team. We are happy to be joined along with CV Remote Solutions as part of the Device Clinic Essentials for the Care Team Academy course. Today I will be discussing remote monitoring device clinic operations and management. I have no disclosures at this time. The objectives for this module are to discuss the structure, standardization, and data management around remote monitoring. We're also going to talk about key operational considerations such as staffing, scheduling, etc., metrics for success, compliance and quality assurance, and best practice examples. To begin, we're going to start with the remote monitoring structure and landscape. There are key operational components for a successful remote monitoring program. These come down to the people, processes, and technology involved. We're going to touch on these all throughout this module. To begin with the basics, we're going to start with what is a cardiac implantable electronic device or CIED. CIEDs are indicated for the treatment, diagnosis, and monitoring of brachycardia, tachycardia, and heart failure. There are an estimated 1.7 million devices implanted annually across the globe. They include several different device types, the first one being cardiac pacemakers. Next is the implantable cardioverter defibrillators, also known as ICDs, cardiac resynchronization therapy or CRT devices, implantable cardiovascular monitors or ICMs, and implantable loop recorders or ILRs. What we aren't going to cover in this module today is the remote patient monitoring aspect of some of these clinics. So what is remote monitoring? It is the automated and scheduled remote transmission of predefined alerts related to clinical events or related to device function. It is the standard of care for patients with all CIEDs. For the 2023 HRS expert consensus, which you're going to hear me discuss quite a bit throughout and is referenced at the end, these are the goals of a successful CIED remote monitoring program. Ideally, the main goal is to optimize the patient's quality of life. We also want to optimize the device system function to meet the patient's clinical requirements, identify patients at risk and initiate that appropriate follow-up, identify non-CIED-related health programs and make those appropriate referrals, document the appropriate function of the device, and identify and correct any abnormal device behavior as it's happening almost real time. We want to identify the devices approaching end of life, either due to their battery life or due to leads at risk of failure, and identify replacements in a non-emergent manner. We want to document the nature and frequency of arrhythmias over time and correlate those with patient symptoms. And we want to have timely communication with the patient and relevant healthcare providers. There are many benefits of remote monitoring. Ultimately, it reduces the number of healthcare visits to a system. It increases the follow-up adherence and patient retention of these programs. It leads to earlier detection of actionable events. It reduces inappropriate ICD shocks by early detection of AFib in patients. It reduces patients' costs, things like traveling to your healthcare system, paying for parking, all of those little things that add up. Implementing a remote program will reduce those costs to the patient. It reduces in-hospital visits and emergency department visits. It reduces the burden on your diagnostic departments. And it increases safe and effective surveillance of device functioning with alerts for battery depletion, circuit disruption, and lead failure. So how often should you be following up with a patient that has a device implanted? Ideal follow-up cadence should always be determined by the individual patient and the physician. Factors that could influence those decisions are the patient preference, the patient's underlying medical condition, device-related issues, geographic isolation from the system or that direct in-person follow-up, cost-effectiveness of the follow-up, and your clinic resources. Based on the HRS guidelines, as well as billing frequency, the recommended timelines are as followed. And I'm going to set up this table for you. You'll see the four different device types on the left here and the different categories. So for pacemakers, ICDs, and ICMs, ideally enrollment, so once a patient gets a device implanted, the enrollment would ideally happen prior to discharge, but up to two weeks post-implantation. For ILRs, it is imperative that the enrollment in the manufacturer website happens prior to discharge. The minimum frequency of manual interrogation of those remote transmissions for pacemakers and ICDs is every 90 days or four times per year, and for ICMs and ILRs, it's monthly. Every patient should have an annual in-person visit with either the physician or the APP of the device clinic, and you'll see the billing frequency over on the right-hand side. We're now going to move into some operational considerations that anyone that is in or running a device clinic should consider. Shown here is a diagram of the different roles involved in a remote monitoring program and the various responsibilities that each person has. These are based off of the 2023 HRS Consensus Statement as well as MedAxiom experience. The patient is responsible for those transmissions, so the scheduled transmissions, any alerts, and patient-initiated transmissions. The clerical and ancillary staff is responsible for maintaining schedules in the manufacturer portals and the scheduling platform. They manage no-show management, such as letters, calls, et