Different Systems and Formats for Tele-ICU Coverage: Designing a Tele-ICU System to Optimize Functio

Abstract

Technology always changes, yet change or evolution within the tele-ICU has been slow. In developing a modern telemedicine system to manage acute illness, there are several concepts the developer/administrator should consider to include "scalability," centralized/decentralized systems, open/closed architecture, inclusivity of the medical community, mobile technology, price set, and governmental regulation. The intent of this manuscript is to apply these concepts to current tele-ICU technology, explain the concepts in some depth, and finally, to speculate as to how the future tele-ICU might look.

Time changes everything except something within us which is always surprised by change. - Thomas Hardy (died January 11, 1928)

A VARIETY of forces are driving the development and advancement of telemedicine in the intensive care unit (ICU) to include the following:

1. A growing shortage of trained Intensivists 1-5 to manage patients in the ICU;

2. Increasing evidence of the value of Intensivists in the ICU 6-9;

3. Expanding data supporting the utilization of telemedicine in the ICU 10-20;

4. Value of the structured care process when driven by tele-ICU technology 21-29;

5. Manpower maldistribution 30-33; and

6. Corporate pressure to utilize trained experts in the ICU.34

In addition, there are a variety of forces that will drive the more general adoption of telemedicine to include a predicted physician shortage 35,36, a looming nursing shortage,37,38 the "gray tsunami,"39,40 and a flux of new patients as a result of "health care reform."41 However, because of certain initiatives in litigation hindering growth of competition, cost of installation, uncertainty about return on investment (ROI), or efficacy, growth of telemedicine in the ICU has plateaued at about 10% of all ICU beds.

Telemedicine in the ICU dates back to the 1970s prior to current social forces and manpower shortages.42,43 Subsequently, beginning approximately 2000, there has been significant growth in the development of commercial systems to "leverage" intensivists over greater geography and greater number of patients.

During the decade 2000-2010, a single design, Philips, VISICU (Andover, Massachusetts, and Baltimore, Maryland) largely drove growth in the tele-ICU arena.10-12,17,44 As a consequence, the majority of the tele-ICU literature has evolved from the Philips/VISICU technology. However, recently, there has been significant growth with other vendors and technologies to include Cerner (Kansas, Missouri)45 or IMDSoft (Needham, Massachusetts).13,46 In addition, portable systems are growing to include Polycom (Pleasanton, California),47 GlobalMedia (Scottsdale, Arizona),48 Vidyo (Hackensack, New Jersey),49 and Tandberg (Oslo, Norway, and New York).50 As of 2011, the InTouch Health (Goleta, California)15,16,23,27-29,51 robotic technology, known as "Remote Presence," has been installed in almost 600 hospitals (Tim Wright, MBA, oral communication, July, 2012, InTouch Health). It is clear that the choices of systems to support acute care telemedicine and/or the tele-ICU have grown dramatically and that an organized approach to selection will be necessary. To communicate capabilities, it has become apparent that a lexicon describing the tele-ICU is necessary.52 The following is intended to help the reader understand some of the high-level concepts when developing a tele-ICU. Therefore, the program director entering the market now will need to look further and consider a multitude of variables. Technology is always changing and with market forces, technology generally improves and the cost comes down.

The Initial High-Level Design Criteria of a Tele-ICU

In this section we will discuss several characteristics that should be considered when developing a tele-ICU program with currently or soon-to-be available technology. Points of consideration include scalability, centralized versus decentralized systems, open versus closed architecture, staffing nonexclusivity, mobility, price set, and regulatory requirements. For other generic characteristics of the tele-ICU, please see Reynolds et al.52,53 Subsequently, we will imagine what the tele-ICU may look like at the end of the next decade.

Scalability

Ma Bell (American Telephone and Telegraph, now AT&T) grew so powerfully in the last 100 years because it had a very scalable business model in an era when scalable models were scarce.54

Scalability is the characteristic of a system that describes its capability to cope and perform under an increased or expanding workload.55 Scalability is often applied to the technical world of networking and communications.56-59 From a business perspective, meaningful scalability translates into either increased revenues requiring less investment or increased services requiring less incremental costs. Stated differently, a scalable system or technology can tolerate increased volume without impacting the business margin. Essentially all systems are scalable but cost of growth, ROI, or the technical process may be prohibitive.

