Cardiovascular diseases requiring the implantation of cardiac implantable electronic devices (CIEDs) are increasing each year. In North America, an estimated 560,000 pacemakers were implanted in the year 2007.1 During the years 1993 to 2009, an estimated 2.9 million pacemakers were implanted in the United States alone. This equates to an increase in usage by 55.6%.2 Each individual with a pacemaker requires follow-up appointments post implantation and interrogation appointments to monitor the device with a cardiologist. The increasing demand for these appointments is placing a large strain on the providers who are capable of interrogating and monitoring these CIEDs.1
Currently, home telemetry monitoring is a recommendation but not a requirement.3,4 The benefits of a patient utilizing home telemetry monitoring include identifying arrhythmias earlier, improving patient safety, identifying device malfunction, and optimizing device function, as well as monitoring battery life and lead functioning.1,4
This research study, pertaining to individuals with CIEDs and the utilization of home telemetry monitoring devices, took place at a large cardiology office in Connecticut. One specific manufacturer of implantable cardiac devices had a poor rate of patients utilizing the home telemetry monitoring device. Therefore, a chart review was conducted, and patients were asked about potential barriers or reasons why they were not using the home telemetry monitoring device. The 3 most common responses from patients included: “I was unaware of the device”; “I was not educated about the device so I returned it to the office”; and “I do not have a landline.” Approximately 219 patients were asked whether or not he or she used their home telemetry monitoring device. Of these patients, 139 (63%) reported not utilizing the home telemetry monitoring devices.
The purpose of this study was to collect data regarding non-adherence with home telemetry monitoring for individuals with CIEDs, and improve both the safety of device monitoring and quality of care for these individuals. This quality improvement project sought to educate individuals about the standards of care pertaining to home telemetry monitoring and CIEDs, and improve adherence through the use of shared decision making. Furthermore, it examined patient perception of their own health literacy level, as well as attitudes and perceptions toward telemedicine through surveys.
Review of Literature
Advancements made in the technology used to monitor the pacemaker have greatly evolved. Originally, the pacemaker could only be monitored during in-office visits; the wand and transtelephonic monitoring were later invented.5 Presently, pacemakers can be interrogated and monitored daily from the home through the use of a wireless home telemetry monitoring device. If an arrhythmia, a clinically actionable event, or if the device is not functioning properly, the doctor will be notified that day via the web-based server. The latter option is to have the pacemaker monitored once every 3 months at the in-office visit, in which the provider will download and look at those months’ recordings. According to the guidelines, the pacemaker should be interrogated every 3 months, either in office or via remote monitoring.5 The patient has the option of using home telemetry monitoring at 3 months and then an in-office visit every 6 months, alternating or continuing with the pacemaker interrogation in-office visits every 3 months.
A multitude of research has been conducted on determining the safety and efficacy of home telemetry monitoring devices. In one research study involving 897 participants, the clinical benefits of remote monitoring versus transtelephonic monitoring of pacemakers was examined. The number of clinically actionable events detected by the control group using the transtelephonic monitoring versus the remote monitoring group were compared. This research study determined that the use of remote monitoring for pacemaker interrogation as a method of follow-up is clinically more efficient in detecting clinically actionable events than the transtelephonic monitoring method.6
A study was also conducted that compared home monitoring and in-office follow-up of implantable cardioverter-defibrillators (ICDs), and found that remote home monitoring was determined to be a safe and effective way to monitor the ICD device.7 In this study, 908 participants were randomly placed in the home monitoring group and 431 participants were placed in the conventional, in-office follow-up group. The results showed that the home monitoring group had a success rate pertaining to follow-up compliance of 93.5% versus conventional in-office follow-up of only 88.7%.7 The median time to evaluation for arrhythmic events was less than 2 days for the home monitoring group versus 36 days for the conventional group. Therefore, these results showed a higher compliance rate with follow-up and that there is a faster response to arrhythmic events when home monitoring is used appropriately.7
Additionally, a research study evaluating patient satisfaction with remote monitoring was evaluated through the use of a satisfaction survey at baseline, 3, and 6 months that involved a total of 124 patients.8 The study found that 93-99% of the patients reported complete or high satisfaction with remote monitoring and interrogation. The satisfaction survey used 5 measures, and patients reported satisfaction with the convenience and ease of use of the monitoring device.8
Another beneficial component to the use of home telemetry monitoring is the potential financial savings.1 The cost of having an individual participate in the conventional route of follow-up was compared to the expected costs of home telemetry monitoring. When an individual uses home telemetry monitoring, the individual is only required to do in-office follow-up every 6 months compared to every 3 months, eliminating 2 yearly office visits. The device is expected to last approximately 5 years per patient; therefore, the potential total savings per patient is $2,149 when visiting the office only twice a year and using the home telemetry monitoring device.1
Home telemetry monitoring devices have been determined to be a safe, more convenient, and cost-effective form of follow-up and management for patients with CIEDs. There has been research pertaining to patient satisfaction, but no research has been conducted on evaluating patients’ attitudes and perceptions towards home telemetry monitoring devices to improve compliance.
