Welcome

to the

AAMI Foundation’s

Patient Safety Seminar

with

Brad Winters, MD

Sue Verrillo, MSN, RN, CRRN

Johns Hopkins Hospital

Friday, May 20, 2016

1

What system, structural, and

technological changes are necessary

to capture real-time, critical data of

early deterioration in adult

postoperative inpatients, to prevent

failure to rescue?

AAMI Foundation

• Vision: To drive the safe adoption and use of

healthcare technology

• National Coalition to Promote Continuous

Monitoring of Patients on Opioids

• NEW Opioid Safety & Patient Monitoring

Compendium

• National Coalition for Alarm Management

Safety

• NEW AAMI Foundation Alarm Compendium

• Consider making a donation!

• Contact Marilyn Flack at mflack@aami.org.

A Special Thanks

4

Thank You to Our Premier

Industry Partners Without their financial support, we would not be able to undertake the various initiatives under the

National Coalition to Promote Continuous Monitoring of Patients on Opioids. The AAMI Foundation

and its co-convening organizations appreciate their generosity. The AAMI Foundation is managing all

costs for the series. The seminar does not contain commercial content.

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AAMI Foundation’s LinkedIn page.

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Nursing Continuing Education Disclosure Statement • This seminar is jointly provided today with our co-provider, the National Association of

Clinical Nurse Specialists (NACNS).

• 1.0 contact hour will be awarded for this seminar. This seminar may be accessed online at

the AAMI Foundation website for nursing CE up to two years from today’s date.

• This continuing nursing education activity was approved by the Alabama State Nurses

Association, an accredited approver by the American Nurses Credentialing Center's

Commission on Accreditation (ANCC).

• Criteria for successful completion includes attendance at the session and submission of a

completed evaluation form. You can submit the fee for the CE credit by going to the AAMI

store at http://my.aami.org/store/detail.aspx?id=PSSOPIOID16-1. . A link to the evaluation form

will be sent to you for completion and a certificate sent to you upon completion of the

evaluation.

• The planning committee members have declared no conflict of interest along with our faculty

for today’s session.

• Contributions to the AAMI Foundation have been received from the identified sponsors to

support program initiatives and projects. However, the program content for today’s seminar

has been planned independently by AAMI staff with the seminar presenters.

• Approval of the continuing education activity does not imply endorsement by the provider,

ANCC or the Alabama State Nurses Association.

7

Polling Questions

8

Speaker Introductions

• Bradford D. Winters, Ph.D., M.D., FCCM

Associate Professor Anesthesiology and Critical Care

Medicine and Surgery / Core Faculty Armstrong Institute for

Patient Safety and Quality

johns Hopkins University and Johns Hopkins Hospital

• Sue Carol Verrillo, MSN, RN, CRRN

Nurse Manager Zayed 11 East

Johns Hopkins Hospital

Awareness of Problem Statement

HealthGrades 2013 has reported that 1 out of

every 10 postoperative Medicare patients

currently dies after developing either:

• Pulmonary embolism/ Deep Vein thrombosis

• Pneumonia/Sepsis

• Shock/ Cardiac Arrest

• Gastrointestinal Bleeding

10

The Sequence of Failure to Rescue

• Patient found “dead in bed”

• Code Blue called

• Everyone runs

• ACLS performed

• Chaos ensues

• If ROSC patient goes to ICU

• If not patients goes to morgue

• Everyone goes back to what they were doing.

Galvanizing the Initiative

• Until the mid 1990’s few ever asked:

** Why did this patient arrest? AND…

** Could we have prevented it?

12

Turn of the Millennium

• Appreciation that most in-hospital cardio-respiratory arrests have a clear “prodrome” began to emerge. • Schein et al. 1990

• Hillman et al., 1991

• Silber et al., 1992

• Smith and Wood, 1998

• McQuillan et al., 1998

• Buist et al., 1999

• Goldhill et al., 1999

• Hillman et al., 2001

• Kause et al., 2004

• Patients don’t suddenly become critically ill, they are just suddenly recognized as such

The Medical Emergency Team

• Developed in response to

the understanding that

arrests don’t suddenly

happen and that we

should be able to intervene

• The MET is not just a team, it

is a patient safety system

• Consists of: • The Afferent Limb (recognition)

• The Efferent Limb (response)

• Administrative System to collect and analyze data

• Education system to train staff

• Other versions include: Rapid Response Team, Patient at Risk Team, Critical Care Out Reach Team, etc.

