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7/10/2019 1 #FSHP2019 To PADIS and Beyond: Updates and Integration To PADIS and Beyond: Updates and Integration Michael Semanco, PharmD, BCPS, BCCCP Clinical Pharmacy Specialist – Critical Care Lakeland Regional Health August 3, 2019 #FSHP2019 Disclosure Disclosure I do not have (nor does any immediate family member have): a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this presentation any affiliation with an organization whose philosophy could potentially bias this presentation #FSHP2019 Objectives Objectives Highlight changes from PAD to PADIS with a focus on new recommendations Explore the potential uses of nefopam and ketamine for the treatment of pain and agitation in the intensive care unit Develop strategies to implement, integrate, and evaluate the implementation of the new guidelines #FSHP2019 Timeline Timeline 1990 2000 2010 2020 1995 6 recommendations 13 references 2013 54 statements 472 references 2018 74 statements 538 references 2002 28 recommendations 235 references Guidelines #FSHP2019 2018 Guidelines 2018 Guidelines Pain Agitation / Sedation Delirium Immobility (Rehabilitation / Mobilization) Sleep Disruption P A D I S Devlin et al. Crit Care Med 2018;46:e825-e873. #FSHP2019 Methods Methods Working group (multidisciplinary): 32 experts from 5 countries 4 methodologists 4 critical illness survivors 2 medical librarians 2 SCCM staff Balas et al. Crit Care Med 2018;46:1464-1470. Devlin et al. Crit Care Med 2018;46:1457-1463. Statements Literature GRADE Questions 1 2 3 4 5 6

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Page 1: Semanco Handouts - cdn.ymaws.com€¦ · Explore the potential uses of nefopam and ketamine for the treatment of pain and agitation in the intensive care unit Develop strategies to

7/10/2019

1

#FSHP2019

To PADIS and Beyond: Updates and Integration To PADIS and Beyond: Updates and Integration Michael Semanco, PharmD, BCPS, BCCCPClinical Pharmacy Specialist – Critical CareLakeland Regional HealthAugust 3, 2019

#FSHP2019DisclosureDisclosureI do not have (nor does any immediate family member have):• a vested interest in or affiliation with any corporate

organization offering financial support or grant monies for this presentation

• any affiliation with an organization whose philosophy could potentially bias this presentation

#FSHP2019ObjectivesObjectivesHighlight changes from PAD to PADIS with a focus on new recommendations

Explore the potential uses of nefopam and ketamine for the treatment of pain and agitation in the intensive care unit

Develop strategies to implement, integrate, and evaluate the implementation of the new guidelines

#FSHP2019TimelineTimeline

1990 2000 2010 2020

19956 recommendations

13 references

201354 statements472 references

201874 statements538 references

200228 recommendations

235 referencesGuidelines

#FSHP20192018 Guidelines2018 GuidelinesPainAgitation / SedationDeliriumImmobility (Rehabilitation / Mobilization)Sleep Disruption

PADIS

Devlin et al. Crit Care Med 2018;46:e825-e873.

#FSHP2019MethodsMethodsWorking group (multidisciplinary):• 32 experts from 5 countries• 4 methodologists• 4 critical illness survivors• 2 medical librarians• 2 SCCM staff

Balas et al. Crit Care Med 2018;46:1464-1470.Devlin et al. Crit Care Med 2018;46:1457-1463.

StatementsLiterature GRADEQuestions

1 2

3 4

5 6

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#FSHP2019MethodsMethods• 5 topic-based groups developed: 37 recommendations (3 strong, 34 conditional) 2 good practice statements 32 ungraded statements 3 questions with no recommendation

• Need to be easily interpreted, understood, and implemented

Balas et al. Crit Care Med 2018;46:1464-1470.Devlin et al. Crit Care Med 2018;46:1457-1463.

