According to the EarlySense website, EarlySense “has introduced an innovative continuous patient monitoring solution designed to enhance patient safety and reduce risk for general care patients … Without ever touching the patient, the EarlySense System provides continuous patient monitoring for Heart Rate, Respiratory Rate and Motion, to potentially allow the clinical team to manage:

• Early Detection of Patient Deterioration
• Fall Prevention
• Pressure Ulcers Prevention”

PPAHS asked EarlySense to answer the questions that we posed to manufacturers of continuous monitoring devices. PPAHS questions are in blue.

EarlySense’s answers are below in green (provided March 29, 2018). These answers have been prepared by Dalia Argaman (VP of Clinical, Regulatory Affairs and QA) for EarlySense Ltd.

All links were accessed July 18, 2018.

Parameters Monitored

What physiologic parameters of the patient does your device monitor for?

The EarlySense system monitors heart rate, respiratory rate, and patient motion.

What evidence is there that your device provides a reliable and early indicator of deterioration of the patient’s condition or decline?

The EarlySense system is a contact-free, continuous monitoring system that measures heart rate, respiratory rate, and motion. It is well known from published literature that patients frequently demonstrate deterioration hours before cardiac arrests or before urgent and unexpected transfers to intensive care.^1-5

It is also a well-known fact that the most predictive indicators for deteriorations are changes and instabilities in the heart rate and respiration rate.⁶  Previous studies have demonstrated that in many cases, clear cardiac and respiratory instabilities are the earliest warning signs which are present 6-8 hours before cardiac arrest in a high percentage of cases.7-10 Such instabilities include unstable vital signs and respiratory distress. Respiratory rate has been termed “the neglected vital sign” and is a predictor of potentially serious clinical events.¹¹  Acute respiratory insufficiency or compromise is a common reason for cardiac arrest,¹² exceeded only by arrhythmias, and abnormal respiratory rates have been found to be independent predictors of in-hospital mortality.¹³  It is often the delayed detection deterioration that limits the opportunity to provide a timely and meaningful medical intervention, for better patient outcomes.

EarlySense provides a tool that continuously monitors the heart rate and respiratory rates of all patients in a seamless way. Providing clinicians with the data needed to potentially detect deteriorations earlier and intervene as soon as a patient shows signs of deterioration up to 8 hours prior to a code event.

The sensor is placed under the mattress, does not touch the patient allowing for total freedom, and there is no need for patient compliance to wear electrodes or for nurses to place or disconnect electrodes from patients.

The accuracy of the EarlySense system to continuously monitor heart rate and respiration rate were validated during clinical trials in sleep lab and ICU setting.¹⁴  In addition, in a blinded study examining the capability of EarlySense to detect major clinical events that led to patient transfer to higher level of care (ICU) or intubation or mortality, the system was observed to have a high sensitivity, specificity and positive predictive values.¹⁵

In a 7,000-patient outcome study published in the American Journal of Medicine,¹⁶ the utilization of the EarlySense system resulted in a more than 80% reduction in code blue events, 9% reduction in Length of Stay, and those patients that were transferred from the medical-surgical unit to the ICU had a 46% shorter length of stay. In addition, the EarlySense System has been reported by clinicians to substantially reduce patient falls and pressure ulcers. Separately, researchers saw a 47% reduction in falls from bed¹⁷ and a 64% reduction in hospital acquired pressure ulcers.¹⁸ Further, similar patient outcomes have been seen within small rural hospitals, mid-sized community hospitals, and VA hospitals throughout the country.