Within the scalability concept, there is "Horizontal Scaling" also known as "scaling out." Translated, that means adding more entities or services. Alternatively, there is "Vertical Scaling" which translates to increasing the capacity of existing entities.60-62

In terms of the tele-ICU, scalability may include enhancement of the following:

1. On-site and remote manpower

2. Technical install at new sites

3. Enhancement of the communications network

4. Training, education, and efforts to enhance adoption

Generally, tele-ICU scalability has been vertical scaling with establishment of more critical care coverage to more ICUs either within the same facilities or at additional facilities. In so doing, the vertical scaling will require all the elements as described earlier.

Under circumstances of a robust and flexible telecommunications system, the designer/administrator should consider horizontal scaling, which is adding other services such as emergent neurology stroke consultation, burn consultation, pediatric or neonatal intensivists consultation, cardiology, cardiac surgical consultation, etc (Figure 1).

Figure 1 - Click to enlarge in new window

Figure 1. Vertical scaling with the sequential addition of similar critical care services. Horizontal scaling with the sequential addition of new/different services. Horizontal scaling could include a multitude of other services such as burn consultation, pediatric/neonatal acute consultation, etc.

Horizontal scaling may require substantially different communication technology than is common in many current tele-ICU programs. With the ubiquitous availability of the Internet supplemented with very high-speed mobile telecommunications, it is easier to design scalable business models.

It is not as easy to create demand and generate high growth in revenues.61 Specifically, growth of the tele-ICU has been slow and stuttering, at best, because of technical and financial issues as mentioned earlier. However, as important, scalability and even initial deployment may be greatly hindered by physician nonacceptance and administrative reluctance to interfere with physician practice styles. Now that the vertically scalable tele-ICU is well established, horizontal scaling to capture new markets may be the most important growth initiative to create demand, increase revenues, and thereby garner support from administration.

Centralized, Decentralized, and Hybrid Tele-ICU programs

As defined elsewhere,52,53 the centralized tele-ICU program is the typical "Hub-and-Spoke" system with the tele-ICU as the hub and the various remote ICUs as the spokes. In this model, the tele-ICU is a real, definable entity with staffing, a variable fraction of the day. Typically, the defined hub tele-ICU has intensivists, nursing, administrative, and on-site technical staffing.

To provide reliability, most of the centralized tele-ICUs have private, dedicated telecommunications lines from the tele-ICU to the specific ICUs. In the centralized model, physicians managing patients may have little or no other professional connection to the medical facility or patients. The centralized model (Figure 2) is currently the predominate model with the Philips VISICU installations,10-12,17,45 the Cerner Installations,45 and the IMDSoft programs.13,46

Figure 2 - Click to enlarge in new window

Figure 2. Centralized tele-ICU model with defined central work site, staffed a variable time per day as a function of institutional contracts.

The decentralized tele-ICU system (Figure 3) can be described as a reverse "Hub-and-Spoke" system in that a medical facility or multiple medical facilities are located at the center with the physicians located at remote sites such office, home, or mobile. As such, there is not a defined single tele-ICU but rather a process of care.

Figure 3 - Click to enlarge in new window

Figure 3. Decentralized tele-ICU system. Physicians are located remotely at offices, home, or may be mobile. Physicians may connect to a single or multiple medical facilities. Physicians may use a single technology (fixed sites at home or office) or may use multiple technologies including mobile. Background "cloud" indicates Internet connectivity.

To support a decentralized tele-ICU process and provide the flexibility of multiple sites of access to the patient yet remain affordable, the connectivity is generally via the Internet. In the decentralized model, the local physicians are generally managing patients. The decentralized model is more typical of the InTouch Health systems,15,16,23,27-29,51,63 and other portable systems such as the Global Media, Polycom, etc.