#FSHP2019

ImmobilitySleep Disruption

PADIS

PainAgitationDelirium

PAD

SI+ =

Barr et al. Crit Care Med 2013;41:263-306.Devlin et al. Crit Care Med 2018;46:e825-e873.

#FSHP20192018 Guidelines2018 GuidelinesPainAgitation / SedationDeliriumImmobility (Rehabilitation / Mobilization)Sleep Disruption

PADIS

#FSHP2019Protocol-Based Pain Assessment and ManagementProtocol-Based Pain Assessment and Management

Devlin et al. Crit Care Med 2018;46:e825-e873.

#FSHP2019Pain AssessmentPain AssessmentTopic Strength Recommendation

Self-Report Scales Ungraded Reference standard if reliable communication

BehavioralAssessment Tools Ungraded

Unable to self-report and observable behaviors, Behavioral Pain Scale (BPS) and Critical-Care Pain Observation Tool (CPOT)

Proxy Reporters Ungraded When unable to self-report and when appropriate, family may be involved

Physiologic Measures Ungraded Vital signs are cues to initiate further assessment

Devlin et al. Crit Care Med 2018;46:e825-e873.

#FSHP2019Pain TreatmentPain TreatmentPharmacologic Adjuvant Strength Recommendation

Acetaminophen Suggest using Decrease pain intensity and opioid consumption (route?)

Nefopam Suggest using Opioid adjunct or replacement to reduce use and alleviate safety concerns

Ketamine Suggest using Low-dose as an adjunct to opioids in post-surgical

Neuropathic Pain Recommend using With opioids for neuropathic pain (e.g., gabapentin, carbamazepine, and pregabalin)

Lidocaine Suggest not routinely using As an adjunct to opioids

NSAIDs Suggest not routinely using COX-1-selective as an adjunct

Devlin et al. Crit Care Med 2018;46:e825-e873.

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#FSHP2019NefopamNefopam

Evans et al. Br J Anaesth 2008;101:610-617.https://us.lgcstandards.com/US/en/Nefopam-Hydrochloride/p/MM1189.00

https://www.digital-pharmacie.ma/on-ma-donne-de-lacupan-injectable-a-boire

#FSHP2019Mechanism of ActionMechanism of Action

Kim et al. Korean J Pain 2014;27:103-111.Girard et al. Clin Exp Pharmacol Physiol 2016;43:3-12.

#FSHP2019BenzoxazocineBenzoxazocine

Evans et al. Br J Anaesth 2008;101:610-617.https://www.sciencedirect.com/topics/medicine-and-dentistry/nefopam

#FSHP2019PK / PDPK / PD• Administration: IV, IM, oral• Bioavailability: 40%• Peak (IV): 15-20 minutes• Half-life: 3-5 hours• Protein binding: 75%• Metabolism: Hepatic Active & non-active metabolites

• Elimination Renal 87% Feces 8%

Evans et al. Br J Anaesth 2008;101:610-617.https://www.cyprotex.com/insilico/physiological_modelling/chempk

#FSHP2019DosingDosing• IV / IM: 20mg q 6hrs• Oral: 30-90mg tid

• Opioid comparison: 20mg nefopam = 6 mg morphine Morphine sparing effect = 30-50%

Evans et al. Br J Anaesth 2008;101:610-617.Chanques et al. Br J Anaesth 2011;106:336-343.

Acuten [package insert]. ACI Limited. Available at http://www.aci-bd.com/Brand/Acuten.

#FSHP2019Adverse ReactionsAdverse Reactions• Tachycardia• Hypertension• Urine retention• Sweating• Dry mouth• Nausea

• Vomiting• Hot flushes• Heat sensation• Confusion• Convulsions • Drowsiness

Chanques et al. Br J Anaesth 2011;106:336-343.Evans et al. Br J Anaesth 2008;101:610-617.

Girard et al. Clin Exp Pharmacol Physiol 2016;43:3-12.

