Transcript The Futility Dilemma: A More Effective Approach

Welcome to
GRAND ROUNDS
Welcome To Grand Rounds
Ethical Dilemmas in Clinical Practice
Practical Ideas for Solutions
Michael R. Panicola, PhD
Corporate Vice President, Ethics
SSM Health Care
[email protected]
I have nothing to disclose.
Objectives
1) Review real-life cases that raise complex, challenging
ethical issues in health care delivery
2) Discuss practical ideas & strategies for how to
address these types of cases
3) Provide relevant resources
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Case 1: Medical Futility
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Case Description
•
81y/o female admitted over two months ago to SMH for an elective abdominal
aortic aneurysm approximately 5 cm in diameter. Endovascular repair was
unsuccessful & thus an open repair was performed. Patient initially seemed to be
recovering well in the ICU but two weeks post-surgery developed multiple
complications, including: ischemic bowel necessitating colon resection; urosepsis
requiring antibiotic therapy; multiple pneumonias leading to tracheostomy &
ventilation; ischemic stroke resulting in left-side hemiplegia & cognitive deficit;
disseminated intravascular coagulation (or DIC) that has caused significant bleeding
requiring frequent administration of platelets & fresh frozen plasma; & acute renal
failure for which dialysis is necessary. Currently, the patient is in the ICU on
mechanical ventilation at 100% oxygenation; still on antibiotics; receiving blood
products every-other-day for the DIC; has a PEG tube for nutritional support; is
mildly sedated for pain & rest; & has not moved left-side. The intensivist has
approached the family numerous times in recent weeks about limiting treatment
but the family will hear none of it & continues to insist that everything be done. All
the physicians caring for the patient, with the exception of the vascular surgeon (at
least publicly), feel strongly that current course of treatment is futile & a waste of
scarce medical resources. Recently, the intensivist wrote a DNR order for the
patient but when the family objected, threatening to bring suit against him &
hospital, he rescinded it.
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Questions for Discussion
• What would you do if confronted with this
case or asked your advice?
• Is the family’s request to “do everything”
acceptable?
• Are there any limits to familial requests of this
nature? If so, what are they?
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Futility in Perspective
• Requests or demands for “futile” treatment constitute
one of the most intractable ethical challenges
– Patient autonomy & physician integrity
– Beneficence/nonmaleficence & distributive justice
• #1 reason for ethics consults at end of life & major
source of moral distress among patients/families &
caregivers
• Various attempts to address the issue go back well
over 20 years but little progress
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Three Generations of Futility
• Futility: a concept in evolution.
– Chest. 2007 Dec;132(6):1987-93.
– Burns JP, Truog RD.
• Division of Critical Care Medicine, Department of
Anesthesia, Children's Hospital Boston and Harvard
Medical School, Boston, MA 02115, USA.
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Three Generations of Futility
(cont.)
• Generation #1: defining futility (early 1990s)
– Conditions
– Quantitative versus qualitative
• Generation #2: procedural approach (late 1990s)
– Development of policies
– Texas Advance Directives Act (1999)
• Generation #3: communication & negotiation (present)
– Patient/family engagement
– Support for caregivers
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What’s the Real Problem?
• Patients/families
–
–
–
–
Untimely, incomplete, & inconsistent information
Inadequate time to make decision (“right now”)
Fear of abandonment, lower level of care
Uncertainty about patient’s wishes, “right” thing to do
• Physicians & other caregivers
–
–
–
–
Failure to establish goals, address other issues
Poor, inconsistent exchange of information
Lack of skill, nuance in presenting treatment options
Reluctance to have “difficult conversations”
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SSM’s 3rd Generation Approach
• Development of guidelines & tools
– “Enhancing Communication & Coordination of
Care: Guidelines for Physicians & Other
Caregivers”
• Located on corporate ethics intranet site:
http://my.ssmhc.com/SiteDirectory/corporateethics/Pag
es/PoliciesandPositionStatements.aspx
– Care Conference Facilitator Checklist & Resource
Guide
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A Look at the Guidelines
Communication/Coordination
•
•
•
•
•
•
•
•
Communicate early & often with patients/families
Communicate early & often with other caregivers
Determine goals of care & evaluate routinely
Make time for & participate in care conferences
Exercise care in offering/disc treatment options
Address unreasonable requests up-front, candidly
Ensure non-abandonment & quality end of life care
Once the decision has been made…
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A Look at the Guidelines
Conflict Situations
• Establish appropriate setting for conversation
• Determine level of understanding
– Fill in any gaps & allow time to absorb new info
• Clarify hopes and expectations
– Address unrealistic expectations & clarify any misconceptions
• Discuss withholding or withdrawing treatment
– Provide opinion
– Offer alternative care options (hospice, PC)
– Ensure non-abandonment
• Respond to deeper needs
– Remember first time for family
– Identify underlying reasons request to do everything
A Look at the Guidelines
Conflict Situations
• Devise a care plan (if agreement)
• Lack of agreement
– Ethics consult
– Restrict treatment options in light of patient’s best interests
• No treatment options that extend or increase the patient’s suffering
(e.g., amputation of a limb for a patient with end-stage illness) or are
medically contraindicated (e.g., ACLS at end of life)
– Consider time-limited trial
• Only if treatment in question does not extend or increase patient’s
suffering & could perhaps achieve its physiological end
– Consider withdrawing & offer family other options
• Documentation
• Debrief with & support caregivers
A Look at the Guidelines
Care Conferences
• Definition
– Meeting among the patient (if able), family/friends/supporters, & health
care team designed to enhance communication & coordination of care
• What patients?
