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How the ACEP Clinical Policies Standardize and Improve Patient Care Andy Jagoda, MD, FACEP Professor of Emergency Medicine Mount Sinai School of Medicine.

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Presentation on theme: "How the ACEP Clinical Policies Standardize and Improve Patient Care Andy Jagoda, MD, FACEP Professor of Emergency Medicine Mount Sinai School of Medicine."— Presentation transcript:

1 How the ACEP Clinical Policies Standardize and Improve Patient Care Andy Jagoda, MD, FACEP Professor of Emergency Medicine Mount Sinai School of Medicine New York, New York

2 Objectives Introduce the process of how clinical policies / practice guidelines are developedIntroduce the process of how clinical policies / practice guidelines are developed Discuss the medical legal implications of practice guidelinesDiscuss the medical legal implications of practice guidelines Use examples from practice guidelines on brain injury and headache to demonstrate applications to patient careUse examples from practice guidelines on brain injury and headache to demonstrate applications to patient care

3 ACEP and Clinical Policies Committee formed in 1987Committee formed in 1987 Meetings with DM EddyMeetings with DM Eddy Fatal flaw: decision to concentrate on symptoms or complaintsFatal flaw: decision to concentrate on symptoms or complaints Topics chosen from complaints with high frequency, high risk, or high costTopics chosen from complaints with high frequency, high risk, or high cost New directionsNew directions

4 Clinical Policies / Practice Guidelines Over 3000 in existenceOver 3000 in existence ACEP: 15ACEP: 15 Chest Pain 1990Chest Pain 1990 Sunsetting - no longer distributedSunsetting - no longer distributed Archive – reviewed and kept on websiteArchive – reviewed and kept on website National Guideline Clearinghouse:National Guideline Clearinghouse: www.guideline.gov www.guideline.gov Over 550 guidelines registered Over 550 guidelines registered

5 Why are clinical policies being written? Differentiate evidence based practice from opinion basedDifferentiate evidence based practice from opinion based Clinical decision making Clinical decision making Education Education Reducing the risk of legal liability for negligence Reducing the risk of legal liability for negligence Improve quality of health careImprove quality of health care Assist in diagnostic and therapeutic managementAssist in diagnostic and therapeutic management Improve resource utilizationImprove resource utilization May decrease or increase costs May decrease or increase costs Identify areas in need of researchIdentify areas in need of research

6 Guideline Development: Time and Cost Time: 1- many yearsTime: 1- many years Cost:Cost: ACEP:$10,000 ACEP:$10,000 AANS:$100,000 AANS:$100,000 AHCPR:$1,000,000 AHCPR:$1,000,000 WHO:$2,000,000 WHO:$2,000,000

7 Interpreting the literature TerminologyTerminology Mild traumatic brain injuryMild traumatic brain injury Patient populationPatient population Children vs adultsChildren vs adults CT + vs CT -CT + vs CT - Interventions / outcomesInterventions / outcomes Any brain lesionAny brain lesion Lesion requiring ns interventionLesion requiring ns intervention

8 Critically Appraising Clinical Policies Why was the topic chosenWhy was the topic chosen What are the authors credentialsWhat are the authors credentials What methodology was usedWhat methodology was used Was it field testedWas it field tested When was it written / updatedWhen was it written / updated

9 Do clinical policies change practice? ACEP Chest Pain Policy: Emergency physician awareness. Ann Emerg Med 1996; 27:606-609Clinical policy published in 1990ACEP Chest Pain Policy: Emergency physician awareness. Ann Emerg Med 1996; 27:606-609Clinical policy published in 1990 163 / 338 (48%) response to survey163 / 338 (48%) response to survey 54% aware of the policy54% aware of the policy Majority of those aware did not know contentMajority of those aware did not know content Wears. Headaches from practice guidelines. Ann Emerg Med 2002; 39:334-337Wears. Headaches from practice guidelines. Ann Emerg Med 2002; 39:334-337 60% of practicing EPs use narcotics as first line medications60% of practicing EPs use narcotics as first line medications Canadian Headache Society. Guidelines for the diagnosis and management of Migraine in clinical practice.Canadian Headache Society. Guidelines for the diagnosis and management of Migraine in clinical practice. Can Med Assoc J 1997; 156:1273-128US Headache Consortium. www.aan.com/public/practice guidelinesCan Med Assoc J 1997; 156:1273-128US Headache Consortium. www.aan.com/public/practice guidelineswww.aan.com/public/practice

