Data Management Enhances Device Patient Care

31 August 2006 (Last Updated August 31st, 2006 18:30)

Kathy Lewis and Santosh Kumar investigate how medical device data can be consolidated and accessed by clinicians. Focus is particularly on the use of new types of data management systems.

Cardiac clinics in the USA are experiencing an increase in the number of patients requiring care, due to increased life expectancy, the prevalence of sedentary lifestyles and an ageing population. This is causing a strain on the current US healthcare system and, consequently, there is pressure on medicine to be more data driven.

New generations of medical devices and patient monitoring systems provide vast amounts of data. In addition, both healthcare providers and payers are pushing for more efficacious and efficient care. This has been demonstrated by the interest in evidence-based medicine and clinical practice recommendations, as well as pay-for-performance initiatives.

In such a complex medical landscape, it is easy for clinicians to face information overload. Tools to access, filter, manage and use patient data become increasingly important to clinicians as medical developments provide new therapies and data-gathering devices.

The complexity in this data-rich system is caused not only by the volume of information, but by many other dimensions as well. One issue is time – data from one patient over a period of time gathered in multiple encounters. Another dimension is geography. The patient or the physician may travel to multiple locations, and there is a need to keep data accessible and stitched together. Yet another complexity is personnel. A patient may be seen by multiple clinicians co-managing a patient's care.

There is no one system that would fulfil all of the complex needs of patient care in general. Even within the context of cardiac rhythm disease management, Medtronic offers a range of solutions for managing patient data. The Paceart® System helps clinicians gather and synthesise data in the context of device follow-up. Paceart connects not just to Medtronic systems, but also to other systems in the clinic.

DATA MANAGEMENT AND CLINIC WORKFLOW

A patient's cardiac data often comes to the physician from several venues. It can come from different types of devices - a pacemaker, an implantable cardioverter defibrillator (ICD) or a cardiac event monitor. The data from the same device could be read by a programmer in the clinic, or transmitted through a remote monitoring system such as the Medtronic CareLink® Network.

Paceart is the central hub for information in a device follow-up clinic. It serves as both a workflow tool and a data management tool. Paceart is a patient-centric system, gathering all of a patient's data into one system. It is also a clinician-centric system; it gathers the records of all the cardiac patients in one place regardless of their device.

"In such a complex medical landscape, it is easy for clinicians to face information overload."

Paceart supports data download from programmers and cardiac event monitors by all leading vendors. Paceart also handles transtelephonic monitoring (TTM) transmissions and remote monitoring transmissions sent via the Medtronic CareLink Network.

After acquiring Paceart in 2001, Medtronic made a commitment to continue to support the acquisition and display of cardiac device data for all manufacturers, including remote device monitoring. In addition to serving as a data repository, Paceart functions as a clinic efficiency generator by automating scheduling, billing, reporting, documentation and correspondence with referring physicians and patients.

With the advent of electronic health records (EHRs), one of the key advantages of Paceart is its ability to serve as the single point of integration for all of a patient's arrhythmia information. Paceart can facilitate the transfer of this information to the patient's electronic health record.

PACEART BENEFITS

One of the most beneficial features of Paceart is that it allows a patient's device information to be saved electronically into its database. Importing the data directly from the programmer or other source is ideal because it saves time spent on manual data entry and it may decrease human error. A study by the Institute of Medicine reported that medical error is the eighth largest cause of death in the USA.

In addition to facilitating accurate data capture, Paceart helps manage the complex dynamics of time, geography and personnel in clinic workflow. As previously mentioned, it is often a challenge for a physician to interpret device data without seeing it in the context of a patient's past history. In order to decide how to optimise a patient's current therapy, an electrophysiologist (EP) seeks to understand a patient's disease history.

The EP may want to look up, for instance, how the patient's antitachycardia pacing (ATP) sequence was changed when the patient had a ventricular tachyarrhythmia (VT) storm a year ago. Paceart facilitates this analysis by making all the data from a patient's episodes easily accessible. Moreover, automated reports with graphs show the change in parameter values over time. Trending of data is very useful because it is often the magnitude of change in a value rather than its absolute value that is of greatest diagnostic interest.

The second element of complexity that Paceart addresses is that of geography. The data in the Paceart database can be accessed by clinicians in different physical locations as long as they are on the same computer network. Likewise, the record of a patient who has follow-up visits at clinics in varying locations can be kept complete without transferring files between facilities.

In addition, even when there is no direct network access, clinicians can remotely log in to their Paceart system via the internet. They can also benefit from technology that enables them to use their Paceart system on a disconnected laptop and yet keep data current by replicating it with their central system at a later time.