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#FSHP2019ClinicalTrials.govClinicalTrials.govAs of May 2019• Nefopam -> 25 studies• Nefopam + Intensive Care Unit -> 0 studies• Nefopam + Critically ill -> 0 studies

• Nefopam + United States -> 0 studies

https://clinicaltrials.gov

#FSHP2019Future of NefopamFuture of Nefopam

#FSHP2019NonpharmacologicNonpharmacologicTopic Strength Recommendation

Cybertherapy / Hypnosis

Suggest not offering For pain management in ICU

Massage Suggest offering For pain management in ICU

Music Suggest offering For both nonprocedural and procedural pain

Cold Therapy Suggest offering For procedural pain management

Relaxation Techniques Suggest offering For procedural pain management

Devlin et al. Crit Care Med 2018;46:e825-e873.

#FSHP20192018 Guidelines2018 GuidelinesPainAgitation / SedationDeliriumImmobility (Rehabilitation / Mobilization)Sleep Disruption

PADIS

#FSHP2019Agitation / SedationAgitation / SedationTopic Strength Recommendation

Light Sedation Suggest using In critically ill, mechanically ventilated adults

DSI protocols / NP-Targeted sedation Ungraded Both can achieve and maintain light levels

of sedationCardiac Surgery (Prop vs BDZ) Suggest using Propofol over benzodiazepine

Non-Cardiac Surgery (Prop vs Dex vs BDZ) Suggest using Either propofol or dexmedetomidine over

benzodiazepines

Devlin et al. Crit Care Med 2018;46:e825-e873.

DSI = Daily Sedative InterruptionNP = Nursing-protocolized

#FSHP2019

https://www.medicalnewstoday.com/articles/322909.php

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#FSHP2019IndicationsIndications• Dissociative anesthesia• Acute pain management• Chronic pain management• Local anesthetic• Procedural sedation• Rapid sequence intubation• Alcohol withdrawal• ICU sedation• Analgosedation• Refractory status epilepticus• Bronchodilatation• Major depression

Patanwala et al. J Intensive Care Med 2017;32:387-395.Erstad et al. J Crit Care 2016;35:145-149.

#FSHP2019Mechanism of ActionMechanism of ActionAntagonism / Inhibition Effects

NMDA receptorsDissociative anesthesia, amnesiaInhibited sensory perceptionAnalgesia

HCN channels Hypnosis

Calcium channels (L-type voltage-dependent) Negative inotropy

Voltage-gated sodium channels Decreased parasympathetic activityLocal anesthetic effect

BK channels Neuropathic pain

Agonism / Activation EffectsOpioid receptors (µ, Κ) Central antinociception

AMPA receptors Rapid antidepressant effects

GABAA receptors Anesthetic properties

Li et al. Front Hum Neurosci 2016;10:612-626.HCN = hyperpolarization-activated cyclic nucleotideBK = large-conductance potassium channelsAMPA = alpha-amino-3-hydroxyl-5-methyl-4-isoxazolepropionic acid

#FSHP2019

Zanos et al. Molecular Psychiatry 2018;23:801-811.

#FSHP2019NeuropharmacologyNeuropharmacology

Erstad et al. J Crit Care 2016;35:145-149.

HCN1 = hyperpolarization-activated cyclic nucleotide channels

Ach = acetylcholinenACh = nicotinic acetylcholine receptorsAMPA = alpha-amino-3-hydroxyl-5-

methylisoxazole-4-propionic acidmGluR = metabotropic glutamate receptorsERK1/2 = extracellular signal-regulated kinasesNOX = NADPH oxidaseBDNF = brain-derived neurotrophic factormTOR = mammalian target of rapamycinRgs4 = regulator of G protein signaling 4L-type Ca2 = L-type calcium channelsGFAP = glial fibrillary acidic protein

Abbreviations

#FSHP2019PK / PDPK / PD• Administration: IV, IM, oral, intranasal, rectal• Onset (IV): within 30 seconds• Duration: Anesthetic: 5-10 minutes Recovery: 1-2 hours