– Any seriously ill, complex patient but especially those with high
mortality risk, multiple admissions, 3+ specialists, ICU LOS >5 days, or
whose caregiver or family member requests one
• Simple intervention validated for efficacy
– Enhance communication & care coordination, reduce conflict
situations, increase satisfaction, conserve resources, concordance with
patient/family preferences
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SSM St. Louis ICU Care Conference
Pilot Project
• Case manager (CM) driven
– Serve as coordinators & facilitators
• Patients assessed on daily rounds
– Conferences for patients with predicted mortality >50, ICU
LOS >5days, family/caregiver request, or change in treatment
focus (e.g., comfort) or level of support (e.g., hospice)
• Who attends?
– Attending/primary treating physician, bedside nurse, patient (if
able), key family members, and POA (if applicable) a must &
others as appropriate
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SSM St. Louis Care Conference Flowchart
ICU patients
assessed on
daily rounds
Meet at least one
of these criteria:
1.MPM > 50 and ICU
LOS > 5 days
2.Family/caregiver
request
3.Need for change in
treatment focus
4. Change in level of
support (i.e. hospice)
Yes
List of
conferences
prioritized
to no more
than 2 pts
per day
CM contacts
attending/primary
treating MD for a
meeting time w/in
next 48 hours
No
Conference
not needed
Documentation of care
conference is completed by
CM
Feedback from:
• family
•conference team
Meeting date,
time, and
place are
finalized
Care Conference is held, CM
facilitates
Attending/primary treating physician,
bedside nurse, patient (if able), key
family members, and POA (if
applicable) a must
CM notifies the
following of the
meeting date, time,
and place:
•POA/Patient’s family
•Consulting MD’s
•Nursing staff
•Pastoral care
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Return to Case
• Conflict already present, may even be intractable, but still
need to…
–
–
–
–
–
Communicate frequently with family
Focus everyone on patient’s best interests
Attend to needs/distress of caregivers
Provide high quality EoL care to patient
Limit tx ineffective (CPR) or disproportionately burdensome
• Learn from experience
–
–
–
–
Approach patients/families earlier
Set goals, establish care plan
Communicate often & coordinate care among caregivers
If conflict arises, negotiate don’t dominate
Case 2: Donation After
Cardiac Death (DCD)
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Case Description
•
Steven, a 27 year-old with a history of drug abuse, presents to the ED of SMH following
a cardiac arrest induced by a drug overdose. According to EMS, Steven was asystole
upon arrival, perhaps for as long as 15 minutes, but was able to be resuscitated in the
field. Steven was rapidly transferred to the ICU where he remained in a persistent coma
with intermittent seizures. CT showed diffuse edema, EEG showed bilateral periodic
epileptiform discharges (or PEDs), & a diagnosis of severe anoxic encephalopathy was
made by the neurologist. After 14 days with no improvement, the neurologist informed
the family that, while not brain-dead, Steven had little brain activity & an extremely poor
prognosis for meaningful cognitive recovery. Treatment options were discussed & the
family ultimately decided that Steven would not want to live like this & requested
withdrawal of the ventilator. After this decision was made, a “designated requestor” on
staff presented the family with the option of organ donation after cardiac death, which
they accepted enthusiastically. The neurologist subsequently wrote an order for the
withdrawal of treatment followed by organ donation. Upon being notified of the order,
the intensivist, who was not involved in the family meeting, expressed concern that the
decision to withdraw was being made too hastily & that it was being influenced by the
decision to donate. She also made it clear that she was not comfortable with the role
she was being asked to play in implementing the order.
Questions for Discussion
• What would you do if confronted with this case or
asked your advice?
• Is DCD acceptable ethically? If so, what ethical
principles should guide our approach to DCD?
• Would it be acceptable for the intensivist to opt out
of participating in this case of DCD?