Paceart also provides ease of use for personnel by facilitating communications and a shared understanding of the patient across different members of a healthcare team. Furthermore, the communications between the clinic and the patient are enhanced. As well as enabling multiple clinicians to view the same electronic information, Paceart also creates standard reports and letters that can be mailed or faxed to the referring physician or the patient.

Many crucial workflow tasks in clinics, such as contacting patients who have missed appointments, can be automated with Paceart. In fact, many device clinic managers have reported how invaluable the Paceart system has been for handling incidents such as device recalls and alerts.

While company registries track the implanting physician, they may not reflect the most up-to-date status of the follow-up physician. Hence, it becomes necessary for the follow-up physician to search their patient records to find patients who are affected by a recall or alert. This is easier with a database such as the Paceart System than with a paper-chart based system.

PACEART AND ELECTRONIC HEALTH RECORDS

In the USA, interest in electronic health records has increased since April 2004, when President Bush issued Executive Order 13335 calling for widespread adoption of interoperable EHRs within ten years. He also established the position of national coordinator for health information technology.

"Paceart allows a patient's device information to be saved electronically into its database."

Medical device manufacturers are now beginning to develop strategies to support the adoption of EHRs in device clinics and support the information flow to them from devices. Rather than a radical change from no EHR today to a future involving electronic records, it is reasonable to posit that the future holds many states along a continuum between a paper-based manual system and a single paperless system.

The level of complexity of the EHR solutions and the level of adoption will change over the next decade and will vary by clinic and medical speciality. Hence, device manufacturers will need to support different kinds and levels of integration of device data with EHRs.

There are two roles that Paceart can play in an EHR-enabled clinic. The first is the role of a device clinic workflow system and a repository for detailed cardiac device information. There is no single EHR system that can satisfy the needs of all medical specialities. No one system exists that can serve the detailed information and workflow needs of medical specialities such as radiology, pathology, otolaryngology, cardiology, and dermatology, to name a few.

Hence, a more feasible role for an EHR, at least in the short term, is to store the summarised medical record of a patient and communicate directly with the more detailed systems that serve the needs of individual specialities.  In such a scenario, an electrophysiologist can use the Paceart system to dig into a rich set of device data, but an emergency room physician is able to access the top-level device information needed from the patient's EHR.

The second role that Paceart can fulfil in conjunction with an EHR is that of cardiac device information hub, or middleware. It consolidates the interfaces to multiple devices and event monitors, and transfers the information to the EHR. This is invaluable if one considers the number of interfaces an EHR would have to manage in the absence of such middleware.

A device follow-up clinic is just one of the many specialities in a hospital, multi-speciality group practice or cardiology clinic, each with its own set of complex data and devices. Paceart can perform this function even as the EHR takes on increased functionality in the Paceart-dominated device clinic workflow domain.

There are two levels of EHR integration, and Paceart supports both. In the first level of integration, an EHR serves as a hybrid database and document storage system. In this form, the EHR stores documents such as PDFs, faxes and image files. Paceart already allows users to store report files and email or fax them to any system that is set up to receive such information. So, the first level of integration with EHRs or other systems is already available.

The second level of integration is more sophisticated and involves exporting discrete device data elements from Paceart to an EHR. This level of integration is already possible, but is evolving along with industry standards. HL7 is the primary standard for the exchange, management and integration of electronic healthcare information.

However, there is no standard HL7 protocol for cardiac device information interchange at present. Paceart currently has Extensible Markup Language (XML) data export capabilities that can be integrated into compatible EHRs. Paceart is committed to supporting the HL7 standard for data exchange with EHRs and practice management systems. As industry standards evolve, Paceart is dedicated to implementing the latest data integration methods.

WIRELESS TECHNOLOGIES

The advent of wireless telemetry enables wireless communication between a cardiac device and the programmer or home monitor. At implant, there is no need for the programmer head to enter the sterile implant field, and in-office visits are simplified as the physician can interrogate patients' devices via wireless telemetry, without the need for surface electrodes. It also enables automatic wireless data transmission from the patient's device to a home monitor.

Regardless of the method of transmitting data between the device and the programmer, the most commonly used method of data transfer from device programmers into Paceart is still the floppy disk. Therefore, Medtronic has developed SessionSync™ technology that automatically transfers data from the Medtronic programmer into Paceart through an ethernet connection. The next step in the evolution of this technology is to use 802.11b wireless network connectivity. In the long term, additional device manufacturers may take steps to enable diskless transfer of data between their programmers and Paceart.

Healthcare information system adoption will increase, and device data interchange standards to facilitate the integration of these systems will continue to evolve. Clinicians will need tools to access and organise clinically relevant data. They will also require different modes of obtaining data in order to streamline clinic workflow and improve patient satisfaction. The Paceart system will continue playing a key role in this evolving ecosystem of information management tools.