Recent Systematic Review: Adult Non-

ICU CA

Adult Total Mortality

What does this tell us?

• These numbers have changed little since the first systematic review (there are now at least 7)

• Point estimates have shift slightly • CA incidence reduced by ≈40%

• Mortality reduced by≈ 15%

• Confidence intervals

have tightened

• Our current model

seems to have hit a limit;

• But Why???

9/25/2013 17

Evidence of Afferent Limb Failure

Author Year Salient Point

1

Salient Point

2

Salient Point

3 Buist et al 1999 Median time between

documented instability and

cardiac arrest = 6.5 hrs

Range 0-432 hrs Median # physician visits = 2

without any action

Calzavacca et al 2008 Early recognition is most robust

component

Boniatti et al 2013 Calls delayed 21.4% ↑ delay with physician activators 61.8% mortality with delayed

calls

Simmes et al 2012 16% activations delayed 1-2

days

Vetro et al 2011 20% had objective warning

signs, but no MET call

Shearer et al 2012 4.04% of adult population were

medically unstable

Of those patients, 42% did NOT

have RRT called

Despite 69.2% of the staff

recognizing they met criteria

Bucknall et al 2013 Most patients meeting MET

criteria never have call made

Increases hospital mortality at

30 and 60 days

Oglesby et al 2011 71% ICU admissions delayed

from floors

Adelstein et al 2011 Despite process improvements- 26% of episodes of

deterioration

Associated with delays in care

Frydshou and Gillesberg 2013 Only ½ ICU admits went

through an RRT

Guinane et al 2013 14% of sample met MET criteria

– 4% activation rate

Those meeting criteria had 2

X’s LOS

18

Underlying Causes?

• Certainly some is due to hierarchy / Concept of

patient “ownership”

• More likely poor quality of patient monitoring on

general wards

• Intermittent nature

• Poor fidelity

• Inaccuracy

• Delayed communication

Since 2009 TJC Patient Safety

Goal #16……… • Despite the wide

implementation of RRSs this

has not gotten much better.

• We can provide a response

team (better management

and treatment) but we can’t

seem to eliminate the

failure to recognize the

need to activate that

team

20

“Should we call for help?”

Response to this Afferent Failure:

Risk Scoring Systems

Author Year Finding Finding

Subbe et al 2001 MEWS

“SOCCER” 2006 Extended

criteria catch

earlier signs

Bell et al 2006 Extended

criteria → low

sensitivity & ↑

workload

Restricted

criteria →

missed

opportunities to

intervene

Cretikos et al 2007 ↑specificity for

combo vs

↓ sensitivity and

PPV 15.7%

Maurice &

Simpson

2007 Intermittent vs

unable to id at

risk patients

Gao et al 2007 Systematic

review 36

studies

No scoring

system

adequate

21

Response to this Afferent Failure:

Safety Culture Improvement

• Teamwork Tools

• Adaptive Approaches

• Emphasizing Wisdom of Frontline Staff

• Staff Safety Assessments

• Comprehensive Unit Safety Programs

• TEAMSTEPPs training

• Learning from Defects

22

In response to this Afferent Failure:

"In Pursuit of High Reliability”

Sensitivity to operations: Preserving constant awareness by leaders and staff of the state of the systems and processes that affect patient care. This awareness is key to noting risks and preventing them.

• Changing historic vital sign collection process

• Total patient situational awareness vs.

“snapshot in time”

• Recognizes the dynamic nature of

patient condition

• Providing caregivers with essential data to intervene sooner

• Longitudinal data trending

• Identify vital sign patterns predictive of patient deterioration

• Analyze “inter-relationships” between independent parameters

• Integrate alarm management with current nurse call equipment

• Development of meaningful alarm notification algorithms

A new call to arms

Can we do better?

