Meet the Experts 3

The Nightingale Vision

Cor J Kalkman, MD, PhD, Professor of Anaesthesia

University Medical Centre, Utrecht, the Netherlands

John Welch, RN, MSc, Critical Care Nurse, President iSRRS

University College London Hospitals, UK

Five Academic Hospitals seek innovative partners to deliver cutting edge health care solutions for wireless monitoring

of high risk patients, both in hospital and at home

• Working with European Med Tech and IT industries, we will develop innovative wireless wearable technology coupled with intelligent software for patient monitoring both in hospital wards and at home

• We have received over €5 million to help reduce death and disability from undetected patient deterioration in hospital

• The system will allow safe early discharge from hospital

• This could become a ‘disruptive innovation’

We want you to build:

• wireless, multi-parameter vital sign sensors combined with

analysis of laboratory data, patient and nurse inputs

to prevent death and disability in general ward patients and

in the early days after discharge home from hospital

Pre-Commercial Procurement: Nightingale timeline9 4 2

• 91 year old male

• increasing confusion, worsening memory

• hypertension, atrial fibrillation; heart failure

• peripheral vascular disease

• gastritis

• bilateral knee replacements

A patient story

Thursday - fall, hip fracture ED Surgical Assessment Unit

Friday Theatre (hemi-arthroplasty)

Prognosis

• 5% of hip fractures die within 30 days …

• 18% probability male aged 91 will die before reaching 92

• add in long term conditions, atrial fibrillation, frailty …

Thursday - fall, hip fracture ED Surgical Assessment Unit

Friday Theatre (hemi-arthroplasty) ICU

Saturday - ICU ward

Sunday - on ward

Monday - on ward: cardiac arrest

Friday

• Surgery: “straightforward”

• 1L intravenous fluid given

• Operation began at 12.15, patient in ICU by 14.00

• at 15.00: Ur 11.8, Cr 129, K 4.1

• daughter “he’s more

confused than usual”

• physio “unable to follow

commands”

Saturday – on ICU

• 06.30: routine morning bloods - Ur 14.1 (), Cr 161(), K 4.6()

• 08.59 - “PLAN: ready for ward” “monitor for any signs of sepsis”

Saturday afternoon, Sunday, Monday – on ward

• Saturday - observations: 16.00 17.00 21.30

• Sunday - observations: 06.00 10.20 (HR 138*)

16.25 (HR 144*) 20.45

• Monday - observations: 08.00 (HR 135*) 10.20 (HR 144*)

• CARDIAC ARREST at 11:15 (bloods: Ur 24.5, Cr 258, K 7.2)

We have a real problem

• Belgium 2015: a quarter of unplanned transfers to higher levels of care are associated with highly preventable adverse events (AEs)1

• Italy 2012: 57% of adverse events are preventable2

• Ireland 2017: 10% incidence of AEs - 70% are preventable - 7% contribute to death3

• Netherlands 2009: up to 2,032 potentially preventable deaths4

We have a real problem

• UK 2012: 11,859 preventable deaths in English hospitals5

• UK 2014: the most common incidents are failure to recognise/act on deterioration6

16

PLoS Med. 2014;11(6): e1001667.

Remember that vital signs can tell us about other problems too

• Other causes of harm

o falls, infection, skin wounds, embolic events, medication errors, perioperative deaths, errors due to poor handover, failure to access ICU in good time, equipment failure…

• most will cause deterioration “past” the vital sign values that should trigger a potentially lifesaving response …

The Nightingale Vision

• accurately identify patients at risk of deterioration

• ensure timely recognition and communication of deterioration

• improve patient safety in hospital and after discharge

• reduce the length of hospital stays and readmissions

• analyse collected ‘big data’ to increase understanding of specific patient groups

• create a record that can ensure learning from clinical responses to deterioration

• promote active patient involvement in care

The Nightingale Vision

• without burdening the patient – or staff

• no wires

• no unnecessary alarms

How would Nightingale have helped the 91 year old?

• By flagging the risk factors (demographics, long term conditions)

• By flagging abnormal vital signs – and “soft signs”

• Continuous monitoring on the ward - and alerts

• Prompts regarding requirements to take bloods

• Feedback loop about the response to treatment (or lack of response)

When to alert?