A quasi-experimental methodology was used to conduct this pilot study over a 6-month time period, from October 2015 to March 2016. Data collection was conducted after receiving approval from the Institutional Review Board. After completing a chart review and conversing with patients at the cardiology office, 139 of 219 patients were identified as being non-compliant.
Inclusion criteria consisted of participants with a CIED that was compatible with home telemetry monitoring, and participants were post-implantation who did not set up their home telemetry monitoring device. Exclusion criteria consisted of participants who did not have a landline, compatibility for wireless monitoring, or individuals who did not have a landline but also refused the monthly fee for wireless monitoring.
A convenience sample of participants was recruited for participation during their interrogation appointments at the cardiology office. During the interrogation appointment, individuals who were non-compliant with the home telemetry monitoring device were recruited. Individuals who agreed to partake in the research study were then asked to complete a demographic sheet, a Brief Health Literacy Screen (BHLS), and the telemedicine perception questionnaire. The BHLS (∝ 0.79) is composed of 5 questions that are rated using a Likert scale. The BHLS evaluates each patient’s perceptions of their own health literacy levels.9 The telemedicine perception questionnaire (∝ 0.80) is a 17-item questionnaire that asks the patients to respond to statements also using a Likert scale.10 When responding to the telemedicine perception questionnaire, patients were asked to apply the questions towards their home telemetry monitoring devices.
After the participants completed the forms, the primary researcher conducted an individualized educational session about the how, what, why, setup, and importance of the home telemetry monitoring device. Through conversing with patients and the use of shared decision making, individuals could agree to be enrolled to have a home telemetry monitoring device delivered to their house. If the participant had their home telemetry monitoring device at their home, he or she was asked to set up their device whenever convenient for them in the near future. The participants would also receive a pre-stamped and pre-addressed envelope to mail the completed telemedicine perception questionnaire back to the office. The participants were then notified that he or she would receive the telemedicine perception questionnaire in the mail in approximately 2 weeks’ time.
A total of 23 individuals participated in this research study. The mean age of the participants was 74 years old, with the youngest participant being 53 and the oldest participant being 90 years old. The majority of the patients were male: 19 male and 4 female participants. Approximately 43% were married, and 91% reported English to be their first language. In regards to education, 12 patients reported that he or she was a college graduate, had an associate’s degree or higher, and the other 11 patients reported a high school education.
Analysis of the BHLS showed that the participants felt confident in regards to their health literacy level. Participants responded to 5 questions using this Likert scale: 1 = always, 2 = often, 3 = sometimes, 4 = occasionally, and 5 = never. None of the participants reported “1 = always” when asked if they had difficulty reading and understanding or remembering instructions about their health. According to the participants’ responses and confidence in their health literacy level, it was determined that participants should not experience difficulty in remembering what was told to them about the importance, how, why, what, or setup of the home telemetry monitoring device. See Table 1 for the mean and standard deviation of patient responses to the BHLS.
Statistical analysis was conducted to compare the patients’ responses for the telemedicine perception questionnaire pre-setup of the home telemetry monitoring to patients’ responses to the telemedicine perception questionnaire 2-3 weeks after setup of the home telemetry monitoring. All 23 participants completed the telemedicine perception questionnaire; 14 (61%) of the participants completed and mailed the telemedicine perception questionnaire back to the office. The results were not statistically significant (P = 0.88). Analysis of each question was conducted, and the mean and SD were calculated per question.
After comparing the individual responses, certain questions were identified in which participants’ responses were noted to be more positive towards telemedicine. See Table 2 for the mean and SD scores for participants’ pre and post responses to the telemedicine perception questionnaire. Participants’ responses were noted to be more positive after setting up the home telemetry monitoring devices in questions 1, 8, 10, 11, 12, 13, and 14.
Through the use of shared decision making, participants successfully set up their home telemetry monitoring devices and were more compliant with the management, monitoring, and plan of care for their CIED. Of the 23 participants, 20 successfully set up their home telemetry monitoring device after participating in this research study, an 87% success rate.