• The RRS Afferent Limb Consensus Conference concluded that, at present and for the foreseeable future, identifying and stratifying who is at risk for clinical deterioration on general wards is difficult and likely to be imperfect despite much research.

• Patients are dying and being harmed and we can’t wait

• They issued a call to industry to partner with clinicians to develop and implement continuous high fidelity monitoring systems that were acceptable to patients, had minimal false alarms, could improve nurse workflow and workload and prevent unrecognized deterioration.

Surveillance Monitoring

• Why? • Because of Afferent Limb Failure

• APSF (2011) • Continuous monitoring while on

parenteral narcotics

• Caregiver notification system

• Joint Commission Sentinel Event Alert (2012) • Systematic protocols for assessing, management & opioid dosing

• Continuous monitoring of oxygenation & ventilation

• Center for Medicare and Medicaid Services (2012) • Respiratory Rate, sedation, and pulse oximetry monitoring of all patients receiving PCA

• Joint Commission New Safety Goal (2014) • Alarm Management & Safety

• Reduce alarm fatigue

• Phased implementation by 2016

Surveillance vs. Condition Monitoring

• Condition Monitoring • The patient has known problems or a predefined risk

for a problem that we are watching for, eg. OSA

• Actionable alarms are likely to be more common

• Surveillance Monitoring is what we should be able to do on the general wards • Risk profile is unclear and possibly undefinable

• We don’t know who is at risk for what

• Actionable alarms are likely to be less common

• We watch not so much for the problem but for the changing risk profile.

A new addition to the RRS

Taenzar et al. Anesthesiology 2011

Requirements

• ???Needs to be affordable

• Acceptable False alarm rate

• Mobile (hence wireless)

• Able to provide usable

data to clinicians

(communication, human

factors informed data displays etc.)

• Needs to be tolerable to the patient (minimal “probes” and especially no annoying bedside alarms)

• Needs to integrate into nurse workflows and ideally free nursing up for other tasks

• Customizable and individually adaptable

• Interface with EMRs

Dartmouth Experience

• Taenzar et al. (2010) examine use of pulse ox

surveillance monitoring on a post-surgical ward

(orthopedics)

• Average number of alarms was 4/pt/day

• Observed deaths were 2 compared to 4 in pre-

implementation period

Pulse Oximetry

• Taenzar et al. (2014) found in a group of patients

at high risk of prolonged desats (OSA) manually

collected pulse ox values over-estimated

saturation compared to continuous non-invasive

pulse ox surveillance monitoring by an avg of

6.5%.

Rescue events dropped from 3.4

(1.89-4.85) to 1.2 (0.53-1.88)

p=0.01

Unanticipated ICU transfer dropped

from 5.6 (3.7–7.4) to 2.9 (1.4–4.3),

p=0.02

Cohort comparison wards (other surgical

services) had no significant change for

either outcome.

Taenzar et al. 2011 Anesthesiology

We do poorly as well

In Fiscal year 2015:

• 40% of sudden deaths in Johns Hopkins Hospital were

on Zayed 11 East

• 32 Rapid Response Team calls were made and of those

calls:

* 5 patients experienced acute respiratory

compromise, requiring emergent intubation

• So what is best practice for clinicians to detect early

signs of deterioration sooner?

• What is best practice to support and build nurse capacity

in a rapid paced, complex surgical unit?

33

Evidence base for the intervention

• Surveillance monitoring- no official definition, from the literature:

continuous vital sign monitoring, that can measure single or multiple

parameters, with automated alarm alerts sent to a mobile nurse call

device, without requiring a change in the staffing level

• Use surveillance monitoring to provide data of early deterioration

due to sepsis, carbon dioxide narcosis, or terminal arousal failure

due to obstructive sleep apnea

• Automate vital sign collection to give a more accurate picture of the

patient’s physiologic state

• Empower new graduate nurses with continuous vital sign data to

incorporate with assessments to give an integrated clinical picture to

the provider

• Fulfill the National Patient Safety Goal to make alarms safe for all

patients

34

Intervention • IRB approved

• Wireless monitor deployed that recorded continuous vital signs

• HR, RR, Oxygen saturation, BP, Temp

• Created escalation system of alarms and built-in delays to control

false alarms reaching the nurses

• Multi level Education program

• Training

• Feedback

• Listened to nurses and adjusted plans based on their feedback

35

Pilot Team

• Clinical Team

* Dr. Brad Winters

* Dr. Maria Cvach

* Sue Verrillo

* Zayed 11 East

Nursing

* Vendor Clinical

Specialists

• Biomedical

Engineering & IT

* Jeff Frank

* Chuck Sproul

* Jim Mattheu

* Scott Livesay

* Peter Doyle

36

• Middleware

• Assignment management

• Pre-determined alarm escalation

• Wireless Communication System

• Alarm notification

Alarm Notification Integration

Pilot Implementation

• Training

* All staff education

sessions

* Device set up

* Disposable supply

management

* Alarm parameters

* Data collection

• Impact

* Paradigm shift

* Use translational

framework and

methods

* Teach data

integration

* Connect the dots to

show it’s working

38

Purpose: Demonstrate that continuous vital sign monitoring

can identify early, actionable signs of deterioration in adult,

postoperative inpatient, to prevent failure to rescue

PPV= Number of True Alarms

Number of True + False

Alarms

ICU’s are typically in 11-15%

range

Surveillance monitoring was

86 % from 1/30/16 – 3/8/2016

Findings of real, actionable types

of early deterioration:

• 3 Pulmonary embolisms

• 2 New onset a fib

• 3 SIRS/Sepsis

• 3 AMI

• 2 Autonomic dysreflexia in

paraplegic spine patients

• Multiple Hypertension- all

cause

• Multiple Sleep related

disordered breathing

9/25/2013 39

What we have found

(soon to be published)

• False alarms rates are acceptable≈30%

• Large numbers of patients (1/3) never alarm

• A small number of patients account for the vast

majority of alarms, especially false ones

• This is an opportunity for targeted improvement

• Patients like it

• Nurses like it

• Creates real opportunities for saving patients

who otherwise might be found “dead in bed”

Lessons Learned

• Clinical

* Keep repeating the

essential messages

* The details matter-

lost equipment

* Communicate often

to the team

* Be alert to success

and needed tweaks

• Biomedical

* Start early

* Involve all levels to

get a good picture

* Know limitations

* Know competing

priorities

* Align all the moving

parts as best you can

41

Future Ongoing Initiatives

• Communicate findings to colleagues

• Garner interest through internal ongoing updates

• Align with institutional strategic priorities

• Align with national standards

• Persevere to maintain interest

• Keep results on front burner

42

The Goal

Unrecognized clinical deterioration

on general wards resulting in

Failure to Rescue

should be a

NEVER EVENT

Polling Questions

44

Complimentary Resources

Safety Innovations Series

Alarms Management Patient

Safety Seminars

• Webinar Recordings

• Webinar Slides

• Key Points Checklists

NEW Opioid Safety & Patient

Monitoring

NEW AAMI Foundation

Alarm Compendium

Mark Your Calendars!

• Friday, June 24, 2016 @ 12N EDT

• Raising the Bar On Infusion Safety: A Patient Safety

Program at Catholic Health Initiatives

• Mary Kane, MS, RN

Vice President, Regional Chief Nursing Informatics Officer

Catholic Health Initiatives

• To register, please click here.

https://attendee.gotowebinar.com/register/324531119726

8717057

An application for Nursing CE credit is being submitted for this seminar.

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• Type your question in the “Question” box on your webinar dashboard

• Or you can email your question to: pmiller@aami.org.

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numerous free papers, seminars, and compendiums. Please go to

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please go to the AAMI Store at http://my.aami.org/store/detail.aspx?id=PSSOPIOID16-1.

• The credit costs $25. A link to the evaluation form will be sent to you to

complete and then a certificate sent to you upon completion of the evaluation.

Thank You to Our Premier

Industry Partners Without their financial support, we would not be able to undertake the various initiatives under the

National Coalition to Promote Continuous Monitoring of Patients on Opioids. The AAMI Foundation

and its co-convening organizations appreciate their generosity. The AAMI Foundation is managing all

costs for the series. The seminar does not contain commercial content.

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