• Half-life elimination: 10-15min vs 2.5hrs• VD: 2.4L/kg• Protein binding: 27%• Metabolism: Hepatic via P450 Active metabolite: norketamine (33% potency)

Erstad et al. J Crit Care 2016;35:145-149.Ketamine. Lexi-Drugs. Lexi-comp. Wolters Kluwer Health, Inc.

https://www.cyprotex.com/insilico/physiological_modelling/chempk

#FSHP2019DosingDosingIndication and Reference Specific• Anesthesia: Induction -> 0.5-4.5 mg/kg IVP Maintenance -> 0.1-6 mg/min (depending on adjuvants)

• Procedural sedation/analgesia: 0.5-2 mg/kg IVP• Intensive Care Unit: Opioid adjunct -> 0.5 mg/kg IV then 1-2 mcg/kg/min (0.06-0.12 mg/kg/hr) Sedation -> 0.5-2 mg/kg IV then 0.5-5 mg/kg/hr (8.3-83.3 mcg/kg/min)

Devlin et al. Crit Care Med 2018;46:e825-e873.Ketamine. Lexi-Drugs. Lexi-comp. Wolters Kluwer Health, Inc.

Ketamine. Micromedex Solutions. Truven Health Analytics, Inc.

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#FSHP2019Adverse ReactionsAdverse Reactions• Emergence• Tachycardia • Dysrhythmias• Hypertension• Hypotension• Hypersalivation• Heart failure• Nystagmus

• Diplopia• Anaphylaxis• Nausea• Vomiting• Increased IOP• Respiratory depression• Laryngeal spasm• Drug abuse

Erstad et al. J Crit Care 2016;35:145-149.Ketamine. Lexi-Drugs. Lexi-comp. Wolters Kluwer Health, Inc.

Ketamine. Micromedex Solutions. Truven Health Analytics, Inc.

#FSHP2019Clinical EffectsClinical EffectsAdvantages• Sympathomimetic (HR, BP)• Lacks respiratory depression• Pharyngeal and laryngeal reflexes• Lowers airway resistance• Increases lung compliance• No GIB (vs. NSAIDS)• No AKI (vs. NSAIDS)• No constipation (vs. opioids)• No ICP interactions• Cost

Disadvantages• Psychotomimetic (emergence reactions)• Aggravate pulmonary hypertension• CNS excitation• Psychiatric history• Drug withdrawal• Myocardial depression• Hydrocephalus• Hypersalivation• Legality (administration)

Erstad, et al. J Crit Care 2016;35:145-149, Miller et al. Minerva Anestesiol 2011;77:812-820.

#FSHP2019AnalgosedationAnalgosedationAnalgesia-based or Analgesia-first sedation

“Emphasis is placed on relieving pain and discomfort prior to instituting sedative-hypnotic agents that do not have analgesic properties”

Devabhakthuni et al. Ann Pharmacother 2012;46:530-540.Patanwala et al. J Intensive Care Med 2017;32:387-395.

#FSHP2019

Impact of Ketamine Use on Adjunctive Analgesic and Sedative Medications in Critically Ill Trauma Patients

Objective Examine the impact of ketamine infusions on sedative and analgesics in mechanically ventilated critically ill trauma patients

Methods• Single center, retrospective study (2014-2015)• Included ICU patients who received ketamine continuous infusions• Excluded indications other than ICU sedation and agitation

Results(n=36)

• Avg. ketamine (mg/kg/hr): < 24 hrs (0.64), 24-48 hrs (0.81), and 48-72 hrs (0.94)• 72 hrs pre-ketamine vs 72 hrs post-ketamine:

No ∆ RASS goal, midazolam equivalents, IV haloperidol or quetiapine Less morphine equivalents (p=0.026) and propofol (p=0.002) More dexmedetomidine (p=0.002) and ziprasidone (p=0.018)

Conclusions Routine use of ketamine should not be recommended until large prospective studies assess efficacy and safety and determine the ideal dosing strategy

Pruskowski et al. Pharmacotherapy 2017;37:1537-1544.