cetera, and they triage patient questions. The device nurse or tech is generally responsible for getting that patient registered in the manufacturer device portal, retrieving the data from the websites, the reports that come from those websites, and getting them into the designated platform, whether that's a manual process or there's an interface with your EHR. They initiate any orders. They are also generally responsible for the initial review of alerts and transmissions per your department's protocols. They send notifications to the providers. They start the preliminary report and route that to the provider, and they are responsible usually for the education of the patient, calls, et cetera. The provider, in this case, it is typically a physician or an APP, will respond to those alert notifications per the protocol. They'll finalize and sign off on that and begin the charge capture process. This is an example of a remote monitoring workflow. This is very high level. Obviously, your organization or any organization you may work in may have a slightly different flow, but generally, this is what we see. The patient receives some sort of education or training on the device that is going to be implanted. Then they go in, they have that device implanted, and they're enrolled in the manufacturer website. As stated in a previous slide, generally, that happens prior to discharge, but up to two weeks after, depending on the device type. Then there are those automatic or scheduled transmissions of data. There's a preliminary review of the transmission to determine if there needs to be any intervention. If so, then a second line review, which is performed by the APP or physician, takes place. Then the device tech or nurse will start the documentation and the data import. There's the charge capture process. The physician will interpret and sign, and then the encounter is billed. As I stated, this is very high level. You could expand all of these boxes into many more steps, but I just wanted to give you an overall picture of what this process looks like. The Heart Rhythm Society has put out some staffing requirements and recommendations. They, along with MedAxiom, recommend that there is a team-based organization model that includes your device techs, your device nurses, your ancillary staff, your physicians, and your APPs. They all have formal policies, procedures, and clearly defined roles and responsibilities of the qualified staff. Another recommendation is that there's adequate, dedicated time to perform all of your remote monitoring tasks, including the scheduled and non-scheduled transmissions, patient follow-up, and all the administrative tasks. We're going to go into a little more detail on that shortly. You also want to make sure that your staff-to-patient ratios in these clinics reflect the increasing unscheduled transmission burden. As more and more of these devices are implanted, the increase in transmissions is becoming huge, so you've got to be sure that your device clinic can manage that. Along those lines, HRS has recommended that there's a minimum of three FTEs for every 1,000 patients you have enrolled in your remote monitoring program. This includes all clinical, so your physicians and your APPs, as well as administrative staff. As someone who may work in a device clinic, there are some staffing challenges that you need to be aware of. Our current environment is leading to recruitment and retention issues with staff in these clinics. The staff that's required to be in these clinics have a specialized knowledge base, and they require in-depth training. There's also the consideration of more of these devices getting implanted every year, and an increasing volume of patients and data that is always flowing in, and how to manage that. In addition, a lot of organizations are having challenges with having competitive salary and benefits, as there are competing organizations that are vying for device clinic staff. These next few slides will get into some nitty-gritty details on approximate times it takes to manage these patients. This is meant to guide device clinics so that they are able to appropriately staff their clinics. The data here come from a study completed in 2021, where the researchers went into 11 programs across the U.S. and Europe and did a time study on the different tasks involved in a device clinic. The idea behind the study was to quantify the clinic staff time required to manage patients with CIEDs. The study itself is cited at the end, and I encourage you to look it up and read through it. The mean staff time per remote transmission is anywhere from 9.4 to 13.5 minutes for therapeutic devices, and 11.3 to 12.9 minutes for diagnostic devices. The tasks that go into these minutes are things like transmission reviews, the transmission diagnosis, communicating with the patient, any clinical action that needs to take place, charting the findings, and starting the billing process. The researchers went further to break down the data by device type and actionable versus non-actionable transmission. An actionable transmission is one that requires clinical follow-up because of either abnormal device functioning or a clinical patient event, such as an arrhythmia. 