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DCD Fast Facts
• Definition:
– Recovery & use of organs from pts declared dead using cardiopulmonary criteria
• Who & what :
– Pts who have a non-recoverable & irreversible neurological injury resulting in vent
dependency but not fulfilling brain death criteria…Others may include those with endstage musculoskeletal disease, pulmonary disease, & high spinal cord injury
– Most commonly kidneys & liver but also pancreas, lungs, &, in rare cases, heart
• Process:
– Pt/fam decision to w/d MV & other life-sustaining measures; request for organ donation
– Usually pt moved from ICU to surgery with family saying “good-byes” prior to death
– Extubation & w/d of other life-sustaining measures; meds given (e.g., Heparin) & perhaps
advance placement of catheters in large arteries/veins to facilitate rapid infusion of
organ-preservation solutions after death
– Monitor for asystole (absence of sufficient cardiac activity to generate a pulse or blood
flow, not necessarily absence of all electrocardiographic activity)…if occurs in required
time (60 or 120 min), death declared by attending or designee after 2 or 5 min
– Transplant team enters & begins organ retrieval process
DCD in Perspective
• DCD traditional approach to organ donation
– Prior to 1970s all organ donation involved patients
declared dead based on cardiopulmonary criteria
– DCD all but abandoned in U.S. after brain death
criteria widely adopted because transplant
outcomes were better
– With critical shortage of organs & longer waitlists, interest revived
• 6,290 candidates died while awaiting organs in 2008
• Waiting List for Life has doubled in 10 years from
46,961 to 100,532 in 2009
DCD in Perspective (cont.)
• DCD deemed ethically acceptable
– Institute of Medicine (3 reports: ‘97, ‘00, ‘06), Canadian
Council on Organ Donation & Transplantation’s National
Forum, U.S. Consensus Conference, American Medical
Association, & Society of Critical Care Medicine
• TJC requirement:
– LD.3.110 EP 12: Develop a donation policy that addresses
opportunities for asystolic recovery, based on an organ
potential for donation that is mutually agreed upon by the
designated OPO, hospital, and medical staff.
– The standard requires that relevant hospitals have policies
in place, not allow the practice—can choose to opt out
because of concerns about ethics, quality of end-of-life
care, or other reasons
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DCD in Perspective (cont.)
• Still, ethical concerns abound—not from
patients/families but among caregivers
• Positive possibilities but…
– Circumventing brain death criteria
– Quality of donor organs
– Co-mingling of decision to w/d & donate
– Time requirement for declaring death too short
– Pastoral concerns related to family
– Similarities/slippery slope to euthanasia
– Pre-mortem administration of anticoagulants
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Ethical Criteria
• Healthy degree of skepticism & suspicion acceptable
– Different interests & motives among the various parties involved
• Still, DCD can be done ethically if…
Decision to withdraw separate from decision to donate
Those requesting donation not involved in the direct care of patient
True informed consent is obtained (patient or family)
Patient not subjected to disproportionate risks for good of donation
EoL (inc. palliative & pastoral) care of the patient not compromised
Families given option of being present until death & viewing body after organ
retrieval if desired
– Death declared by qualified physician who is not member of transplant team
– Staff allowed to opt out of participating in DCD if morally opposed
–
–
–
–
–
–
Unresolved Ethical Question
• Pre-mortem administration of Heparin
– Initially, many OPO protocols did not require (1990s)
– Some OPOs began incorporating at “therapeutic” levels (e.g., 80 units/kg or 5000
units/70kg not to exceed 10,000 units)
– Now virtually all OPOs require at higher levels (e.g., 400 units/kg)
• According to the 2005 IOM conference, providing Heparin at the time of
w/d “is the current standard of care” because “the long-term survival of
the transplanted organ may be at risk if thrombi impede circulation to the
organ after reperfusion
• Ethical concern: could the pre-mortem administration of Heparin cause or
exacerbate bleeding in typical DCD candidate & as a result hasten death?
Unresolved Question (cont.)
• Seems unlikely pre-mortem administration of Heparin, even at high doses
(e.g., 400 units/kg), causes harm to DCD donors or hastens their death,
– But no empirical data to prove this (only anecdotal)…driven more by desire to
improve transplant outcomes
• Still, ethically pre-mortem administration of Heparin can be justified using
the principle of double effect
– Any harm caused would be morally acceptable as an unintended side effect
caused by the action taken to bring about the good of organ preservation
• Given uncertainty, is explicit & separate consent for the pre-mortem
administration of Heparin required?
– Some say “yes,” others say “no”
– Not necessary if during the general consent process the risk of harm from the
use of Heparin as well as from other measures taken that do not directly
benefit the DCD donor are spelled out clearly to the patient &/or
family/surrogate
Principle of Double Effect
Action
two effects
good
evil
morally justified?
Four Conditions Must Be Met
1.
2.
3.
4.
The act must be morally good or indifferent.
One must intend the good & not the evil.
The evil cannot be a means to achieve the good.
There must be a proportionate reason.
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Return to Case
• In this case, it seems everything handled properly
with exception of including intensivist in the family
meeting
• Ethical criteria, as best as we can tell, seem to have
been addressed
• Should accommodate intensivist if concern primarily
that w/d not appropriate
– What about if concerns over DCD itself?
Additional Resources
• For further guidance, refer to “Donation After
Cardiac Death: System Guidelines for Policy
Development”
– Located on corporate ethics intranet site:
http://my.ssmhc.com/SiteDirectory/corporateethic
s/Pages/PoliciesandPositionStatements.aspx
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Questions & Discussion
Today’s presentation & handouts will be placed on
both HS & St. Mary’s Intranet sites
Next Grand Rounds:
Thursday, September 2, 2010
“Treatment and Evaluation of Atypical GERD”
John Hamilton, MD, Carl Sunby, MD
& Timothy Shaw, MD