#FSHP2019

Ketamine Infusion for Adjunct Sedation in Mechanically Ventilated Adults

Objective Describe experience using ketamine infusions as adjunct sedation targeting light levels of sedation in mechanically ventilated critically ill patients

Methods

• Single center, retrospective study (2012-2016)• Receiving continuous sedation or analgesia with goal SAS 3-4• Ketamine infusion for at least 6 hrs• Excluded deep sedation and nonsedation indications

Results(n=91)

• Ketamine – start 0.1 mg/kg/hr with median 0.41 mg/kg/hr for 2.8 days• Reduced or discontinued sedatives without initiation of another at 24 hrs (63%)• Increased SAS scores at goal (pre-24hr vs post-24hr) (p=0.001)• No difference in rates of ADRs, < 8% with ketamine

Conclusions Continuous infusion ketamine is well tolerated with an acceptable safety profile when used for adjunct sedation in critically ill adults

Groetzinger et al. Pharmacotherapy 2018;38:181-188.

#FSHP2019

Continuous Infusion Ketamine for Adjunctive Analgosedation in Mechanically Ventilated, Critically Ill Patients

Objective Adjunctive ketamine will decrease concomitant analgesic/sedative infusions and increase or maintain time within goal sedation range

Methods• Two-center, retrospective study (2016-2017)• One analgesic or sedative infusion with ketamine infusion for at least 24hrs• Excluded status epilepticus and NMB administration

Results(n=104)

• Ketamine – median 5 mcg/kg/min for 90.5 hrs (max 7 mcg/kg/min @ 72 hrs)• 20% reduction of concomitant analgesics and sedatives (p=0.001)• Improved time in goal RASS (7.1% pre- vs. 25% post-ketamine) (p=0.005)• No difference median RASS, # RASS assessments, or CAM-ICU• If vasopressors (n=12), 70.5% had decrease or discontinue with ketamine• No difference responders vs non-responders

Conclusions Ketamine infusions promote concomitant analgesic/sedative dose-sparing effects while increasing time within goal RASS in mechanically ventilated patients

Garber at al. Pharmacotherapy 2019;39:288-296.

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#FSHP2019ClinicalTrials.govClinicalTrials.govAs of May 2019• Ketamine -> 624 studies• Ketamine + Continuous infusion -> 46 studies• Ketamine + Intensive Care Unit -> 19 studies• Ketamine + Critically ill -> 7 studies• Ketamine + Analgosedation -> 3 studies

https://clinicaltrials.gov

#FSHP2019Future of Ketamine in ICUFuture of Ketamine in ICU• Procedures• Adjunct to opioids• Continuous sedation: Indications? Dosing regimens? Other effects?

• Future studies?

https://www.123rf.com/photo_110475100...

#FSHP20192018 Guidelines2018 GuidelinesPainAgitation / SedationDeliriumImmobility (Rehabilitation / Mobilization)Sleep Disruption

PADIS

#FSHP2019DeliriumDeliriumTopic Strength Recommendation

Risk Factors Ungraded Modifiable and non-modifiable

Prediction Ungraded Validated at ICU admission and in first 24 hours of ICU

Assessment Good Practice Statement Regular assessment with a validated tool

Outcomes Ungraded Screenings and delirium associated with a variety of outcomes

Devlin et al. Crit Care Med 2018;46:e825-e873.