10 Cabana et al. Why dont physicians follow clinical practice guidelines. JAMA 1999; 282:1458-1465 Review of 76 articles dealing with adherenceReview of 76 articles dealing with adherence Barriers to physician adherence identified:Barriers to physician adherence identified: Lack of familiarity (more common than lack awarenessLack of familiarity (more common than lack awareness Lack of agreementLack of agreement Lack of self-efficicy (lack of access to intervention, lack of resources / support / social systems)Lack of self-efficicy (lack of access to intervention, lack of resources / support / social systems) Thrombolytics in strokeThrombolytics in stroke Lack of outcome expectancy (lack of confidence that an intervention will change the outcome)Lack of outcome expectancy (lack of confidence that an intervention will change the outcome) Amiodarone in v-fibAmiodarone in v-fib Patient related barriers (inability to overcome patient expectation)Patient related barriers (inability to overcome patient expectation) Ottawa ankle rulesOttawa ankle rules

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12 Medical Legal Implications Clinical policies can set standards for care and have been used in malpractice litigationClinical policies can set standards for care and have been used in malpractice litigation May protect against expert testimonyMay protect against expert testimony Regional practice vs national standardsRegional practice vs national standards Steroids in spinal traumaSteroids in spinal trauma Clinical policies developed using flawed methodology may be challengedClinical policies developed using flawed methodology may be challenged Consensus / Policy statementsConsensus / Policy statements

13 Do the authors seriously believe that patients with a first seizure can be discharged from the ED after a serum glucose and a pregnancy test without additional lab testing? This flies in the face of common sense and would perhaps be considered malpractice in some parts of the country. Journal Reviewer 1995

14 Medical Legal Implications 1994 Physician Payment Review Commission1994 Physician Payment Review Commission 32 cases reviewed where guidelines were used to demonstrate departure from standard of care32 cases reviewed where guidelines were used to demonstrate departure from standard of care 259 insurance claims carriers: 6.6% cited guidelines259 insurance claims carriers: 6.6% cited guidelines 980 attorneys surveyed:980 attorneys surveyed: 75% were aware of practice guidelines75% were aware of practice guidelines 36% reported cases with important role36% reported cases with important role 25% reported that they had influenced a decision to settle or not take a case25% reported that they had influenced a decision to settle or not take a case

15 Deposition of Dr. X in a case of missed meningitis Q. Do you read the policies of the American College of ER physicians? A. I dont recall reading that policy. Is it something published by ACEP? Q. Yes. A. I dont recall reading it.

16 Deposition of Dr. X in a case of missed meningitis Q. So if torodol releives a headache, does that cause you to believe the patient does not have meningitis in a patient in whom you are suspecting meningitis a a possible cause of their headache A. Its an indicator that would decrease the likelihood. Q. If torodol relieved their headache, would you rely on that as a factor in ruling out meningitis? A. It is part of the package.

17 Clinical Policy: Critical issues in the evaluation and management of patients presenting to the ED with acute headache. Ann Emerg Med 2002; 39:108-122 Does a response to therapy predict the etiology of an acute headache?Does a response to therapy predict the etiology of an acute headache? Level A recommendation: NoneLevel A recommendation: None Level B recommendation: NoneLevel B recommendation: None Level C recommendation: Pain response to therapy should not be used as the sole indicator of the underlying etiology of an acute headacheLevel C recommendation: Pain response to therapy should not be used as the sole indicator of the underlying etiology of an acute headache

18 Guideline Development Informal ConsensusInformal Consensus Formal consensusFormal consensus Evidence basedEvidence based

19 Informal Consensus Group of experts assembleGroup of experts assemble Global subjective judgementGlobal subjective judgement Recommendations not necessarily supported by scientific evidenceRecommendations not necessarily supported by scientific evidence Limited by biasLimited by bias

20 Informal Consensus: Examples MAST trousers in traumatic shockMAST trousers in traumatic shock Hyperventilation in severe TBIHyperventilation in severe TBI Oxygen for patient with chest painOxygen for patient with chest pain Magnesium level for patients who have had a seizureMagnesium level for patients who have had a seizure

21 Formal Consensus Group of experts assembleGroup of experts assemble Appropriate literature reviewedAppropriate literature reviewed Recommendations not necessarily supported by scientific evidenceRecommendations not necessarily supported by scientific evidence Limited by bias and lack of defined analytic proceduresLimited by bias and lack of defined analytic procedures