8.2% of transmissions are estimated to need a second line review. So I'm not gonna go through this whole table, but I'll use the pacemakers as an examples. The average time to review a transmission for a pacemaker is 11.9 to 13.5 minutes per patient. The staff time required to review those actionable transmissions is 19.8 minutes. To review the non-actionable transmissions is 11.2 minutes. On average, there are 3.7 transmissions per patient per year. And that all leads to an annual staff time for the remote transmission of 0.8 hours per patient. Now, as I said, this is nitty gritty details, but the idea here is that you can take these numbers and look at your volumes to see if you are around these average times and if you have appropriate staffing. Other patient management activities that happen in a device clinic that aren't necessarily included in those time studies are things like patient communication, answering the phones, managing the patient portal, requests and questions that come in, troubleshooting any device connectivity issues, procedure clearances, identifying patients lost to follow-up, triaging those patients and triaging transmissions. All of these other activities are estimated to be approximately 17.3 minutes per patient annually. Another way to look at staffing in this tough environment is to look at third-party staffing. Your system may already be utilizing this or exploring the idea given the current staffing challenges. Some benefits to third-party staffing is it does relieve the staffing burden that many organizations are experiencing. There's improved patient care and safety as well as improved staff and provider satisfaction. It also allows you to combine services across locations. And what I mean by this is if you are a larger system that has multiple device clinics in different locations and you want to combine all of your remote monitoring under one umbrella program, a third-party staffing option could make that easily possible. It also leads to decreased cost of facilities. It allows organizations to scale and flex to device clinics. And what I mean by this is if you get an influx of patients that either need devices implanted or you get an influx of transition, you're easily able to flex to those demands at the drop of a hat. They also generally provide 24-7 coverage, which can be hard to get with your in-house staff. So the model for this looks something like if you contract with a remote monitoring organization such as CV Remote Solutions for some or all of your device types, we've seen it done both ways, they would then do the first line of review for all alerts and all scheduled transmissions. There would be a clearly documented protocol for alert management back to that parent facility. And then they can also bill for the remote monitoring services. Some keys to a successful remote monitoring program include having those standard protocols. You've heard me mention protocols multiple times throughout this module, and it's key to have your processes documented so everybody knows what role they play and who is responsible for what. You should also have a patient tracking mechanism as well as defining the source of truth. So whether that's an in-house program that you use to monitor your patients or an external platform. You should focus on the right patient, right schedule, right time. You should have staffing ratios to meet the patient demand and growth. And consider an ongoing relationship with a third-party vendor if applicable, whether that's for staffing, whether that's an external platform, or whether it's those manufacturers that help with the device education, et cetera. Some of those policies that we talked about et cetera. Some of those policies that all organizations that have a device clinic should have are policies around product recall, defining how those patients will be identified. So if there is a specific device that is recalled, how are you gonna find all of them? How are you gonna notify them? And what steps are you gonna take to fix the issue? You should have policies regarding no-show patients as well as termination policies. You should have policies around remote transfer, alert notification protocols defining that 24-7 coverage, and determine how do I identify patients currently lost to follow-up and action items. We're next gonna move on to the technology and essential resources. So some essential resources that every device clinic should consider, especially when it comes to remote monitoring is you do need those dedicated support functions. A lot of scheduling goes into these programs. So you need that dedicated function in your clinic. You need people to manage incoming calls. You need resources to manage recalls, lost to follow-up, terminating patients, et cetera, as well as the management of those alerts. You're gonna need technology support from your IT department, as well as training on all the different platforms, manufacturer websites, et cetera, and possibly even a platform integrating your in-person and your remote monitoring patients, so you're not looking in multiple locations. You're also gonna need educational resources, and that's education for the staff as well as the patients. When it comes to technology solutions, there's a couple of ways you can look at this. Some organizations have in-house management platform, something as simple as an Excel spreadsheet to track all your patients, and something as robust as a third-party external management platform. The third-party platforms are ever-growing in this environment. You'll hear names such as PaceArt, Merge, Vector Remote, ScottCare, et cetera. They all have different levels of involvement. Some provide equipment directly to those patients. Some provide patient education. Some have billing support. Some have those third-party staffing resources that we talked about earlier. Some integrate with your EHR. Some don't. So there are some considerations if your program is