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Policy Action Plan: Resolving Conflicts over Life- Sustaining Treatment in Virginia Dea Mahanes, MSN, RN, CCNS, FNCS NURS638 Health Policy, Leadership & Advocacy Virginia Commonwealth University Learning Objectives Understand the


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Policy Action Plan: Resolving Conflicts over Life- Sustaining Treatment in Virginia

Dea Mahanes, MSN, RN, CCNS, FNCS NURS638 Health Policy, Leadership & Advocacy Virginia Commonwealth University

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Learning Objectives

  • Understand the current state of policy action in

Virginia pertaining to conflict between patients/surrogates and clinicians over life-sustaining treatment (LST).

  • Apply environmental scanning principles to evaluate

the barriers and supports for LST policy action.

  • Analyze the impact of the Joint Commission Health

Care Decision Matrix for 2018 on LST policy action.

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Health Policy Issue Introduction

  • Life-sustaining treatment (LST), also referred to as

life-sustaining care: mechanical/artificial means to sustain, restore or replace a spontaneous vital function (paraphrased from the Va. Code Ann. §54.1-2990, 2009)

  • Conflict over life-sustaining treatment is common

(Pope & Kemmerling, 2016)

– Can cause moral distress (Whitehead, Herbertson, Hamric, Epstein, & Fisher, 2015; Hamric & Epstein, 2017)

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Ethical Implications

  • Autonomy

– Supports patient/surrogate ability to make decisions about care

  • Beneficence

– Obligated to provide interventions that will help

  • Non-maleficence

– Ethical responsibility to avoid harm

  • Justice

– Costs of care, fairness/non-discrimination

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Health Policy Issue Introduction

  • Code of Virginia, §54.1-2990 (2009)

– Clinicians are not obligated to provide treatment that is medically or ethically inappropriate – Care must be continued for a period of 14 days to enable the patient’s agent to seek transfer to another provider or facility – Does not address actions to be taken at the end of the 14-day period if no provider or facility has been located

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Health Policy Issue Introduction

  • Virginia Joint Commission on Health Care: Life-

Sustaining Treatment Work Group (Mitchell, 2017)

– Survey of health systems in Virginia – Drafted language for proposed amendment

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Health Policy Issue Introduction:

Draft Amendment (Mitchell, 2017)

  • Allows for cessation of medically or ethically

inappropriate treatments after 14 days

– Special considerations for artificial hydration and nutrition

  • Requires hospitals to enact policies that outline

actions to be taken in the event of treatment conflict

– Second medical opinion – Interdisciplinary medical review committee with

  • pportunity for the patient/surrogate to participate

– Inclusion of decision (with explanation) in medical record

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Health Policy Issue Introduction

  • Virginia JCHC LST Work Group (Mitchell, 2017)

– Public comment period through October 12th

  • No Action
  • Introduce legislation to amend §54.1-2990

– Decision Matrix Meeting November 21st

Decision: No action

Joint Commission on Health Care. (2017, November 21). Decision matrix: policy options for 2018 General Assembly session – actions taken. Retrieved from http://jchc.virginia.gov/Decision%20Matrix%202017%20with%20actions%20taken.pdf

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Health Policy Issue’s Relevance to Quality & Safety

  • Population health

– Families as a vulnerable population

  • Experience of care

– Communication – Transparency

  • Cost

– Futile care cost estimate

  • f $4004/day (Huynh et

al., 2013)

The Triple Aim Berwick, Nolan, & Whittington, 2008

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Health Policy Issue’s Relevance to Quality & Safety

  • Population health,

experience of care, cost plus…

  • High quality health

care includes a focus

  • n clinicians

– Meaning in work – Avoiding burnout

Population Health Cost Clinician Health Experience

  • f Care

The Quadruple Aim

Bodenheimer & Sinsky, 2014. Sikka, Morath, & Leape 2015.