The hybrid centralized/decentralized model concept includes favorable characteristics from both models. The centralized system providing greater continuity of care, greater data collection, and reliable dedicated lines while the decentralized elements provides inclusivity of multiple specialists as well as local physicians with higher level of personal patient knowledge. As vendors evolve, it is expected that there will be greater adoption of the combined model. Currently, the only reports of using a hybrid model originate from Youn (Figure 4) at Parkland, Indiana, which had deployed a hybrid model using both the VISICU and InTouch Health technologies.23,28

Figure 4 - Click to enlarge in new window

Figure 4. Youn at an "eICU" control station (left) with the VISICU technology combined with the InTouch Health technology (single, lower screen and joystick).

Open architecture versus closed architecture

Open architecture 52,53 is a communication system that permits care providers (physicians of multiple specialties, nurse practitioners, nurses, etc) to access a particular patient from essentially anywhere. Therefore, this generally implies connectivity via the Internet and commonly including a broadband, mobile component to maximize flexibility (Figure 5). In addition, the open architecture may provide for simultaneous visualization and virtual visit by many different care providers concurrently.

Figure 5 - Click to enlarge in new window

Figure 5. Open architecture system for the care of the acutely ill. Multiple specialties may access either the tele-ICU or the patient directly and do so from home-, office-, hospital-based site, or via mobile technology.

Closed architecture refers to systems where care providers must be located at designated sites and only those individuals can access a patient via the telecommunications system.

Care providers or consultants located outside the closed system (Figure 6) will only be able to access patient information via phone conversation from staff located within the tele-ICU system. Therefore, generally, the outside consultants will be denied the opportunity to access the audio-video technology. The VISICU, Cerner, and IMDSoft technologies have generally been closed architecture models.

Figure 6 - Click to enlarge in new window

Figure 6. Closed architecture with connectivity to the patient generally limited to those care providers stationed at the tele-ICU site. Those care providers located outside the confines of the tele-ICU will not have audio-video access to the patient and will be limited to traditional connection to the tele-ICU staff.

Inclusivity

The practice of critical care medicine invariably involves the consultation with a multitude of specialists. Ideally, the tele-ICU should recreate, as nearly as possible, the on-site ICU. Therefore, the specialists should be provided access to the patient at the level of the intensivist. An "Inclusive" system will provide the remote consultant with the same information as is available to the Intensivist in the tele-ICU. Functionally, to be inclusive and develop an affordable, horizontally scaled program it would be impossible to have all the subspecialists and consultants reside within the confines of a defined tele-ICU. As a consequence, an inclusive system directly implies an open architecture system.

Mobility

Mobile, by definition means "moving or capable of being moved". However, current second definitions include "pertaining to or noting a cell phone particularly one with computing capability".64

In the communications industry, the word mobile has become completely synonymous with mobile telephony or cellular communications. Therefore, in this discussion, mobile is intended to mean cellular communications only. The word "broadband" is often connected to "mobile" and implying very rapid communications and specifically referring to wireless carriers providing Internet access. Bandwidth is a misnomer dating back to conversion of auditory frequency to analog signals, which were described by speed. Ultimately, "bandwidth" has nothing to do with width but rather speed. The minimalists definition of "broadband is "Internet access that is always active and faster than dial-up."65 In the interim since the first advent of mobile technology, there has been great advances (see Table 1). As of 2011, "third generation"66 cellular communication is widely available and "fourth generation" (4G) is rapidly expanding.67

Table 1 - Click to enlarge in new window

Table 1 Characteristics of past and current "Broad-band" cellular communications

A brief review of cellular communications may add some background. If there is a 3G, it implies the existence of prior first and second generations, so-called 1G and 2G. The incremental evolution has come, approximately every decade.

Videoconferencing, as defined by the American Telemedicine Association,68 is the "real-time, generally 2-way transmission of digitized video images between 2 or more locations (and generally including concurrent audio). For telemedicine communications, estimated "bandwidth" requirements range from 384 Kbps to 1.9 Mbps using H.323 standard or high definition videoconferencing.69 Even the highest rates are well within the capabilities of current 3G and future 4G capabilities. With "compression" technology,70 that is, the automatic deletion of unchanging or indiscernible digital elements, bandwidth requirements could be even less. Finally, with proper security and encryption,71 accessibility, quality, and safety of patient information is now available to the physician (Figure 7) or other care providers from anywhere.72,73

Figure 7 - Click to enlarge in new window

Figure 7. Mobile clinician with real-time access to radiographic data, vital signs, and other clinical data from anywhere to anywhere, anytime.