looking at getting a third-party device platform. And even if you're not, your in-house program should answer a lot of these questions. So when it comes to looking at these third-party devices or finding a way to manage these patients, track these patients, and integrate all of the transmissions. When you're looking at the technology side of a platform, is it cloud-based versus an independent software solution? Most importantly, does it interface with your EHR? And if so, what interfaces, and is there any time-intensive IT time required from your IT department? If it doesn't interface, how are you going to deal with that? Do you still have to access the manufacturer websites if there is one of these platforms? And the list goes on. When it comes to processes, things you want to consider and look at is, does it manage noise alerts? Does it automatically enroll new patients? Is there any sort of delay with that? And does it provide a preliminary interpretation? When it comes to support, you want to consider things like, do they provide full-time FTEs to support those remote services, if that's something you're interested in? What about in-person services? Some of these platforms and organizations will also provide what we call gap staffing. So if you have an intermediate need for a staff member, whether it's for your in-person or your remote, they're able to flex up and handle some of those. Do they support 24-hour services? Do they provide any education? The list goes on on what you can look at for a platform. When it comes to a best practice, whether, again, that's an in-house solution for your technology, or we're looking at a third-party vendor, you want to, ideally, you want to make sure it integrates with your EHR. You want to see if it has a purposeful customization of protocols and alerts so that you can adjust those as needed. Does it have a discrete data query and reporting so you're able to look at how your program's doing overall and report those out to others in the organization? Does it eliminate rework? Is there a lot of manual data entry? And ultimately, is it patient-centered and it promotes quality and compliance? We're not going to spend too much time on this slide, but if the immediate interfaces with whatever platform you go with, again, whether that's in-house or external, do not integrate with your EHR. I just advise you to have a solution for that. Try to find ways to work around that that aren't too manual, and hopefully work towards something that does integrate with your EHR. In summary, I want to bring us back to the HRS consensus statement and leave you with a few key points that any successful remote device clinic should consider. As an employee in a device clinic, these are things that should affect you, too, and should be part of your day-to-day practices. First and foremost, remote monitoring is the standard of care for patients with CIEDs. Some essentials for a successful remote monitoring program are timely patient enrollment, caregiver education and long-term patient adherence, and routine maintenance of connectivity to that device. Some staffing considerations that we went over earlier are utilizing both clinical and non-clinical staff, sufficient patient-to-staff ratios, having those clearly defined roles and responsibilities so everybody knows what their job is, appropriate education and or certification for your clinical staff, and your clinical staff being engaged in quality assurance and improvement programs. Continuing on, you should have device and indication-specific alerts, so establishing those protocols for quickly addressing those high-priority alerts, individual device clinic workflows should incorporate secure and confidential communication of the results back to the patient, their healthcare providers, and the patient's EHR. Collaboration between remote monitoring clinics and device manufacturers or third parties facilitates a reciprocal exchange of ideas for staff training, patient education, patient care services, management of safety advisories and recalls. So it's really important that you establish those relationships and keep them ongoing. Advantages of using third-party resources are that they aid in managing increased volumes of patients and transmissions, and they can bridge that gap with the current staffing challenges. Special considerations should be given to pediatric patients, which we didn't really touch on as it's a whole different realm, but they should have special considerations and your organization should have protocols for what to do with pediatric patients. Special programming needs for ILRs, so those loop recorders, and that they're based on clinical indication, and that they should be immediately connected so there's not that delay in getting them enrolled. When it comes to alerts-based remote monitoring, it's dependent on that continuous connectivity, and it also allows for extended time intervals between in-office device interrogations. And finally, I'm gonna leave you with a list of references that were mentioned throughout. I highly recommend that you review the full context of these publications as you continue your educational journey on device clinic patients. If you have any questions regarding this module, please reach out to our Academy email address at academy at medaxium.com, and I wanna thank you for your time today.

remote monitoring

clinic operations

management

cardiac implantable electronic devices

CIEDs

patient care

remote monitoring device clinics

structure and landscape

goals and benefits

staffing requirements

time management