Continuous wireless remote monitoring:

• Effectively reducing false alarm rate requires

advanced Clinical Decision Support,

• using prognostic models to calculate risk in real-time

(multivariable logistic regresssion, machine learning/AI)

What do users hope to gain (and what they fear) from Nightingale?

Results of intensive stakeholder interaction

Value Sensitive Design

Value Sensitive Design• Identify your stakeholders (mind the gap!)• Translate values in to Nightingale benefits and risks• Feed these data back to industry as input

for critical design choices

Who are the stakeholders of a Nightingale remote monitoring system?

• Patients

• Informal carers

• Nurses

• Doctors

• Health care systems/payers

• Industry: designers, engineers, software architects,business experts

Focus group sessions

• To understand the perceptions of direct stakeholders (nurses,

patients and carers, junior doctors) regarding benefits and risks of

the Nightingale solution

• To retrieve insight in the preferences of direct stakeholders (nurses,

patients and carers, junior doctors) regarding the use of the

Nightingale solution

• To also make sure that the final solution is valued positively and

beneficial for all direct stakeholders

Patients

• The solution needs to be very easy to use by patients. • elderly patients• frustration → will stop using • anxiousness and stress

• Freedom of movement is important to patients • solution should be comfortable to wear (without wires, tubes) and easy

to use in the shower• this allows for early mobilization of patients• wireless is important to patients• important to have a clear description how and when the solution needs

to be charged (if needed at all)

Patient quotes

• “fantastic with safety both in hospital and at home”

• “make it as easy as possible! not too many buttons or tools, it needs to be as simple and user-friendly as possible”

• “panic if the technology malfunctions; there’s panic already if the kids are shouting ‘dad, the WiFi isn’t working!’ ”

• “I measured my temperature, my blood pressure and my oxygen saturation with 3 different devices today; this product will simplify my care”

• “great, with no cables; wireless is important”

• “… but how do I charge the product?”

• “If my blood pressure is dramatically increasing to 200 mmHg, and a nurse does not do anything, the physician doesn’t do anything and they explain to me that they don’t know, then you lose faith in healthcare professionals. Sometimes you really have to fight to get a response from anyone”

Informal carer quotes:

• “The software may now easily keep track my dad’s condition. So nurses may have more time for other things, to ask other things, how the patient feels, for example”

Nurses

• Easy to apply and use, actionable recommendations

• Nurse clinical judgment must be built into the Nightingale solution

• Nurse must go and actually see the patient to observe the patient

• risk of remote monitoring diminishing the frequency of patient contact

• nurses might lean back (‘the vital signs are being monitored anyhow’)

• accidentally forget to ‘see’ the patient at night or in the evening when they

are alone and extremely busy

Indicator Underlying signs and symptoms

Change in breathingNoisy breathing and/or short of breath and/or unable to speak full sentences and/or use of accessory muscles

Change in circulationcolor changes and/or clammy and/or coldness and/or impaired perfusion and/or edema

Rigors rigors

Change in mentation lethargic and/or confused

Agitation restless and/or anxious

Pain new pain and/or increasing pain

No progressno progress and/or abdominal distension and/or nausea and/or bleeding and/or dizzy/fall

Patient indicates not feeling well and/or feeling of impending doom

Subjective nurse observationchange in behavior and/or doesn’t look good and/or look in the eyes

Dutch-Early-Nurse-Worry-Indicator-ScoreDouw G. et al., Int J Nursing Studies 2016; 59: Pages 134-140

Nurses quotes

• “Very important, combined with education and proper implementation”.

• “Especially at night it is of added value to be able to see the vital signs without the necessity to disturb the patient”

• “Patient not bed-bound by wires and monitors facilitates early mobilization and even earlier discharge”

• “It is not solely about retrieving (vital signs) measurements, one needs the interaction with the patient• if you want to check pain or consciousness, you need direct interaction”

• “It is important that you as a care professional can adapt the alarm settings”• for example that you can accept certain lower target values for oxygen saturation”

What to measureand how often?

Capabilities of today’s wireless sensors

• heart rate (ECG or photoplethysmogram)

• respiratory rate (various algorithms)

• (skin) temperature

• movement/position

• NOT: arterial blood oxygen saturation (not in ‘patches’)• unless pulse oximeter finger or ear probe applied

(Masimo Radius-7, various ‘watches’)

• NOT yet: continuous noninvasive blood pressure, (cuffless cNIBPmethods are becoming available)

• NOT possible with a sensor (yet): consciousness, pain (!)