22 Formal Consensus: Limitations Plain film radiographs after head traumaPlain film radiographs after head trauma Phenytoin to prevent development of epilepsy after head traumaPhenytoin to prevent development of epilepsy after head trauma

23 Evidence Based Guidelines Define the clinical questionDefine the clinical question Focused question better than global questionFocused question better than global question Outcome measure must be determinedOutcome measure must be determined Grade the strength of evidenceGrade the strength of evidence Incorporate practice patterns, available expertise, resources and risk benefit ratiosIncorporate practice patterns, available expertise, resources and risk benefit ratios External validityExternal validity

24 Description of the Process Medical literature searchMedical literature search Secondary search of referencesSecondary search of references Articles gradedArticles graded Recommendations based on strength of evidenceRecommendations based on strength of evidence Multi-specialty and peer reviewMulti-specialty and peer review

25 Description of the Process Strength of evidence (Class of evidence) I: Randomized, double blind interventional studies for therapeutic effectiveness; prospective cohort for diagnostic testing or prognosisI: Randomized, double blind interventional studies for therapeutic effectiveness; prospective cohort for diagnostic testing or prognosis II: Retrospective cohorts, case control studies, cross- sectional studiesII: Retrospective cohorts, case control studies, cross- sectional studies III: Observational reports; consensus reportsIII: Observational reports; consensus reports Strength of evidence can be downgraded based on methodologic flaws

26 Description of the process: Strength of recommendations: Strength of recommendations: A / Standard: Reflects a high degree of certainty based on Class I studies A / Standard: Reflects a high degree of certainty based on Class I studies B / Guideline: Moderate clinical certainty based on Class II studies B / Guideline: Moderate clinical certainty based on Class II studies C / Option: Inconclusive certainty based on Class III evidence C / Option: Inconclusive certainty based on Class III evidence

27 Evidence Based Guidelines: Limitations Different groups can read the same evidence and come up with different recommendationsDifferent groups can read the same evidence and come up with different recommendations MTBIMTBI t-PA in stroket-PA in stroke Steroids in spinal traumaSteroids in spinal trauma

28 Concussion in Sports American Academy of NeurologyAmerican Academy of Neurology Evidence based methodologyEvidence based methodology Concussion: a trauma induced alteration in mental status, with or without LOCConcussion: a trauma induced alteration in mental status, with or without LOC Confusion and amnesia are the hallmarksConfusion and amnesia are the hallmarks Justifications:Justifications: Repeated concussions can cause cumulative brain injuryRepeated concussions can cause cumulative brain injury Provide physicians with guidelines to help overcome the bias in management from athletes, coaches, media, spectatorsProvide physicians with guidelines to help overcome the bias in management from athletes, coaches, media, spectators

29 Guidelines for the management of concussion in sports. American Academy of Neurology Grade 1: Confusion: No LOC or amnesiaGrade 1: Confusion: No LOC or amnesia remove from event for 20 minutesremove from event for 20 minutes 2 grade 1 concussions; no play for one day2 grade 1 concussions; no play for one day 3 grade 1 concussions; no play for 3 months3 grade 1 concussions; no play for 3 months Grade 2: No amnesia; + amnesiaGrade 2: No amnesia; + amnesia remove from eventremove from event no play for 1 weekno play for 1 week 2 grade 2 concussions; no play for 1 month2 grade 2 concussions; no play for 1 month 3 grade 2 concussions; no play for the season3 grade 2 concussions; no play for the season Grade 3: LOCGrade 3: LOC hospital evaluationhospital evaluation no play for 1 monthno play for 1 month 2 grade 3 concussions: no play for the season2 grade 3 concussions: no play for the season

30 Guidelines for Prehospital Management of TBI Multidisciplinary: Brain Trauma Foundation / Grant from NHTSAMultidisciplinary: Brain Trauma Foundation / Grant from NHTSA Evidence BasedEvidence Based Prehospital care is the first link in appropriate care in TBIPrehospital care is the first link in appropriate care in TBI Prehospital providers play a key role in determining the need for trauma center accessPrehospital providers play a key role in determining the need for trauma center access

31 Guidelines for Prehospital Management of TBI Identifies the need for focused prehospital researchIdentifies the need for focused prehospital research Establishes need to perform a field assessment including vital signs, GCS, pupilsEstablishes need to perform a field assessment including vital signs, GCS, pupils Guidelines: Hypotension and hypoxia must be preventedGuidelines: Hypotension and hypoxia must be prevented Option: Secure the airway with intubation Option: Secure the airway with intubation Option: Herniation should be treated with hyperventilationOption: Herniation should be treated with hyperventilation

