1. Ventilator Allocation and Mental Health Interventions in a Pandemic Flu Event Patricia Anders Director, Emergency Preparedness Training New York State Department of Health Office of Health Emergency Preparedness Confronting the Ethics of Pandemic Influenza Planning The 2008 Summit of the States

2. Ventilator Shortage in a Pandemic Different estimates of severity based on CDC calculations Different estimates of severity based on CDC calculations Federal ventilator stockpile Federal ventilator stockpile NYS ventilator stockpile NYS ventilator stockpile Most severe epidemic: Most severe epidemic: Too few ventilators for patients Too few ventilators for patients Too few staff for more ventilators Too few staff for more ventilators Rationing of ventilators needed Rationing of ventilators needed

3. Ventilator Allocation Guidance Document Written by the New York State Task Force on Life and Law Written by the New York State Task Force on Life and Law Co-chaired by Tia Powell, M.D., and Gus Birkhead, M.D. Co-chaired by Tia Powell, M.D., and Gus Birkhead, M.D. Released in draft in March, 2007 for comment Released in draft in March, 2007 for comment Available on NYSDOH website: Available on NYSDOH website: http://www.nyhealth.gov/diseases/communicable/influe nza/pandemic/ventilators/ http://www.nyhealth.gov/diseases/communicable/influe nza/pandemic/ventilators/ Planning focus groups for community education, comment, and revision Planning focus groups for community education, comment, and revision

4. Rationing – Ethical Implications Limits patient autonomy Limits patient autonomy Limits physician autonomy Limits physician autonomy Shifts doctor’s obligation from patient to group Shifts doctor’s obligation from patient to group Radical threat to doctor- patient relationship Radical threat to doctor- patient relationship

5. Ethical Framework Duty to Care ** Duty to Care ** Duty to Steward Resources ** Duty to Steward Resources ** Duty to Plan Duty to Plan Transparency Transparency Justice Justice ** Key ethical concepts

6. Duty to Care Physician must care for individual patient Physician must care for individual patient Autonomy not decisive factor Autonomy not decisive factor Palliative Care Palliative Care

7. Duty to Steward Resources Disaster = Scarcity Disaster = Scarcity Survival for greatest number Survival for greatest number Allocation of resources Allocation of resources First come, first served First come, first served Most vulnerable Most vulnerable Best balance of resource use and survival Best balance of resource use and survival

8. Duty to Plan Obligation to healthcare professionals and community Obligation to healthcare professionals and community Lack of planning creates vulnerability for front- line providers Lack of planning creates vulnerability for front- line providers Flawed plan versus no plan Flawed plan versus no plan Predictable emergency Predictable emergency

9. Justice Objective clinical criteria Objective clinical criteria Applied broadly and evenly Applied broadly and evenly No differential access for special groups No differential access for special groups

10. Transparency Public Communication Public Communication Disaster care different Disaster care different Patient preference does not determine withdrawal or withholding of care Patient preference does not determine withdrawal or withholding of care Objective criteria guide patients and professionals Objective criteria guide patients and professionals

11. Recommendations Pre-triage Requirements Pre-triage Requirements Patient categories Patient categories Facilities Facilities Clinical algorithm Clinical algorithm Triage decision-makers Triage decision-makers Palliative care Palliative care Appeals process Appeals process Communications Communications

12. Pre-triage Requirements Obligation to plan Obligation to plan Reduce vent need Reduce vent need Elective surgery Elective surgery Increase vent supply Increase vent supply Stockpile Stockpile Collaborative arrangements Collaborative arrangements Use of OR, transport, additional vents Use of OR, transport, additional vents Alter staffing Alter staffing

13. Patient Categories All patients in acute care facilities will be equally subject to triage guidelines All patients in acute care facilities will be equally subject to triage guidelines Not flu only Not flu only Disease category or role in the community not a factor Disease category or role in the community not a factor Health care workers, first responders not given special priority Health care workers, first responders not given special priority

14. Facilities Stepwise permission to initiate pre-triage steps, then adopt triage algorithm to allocate ventilators Stepwise permission to initiate pre-triage steps, then adopt triage algorithm to allocate ventilators Regional differences in severity, but statewide consistency will prevent inequities Regional differences in severity, but statewide consistency will prevent inequities Chronic care facilities will maintain different standards from acute care facilities Chronic care facilities will maintain different standards from acute care facilities

15. Clinical Evaluation Objective, clear, easily measured criteria Rule-in: severe respiratory compromise Rule-out: end-stage illness Exclusion Criteria for Ventilator Access* Exclusion Criteria for Ventilator Access* Cardiac arrest: unwitnessed arrest, recurrent arrest, arrest unresponsive to standard measures; Trauma-related arrest Cardiac arrest: unwitnessed arrest, recurrent arrest, arrest unresponsive to standard measures; Trauma-related arrest Metastatic malignancy with poor prognosis Metastatic malignancy with poor prognosis Severe burn: body surface area >40%, severe inhalation injury Severe burn: body surface area >40%, severe inhalation injury End-stage organ failure: End-stage organ failure: Cardiac: NY Heart Association class III or IV Cardiac: NY Heart Association class III or IV Pulmonary: severe chronic lung disease with FEV1** < 25% Pulmonary: severe chronic lung disease with FEV1** < 25% Hepatic: MELD*** score > 20 Hepatic: MELD*** score > 20 Renal: dialysis dependent Renal: dialysis dependent Neurologic: severe, irreversible neurologic event/condition with high expected mortality Neurologic: severe, irreversible neurologic event/condition with high expected mortality *Adapted from OHPIP guidelines *Adapted from OHPIP guidelines ** Forced Expiratory Volume in 1 second, a measure of lung function ** Forced Expiratory Volume in 1 second, a measure of lung function *** Model of End-stage Liver Disease *** Model of End-stage Liver Disease