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Implication of Policy Action/Inaction

  • Current Virginia statistics (Mitchell, 2017)

– 56% of health systems surveyed have a written process for managing intractable treatment conflict – 7 of 8 health systems without a written process believe a process is needed

  • 5 of 7 identified lack of legislative clarity as a barrier
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Implication of Policy Action:

Amendment Proposed and Passed

  • Patients

– Protections against discrimination (Mitchell, 2017)

  • Surrogate

– Clear process with opportunity for participation (Mitchell, 2017) – Potential relief at removal of decision-making pressures (Fine & Mayo, 2003)

  • Clinicians

– Legislative protections if process followed (Mitchell, 2017) – Impact on moral distress

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Implication of Policy Inaction:

State Statute Remains Unchanged

  • Continue current practices

– Variability for patients, surrogates, and clinicians based on health system/organization

  • Lack of clarity about actions to take after 14-day period
  • Current Virginia statistics (Mitchell, 2017)

– 40 cases over 12 months in hospitals with a policy

  • On average (by health system), 5% cases resulted in

withdrawal/withholding over objection

– Hospitals without a policy estimate 45-90 cases/yr

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Theoretical Frame of Reference

Overview of the Kingdon Model (Kingdon, 1995)

  • Information indicates the existence
  • f a problem

Problem Stream

  • Available solutions

Policy Stream

  • Policy-makers/administration have

motive and opportunity to act

Political Stream

Window of Opportunity

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Integrating Policy and Theory:

Kingdon and Treatment Conflict in Virginia

  • Treatment conflict
  • Common and impactful
  • Lack of legislative clarity

Problem Stream

  • National guidance documents (Bosslet et

al., 2015; Kon et al., 2016)

  • Draft language from JCHC LST Work Group

Policy Stream

  • November Elections
  • House of Delegates, Executive Branch
  • JCHC recommendation

Political Stream

Window of Opportunity

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Stakeholder Analysis

  • Three primary stakeholder groups

– Patients and families – Clinicians – Healthcare organizations

  • Represented by multiple associations and

groups, with some crossover

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Government Agencies & Officials Health Systems & Organizations Professional Organizations Disability & Aging Rights Groups Religious Organizations Virginia Dept. of Aging & Rehab. Services Bon Secours Virginia Medical Society of Virginia disAbility Law Center of Va. The Family Foundation of Virginia Virginia Dept. of Health Carillion Clinic Virginia Assoc. for Hospices & Palliative Care LeadingAge Virginia Virginia Catholic Conference

  • Va. Dept. of Health

Professions Inova Health System Virginia Assoc. of Health Plans The Arc of Northern Virginia Virginia Society for Human Life Delegate Christopher Stolle Mary Washington Healthcare Virginia Healthcare

  • Assoc. – Va. Centers

for Assisted Living

  • Va. Assoc. of Center

for Independent Living Riverside Health System Virginia Hospital & Healthcare Assoc.

  • Va. Caregiver

Coalition Sentara Healthcare Virginia Nurses Assoc. Univ of Va. Health System Virginia Trial Lawyers Assoc.

  • Va. Commonwealth

University LifeNet Health

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Stakeholder Differentiation

High Influence, Less Interested High Influence, Highly Interested Virginia Department of Aging and Rehabilitative Services Virginia Department of Health Virginia Department of Health Professions Medical Society of Virginia Virginia Association of Health Plans Virginia Association for Hospices and Palliative Care Virginia Nurses Association Virginia Trial Lawyers Association LeadingAge Virginia The Family Foundation of Virginia Virginia Catholic Conference Delegate Stolle Bon Secours Health System Carilion Clinic Inova Health System Sentara Healthcare University of Virginia Health System Virginia Commonwealth University Health System Virginia Hospital and Healthcare Association disAbility Law Center of Virginia Virginia Association of Centers for Independent Living Low Influence, Less Interested Low Influence, Highly Interested LifeNet Health Virginia Health Care Association-Virginia Center for Assisted Living The Arc of Northern Virginia Virginia Caregiver Coalition Virginia Society for Human Life Mary Washington Healthcare Riverside Health System

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Stakeholder Mobilization

  • By December 20, 2017, members of the LST Workgroup will determine

whether or not to pursue a legislative outside of the JCHC decision.

  • By January 15, 2018, additional stakeholders will be identified who

represent the interests of surrogate decision-makers and of individuals with disabilities.

  • By February 1, 2018, stakeholders from the LST Workgroup will identify

and contact key members of the General Assembly.

  • By March 1, 2018, representatives from VHHA member organizations will

draft a sample hospital policy that is consistent with the requirements of the proposed amendment.

