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PROTOCOL REVIEW GAP ANALYSIS

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1 PROTOCOL REVIEW GAP ANALYSIS
Amy Gutman MD David Violante, MPH, MPA, AEMTP

2 OVERVIEW What is a “Gap Analysis”?
How Gap Analysis changed the way we manage advanced airways Using Gap Analysis to identify potential flaws in a current protocol Buzzanalysis.com

3 WHAT IS A GAP ANALYSIS? Assess current vs “best” standards
Identify “gap” between ideal & present state Analyze process needing improvement Take appropriate action Buzzanalysis.com

4 Does Current Protocol Practically Work?
No Change Needed Fix Now! YES NO Is Current Protocol Supported by Evidence Based Medicine (EBM) No Change Needed Fix Now! YES NO Does Current Protocol Meet National Standards? No Change Needed Fix Now! YES NO

5 EXAMPLE: SPINE BOARDING

6

7 QUESTION: IS PLACEMENT OF AN ENDOTRACHEAL TUBE WITHOUT ETCO2 CONFIRMATION SAFE?

8 In order to function efficiently, what does a cell need?
THE CELL In order to function efficiently, what does a cell need?

9 MEASURING ENVIRONMENT
Oxygen Glucose Carbon Dioxide Acids Electrolytes Ability to fight disease Water Function Blood components Others… Pressure Temperature

10 OXIMETRY (SPO2) Measurement of oxygen bound to hemoglobin by evaluating color differences of blood in peripheral vasculature Pros? Gross evaluation of oxygen availability to cells Cons? Dependent on amount of hemoglobin & perfusion lag time

11 Measurement of exhaled carbon dioxide
CAPNOGRAPHY (ETCO2) Measurement of exhaled carbon dioxide Pros? Great information Waveform shows ventilation activity Cons? Must interpret values based on patient’s condition & situation

12 SPO2 vs ETCO2 Evaluate & Improve: Metabolism Perfusion Respiration
Ventilation Determine: ETT position ROSC

13 EVALUATING ROSC WITH ETCO2

14 73 YO VF ARREST

15 ETCO2 WAVEFORMS

16 Does Current Protocol Practically Work?
No Change Needed Fix Now! YES NO Is Current Protocol Supported by Evidence Based Medicine (EBM) No Change Needed Fix Now! YES NO Does Current Protocol Meet National Standards? No Change Needed Fix Now! YES NO

17 SAL SILVESTRI MD Ann Emerg Med. 2005 May;45(5):497-503
The effectiveness of out-of-hospital use of continuous ETCO2 monitoring on rate of unrecognized misplaced intubation within a regional EMS system Objective Evaluate association between out-of-hospital use of ETCO2 monitoring and unrecognized misplaced intubations Methods Prospective, observational study over 10 months All patients arriving at a Level I trauma center who underwent out-of-hospital ETI Outcome measure: unrecognized misplaced intubation rate with & without use of continuous ETCO2 monitoring

18 Silvestri... Ann Emerg Med. 2005 May;45(5):497-503.
SAL SILVESTRI MD Ann Emerg Med. 2005 May;45(5): Silvestri... Ann Emerg Med. 2005 May;45(5): Results 153 Intubations 93 Had continuous ETCO2 0% Rate of unrecognized misplaced ETI in ETCO2 group 60 Did not have continuous ETCO2 23% Rate of unrecognized misplaced ETI in non-ETCO2 group Conclusion No unrecognized misplaced ETI in patients with continuous ETCO2 monitoring Failure to use continuous ETCO2 monitoring associated with a 23% unrecognized misplaced intubation rate

19 ETT PLACEMENT “Waveform Capnography is the most definitive evidence of correct endotracheal tube placement” Kodali, et al. Capnography during cardiopulmonary resuscitation: Current evidence and future directions. J Emerg Trauma Shock. 2014;7(4): Meaney, et al. Cardiopulmonary Resuscitation Quality: Improving Cardiac Resuscitation Outcomes Both Inside and Outside the Hospital. A Consensus Statement From the AHA Endorsed by ACEP and SCCM. Circulation. 2013;128: Štefek Grmec, Comparison of three different methods to confirm tracheal tube placement in emergency intubation. Intensive Care Medicine. 2002;28(6):

20 HOW WE CHANGE PRACTICE & PROTOCOLS
Medical Advisory Committees COUNTY REGION STATE NATIONAL Medical Standards Committee Organizations of Authority Studies / Research / EVIDENCE Gathering of Eagles, Dallas 2016

21 PROTOCOL REVIEW PATIENT REFUSALS

22 QUESTION: ARE PATIENT REFUSALS FOR OPIOID OVERDOSAGES POST NALOXONE REVERSAL MEDICALLY-LEGALLY SAFE & APPROPRIATE?

23 Does Current Protocol Practically Work?
No Change Needed Fix Now! YES NO Is Current Protocol Supported by Evidence Based Medicine (EBM) No Change Needed Fix Now! YES NO Does Current Protocol Meet National Standards? No Change Needed Fix Now! YES NO

24 FACT: AN INTOXICATED PATIENT CANNOT GIVE INFORMED CONSENT QUESTION: CAN A PATIENT POST OPIATE OVERDOSE GIVE INFORMED CONSENT?