1. Buist et al, “Recognizing clinical instability in hospital patients before cardiac arrest or unplanned admission to intensive care: A pilot study in a tertiary-care hospital“
2. Goldhill et el, “Physiological values and procedures in the 24 h before ICU admission from the ward“
3. Hillman et al, “Duration of life-threatening antecedents prior to intensive care admission” 
4. Jacques et al, “Signs of critical conditions and emergency responses (SOCCER): a model for predicting adverse events in the inpatient setting” 
5. Kause et al, “A comparison of antecedents to cardiac arrests, deaths and emergency intensive care admissions in Australia and New Zealand, and the United Kingdom–the ACADEMIA study“
6. Churpek et al, “Predicting Cardiac Arrest on the Wards: A Nested Case-Control Study” 
7. Buist et al, “Recognizing clinical instability in hospital patients before cardiac arrest or unplanned admission to intensive care. A pilot study in a tertiary-care hospital“
8. Hillman et al, “Duration of life-threatening antecedents prior to intensive care admission“
9. Schein et al, “Clinical antecedents to in-hospital cardiopulmonary arrest“
10. Franklin et al, “Developing strategies to prevent inhospital cardiac arrest: analyzing responses of physicians and nurses in the hours before the event“
11. Cretikos et al, “Respiratory rate: the neglected vital sign“
12. Peberdy et al, “Cardiopulmonary resuscitation of adults in the hospital: a report of 14720 cardiac arrests from the National Registry of Cardiopulmonary Resuscitation” 
13. Buist et al, “Association between clinically abnormal observations and subsequent in-hospital mortality: a prospective study“ 
14. Ben-Ari et al, “Contactless respiratory and heart rate monitoring: validation of an innovative tool” 
15. Zimlichman et al, “Early recognition of acutely deteriorating patients in non-intensive care units: : assessment of an innovative monitoring technology” 
16. Brown et al, “Continuous Monitoring in an Inpatient Medical-Surgical Unit: A Controlled Clinical Trial” 
17. Palace et al, “The Effect of a Continuous Patient Monitoring System on Reducing Falls and Hospitalization in Skilled Nursing Facilities“
18. Brown et al, “Improved Outcomes and Reduced Costs with Contact-free Continuous Patient Monitoring on a Medical-Surgical Hospital Unit: Interim Results”

Best Clinical Usage

What is the target population for your equipment?

The EarlySense system is traditionally used in areas of the hospital where patients are not being continuously monitored, care areas such as: medical, surgical, general care, orthopedic, and oncology units. Further the system is utilized outside of the hospital in post-acute care areas such as: skilled nursing, rehab, and long-term care.

Reducing Adverse Events and Patient Deaths – Is there a patient condition, clinical unit, or area that you believe that your device provides an earlier indication of patient deterioration vs. your competitors?

In general, the system is designed to be a second set of eyes for clinical staff for units where nurse to patient ratios make it difficult to closely monitor all patients. By continuously monitoring heart rate and respiratory rate, the system can alert the clinician to changes in patient condition when they occur, to allow clinicians to intervene at the first signs of deterioration. This proactive approach to patient care allows the clinical staff the opportunity to intervene or escalate care before a situation becomes critical. In addition, the system is also able to alert to immediate changes such as opioid induced respiratory depression, or monitoring of chronical respiratory diseases such as COPD, and Asthma patients.

In general, since EarlySense provides accurate continuous monitoring of respiration rate and patterns, the system is valuable to monitor patients where respiratory distress is an indication of potential exacerbations (e.g., CHF patients, pneumonia conditions)

Further, the system allows clinicians to review up to seven days of vital signs data at the bedside for a comprehensive view of changes in patient condition. Clinicians using the EarlySense system commonly cite the early intervention and care for: SIRs/pre-sepsis, infection, respiratory distress, respiratory depression, changes in cardiac condition, new onset cardiac conditions, GI bleeding, pain management, falls from bed/chair, HAPU prevention, as typical use cases. 

Sample cases studies:

Reducing Adverse Events and Patient Deaths – Have your customers experienced a reduction in serious adverse events (“near misses”) or patient deaths using your device? This may be evidenced by a reduction in use of naloxone, decreased transfers to the ICU, reduction in length of stay, etc.

There have been a number of clinical outcomes associated with the introduction of the EarlySense system. As mentioned above, in a 7,000-patient outcome study published in the American Journal of Medicine, the utilization of the EarlySense system resulted in a more than 80% reduction in code blue events, 9% reduction in Length of Stay, and those patients that were transferred from the medical-surgical unit to the ICU had a 46% shorter length of stay.¹

Also mentioned above were two additional separate references where researchers saw a 47% reduction in falls from bed and a 64% reduction in hospital acquired pressure ulcers.