#FSHP2019PharmacologyPharmacologyTopic Strength Recommendation

Prevention in all ICU patients Suggest not using

Haloperidol, atypical antipsychotics, dexmedetomidine, HMG-CoA reductase

inhibitors, or ketamineSubsyndromalTreatment Suggest not using Haloperidol or atypical antipsychotics

Treatment Suggest not routinely using

Haloperidol, atypical antipsychotics, or HMG-CoA reductase inhibitors

Dexmedetomidine Suggest usingDexmedetomidine if mechanically

ventilated where agitation is precluding weaning/extubation

Devlin et al. Crit Care Med 2018;46:e825-e873.

#FSHP2019NonpharmacologicNonpharmacologicTopic Strength Recommendation

Bright Light Therapy Suggest not using To reduce delirium

MulticomponentStrategy Suggest using

Focused on reducing modifiable risk factors, improving cognition, and optimizing sleep,

mobility, hearing, and vision

Devlin et al. Crit Care Med 2018;46:e825-e873.

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#FSHP20192018 Guidelines2018 GuidelinesPainAgitation / SedationDeliriumImmobility (Rehabilitation / Mobilization)Sleep Disruption

PADIS

#FSHP2019Immobility (Rehabilitation / Mobilization)Immobility (Rehabilitation / Mobilization)• ICU-acquired muscle weakness (ICUAW): 25-50% of critically ill patients Associated with long-term survival, physical functioning, and QOL

• 2013 – beneficial as part of delirium management • Current / Future: Growing literature Interplay with PAD

Devlin et al. Crit Care Med 2018;46:e825-e873.

#FSHP2019ImmobilityImmobilityTopic Strength Recommendation

Efficacy & Benefit SuggestPerforming

Either in-bed or out-of-bed improves patient, family, or health system outcomes

Safety and Risk Ungraded Serious safety events or harms do not commonly occur

Initiation Ungraded Stability of cardiovascular, respiratory, and neurologic status

Stopping Ungraded Development of new cardiovascular, respiratory, or neurologic instability

Devlin et al. Crit Care Med 2018;46:e825-e873.

#FSHP2019Safety CriteriaSafety CriteriaCardiovascular• HR: 60-130 bpm• SBP: 90-180 mmHg• MAP: 60-100 mmHgRespiratory• RR: 5-40 bpm• SpO2 ≥ 88%• FiO2 < 0.6 and PEEP <10• Secure airwayNeurologic – multipleOther – sheath, CRRT, pressors

Devlin et al. Crit Care Med 2018;46:e825-e873.

#FSHP20192018 Guidelines2018 GuidelinesPainAgitation / SedationDeliriumImmobility (Rehabilitation / Mobilization)Sleep Disruption

PADIS

#FSHP2019Sleep DisruptionSleep DisruptionICU sleep disruption• ↑ light (N1 + N2)• ↓ slow-wave (N3)• ↓ REM

Delirium sleep disruption• ? light (N1 + N2)• ? deep (N3)• ↓ REM

Devlin et al. Crit Care Med 2018;46:e825-e873.https://www.webmd.com/sleep-disorders/ss/slideshow-sleep-body-effects

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#FSHP2019CharacterizationCharacterizationHealthy ICU Delirium Mechanical

Ventilation (MV)*

Total sleep time (TST) Normal ↔ ?

Sleep efficiency Normal ↔ ↑ / ↔Circadian rhythm Abnormal Abnormal Abnormal

Sleep fragmentation ↑ ↔ ↔Daytime sleeping ↑ ↑ ↑Subjective quality ↓ ? ?

Devlin et al. Crit Care Med 2018;46:e825-e873.

MV* = effects variable and not fully investigated

#FSHP2019PharmacologicPharmacologicTopic Strength Recommendation

Melatonin No recommendation

Limited data, concerns with quality and consistency of product

Dexmedetomidine No recommendation

If hemodynamically stable, reasonable option (potential to improve sleep

architecture)

Propofol Suggest not using Solely for sleep, may use if procedural or continuous sedation required

Sleep-Promoting Protocol Suggest using Incorporate multiple interventions

Devlin et al. Crit Care Med 2018;46:e825-e873.