25 INFORMED CONSENT Informed consent criteria:
Given complete & accurate information about risks refusal risks & treatment benefit Able to understand & communicate risks & benefits Able to make decision consistent with beliefs & life goals

26 INFORMED CONSENT REQUIRED FOR REFUSAL
ACDC Autonomous Capable Disclosure of information Comprehension “Sliding Scale” Comprehension / Capacity The more serious risk posed by decision, the more stringent capacity standard Refusal of EMS transport proven considered “high risk”

27 CAPACITY ALTERED DETERMINING CAPACITY Intoxication
Certain psychiatric illness Dementia / mentally disabled No deficits in Cognition Judgment Understanding Expression of choice Mental stability Talk to patient Information processing? Signs of impairment? Examine: Glasgow Coma Scale Normal vitals & glucose Absence of injury or AMS

28 NYS EMS COLLBORATIVE PROTOCOLS

29 SCOPE OF THE PROBLEM From US deaths due to OD increased >600%1 Opioid analgesics = 74% prescription drug deaths2 Oxycodone, methadone, morphine, fentanyl Opioids surpass total deaths involving heroin or cocaine3 Is current policy allowing patients post opioid overdose with naloxone reversal appropriate & safe? 1Warner M, Chen LH, Makuc DM, Anderson RN, Minino AM. Drug poisoning deaths in the United States,  NCHS data brief 2011;(81):1–8. NCHS data brief 2014;166:1–8.[3MMWR 2011;60(43):1487–92

30 NALOXONE / NARCAN Opioid antagonist
Reverses CNS / respiratory depression secondary to opioids Important component in EMS response to opioid overdoses1 1 Belz D, Lieb J, Rea T, Eisenberg MS. Naloxone use in a tiered-response emergency medical services system. Prehosp Emerg Care. 2006;10(4):468–71.

31 AT 1ST GLANCE… REFUSALS APPEAR SAFE
Objective Assess mortality during 48 hrs after patients receive naloxone followed by patient-initiated refusal of transportation  Methods San Antonio fire-based EMS system Patients treated with naloxone & not transported List compared with ED database for 30 days Results 552 received naloxone, not transported 40 in cardiac arrest received naloxone, terminated in the field 0 receiving naloxone died within 48 hours 9 receiving naloxone died within 30 days (1.5%) Wampler DA, Molina DK, McManus J, et al. No deaths associated with patient refusal of transport after naloxone-reversed opioid overdose. Prehosp Emerg Care 15(3): 320–4, Jul–Sep 2011.

32 AT 2ND GLANCE… REFUSALS APPEAR SAFE
4 “major” studies Studies varied in methodology, but similar results Risk of death from recurrent opioid toxicity after naloxone administration % Hayes B. ‘Treat and Release’ after Naloxone – What is the Risk of Death?August 24th, ALIEM.org; Vilke G, Assessment for deaths in out-of-hospital heroin overdose patients treated with naloxone who refuse transport. Acad Emerg Med. 2003;10(8):  Boyd J. Recurrent opioid toxicity after pre-hospital care of presumed heroin overdose patients. Acta Anaesthesiol Scand. 2006;50(10):  Wampler D. No deaths associated with patient refusal of transport after naloxone-reversed opioid overdose. Prehosp Emerg Care. 2011;15(3):  Rudolph S. Prehospital treatment of opioid overdose in Copenhagen–is it safe to discharge on-scene? Resuscitation. 2011;82(11):

33 Does Current Protocol Practically Work?
No Change Needed Fix Now! YES NO Is Current Protocol Supported by Evidence Based Medicine (EBM) No Change Needed Fix Now! YES NO Does Current Protocol Meet National Standards? No Change Needed Fix Now! YES NO

34 WHAT’S THE PROBLEM? Does Current Protocol Practically Work?
Studies asking wrong question EBM primarily studied IN naloxone EBM subjects primarily used heroin, not longer-acting agents Follow-up data “Twainish” YES Is Current Protocol Supported by Evidence Based Medicine (EBM) ?

35 ASK A DIFFERENT QUESTION
Determine frequency of opioid toxicity recurrence post naloxone vs death post naloxone 45% recurrent toxicity Majority = oral longer acting opioids vs heroin Take home point: Recurrence frequent with long-acting opioids & also occurred with short-acting opioids including heroin Watson W, et al. Opioid toxicity recurrence after an initial response to naloxone. J Toxicol Clin Toxicol. 1998;36(1-2):11-17. 