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Environmental Scanning

Sociocultural

  • Concern about

death panels and governmental control of healthcare decisions

  • Media

attention to Charlie Gard case Legal

  • Marsala v.

Yale-New Haven Hospital

  • Kelly v.

Methodist Hospital

  • Threats to

TADA Standards

  • Multi-society

position statement on responding to requests for inappropriate treatment (Bosslet et al., 2015) Political

  • Shift in

Virginia House

  • f Delegates
  • Re-election of

Delegate Stolle

  • Election of

Ralph Northam

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Sociocultural

"The America I know and love is not one in which my parents

  • r my baby with Down Syndrome will have to stand in front
  • f Obama's 'death panel' so his bureaucrats can decide,

based on a subjective judgment of their 'level of productivity in society,' whether they are worthy. Such a system is downright evil.“ (Palin, 2009) Charlie Gard case (Bilefsky, 2017; BBC 2017) Born August 4, 2016 with mitochondrial disorder Parents requested aggressive and experimental treatments not felt by clinicians to be indicated or ethical Pope and Donald Trump offered assistance to parents Courts denied parental requests Died July 28, 2017

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Legal

  • Marsala v. Yale-New Haven

Hospital

– Medical futility case, discontinuation

  • f mechanical ventilation over family

protest (Pope & Kemmerling, 2016) – Husband filed suit for wrongful death, loss of consortium, and medical malpractice (Pope & Kemmerling, 2016) – Pre-trial activities underway (State of Connecticut Judicial Branch, 2017)

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Legal

  • Texas Advanced Directive Act (TADA)

– Evolved over 6-yr period from 1993-1999, signed into law in June 1999 (Pope, 2016) – Most conflicts solved without unilateral decision (Fine & Mayo, 2003; Pope, 2016) – Largely upheld, with some amendments (Pope & Kemmerling, 2016)

  • Kelly v. Houston Methodist Hospital (Pope, n.d.)

– Process implemented consistent with TADA – Restraining order granted, support continued – Suit filed that questioned whether TADA was constitutional – Courts rejected suit, dismissed claims of intentional emotional distress – Notice of appeal recently filed

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Standards

  • Multi-society position statement: responding to

requests for inappropriate or potentially inappropriate treatment (Bosslet et al., 2015)

– Seven-step process to resolve conflicts

  • SCCM policy statement: defining futile or potentially

inappropriate treatments (Kon et al., 2016)

– No reasonable expectation of improvement that would allow patient to survive outside of the acute care setting,

  • r perceive the benefits of treatment
  • “Clinicians should recognize the limits of prognostication…”
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Political

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SWOT Analysis

Strengths (Helpful, Internal Origin) Weaknesses (Harmful, Internal Origin)

Strong ethical basis for policy action Strong support from diverse stakeholders who were part of the LST Workgroup Re-election of Delegate Stolle Member of the LST Workgroup with experience in developing policy using the community standard approach Draft language includes emphasis on non- discrimination Draft amendment is consistent with international position statement on managing requests for inappropriate treatment Topic is highly emotionally charged for stakeholders, legislators, and the public Much negotiation by stakeholders was required to reach consensus on draft language Draft amendment does not define inappropriate treatment Process outlined in draft amendment requires significant time for completion JCHC ultimately voted to take no action on proposed amendment

Opportunities (Helpful, External Origin) Threats (Harmful, External Origin)

Change in political climate related November 2017 election cycle (change in composition of House of Delegates) Election of Northam as Virginia Governor Overall, court cases have supported clinicians in treatment conflict provided due process is followed Legal cases that threaten TADA Societal reluctance to discuss the financial implications of providing medically inappropriate treatment solely based on patient/surrogate request

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SWOT Analysis

Strengths (Helpful, Internal Origin) Weaknesses (Harmful, Internal Origin)

Strong ethical basis for policy action Strong support from diverse stakeholders who were part of the LST Workgroup Re-election of Delegate Stolle Member of the LST Workgroup with experience in developing policy using the community standard approach Draft language includes emphasis on non- discrimination Draft amendment is consistent with international position statement on managing requests for inappropriate treatment Topic is highly emotionally charged for stakeholders, legislators, and the public Much negotiation by stakeholders was required to reach consensus on draft language Draft amendment does not define inappropriate treatment Process outlined in draft amendment requires significant time for completion JCHC ultimately voted to take no action on proposed amendment