Price set/ROI

Investment in the tele-ICU can be very significant particularly when deploying certain existing models. When investment is high, achieving a positive ROI may be difficult. The peer-reviewed literature has widely different conclusions. Multiple authors 13,15,33,74 make no mention of ROI. Morrison et al.75 suggested a negative impact on ROI while vendor-sponsored literature indicates a positive ROI.10,11 The New England Health Institute (NEHI, 2010), in a non-peer-reviewed format, presented a very thoughtful evaluation demonstrating a significant positive impact on ROI in both the community and tertiary centers.76 However, overall it may be the lack of clarity regarding ROI that has inhibited growth of the tele-ICU concept. Alternatively, it may be that the absolute cost of installation and ongoing expenses or the failure to move the tele-ICU concept beyond the current technology has stifled growth.

Setting price for a service or product has something to do with "direct costs" (for the tele-ICU: hardware, software, licenses, and manpower), "indirect costs" (insurance, rent, advertisement, etc), and knowing the "break even" point.77 Analysis of cost may be further complicated when applying the "loss leader strategy"; that is, to offer a nonprofitable service for the sake of capturing patients who will require other profitable services.78 For instance, critical care medicine or the tele-ICU could be considered a loss leader but necessary to support surgical services, a back up for major cardiac procedures or neurosurgical interventions.

The NEHI with the assistance of Dr Craig Lilly 76 described initial costs of installation and ongoing costs in a program covering +/-106 ICU beds. The program provided 4.67 full time equivalents (FTEs) for MDs, 7.0 FTEs for nurse practitioners (NP) and/or physician assistants (PAs). The combined salary for MDs, RNs, and NPs was $2,270,000, of which the estimated physician component would be approximately $1,578,000 yearly. The initial, one-time start up, was US $7.12 million with an ongoing costs of US $3.15 million yearly. It would seem that a program such as this would be very suited for further vertical scaling, that is, the addition of more critical care services. However, with such major investment in intensivists and supporting staff for the intensivists, there may be less monies for horizontal scaling of other services built on the tele-ICU back bone. Specifically, if the program were to reduce or eliminate the centralized tele-ICU physician component of $1.5 million and apply to a cadre of decentralized physicians, there would be monies for a more horizontally scaled program. In summary, when considering the financial aspects of the development of a tele-ICU, or acute care telemedicine center, overall corporate goals and philosophies must be considered to include the following:

* Corporate willingness to accept more complex evaluations of ROI such as the NEHI evaluation 76

* Corporate willingness to accept tele-ICU as a loss leader

* Likelihood of change of corporate leadership and therefore change of goals/philosophies

* Overall goals whether primarily vertical scaling versus horizontal scaling

* Short-term and long-term manpower supply when designing coverage models

* Corporate willingness to consider alternative staffing models such as 100% NP/RN in the tele-ICU such as the nurse-run program at Eastern Maine Medical Center (Mary McCarthy, Nurse Manager, Tele-ICU, EMMC, oral communication).

REGULATORY REQUIREMENTS

Currently, regulatory requirements for telemedicine practitioners are relatively limited to acquisition of the various state medical licenses and hospital privileging. The technology of telemedicine has a similar limited number of regulations. However, the Federal Food and Drug Administration recently issued guidance regarding differentiating medical device data systems (MDDS) versus devices for active patient monitoring (APM).79 Specifically, devices used for APM must be FDA (Food and Drug Administration) class II certified.

The MDDS Final Rule provides clarification on the critical difference between the handling of medical device data intended simply for documentation versus that of APM. The FDA indicated in its February 14, 2011, press release that MDDS-classified devices are intended only to transfer, store, or convert data from one format to another according to preset specifications, or to display medical device data. The Final Rule further stipulates that as a FDA class I device, an MDDS, is not intended to be used in connection with APM (ie, real time, active, or online patient monitoring). Any device that transmits, stores, converts, or displays medical device data that is intended to be part of immediate clinical action by a health care professional is not an MDDS. Active patient monitoring devices are primarily FDA class II medical devices requiring more stringent manufacturer controls.