#FSHP2019NonpharmacologicNonpharmacologicTopic Strength Recommendation

Ventilator Mode Suggest using Assist-control (vs. pressure support) at night

Adaptive Ventilation Norecommendation Compared to pressure support

NIV-dedicated Ventilator Suggest using NIV-dedicated or standard ICU ventilator

requiring NIV to improve sleepAromatherapy / Acupressure / Music Suggest not using Compared to not using them

Noise and Light Reduction Suggest using Use at night to improve sleep

Devlin et al. Crit Care Med 2018;46:e825-e873.

NIV = Noninvasive ventilation

#FSHP2019Implement, Integrate, and EvaluateImplement, Integrate, and Evaluate• Clinician perspective: Breadth of topics Conditional nature of recommendations Most of the patients, most of the time

• Guidelines -> “what” but not “how”• How are guidelines successful?

Balas et al. Crit Care Med 2018;46:1464-1470.

#FSHP2019TimelineTimeline

1990 2000 2010 2020

1995 2013 20182002Guidelines

Bundles

2011ABCDE

2008ABC Trial

#FSHP2019ABCDEABCDE

Morandi et al. Curr Opin Crit Care 2011;17:43-49.

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#FSHP2019TimelineTimeline

1990 2000 2010 2020

1995 2013 20182002Guidelines

Bundles

2011ABCDE

2016ABCDEF

2008ABC Trial

#FSHP2019SCCM ICU LiberationSCCM ICU Liberation• Improve patient outcomes:

After an ICU stay Reduce the risk of long-term consequences (PICS)

• Empower multi-professional team• Evidence based strategy to implement guidelines• Greatest benefit when interventions combined:

Offer numerous tools and resources Components are clearly defined but flexible to implement

https://www.sccm.org/ICULiberation/AboutMarra et al. Crit Care Clin 2017;33:225-243.

#FSHP2019ABCDEF BundleABCDEF BundleAssess, Prevent, and Manage PainBoth SAT and SBTChoice of Analgesia and SedationDelirium: Assess, Prevent, and ManageEarly Mobility and ExerciseFamily Engagement and Empowerment

https://www.sccm.org/ICULiberation/ABCDEF-Bundles

ABCDEF

#FSHP2019

Pronovost et al. BMJ 2008;337:a1714.

OverviewOverview

#FSHP2019Implementation ProcessImplementation Process• Evaluate clinically / address gaps in guidelines• Begin discussions at hospital and ICU levels Gather information Involve stakeholders

• Engagement

Balas et al. Crit Care Med 2018;46:1464-1470.

#FSHP2019Key StakeholdersKey StakeholdersPhysicians Pharmacists Respiratory

Therapists

Physical Therapists Nurses Occupational

Therapists

Speech Therapists Consultants Pastoral Care

Information Technology

Patients / Family

Balas et al. Crit Care Med 2018;46:1464-1470.

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#FSHP2019StrategyStrategyPlanning• Identify early adopters, opinion leaders, and

champions• Assess current practice• Assess readiness and identify barriers• Provide metrics for tracking• Electronic medical record• Develop incentives / disincentives• Institutional buy-in (executive leadership)• Visit other sites• Develop academic partnerships• Consider participating in a collaborative

Planning

Implementation

Evaluation

Balas et al. Crit Care Med 2018;46:1464-1470.

#FSHP2019Assess Current PracticeAssess Current Practice• Walking rounds• Case reviews• Staff interviews• Perform gap analysis• Previous MUEs or DUEs• Review existing policies & procedures• Evaluate documentation• Identify committee involvement• Explore ICU culture

Balas et al. Crit Care Med 2018;46:1464-1470.https://www.123rf.com/photo_8443366_man-with-magnifying-glass.html

#FSHP2019BarriersBarriers• Strength of evidence• Implementation complexity• Administrative support• Resource availability• Clinician time• Knowledge, beliefs, skills• Education support• Financial barriers / cost• Team communication and

cooperation

• ICU culture• Priority• Guideline adaptability• Organizational incentives• Self-efficacy• Local, district, regional

comparators• International comparators• Learning framework

Balas et al. Crit Care Med 2018;46:1464-1470.