Studies:

• Palace et al, “The Effect of a Continuous Patient Monitoring System on Reducing
  Falls and Hospitalization in Skilled Nursing” Facilities”; and
• Brown et al, “Improved Outcomes and Reduced Costs with Contact-free Continuous Patient Monitoring on a Medical-Surgical Hospital Unit: Interim Resultstinuous Patient Monitoring”

1. Brown et al, “Continuous Monitoring in an Inpatient Medical-Surgical Unit: A Controlled Clinical Trial”

Patient Satisfaction

How is your device connected to the patient?

The EarlySense system is completely contact-free, meaning that there is nothing connected to or touching the patient. A small sensor goes underneath the patient’s mattress or in the cushion of their chair. The system does not require any patient compliance and allows complete patient freedom to enter or leave the bed. The monitoring of vital sign parameters is resumed automatically upon the patient entering the bed or chair. Patients and their families repeatedly report a high patient satisfaction as they understand that even when hospital personnel are not in the patient’s room, their safety is being monitored remotely. A common example of patient satisfaction includes cases where the patient suffers from pain and discomfort (resulting in elevated heart rate) and before the patient has the opportunity to complain, the nursing staff approach the patient in a proactive way and ask about their condition providing required care/medication. Other examples include satisfaction of patients’ families that were advised by the patients that nurses come immediately to their assistance when they are trying to leave bed, to help them and thus avoiding potential falls.

What patient feedback have you had regarding use of your device? Have there been any patient recommendations for improvement? Have these recommendations been included in your device design.

Although no patient compliance is required and majority of patients are unaware they are being monitored, EarlySense is very open to suggestions and inputs from patients, patient’s families, as well as the clinical staff using our devices across the continuum of care. An example of a patient recommendation for improvement was the request that bedside monitor screens (brightness) should be dimmable, as to not interfere with their sleep; this recommendation was included in the system. Another recommendation was to develop a chair sensor, so patients can be monitored when they are out of bed and resting in arm chairs. EarlySense developed and received FDA clearance for a chair sensor, this product is commercially available for use. We continue to ask patients and clinicians for input around the comfort of our chair sensor.

Alarm Fatigue

Does the monitor alarm at the bedside only or is it centrally monitored?

The system has the capability to alarm at the bedside, central monitor, as well as remote displays and hand-held devices. The alerting capabilities are completely customizable based on patients’ needs, and the hospital or facility’s preferred workflow. The vast majority of installations turn off audible alerts at the bedside and only alert at the central monitor or handheld devices.

Have clinicians using your device experienced an increase in the number of alarms sounding? Identify the number or percentage of alarms in terms of criticality.

The frequency of alarms with the EarlySense system is minimal with the typical nurse experiencing 1.7 vital sign alerts per 8 hour shift.¹ Since the system was designed for med-surg and general care areas, there are built in checks to eliminate any non-critical alarms. For example, with a lot of traditional monitoring technology a patient talking or moving would cause an alarm. The EarlySense system is designed to factor in these types of motion to ensure clinical staff are only being alerted to critical clinical alerts requiring immediate medical attention.

1. Brown et al, “Continuous Monitoring in an Inpatient Medical-Surgical Unit: A Controlled Clinical Trial” 

What advice do you provide your customers to help distinguish between actionable and non-actionable alarms?

The EarlySense system provides three different types of color coded alerts. Each alert can be configured to have its own sound if the facility would like to turn on audible alerts at the central monitor. In addition, the alerts are visually distinguishable. Blue alerts indicate a technical issue, red alerts indicate an immediate response needed (for example someone trying to exit the bed, or either heart or respiration rate, or both heart and respiration rates crossed predefined thresholds as set by the clinicians), and yellow alerts are reminders (it is time to go and turn the patient). The facility can also configure an escalation protocol if an alert is not answered within a period of time.

Interoperability – Does your device interface with other technologies, such as EHR or other monitoring devices?

Yes, the EarlySense system is capable of interfacing with EHR and we are Cerner Certified. Further, the system has been integrated into Cisco, Vocera, Spectralink and Verizon phone systems for the relay of notifications without needed redundant technology. In addition, there have been business development initiatives to incorporate the EarlySense system into existing hospital equipment such as the Welch Allyn CVSM.