As of time of this publication, the only FDA class II certified systems for APM in the tele-ICU arena includes the Philips VISICU technology and the InTouch Health Remote Presence technology. Other vendors are likely to acquire FDA class II certification for APM in time. Furthermore, facilities that develop their own systems may be considered device manufacturers:

If a third-party company or hospital develops its own software protocols or interfaces that have an intended use consistent with an MDDS or develops, modifies, or creates a system from multiple components of devices and uses it clinically for functions covered by the MDDS classification, then the entity would also be considered a device manufacturer and would be subject to the FDA ruling.

In simple terms, a private or public institution (hospital) would be in violation of the FDA ruling regarding MDDS versus APM certification if uncertified cameras/speakers/monitoring equipment was used in acute decision making.

In general, when selecting a system for APM, a program will need to consider the risk of operating outside of the FDA requirement, choosing within the limited selection of certified technologies or developing "home-grown" systems to the standard of the FDA class II APM.

The future vision of the tele-ICU

With knowledge of existing technologies including limitations, the author proposes the following evolution of the tele-ICU. The ultimate intent is to envision a more extensive, broad based program yet providing services more economically. The following suggestions are intended to stimulate vision of the future and perhaps further development of the tele-ICU technology. The following concepts are suggested.

1. Maintain a core centralized telemedicine center with relatively high-level staffing. The centralized center would:

* provide continuous monitoring to sites with high level of needs;

* facilitate consultants navigating the system; and

* promote vertical scaling of certain services such as continuous critical care management.

2. Evolve to an Internet and wireless system to facilitate developing an open architecture system.

3. Develop local decentralized systems to:

* expand manpower pool by utilizing local physicians;

* improve continuity of care with local patients and local physicians; and

* empower local community physicians in the telemedicine program thereby enhancing acceptance.

4. Develop an administrative umbrella over all the regional critical care units together to:

* regionalize care within the community of ICUs;

* establish a uniform set of quality indicators;

* standardize practices of care with evidence based medical protocols;

* optimize movement of patients within the system in a bidirectional fashion; and

* repatriate patients to local community facilities from tertiary care centers.

5. Grow the system through horizontal scaling to include addition of many/most/all underserved subspecialists.

6. Develop mobile connectivity to:

* support subspecialists providing consultative emergent services; and

* support local MDs with the management and participation in local decentralized telemedicine systems.

7. Acquire/develop technology with a price set that supports both vertical and horizontal growth.

8. Develop alternative staffing models such as:

* shift some of the burden of monitoring, response, and management to the local MDs working within local decentralized telemedicine systems;

* centralized tele-MD with restricted coverage to select facilities; and restricted

* centralized tele-RN/NP assumes greater role in monitoring and coordinating care.

9. Change name and focus of the tele-ICU to the acute care telemedicine center and provide:

* continuous, reactive, or consultative critical care and acute care services; and

* add episodic acute services such as stroke, trauma, burn, cardiology, pediatrics, neonatology, etc.

10. Market a broad range of acute medical services to:

* local markets,

* regional markets,

* national markets, and

* international markets.

11. Administrative development:

* Develop the tele-ICU/acute care telemedicine MD certification as has been done by AACN for nursing.80

* Develop state legislation to mandate third party payment for telemedicine services in parity with direct face-to-face medical services.

* Work with national legislators to enhance reimbursement for telemedicine services provided to Medicare and Medicaid recipients.

* Develop regional and state unified credentialing processes.

Ultimately, the future Acute Care Telemedicine system may look as suggested later in Figure 8.

Figure 8 - Click to enlarge in new window

Figure 8. An acute care telemedicine system. A centralized acute care telemedicine center with staffing to include primarily, Tele-RNs providing "continuous" monitoring and management. De-centralized community telemedicine systems, in pink cloud, linking local MDs with their patients with concurrent linkage and oversite from the Central Tele-MD. Full cadre of subspecialist physicians are available and connected to real-time telemedicine services with mobile technology. Background orange cloud indicates the wider Internet.