Time constraint was a limitation in this research study. The majority of the patients travel to southern states for the winter months, and since this research study was conducted from October 2015 to March 2016, it potentially impacted the number of participants. Another limitation was that providers were notified of the patient non-compliance with the home telemetry monitoring devices and started to address these patients at their scheduled cardiology appointments.
Home telemetry monitoring has been identified as a safer, more efficient and cost-effective, and higher quality method of monitoring patients with CIEDs. Identification of non-adherence with the home telemetry monitoring device is necessary in order to improve compliance monitoring and management of patients with CIEDs. Three themes were identified, with participants reporting not being educated or unaware the device existed, not having the landline required for remote transmission, or preferring in-office follow-up and monitoring of their CIED. For the purpose of this research study, the issue of participants not being educated or unaware of the home telemetry device was the focus in order to improve adherence. Willing participants were re-educated per the guidelines, and through the use of shared decision making, participants were enrolled and successful in setting up their home telemetry monitoring devices. The use of this shared decision making module is now being utilized by the other providers within the office to improve patient compliance with their home telemetry monitoring device.
The TRUST trial reported that patients who utilized the home telemetry monitoring devices had higher compliance rates with their follow-up.7 For the participants who successfully set up the home telemetry monitors and responded to the post telemedicine perception questionnaire, a more positive response was noted pertaining to how the home telemetry monitoring device could save them time and was a more convenient form of health care delivery, therefore improving their compliance with follow-up. Participants also had a more positive response towards the statement that this could be in addition to the regular care that they received.
The results of this research study compare similarly to the results of another previous research study, in which patients reported being satisfied with the home telemetry monitoring device and with the convenience of the device.8 The results of this research study show a more positive response towards the home telemetry monitoring devices after setup, in regards to the convenience and ability of the device to save the participant time.
Through the telemedicine perception questionnaire, an improvement in participants’ attitudes and perceptions towards telemedicine was noted after analyzing the participants’ responses to the telemedicine perception questionnaire pre and post setup of the home telemetry monitoring devices. Participants disagreed with questions asking if telemedicine could violate their privacy or if the use of the necessary equipment was difficult for them.
Evaluating patient attitudes and perceptions towards telemedicine is critical in terms of compliance with the plan of care and health promotion. Through the use of shared decision making, participants were more responsive and adherent to their health care plan as well as with utilizing the home telemetry monitoring device. Further research regarding patient attitudes and perceptions towards telemedicine will benefit patient compliance with their plan of care, improve monitoring of their health conditions, as well as improve management and optimization of their health status.
Disclosure: The authors have no conflicts of interest to report regarding the content herein.
We would like to thank Bonnie Wakefield and her co-researchers for allowing us to use the Telemedicine Perception Questionnaire for this research study.
- Lakshmanadoss U, Shah A, Daubert JP. Telemonitoring of the Pacemakers. INTECH Open Access. Published February 14, 2011. doi: 10.5772/13316
- Greenspon AJ, Patel JD, Lau E, et al. Trends in Permanent Pacemaker Implantation in the United States from 1993 to 2009: Increasing Complexity of Patients and Procedures. J Am Coll Cardiol. 2012;60(16):1540-1545.
- Carlson MD, Wilkoff BL, Maisel WH, et al. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines Endorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) and the International Coalition of Pacing and Electrophysiology Organizations (COPE). Heart Rhythm. 2006;3(10):1250-1273.
- Slotwiner D, Varma N, Akar JG, et al. HRS Expert Consensus Statement on Remote Interrogation and Monitoring for Cardiovascular Implantable Electronic Devices. Heart Rhythm. 2015;12(7):e69-e100.
- Tracy CM, Epstein AE, Darbar D, et al. 2012 ACCF/AHA/HRS Focused Update Incorporated Into the ACCF/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2012;61(14):1297-1313.
- Crossley GH, Chen J, Choucair W, et al. Clinical Benefits of Remote Versus Transtelephonic Monitoring of Implanted Pacemakers. J Am Coll Cardiol. 2009;54(22):2012-2019.
- Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; TRUST Investigators. Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up: The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) Trial. Circulation. 2010;122(4):325-332.
- Joseph GK, Wilkoff BL, Dresing T, et al. Remote interrogation and monitoring of implantable cardioverter defibrillators. J Interv Card Electrophysiol. 2004;11(2):161-166.
- Sand-Jecklin K, Coyle S. Brief Health Literacy Screen. PsycTESTS. 2014. doi: 10.1037/t37729-000
- Wakefield BJ, Bylund CL, Holman JE, et al. Telemedicine Perception Questionnaire—Revised. PsycTESTS. 2008.