Engagement of ICD Patients: Direct Electronic Messaging of Remote Monitoring Data via a Personal Health Record

Introduction

Cardiac implantable electronic devices (CIED) are critical for the detection of abnormal heart rhythm events. Historically, patients have made routine visits to the clinic for device checks and monitoring. Remote monitoring, however, can detect device performance in a more timely manner with nearly identical information as an in-clinic device check.¹ Accessibility of information about the device can prevent serious adverse events related to battery depletion, lead impedance changes, and abnormal sensing. 

A typical clinic setting involves trained personnel who perform in-clinic device checks and manage remote monitoring transmissions. The clinic personnel follow up with patients regarding any instructions or to indicate that the device check was normal, and that the data is available for physician review. Remote monitoring of ICD data has been shown to result in a 43% reduction in visits per patient-year, and allows for improved patient safety, satisfaction, and potential cost reductions.² Currently, patients do not receive information directly from their device. Within the past few years, patient advocates have spoken out about the lack of access to the data from their CIEDs.³ Despite consumer demand, there exists significant barriers to delivering data from ICDs directly to patients. These barriers include: 1) the technical challenges related to information exchange across device systems and the patient portal to the EHR, 2) concerns regarding patient ability to understand and use the device data (e.g., what data to present and in what form), and 3) the potential for adverse effects on clinic workflow (e.g., clinicians fear that patients would frequently call in with more questions about device data). 

While studies have demonstrated the value of transmitting data from remotely monitored ICDs into EHRs,⁴ to our knowledge, no research exists on delivering data directly to patients. Parkview Research Center, Parkview Physicians Group-Cardiology (PPG-Cardiology), St. Jude Medical, and NoMoreClipboard, LLC have worked together to deliver detailed information to patients and to address the three primary barriers facing patient access to data. 

First, the barrier of technical challenges was addressed with the Implantable Device Cardiac Observation (IDCO) profile.⁵ The IDCO profile is a standards-based method of delivering data from cardiac devices. This method uses IEEE 11073-10103 terminology, HL7 v.2 messaging, and standards set by Integrating the Healthcare Enterprise (IHE) for landing the data in the EHR. This technology has the capability to generate standard reports for clinician and patient viewing and integration regardless of the device vendor. Second, the concern for patient understanding of the information was addressed with the creation of the Patient Notification Summary by the technical and design team at NoMoreClipboard (Figure 1). With guidance from the Heart Rhythm Society and the American College of Cardiology, the Patient Notification Summary displayed high value data for patients including battery status, lead status, and ventricular events. Patients could access the full report of their ICD data by clicking on a separate link in the NoMoreClipboard portal. Finally, the concern regarding the effect on clinic workflow was taken into consideration with the study design. In order to avoid overwhelming the clinic, we began with this small feasibility study that included only a small sample of patients who were monitored closely over three months. The small sample size worked well for the first demonstration of delivering data to patients, and to show how patients reacted to receiving more information about their ICD (e.g., if they called the clinic more frequently with questions).

We believe that providing patients with access to their data will improve clinic workflow by enhancing patient understanding of ICD data and increasing engagement in their care. The Arrhythmia Diagnostic Center (ADC) at PPG-Cardiology consists of highly trained nurses and technical staff to manage CIED data from remote monitoring and generate reports. The clinic dedicates a trained RN to the task of managing and processing daily transmissions of data. Since 2012, increased use of home monitoring for patients has resulted in an estimated 25.5% increased use of nurse time for evaluation of remotely generated data at PPG-Cardiology. An estimated 95% of these reports fall within “normal” parameters and require no action or changes in care for the patient. PPG-Cardiology is interested in finding efficient ways to increase patients’ ability to partner in their care while developing efficient and effective means to manage this data in the clinic setting. In this paper, we share our findings from a 3-month feasibility study that showed it is possible to share meaningful ICD data directly with patients and that this data sharing did not adversely impact clinic workflow. 

Methods

The study was conducted at Parkview Research Center and PPG-Cardiology, part of Parkview Health. Parkview Health is a system of 8 hospitals located in 6 counties in northeast Indiana. Parkview serves an area with a population of approximately 890,000. As a health system, Parkview has nearly 9,000 employees and 1,600,000 patient encounters each year. PPG-Cardiology has 15 offices located throughout our service area and conducts more than 51,000 patient encounters annually. 

The ADC at Parkview Health currently accesses the Merlin.net^™ database (St. Jude Medical) to retrieve data from remote transmissions of St. Jude Medical ICDs. A PDF report is generated using the Paceart^® System (Medtronic). This PDF is accessible in the healthcare system’s EHR, and is available for physician review and sign-off. Once the physician has reviewed the data, the clinic nurse generates a standard letter to mail to the patient via postal mail indicating the status of their device. 

A new workflow was developed for this study, completely based on the electronic transfer of information with no human intervention to transfer the data. The data was transmitted directly from the patients’ devices to the Merlin.net database and on to the clinic EHR, WebChart, and untethered personal health record (PHR), NoMoreClipboard. Patients who were enrolled in the study were flagged in the EHR, which triggered the data to flow automatically to their PHR (Figure 2). WebChart is owned and operated by Medical Informatics Engineering, which is the parent company for NoMoreClipboard, the PHR used in this study. The option to sign up for the NoMoreClipboard PHR has been provided to patients of PPG-Cardiology since 2006; however, none of the patients who enrolled in this feasibility study had previously used the NoMoreClipboard PHR.