36 ASK A DIFFERENT QUESTION
Most common opioid in early studies = heroin Opioid epidemic changed, with many opioids longer acting than naloxone’s minute duration of effect Data supports ‘treat and release’ strategy for heroin users Only if returned to baseline with stable vitals, with capacity If long-acting opioids, research does not support treat & release Example: insulin vs oral hypoglycemic agents EMJClub Emergency Medicine Podcast

37 LIES, DAMN LIES & STATISTICS
ME records of OD deaths x 5-years Compare databases of patients receiving naloxone who refused treatment to ME databases for deaths <12 hours later No cross-reports showed patients treated with naloxone then refusing medical treatment were not later found dead Therefore it is safe to allow OD patients to refuse treatment Is that a logical assumption? Vilke et al. 1999, 2003

38 ASK A DIFFERENT QUESTION
Buajordet et al, 2004 Adverse events after naloxone for acute opioid OD 1192 patients receiving IM + IV 0.4 dose 726 adverse events in 538 patients (45%) Osterwalder, 1996 485 patients admitted to the hospital 538 times for heroin ODs 453 received naloxone IV, IM, or IV + IM 46 adverse events including 8 deaths (10%) Respiratory arrest Pulmonary edema Status epilepticus Aspiration pneumonia / sepsis Buajordet et al, 2004; Osterwalder J. Naloxone - for intoxications with intravenous heroin and heroin mixtures – harmless of hazardous? A prospective clinical study. Clin Toxicol : 409–416

39 NALOXONE-RELATED ADVERSE EFFECTS
Acute withdrawal Seizures Cardiac arrest Tachycardia Pulmonary edema Emsimcases.com

40 RE-EXAMINE EVIDENCE Does Current Protocol Practically Work? YES
Is naloxone safe to utilize in patients likely to later refuse further treatment and transport? IN naloxone = yes / IV naloxone = no Different patients Different drugs Different levels of critical illness Heroin = yes / Long acting opiates = no Does Current Protocol Practically Work? YES Is Current Protocol Supported by Evidence Based Medicine (EBM) NO Buajordet et al, 2004

41 DECISION-MAKING TIME Current protocols based on old data & different opioids No new EMB research into outcomes Adverse events from IV naloxone not insignificant Should the current protocol be changed?

42 REFERENCES Blain H, Masud T, Dargent-Molina P, et al, for the EUGMS Falls and Fracture Interest Group; European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO), Osteoporosis Research and Information Group (GRIO), and International Osteoporosis Foundation (IOF). A comprehensive fracture prevention strategy in older adults: The European Union Geriatric Medicine Society (EUGMS) statement. J Nutr Health Aging. 2016;20(6):647-52 Burns ER, Stevens JA, Lee R. The direct costs of fatal and non-fatal falls among older adults - United States. J Safety Res. 2016 Sep;58: PMID: Bradley SM. Falls in older adults. Mt Sinai J Med. 2011 Jul-Aug;78(4):590-5 Carneiro MB, Alves DP, Mercadante MT. Physical therapy in the postoperative of proximal femur fracture in elderly. Literature review. Acta Ortop Bras May;21(3):175-8 Caroline’s Emergency Care in the Street. Jones & Bartlett. 2012 Centers for Disease Control and Prevention. Injury prevention & control: traumatic brain injury & concussion. TBI: get the facts. Updated: September 20, 2016 Cenzer IS, Tang V, Boscardin WJ, et al. One-year mortality after hip fracture: development and validation of a prognostic index. J Am Geriatr Soc. 2016 Sep;64(9):1863-8 Filer W, Harris M. Falls and traumatic brain injury among older adults. N C Med J Apr;76(2):111-4 Institute of Medicine (US) Division of Health Promotion and Disease Prevention. Falls in older persons: risk factors and prevention. In: Berg RL, Cassells JS, eds. The Second Fifty Years: Promoting Health and Preventing Disability. Washington, DC: National Academies Press: 1992 Levine M, Sanko S, Eckstein M. Assessing the Risk of Prehospital Administration of Naloxone with Subsequent Refusal of Care. Prehosp Emerg Care. March 2016:1-4 Limmer et al. Emergency Care 11th ED. Brady. 2009 NAEMT.org, NAEMSE.org. IAFF. Org Page, Wolfberg & White Website; pwwemslaw.com Stevens JA, Ballesteros MF, Mack KA, Rudd RA, DeCaro E, Adler G. Gender differences in seeking care for falls in the aged Medicare population. Am J Prev Med. 2012 Jul;43(1):59-62. Tom SE, Adachi JD, Anderson FA Jr, et al. Frailty and fracture, disability, and falls: a multiple country study from the global longitudinal study of osteoporosis in women. J Am Geriatr Soc. 2013 Mar;61(3):327-34 Watson W, Steele M, Muelleman R, Rush M. Opioid toxicity recurrence after an initial response to naloxone. J Toxicol Clin Toxicol. 1998;36(1-2):11-17 Willman M, Liss D, Schwarz E, Mullins M. Do heroin overdose patients require observation after receiving naloxone? Clin Toxicol (Phila). November 2016:1-7

43 SUMMARY How Gap Analysis changed advanced airway management
Using Gap Analysis to identify potential flaws in a current protocol If a “fact” not backed by evidence, ask a different question and do your own research

44 Thank You! Amy Gutman MD David Violante, MPH, MPA, AEMTP
Chief of Emergency Medicine HAHV @prehospitalmd David Violante, MPH, MPA, AEMTP @ViolanteDavid

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