16. Measuring Clinical Status Sepsis-related Organ Failure Assessment (SOFA) criteria Sepsis-related Organ Failure Assessment (SOFA) criteria Non-proprietary Non-proprietary Simple, reproducible Simple, reproducible Evidentiary basis for estimating mortality Evidentiary basis for estimating mortality Points added based on objective measures of function in six key organs and systems: lungs, liver, brain, kidneys, blood clotting, and blood pressure Points added based on objective measures of function in six key organs and systems: lungs, liver, brain, kidneys, blood clotting, and blood pressure

17. SOFA Scoring Range from 0 -24 0 is the best possible score; 24 is the worst Milestone Scores 7

18. Time Trials Initial Assessment Initial Assessment 48 hour Assessment 48 hour Assessment 120 hour Assessment 120 hour Assessment Patients may lose access to ventilators and other critical care resources if their SOFA score increases. Patients may lose access to ventilators and other critical care resources if their SOFA score increases. Patients may lose access if SOFA scores fail to improve within the allocated period. Patients may lose access if SOFA scores fail to improve within the allocated period.

22. Triage Decision-Making Based on Based on Time trials Time trials Objective clinical criteria Objective clinical criteria Primary clinicians will care for patients Primary clinicians will care for patients Will not determine ventilator allocation Will not determine ventilator allocation Role sequestration for decision-makers Role sequestration for decision-makers Supervising physician will take responsibility for triage decisions Supervising physician will take responsibility for triage decisions

23. Palliative Care Triage, not abandonment Triage, not abandonment Policies for end-of-life care Policies for end-of-life care Continue non-ventilator treatments Continue non-ventilator treatments Provide comfort to patients, including those ventilator ineligible Provide comfort to patients, including those ventilator ineligible

24. Appeals Process Real-time or retrospective Real-time or retrospective Review process needed to assure consistency and justice Review process needed to assure consistency and justice System to appeal triage decisions System to appeal triage decisions Multiple person review Multiple person review Daily retrospective review of all triage decisions Daily retrospective review of all triage decisions Assure that standards are consistent Assure that standards are consistent Opportunity to correct guidelines or implementation Opportunity to correct guidelines or implementation

25. Communication Government and clinicians need to provide Government and clinicians need to provide Clear, accurate, consistent communication about guidelines Clear, accurate, consistent communication about guidelines Date gathering and public comment can help improve the triage system Date gathering and public comment can help improve the triage system

26. Project with Hospice and Palliative Care Association of NYS Curriculum Planning Template for Healthcare Providers - Provide a focused resource for palliative care and hospice providers serving ventilator-ineligible patients in an acute care setting Curriculum Planning Template for Healthcare Providers - Provide a focused resource for palliative care and hospice providers serving ventilator-ineligible patients in an acute care setting Decision will be made to withdraw or withhold ventilator support prior to referral to these providers Decision will be made to withdraw or withhold ventilator support prior to referral to these providers Web-based curriculum Web-based curriculum

27. Curriculum Planning Template for Healthcare Providers Objectives Objectives Offer support and an explanation of palliative and/or hospice care management options Offer support and an explanation of palliative and/or hospice care management options Identify pandemic influenza symptoms, both psychological and physical Identify pandemic influenza symptoms, both psychological and physical Identify effective non-pharmacological symptom management for ventilator-ineligible patients Identify effective non-pharmacological symptom management for ventilator-ineligible patients Educate patients and families regarding infection control strategies Educate patients and families regarding infection control strategies

28. Curriculum for Non-Providers in In-Patient Settings Provide an educational resource for non- providers supporting ventilator-ineligible patients in acute care settings Provide an educational resource for non- providers supporting ventilator-ineligible patients in acute care settings Exigencies of a pandemic influenza event will mean that health care providers will not always be available, even in an in-patient setting Exigencies of a pandemic influenza event will mean that health care providers will not always be available, even in an in-patient setting Web-based curriculum Web-based curriculum

29. Curriculum for Non-Providers in In-Patient Settings Objectives Objectives Access basic information about pandemic influenza Access basic information about pandemic influenza Identify physical and emotional symptoms of affected patients Identify physical and emotional symptoms of affected patients Identify supportive interventions which non-health care providers can offer Identify supportive interventions which non-health care providers can offer Educate patients and families about infection control strategies Educate patients and families about infection control strategies

30. Sources Ontario Health Plan for an Influenza Pandemic (OHPIP) Working Group on Adult Critical Care Admission, Discharge, and Triage Criteria, “Critical Care During a Pandemic,” April 2006. Available at http://www.health.gov.on.ca/english/providers/program/emu/pan_flu/flusurge.html. Ferreira Fl, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA 2001; 286(14): 1754-1758. J. L. Hick, D. T. O’Laughlin, “Concept of Operations for Triage of Mechanical Ventilation in an Epidemic,” Academic Emergency Medicine, 2006;3(2):223-229. University of Toronto Joint Centre for Bioethics Pandemic Influenza Working Group, “Stand on Guard for Thee: Ethical considerations in preparedness planning for pandemic influenza,” November 2005.

31. QUESTIONS?

32. Pat Anders (518) 474-2893 pea02@health.state.ny.us pea02@health.state.ny.us