Twenty-one patients were enrolled in January through March 2014, and followed over 3 months. Upon enrollment, patients registered for a NoMoreClipboard PHR account updated with a Patient Notification Summary widget. During the initial study visit, the study coordinator manually exported patients’ most recent transmission in Merlin.net, so that patients could view the Patient Notification Summary and full data report in their newly acquired PHR. Patients were shown how to access their Patient Notification Summary and given a baseline survey to assess patient engagement and their attitudes regarding their current way of receiving information about their ICD and the potential to receive more information. Patient engagement was assessed using the Patient Activation Measure (PAM).⁶ The PAM is a 13-item validated survey tool developed in 2005 that provides a reliable measure of how active a patient is in their care (Figure 3). A second visit took place at three months, and patients engaged in a semi-structured interview with the study coordinator regarding their experience with remote monitoring and the Patient Notification Summary. The number of remote transmissions for each patient along with the number of times each patient logged into their PHR during the study period were recorded. To assess the concern for the increase in work for the clinic, calls in and out of the clinic were calculated over the study period and three months prior to the study period. In addition to gaining patient attitudes and perspectives, a survey was sent to healthcare providers at PPG-Cardiology, including physicians, nurses, and ADC staff, at the end of the study period. The survey provided insight into provider attitudes about the value and role of the Patient Notification Summary in patient care. 

Results

All of the transmissions from remote monitoring were successfully delivered to the patients’ PHRs. There were a total of 32 transmissions and patients logged in 2 (minimum) to 17 (maximum) times during the 3-month study period. The PAM scores were calculated at baseline and 3 months to assess patient activation levels. Overall, PAM scores increased for 29% of patients during the study period (Figure 4). The increase in patient engagement levels could be an indicator that providing patients with their data can affect patient engagement and influence their understanding and management of their device and data.

The provider survey offered valuable insight into provider opinions and attitudes about the Patient Notification Summary. Of the 34 providers that responded to the survey (N=103), 35% of providers believed that the Patient Notification Summary could reduce work for the clinic, and 74% of providers believed it will allow for better patient care. Forty-seven percent of providers believed that transmitting ICD information to patients has a positive effect on patient-provider communication. None of the respondents believed there was a negative impact on patient-provider communication. The results of the survey suggest that overall providers were not concerned about the effect of the Patient Notification Summary on the clinic workflow; rather, they indicated that the benefits of the value of the Summary could perhaps outweigh any potential increase in workload (Figure 5). Additionally, concerns with giving patients the data were addressed by looking at the calls to and from the clinic prior to the study as compared to during the study. We found a lower frequency of calls from study participants during the study period when compared to the frequency prior to the study period. This suggests that giving patients their ICD data did not cause any additional influx of calls to the clinic. 

The interviews revealed that patients appreciate having access to this information, and the majority of patients would like further education regarding the information on the Summary and detailed report. Although the interest in more information is abundant, some patients would prefer to just receive a simple overall status update and not have so much information. For a deeper discussion of the technical aspects of the study, please reference our recent publication.⁷ 

Discussion

This study demonstrated direct delivery of ICD data to patients. To our knowledge, no other studies of this kind currently exist. Further, the study utilized a standard method of transferring the data, the IDCO profile, which secured the data as discrete data elements instead of a PDF file. The discrete data elements were more accessible in the EHR than a buried PDF file, and also allowed specific pieces of information to be displayed meaningfully in the widget of the PHR. The technical and design teams at NoMoreClipboard were able to take the observations from the HL7 message and display them in the Patient Notification Summary for patients to read and understand. This is a breakthrough in current technology surrounding data from remote monitoring devices. In addition to providing the data in a useful format, this standard method could potentially be used by all device vendors, allowing for standardized reports to be integrated into EHR and PHR systems regardless of the vendor. 

The results of the study suggest that there is potential value in directly transmitting ICD data to patients to improve patient outcomes. Patient compliance with remote monitoring, knowledge of their device function, and modified behaviors to support their ICD function could be enhanced by the Patient Notification Summary. Providing patients with a better understanding of their data and engaging patients in their healthcare has the potential to reduce the amount of work for the clinic while providing patients with more information, such as their battery status, and greater peace of mind. 

The short duration of the study and small sample size provide a glimpse into the potential impact of the Patient Notification Summary on patient engagement; further research is necessary to make conclusions regarding the effect of providing ICD data to patients. There is space for exploring further impact of the Patient Notification Summary on the management of health behaviors associated with potential arrhythmias or ventricular events. For example, awareness of stress and behaviors during times of symptomatic events could help patients manage their lifestyles, and as a result, reduce the amount of therapies deployed by their device. Further, we found that some patients preferred only a small amount of information, such as a simple update on device status. This observational finding suggests that further research is necessary to discover the appropriate type and amount of information for each patient; future research efforts could focus on the ability to make delivery of device data customizable to the needs of the patient. The findings from this study are also translatable to other devices. This research presents an innovative way to improve patient care and clinic workflow by enhancing patient engagement using a standardized technology that can be applied to remote monitoring data from devices regardless of vendor. The technology and overall impact of delivering device data to patients can be applied beyond ICDs to other CIEDs, potentially improving the way that patients and care teams manage healthcare for all implanted cardiac devices under remote monitoring. 

Acknowledgements: Jeff Donnell, President of NoMoreClipboard, Fort Wayne, Indiana; Doug Horner, CTO, Medical Informatics Engineering, Fort Wayne, Indiana; and engineers from St. Jude Medical.

Disclosures: Ms. Daley, Ms. Allmandinger, Ms. Heral, Dr. Toscos, and Dr. Plant report grants from NoMoreClipboard; Dr. Mirro reports grants and options from NoMoreClipboard. The authors also report non-financial support (technical assistance) from St. Jude Medical. Outside the submitted work, the authors report grants from St. Jude Medical, Boston Scientific, BIOTRONIK, and Medtronic for ongoing research studies. 

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