Engineering/Design – Did the design of your device include input from human factors engineers, clinicians, or hospital biomedical department? If so, what was that input and how did it affect the marketed version of your device?

EarlySense continuously works with clinicians, human factor engineers and hospital biomedical departments to improve our product versions. Usability studies are performed to ensure that the system design is appropriate for the target users. Lessons are learned and implemented into the system’s design.

Example of such continuous improvements are:

1. Allow modular setup of our system’s graphical user interface. Clinicians indicated that in various hospital units, various parameters might be more relevant than others. EarlySense has developed a modular configuration of parameters display (modular GUI). Users can decide to visualize or not visualize certain parameters on screen (Safety module: provides motion and Bed Exit), Vitals module: provides HR and RR and alerts, and All-in-one module: provides all parameters.
2. Clinicians suggested that in certain long term care / SNF units there is lack of space and therefore no local GUI required (at the bedside). EarlySense engineers worked to develop a system version without GUI and very small footprint (no touch screen and only hard buttons).
3. Visualization of the alerts (color coding) were developed by human factor engineers.
4. The size of the fonts on the bedside unit display have been designed so it is visible from the door’s entrance.
5. Inputs from Biomedical engineering and IT resulted in developing connectivity to HER, as well as expanding various security (SSH, SSL security protocols and wifi network protocols (2.4 and 5 GHz)) that the systems are compatible with.

Recalls – Have there been product recalls of this equipment? If yes, when, what were the key safety issues, and what was the resolution?

No, there have not been any product recalls.

Training – What training, on-going staff education, equipment troubleshooting, and other assistance do you provide your customers to ensure their use of your device is kept up-to-date and state of the art in terms of high quality patient care delivery?

EarlySense maintains a team of engineers and clinicians to help address all ongoing needs of customers. Typically, the team will provide initial clinical training for all areas of the facility that will come in contact with the system. This is followed by Go Live support to ensure staff understands how to use the technology. After initial training ongoing clinical resources and teams will be developed to share best practices, provide on-going education, and mentorship to ensure clinical success and adoption of new technology.

In addition, the engineering team is available to troubleshoot any equipment issues. They will also provide basic troubleshooting training to the biomedical team within a facility.

Install Base – In North America, approximately how many patients are monitored each day using your monitoring equipment?

As of the beginning of April 2018, the EarlySense system is currently monitoring approximately 3,000 patients per day. This number is growing on a daily basis.

Equipment Usage – Approximately what are the percentages that your equipment is being used in:

1. ICU
2. PACU
3. Med-surg: 30%
4. Pediatrics: 1%
5. General care floor: 18%
6. Telemetry or step down units: 1%
7. During conscious sedation or MAC (Monitored Anesthesia Care)
8. In healthcare facilities other than at a hospital hospital (e.g. ambulatory surgical settings, surgi centers, outpatient clinics that provide endoscopy capabilities)
9. ______ (pls provide details) – post acute/skilled nursing/long term care: 50%

Equipment Costs (approximates are acceptable)

What is the cost per patient per day to monitor with your equipment? Is there a specific ICD 10 code or bundled payment code which applies to your device?

The EarlySense system can be acquired using several different payment models and costs less per patient than traditional monitoring technology.

Have your customers seen a return on their investment? (please specify parameters for measuring ROI)

Yes, customers have seen a return on their investment. The typical breakeven point is between 6 and 9 months.¹ In a ROI analysis of the AJM data published in Critical Care Journal, a net benefit of between $2,687,000 ($658,000 annualized) and $8,508,000 ($2,085,000 annualized) was reported, with the hospital breaking even on the investment after 0.5 and 0.75 of a year, respectively. These financial impacts are simply the result of identifying and treating patients as soon as they show signs of deteriorating effectively preventing the costly adverse events.

1. Slight et al, “The return on investment of implementing a continuous monitoring system in general medical-surgical units”  

This Guide is moderated by the Physician-Patient Alliance for Health & Safety. The statements and opinions expressed in this guide are solely those of the manufacturer’s representative and of any health experts cited. Such statements and opinions do not represent the opinion of the Physician-Patient Alliance for Health & Safety, its staff or its board of advisors.