32 ED Management of MTBI in Adults Multidisciplinary group funded by a grant from the IBIA: ACEP, ASNR, AANSMultidisciplinary group funded by a grant from the IBIA: ACEP, ASNR, AANS Evidence based: Three Questions:Evidence based: Three Questions: Is there a role for plain film radiographs in the assessment of MTBI in the EDIs there a role for plain film radiographs in the assessment of MTBI in the ED Which patients with acute MTBI should have a noncontrast head CT in the EDWhich patients with acute MTBI should have a noncontrast head CT in the ED Can a patient with MTBI be safely discharged from the ED if a noncontrast CT shows no evidence of acute injuryCan a patient with MTBI be safely discharged from the ED if a noncontrast CT shows no evidence of acute injury

33 ED Management of MTBI in Adults Blunt trauma to the head within 24 hours of presentation to the EDBlunt trauma to the head within 24 hours of presentation to the ED Any period of post-traumatic LOC or PTAAny period of post-traumatic LOC or PTA A GCS score at initial evaluation in the ED of 15A GCS score at initial evaluation in the ED of 15 A nonfocal neurologic examA nonfocal neurologic exam Age greater than 15 yearsAge greater than 15 years

34 ED Management of MTBI in Adults Outcome measures in the TBI literature:Outcome measures in the TBI literature: Acute traumatic abnormality on CTAcute traumatic abnormality on CT Clinical deteriorationClinical deterioration Need for neurosurgical interventionNeed for neurosurgical intervention Development of post-concussive syndromeDevelopment of post-concussive syndrome Outcome measure for this policy:Outcome measure for this policy: Presence of an acute intracranial abnormality on noncontrast head CTPresence of an acute intracranial abnormality on noncontrast head CT

35 Is there a role for plain film radiographs in the assessment of MTBI in the ED Masters 1987 NEJM: Prospective study 7035 pts.Masters 1987 NEJM: Prospective study 7035 pts. Flawed methodology. 63% with + xray had - CT; 50% with +CT had negative xrayFlawed methodology. 63% with + xray had - CT; 50% with +CT had negative xray Skull films have low sensitivity for intracranial lesionsSkull films have low sensitivity for intracranial lesions Hoffman 2000 Lancet: Meta-analysisHoffman 2000 Lancet: Meta-analysis 20 articles reviewed out of 200 identified20 articles reviewed out of 200 identified Sensitivity.13-.75; PPV of skull fracture in predicting +CT.4Sensitivity.13-.75; PPV of skull fracture in predicting +CT.4 Specificity.9-.99; NPVof skull fracture in predicting +CT.94Specificity.9-.99; NPVof skull fracture in predicting +CT.94 Recommendation Level B: Skull films are not recommended in the evaluation of MTBI; although the presence of a skull film increases the likelihood of an intracranial lesion, its sensitivity is not high enough to allow it to be a useful screenRecommendation Level B: Skull films are not recommended in the evaluation of MTBI; although the presence of a skull film increases the likelihood of an intracranial lesion, its sensitivity is not high enough to allow it to be a useful screen

36 Various studies in patients with a GCS of 15 report a 5% - 15% incidence of an intracranial lesionVarious studies in patients with a GCS of 15 report a 5% - 15% incidence of an intracranial lesion.3-.5 incidence of lesions needing neurosurgical intervention.3-.5 incidence of lesions needing neurosurgical intervention Stiell 2001 Lancet. Prospective 3021 patientsStiell 2001 Lancet. Prospective 3021 patients Outcome: Neurosurgical interventionOutcome: Neurosurgical intervention 67% had CT; only 33% of the remainder had telephone follow-up67% had CT; only 33% of the remainder had telephone follow-up Survey used to determine insignificant lesions: patients with those lesions were not followed upSurvey used to determine insignificant lesions: patients with those lesions were not followed up 5 high risk predictors: failure to reach GCS 15 within 2 hours; suspected open skull fracture; sign of basal skull fracture; vomiting more than once; age over 645 high risk predictors: failure to reach GCS 15 within 2 hours; suspected open skull fracture; sign of basal skull fracture; vomiting more than once; age over 64 High risk factors were 100% sensitive identifying need for neurosurgery and would decrease CT by 68%High risk factors were 100% sensitive identifying need for neurosurgery and would decrease CT by 68% Which patients with acute MTBI should have a noncontrast head CT in the ED