Opportunities (Helpful, External Origin) Threats (Harmful, External Origin)

Change in political climate related November 2017 election cycle (change in composition of House of Delegates) Election of Northam as Virginia Governor Overall, court cases have supported clinicians in treatment conflict provided due process is followed Legal cases that threaten TADA Societal reluctance to discuss the financial implications of providing medically inappropriate treatment solely based on patient/surrogate request

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Financial & Economic Impact

  • Cost of care

– ICU costs/day: $3,184 - $10,794 (Dasta et al., 2005) – Average cost of care/patient who dies in ICU = $39,300 +/- $45,100 (Khandelwal et al., 2016) – One-third of all ICU patients receive non-beneficial treatment at EOL (Cardona-Morrell et al., 2016) – Futile care cost estimate of $4004/day (Huynh et al., 2013)

  • Intangible costs

– Healthcare providers

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Next Steps: Plan for Change

  • Pursue community

standard

  • Collaborate with

legislator to introduce amendment during the 2018 General Assembly session

– Stakeholder groups – Delegate Stolle?

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Next Steps: Plan for Change

A

  • AWARENESS of the need for change
  • Review of cases, impact on patients/families/clinicians, costs

D

  • DESIRE to support and participate in the change
  • Review of cases, impact on patients/families/clinicians, costs, legislation

K

  • KNOWLEDGE of how to change
  • Review of established policies, learning from TADA

A

  • ABILITY to implement the change
  • Sample policies, procedures

R

  • REINFORCEMENT to support the change
  • Data analysis, data sharing

Prosci, Inc. (2017). ADKAR Change Management Model Overview. Retrieved from https://www.prosci.com/adkar/adkar-model

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Learning Objectives

  • Understand the current state of policy action in

Virginia pertaining to conflict between patients/surrogates and clinicians over life-sustaining treatment (LST).

  • Apply environmental scanning principles to evaluate

the barriers and supports for LST policy action.

  • Analyze the impact of the Joint Commission Health

Care Decision Matrix for 2018 on LST policy action.

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SLIDE 32

References

  • Berwick, D. M., Nolan, T. W., & Whittington, J. (2008). The triple aim: Care, health, and cost.

Health Affairs (Project Hope), 27(3), 759-769. doi:10.1377/hlthaff.27.3.759

  • Bilefsky, D. (2017, July 28). Charlie Gard dies, leaving a legacy of thorny ethical questions. The

New York Times. Retrieved from https://www.nytimes.com/2017/07/28/world/europe/charlie-gard-dead.html

  • Bodenheimer, T., & Sinsky, C. (2014). From triple to quadruple aim: Care of the patient

requires care of the provider. Annals of Family Medicine, 12(6), 573-576. doi:10.1370/afm.1713

  • Bosslet, G. T., Pope, T. M., Rubenfeld, G. D., Lo, B., Truog, R. D., Rushton, C. H., . . . Society of

Critical Care. (2015). An official ATS/AACN/ACCP/ESICM/SCCM policy statement: Responding to requests for potentially inappropriate treatments in intensive care units. American Journal

  • f Respiratory and Critical Care Medicine, 191(11), 1318-1330. doi:10.1164/rccm.201505-

0924ST

  • British Broadcasting Corporation. (2017, July 27). Charlie Gard: The story of his parents' legal
  • fight. BBC News. Retrieved from http://www.bbc.com/news/health-40554462#
  • Cardona-Morrell, M., Kim, J., Turner, R. M., Anstey, M., Mitchell, I. A., & Hillman, K. (2016).

Non-beneficial treatments in hospital at the end of life: A systematic review on extent of the

  • problem. International Journal for Quality in Health Care : Journal of the International Society

for Quality in Health Care, 28(4), 456-469. doi:10.1093/intqhc/mzw060

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References

  • Dasta, J. F., McLaughlin, T. P., Mody, S. H., & Piech, C. T. (2005). Daily cost of an intensive care

unit day: the contribution of mechanical ventilation. Critical care medicine, 33(6), 1266-1271.

