Clin Res Cardiol. 2016;105: 307–313. doi: 10.1007/s00392-015-0921-5
    1. Duru F, Büchi S, Klaghofer R, Mattmann H, Sensky T, Buddeberg C, et al.. How different from pacemaker patients are recipients of implantable cardioverter-defibrillators with respect to psychosocial adaptation, affective disorders, and quality of life? Heart. 2001;85: 375–379. doi: 10.1136/heart.85.4.375
    1. Leosdottir M, Sigurdsson E, Reimarsdottir G, Gottskalksson G, Torfason B, Vigfusdottir M, et al.. Health-related quality of life of patients with implantable cardioverter defibrillators compared with that of pacemaker recipients. Europace. 2006;8: 168–174. doi: 10.1093/europace/euj052
    1. Cottrell E, McMillan K, Chambers R. A cross-sectional survey and service evaluation of simple telehealth in primary care: what do patients think? BMJ Open. 2012;2: e001392. doi: 10.1136/bmjopen-2012-001392
    1. Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, et al.. Remote Monitoring of CRT-ICD: The Multicenter Italian CareLink Evaluation-Ease of Use, Acceptance, and Organizational Implications. PACE. 2008;31: 1259–1264. doi: 10.1111/j.1540-8159.2008.01175.x
    1. Varma N. Remote monitoring of patients with CIEDs following the updated recommendations-Easing or adding to postimplant responsibilities? Cont Cardiol Educ. 2016;2: 198–204. doi: 10.1002/cce2.45
    1. Car J. Improving quality and safety of telephone based delivery of care: teaching telephone consultation skills. Qual Saf Health Care. 2004;13: 2–3. doi: 10.1136/qshc.2003.009241
    1. Souza-Junior VD, Mendes IAC, Mazzo A, Godoy S. Application of telenursing in nursing practice: an integrative literature review. Appl Nurs Res. 2016;29: 254–260. doi: 10.1016/j.apnr.2015.05.005
    1. Morony S, Weir K, Duncan G, Biggs J, Nutbeam D, Mccaffery KJ. Enhancing communication skills for telehealth: development and implementation of a Teach-Back intervention for a national maternal and child health helpline in Australia. BMC Health Serv Res. 2018;18: 162. doi: 10.1186/s12913-018-2956-6
    1. Bautista-Mesa RJ, Lopez-Villegas A, Peiro S, Catalan-Matamoros D, Robles-Musso E, Lopez-Liria R, et al.. Long-term cost-utility analysis of remote monitoring of older patients with pacemakers: the PONIENTE study. BMC Geriatr. 2020;20: 474. doi: 10.1186/s12877-020-01883-3
    1. Meneguin S, Machado Cesar LA. Motivation and frustration in cardiology trial participation: the patient perspective. Clinics (Sao Paulo). 2012;67: 603–608. doi: 10.6061/clinics/2012(06)10
    1. Van Cleave AC, Roosen-Runge MU, Miller AB, Milner LC, Karkazis KA, Magnus DC. Quality of Communication in Interpreted Versus Noninterpreted PICU Family Meetings*: Crit Care Med. 2014;42: 1507–1517. doi: 10.1097/CCM.0000000000000177
    1. Yuan K-H, Maxwell S. On the Post Hoc Power in Testing Mean Differences. J Educ Behav Stat. 2005;30(2):141–167. doi: 10.3102/10769986030002141
    1. Zhang Y, Hedo R, Rivera A, Rull R, Richardson S, Tu XM. Post hoc power analysis: is it an informative and meaningful analysis? Gen Psychiatr. 2019;32(4):e100069. doi: 10.1136/gpsych-2019-100069
    1. Lovakov A, Agadullina ER. Empirically derived guidelines for effect size interpretation in social psychology. Eur J Soc Psychol. 2021; 51(3): 485–504. doi: 10.1002/ejsp.2752
    1. Wakefield BJ, Bylund CL, Holman JE, Ray A, Scherubel M, Kienzle MG, et al.. Nurse and patient communication profiles in a home-based telehealth intervention for heart failure management. Patient Educ Couns. 2008;71: 285–292. doi: 10.1016/j.pec.2008.01.006
    1. Catalán-Matamoros D, López-Villegas A. La Telesalud y la sociedad actual: retos y oportunidades (Telehealth and the current society: challenges and opportunities). Rev Esp Comun Salud. 2016;7: 336–345. doi: 10.20318/recs.2016.3458

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