#FSHP2019StrategyStrategyImplementation• Develop formal plan• Ensure orders and documentation• Model and stimulate change• Mandate change• Provide ongoing education and outreach• Use reminders• Promote adaptability• Trial changes (PDSA)

Planning

Implementation

Evaluation

Balas et al. Crit Care Med 2018;46:1464-1470.

#FSHP2019Plan-Do-Study-Act (PDSA)Plan-Do-Study-Act (PDSA)

https://innovations.ahrq.gov/qualitytools/plan-do-study-act-pdsa-cycle

Step 1

• Plan test or observation

• Plan data collection

Step 2

• Do• Test on a

small scale

Step 3

• Study• Analyze

data and results

Step 4

• Act• Refine

change

#FSHP2019StrategyStrategyEvaluation• Audit and provide feedback (process &

outcomes)• Identify additional barriers• Tailor strategies• Use data experts• Conduct cyclical small test of change• Broaden comparators

Planning

Implementation

Evaluation

Balas et al. Crit Care Med 2018;46:1464-1470.

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#FSHP2019SustainabilitySustainability• Multiple initiatives• Goal setting• Champions• Benchmark data• Rounding checklists• Competition

Balas et al. Crit Care Med 2018;46:1464-1470.http://livingflow.ca/spinning-plate-syndrome-anxious-stressed-depressed-how-to-relieve-the-spinning/

#FSHP2019ApplicabilityApplicability

Barnes-Daly et al. Crit Care Med 2017;45:171-178.

#FSHP2019Improving Hospital Survival and Reducing Brain Dysfunction at Seven

California Community Hospitals: Implementing PAD Guidelines Via the ABCDEF Bundle in 6064 Patients

Objective Study the relationship between ABCDEF bundle compliance and outcomes including hospital survival and delirium-free and coma-free days (DFCFDs)

Methods(n=6064)

• QI initiative utilizing an interprofessional team (IPT) model to implement bundle• Seven community-based ICUs in California, calendar year 2014• Bundle elements implemented for every patient every day

Bundle Elements

A: SAT - turn of all sedation and pain meds unless active painB: SBT – safety screen then CPAP for 30 minsC1: Coordination of A & B – RN & RT communicationC2: PharmD PAD guidelines – light sedation, avoid BDZs, analgosedationD: CAM-ICU - evaluate delirium on both current and previous shiftsE: Mobilization – to maximum potential following safety screenF: Patient/Family – participated in rounds or family conference

Barnes-Daly et al. Crit Care Med 2017;45:171-178.

#FSHP2019

Barnes-Daly et al. Crit Care Med 2017;45:171-178.

#FSHP2019Components to SuccessComponents to Success• Tenets of the interprofessional team (IPT) model• Training provided to teams• Practice and embedding behaviors Collaborations Shared decision making

Barnes-Daly et al. Crit Care Med 2017;45:171-178.https://www.skmurphy.com/blog/2009/06/28/michael-schrage-on-innovation-collaboration...

#FSHP2019ConclusionsConclusionsPADIS builds upon the PAD guidelines with an emphasis on immobility and sleep disruption

Although the future of nefopam looks unclear, ketamine provides multiple opportunities to positively impact the care of critically ill patients

The implementation, integration, and evaluation of the guidelines is complex and requires a dedicated multidisciplinary team

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#FSHP2019

To PADIS and Beyond: Updates and Integration To PADIS and Beyond: Updates and Integration Michael Semanco, PharmD, BCPS, BCCCPClinical Pharmacy Specialist – Critical CareLakeland Regional HealthAugust 3, 2019

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