37 Haydel 2000 NEJM; Class I study; 2 phasesHaydel 2000 NEJM; Class I study; 2 phases Phase I 520 patients to establish predictive criteriaPhase I 520 patients to establish predictive criteria Phase II 909 patients to validate criteriaPhase II 909 patients to validate criteria 7 predictors identified with 100% sensitivity for predicting intracranial lesion.7 predictors identified with 100% sensitivity for predicting intracranial lesion. Use of criteria would decrease head CT by 22%Use of criteria would decrease head CT by 22% No follow-up provided after dischargeNo follow-up provided after discharge Recommendation Level A: A head CT is not recommended in those patients with MTBI who do not have HA, vomiting, age > 60, drug or ETOH intoxication, deficits in short term memory, physical evidence of trauma above the clavicle, or seizure.Recommendation Level A: A head CT is not recommended in those patients with MTBI who do not have HA, vomiting, age > 60, drug or ETOH intoxication, deficits in short term memory, physical evidence of trauma above the clavicle, or seizure.

38 Can a patient with MTBI be safely discharged from the ED if a noncontrast CT shows no evidence of acute injury Stein 1992 J Trauma. RetrospectiveStein 1992 J Trauma. Retrospective 1339 patients with negative CT, none deteriorated1339 patients with negative CT, none deteriorated Dunham 1996 J Trauma Infect Crit Care. Retrospective review of a prospectively collected data baseDunham 1996 J Trauma Infect Crit Care. Retrospective review of a prospectively collected data base 2587 patients, no patient with a negative CT deteriorated; those patients who did deteriorate (without initial CT), did so within 4 hours2587 patients, no patient with a negative CT deteriorated; those patients who did deteriorate (without initial CT), did so within 4 hours Nagy 1999 J Trauma Infect Crit Care. RetrospectiveNagy 1999 J Trauma Infect Crit Care. Retrospective 1190 patients with CT and admission1190 patients with CT and admission No patient with a negative CT deteriorated (spectrum bias towards sicker patients)No patient with a negative CT deteriorated (spectrum bias towards sicker patients) Recommendation Level C: Patients with MTBI who are 6 hours out from their injury and who have a head CT that does not demonstrate acute injury can be safely discharged from the EDRecommendation Level C: Patients with MTBI who are 6 hours out from their injury and who have a head CT that does not demonstrate acute injury can be safely discharged from the ED

39 Severe TBI Guidelines AANS / Grant from the BTFAANS / Grant from the BTF StandardsStandards prophylactic hyperventilation should be avoidedprophylactic hyperventilation should be avoided use of glucocosteriods is not recommendeduse of glucocosteriods is not recommended prophylactic phenytoin is not recommended for late szprophylactic phenytoin is not recommended for late sz Guidelines:Guidelines: hypotension and hypoxia must be avoidedhypotension and hypoxia must be avoided ICP monitoring is appropriateICP monitoring is appropriate mannitol is effective for controlling raised ICPmannitol is effective for controlling raised ICP OptionsOptions Hyperventilation may be necessary for brief periods when there is acute neurologic deteriorationHyperventilation may be necessary for brief periods when there is acute neurologic deterioration AEDs may be used to prevent early posttraumatic szAEDs may be used to prevent early posttraumatic sz

40 Huizenga et al. Guidelines for the management of severe head injury: Are emergency physicians following them? Acad Emerg Med 2002; 9:806-812 319 / 566 survey responses (56%) to 3 cases319 / 566 survey responses (56%) to 3 cases 78% corrected hypotension78% corrected hypotension 46% used prophylactic hyperventilation46% used prophylactic hyperventilation 14% used glucocorticoids14% used glucocorticoids 8% used prophylactic mannitol8% used prophylactic mannitol Authors conclusion: A majority of emergency physicians are managing TBI according to the guidelinesAuthors conclusion: A majority of emergency physicians are managing TBI according to the guidelines My conclusion: 7 years post publication, a significant number of emergency physicians are not correctly managing severe TBIMy conclusion: 7 years post publication, a significant number of emergency physicians are not correctly managing severe TBI

41 Conclusions Evidence based clinical policies are useful tools in clinical decision makingEvidence based clinical policies are useful tools in clinical decision making Clinical policy development must be rigorousClinical policy development must be rigorous Clinical policies do not create a standard of care and do not necessarily override expert witnessClinical policies do not create a standard of care and do not necessarily override expert witness Clinical policy dissemination continues to be a challengeClinical policy dissemination continues to be a challenge

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