Importance of physiologic variables, scaled to a maximum of 100, in a random forest model developed to predict clinical

deterioration on the wardAdapted from Churpek et al, 2016

Future capabilities of wireless sensors

• arterial blood oxygen saturation• technically hard with patch sensors

• continuous noninvasive blood pressure, cardiac output(‘cuffless’ cNIBP methods)• requires high quality PPG signals, and superior artefact handling

• consciousness requires a ‘challenge response’ system, built into the gateway device (smart phone, tablet or dedicated hardware device)

Measure how often? (the eternal conundrum)

• Very often, fast response rate: • high likelihood of false alarms

• Infrequent (once every hour or less): • high likelihood of missing rapid clinically relevant deterioration

• Emerging consensus: among all users:• In the hospital setting: once every 2-5 min

• In the home setting: no more than once every 15 min

Alarms and alarm settings

Alarm strategy:• the different types of alarms, • the risk of false alarms and alarm fatigue• possibility to use smart algorithms

• identification of trend patterns of patient deterioration

Alarm settings? (’tight’ or ‘loose’)

• tight, fast response rate: • high likelihood of false alarms

• loose (alert only to major changes):

• higher likelihood of missing clinically relevant deterioration

• subtle changes may go unnoticed

• consensus: among all nurses and doctors:• alarms should not be set too tight; frequent false alarms are ‘no-go’

• doctors and nurses must be able to overrule/change default alarm settings for specific patients (cf. SpO2 in NEWS 2)

Alarm settings - nurses views

• Smart algorithms: the solution should take into account whether the patient is resting or active (need for a motion sensor)

• If an alarm is generated, nurses want to be able to see a complete overview of the patient’s status, not only the alarm

• The nurse must be able to overrule an alert if they are unable to see the patient at that particular moment. The system should then be able to forward the alert to another ‘nearby’ nurse

• If somehow an alarm is generated for an emergency situation (e.g., cardiac arrest needing immediate resuscitation), then this alarm should notify a larger number of care professionals (and maybe also in a different way), to avoid unnecessary delay in response to the alarm

Alarm settings - junior doctors views

• If an alarm is generated, doctors want to be able to see a complete overview of the patient’s status, not only the alarm

• Doctors can be extremely busy during night (2 phone calls a minute!)• they want the nurse to act as a reliable ‘filter’

• Display screens must be simple, with option to ‘drill down’ to more detail, if needed

A false sense of security?

• being continuously monitored may cause a sense of securitythat might be misplaced.

• monitoring does not equal intervention

• potential benefit of monitoring is a more timely recognition of patient deterioration (diagnostics)

• however, the correct intervention still needs to be performed in a timely fashion

A false sense of security? Quotes:

• Patient: “too much trust in the device (or patch),and less on your own body signals”

• “you need to justify why you haven’t been to that patient.If something goes wrong, then you need to justify it. The vitals on ‘the

monitor’ may look good, but what if you only have seen the monitor for 2 hours instead of going to ‘see’ a patient?”

Do patients get to see their own data?

Views and concerns from stakeholders (1)

• Wide appreciation for the proposed solution, from patients and nurses

• many potential advantages identified:• timely detection of deterioration• ability to personalize care and more reassurance for both the patient,

informal carer and nurse • transitions in care settings often mean loss of vital information that could be

remedied by Nightingale• providing monitoring for patients will probably increase the sense of security,

not only for high-risk patients in the hospital, but also at home, and even in palliative care

• signs of patient deterioration and signs of anxiety and stress or pain will be recognized.

Views and concerns from stakeholders (2)

• main concerns raised: • reduced contact between patient and nurses

• ‘ICU patients’ on the ward

• Poor implementation, lack of training:• education and correct implementation of the solution is paramount

• must include a very clear, local description on how the solution will work in any given setting (ICU, ward, home)

• false sense of security if poorly implemented

• regions with poor internet/cellular coverage may pose a problem

Interaction with industry

• Stakeholder input from patients and nurses perceived as highly useful

• “You cant have it all”:

• all vital signs, transmitted continuously, in an tiny patch

• large update rate -> larger battery, heavier sensor, less usable

• PPG (optical pulse plethysmography): high quality signal is necessary

for SpO2 and BP, but difficult to obtain from ‘non-standard’ locations

Thank you for your attention!