  • Fine, R. L., & Mayo, T. W. (2003). Resolution of futility by due process: Early experience with

the Texas advance directives act. Annals of Internal Medicine, 138(9), 743-746. doi:200305060-00011

  • Hamric, A. B., & Epstein, E. G. (2017). A health system-wide moral distress consultation

service: Development and evaluation. HEC Forum : An Interdisciplinary Journal on Hospitals' Ethical and Legal Issues, doi:10.1007/s10730-016-9315-y Huynh, T. N., Kleerup, E. C., Wiley, J. F., Savitsky, T. D., Guse, D., Garber, B. J., & Wenger, N. S. (2013). The frequency and cost of treatment perceived to be futile in critical care. JAMA Internal Medicine, 173(20), 1887-1894. doi:10.1001/jamainternmed.2013.10261

  • Joint Commission on Health Care. (2017, November 21). Decision matrix: policy options for

2018 General Assembly session – actions taken. Retrieved from http://jchc.virginia.gov/Decision%20Matrix%202017%20with%20actions%20taken.pdf

  • Khandelwal, N., Benkeser, D., Coe, N. B., Engelberg, R. A., Teno, J. M., & Curtis, J. R. (2016).

Patterns of cost for patients dying in the intensive care unit and implications for cost savings

  • f palliative care interventions. Journal of palliative medicine, 19(11), 1171-1178.

doi:10.1089/jpm.2016.0133

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References

  • Kingdon, J. W. (1995). The policy window, and joining the streams. In Agendas, alternatives, and

public policies (2nd Ed., pp. 165-195). New York: Longman

  • Kon, A. A., Shepard, E. K., Sederstrom, N. O., Swoboda, S. M., Marshall, M. F., Birriel, B., &

Rincon, F. (2016). Defining futile and potentially inappropriate interventions: A policy statement from the society of critical care medicine ethics committee. Critical Care Medicine, 44(9), 1769-

  • 1774. doi:10.1097/CCM.0000000000001965
  • Mitchell, A. (2017, September 19). Life-sustaining treatment guidelines work group – final

report to the Joint Commission on Health Care. Retrieved from http://jchc.virginia.gov/2.%20Life%20Sustaining%20Treatment%20Guidelines%20- %20final%20report%20-%20revised%20-%209.20.17.pdf

  • Palin, S. [Sarah]. (2009, August 7). Statement on the current health care debate [Facebook post].

Retrieved from https://www.facebook.com/notes/sarah-palin/statement-on-the-current-health- care-debate/113851103434/

  • Pope, T. M. (n.d.). Medical futility & non-beneficial treatment cases. Retrieved from

http://www.thaddeuspope.com/medicalfutility/futilitycases.html

  • Pope, T. (2016). Texas advance directives act: nearly a model dispute resolution mechanism for

intractable medical futility conflicts. Faculty Scholarship, Paper 378. Retrieved from http://open.mitchellhamline.edu/facsch/378

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References

  • Pope, T. M., & Kemmerling, K. (2016). Legal briefing: Stopping nonbeneficial life-sustaining

treatment without consent. The Journal of Clinical Ethics, 27(3), 254-264. doi:2016273254

  • Sikka, R., Morath, J. M., & Leape, L. (2015). The quadruple aim: Care, health, cost and meaning

in work. BMJ Quality & Safety, 24(10), 608-610. doi:10.1136/bmjqs-2015-004160

  • State of Connecticut Judicial Branch. (2017, November 18). Marsala, Clarence et al v. Yale-New

Haven Hospital, Inc., AAN-CV12-6010861-S. Retrieved from http://civilinquiry.jud.ct.gov/CaseDetail/PublicCaseDetail.aspx?DocketNo=AANCV126010861S

  • Va. Code Ann. §54.1-2990, 2009, Retrieved from

https://law.lis.virginia.gov/vacode/title54.1/chapter29/section54.1-2990/

  • Whitehead, P. B., Herbertson, R. K., Hamric, A. B., Epstein, E. G., & Fisher, J. M. (2015). Moral

distress among healthcare professionals: Report of an institution-wide survey. Journal of Nursing Scholarship : An Official Publication of Sigma Theta Tau International Honor Society of Nursing / Sigma Theta Tau, 47(2), 117-125. doi:10.1111/jnu.12115

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Questions