Informed Consent

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Informed Consent

• Sandra A. Price, JD
• Risk Manager
• WVU Health Sciences Center
• 293-3584

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Informed Consent

• Is it good for the patient or good for the
  provider or both?

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Why?

• It promotes patient autonomy and encourages self
  determination
• It promotes shared decision making
• It is a communication tool
• It is a tool to encourage patient compliance
• It is a legal document

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General Rule

• The adult patient with decision making capacity
  has the right to decide how and when to be
  treated after receiving information about the
  proposed procedure or treatment.

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Threshold Question

• Does the patient have decision making capacity?
• If yes, how is informed consent obtained?
• If not, who can/should make decisions for the
  patient?

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Lane v. Candura Case Discussion

• Mrs. Candura was a 77 year old widow suffering
  from gangrene in her right foot and lower leg.
  Her physician recommended amputation without
  delay. After some vacillation, Mrs. Candura
  refused to consent to the operation.
• Mrs. Candura was confused and depressed since the
  death of her husband. Her relationship with her
  children was marked with conflict. She lived on
  her own until her recent hospitalizations.

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Case Continued

• She earlier had an infection in her right foot
  and her toe was amputated.
• She again developed gangrene in her foot and part
  of her foot was amputated. She then developed
  gangrene in the remainder of her right foot.
• After persuasion from her physician, she
  consented to the operation twice, but changed her
  mind and withdrew her consent both times.

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Case Continued

• She was discouraged by the failure of the earlier
  operations to stop the gangrene.
• She wanted to get well but understood that her
  refusal to consent to surgery could lead to her
  death.
• She was lucid on some matters and confused on
  others and her train of thought wandered.
• Her reasons for refusing to consent were
• She did not want to be a burden.
• She did not want to be an invalid or live in a
  nursing home.
• She did not believe the operation will cure her.
• She did not fear death, but welcomed it.

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Case Continued

• Her daughter petitioned the court and was
  appointed guardian. Mrs. Canduras lawyer
  appealed.
• Did Mrs. Candura have decision making capacity?
• Did she give informed refusal to the surgery?

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What can you do when you believe a patient makes
a bad decision?

• Do what you think will most benefit the patient
  or
• Appoint a surrogate decision maker or
• Coerce the patient into accepting your
  recommendation or
• Persuade the patient to accept your
  recommendation through education.

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Elements of Informed Consent

• Diagnosis
• Nature and purpose of treatment
• Person performing procedure
• Benefits and risks
• Realistic probability of success
• Alternatives
• Their benefits and risks
• Prognosis if no treatment
• Answering patients questions
• Assessing patient understanding

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Patient Need Standard

• WV adopted the patient need standard - What does
  the average, reasonable person need to know to
  make an intelligent choice?
• Cross v. Trapp, 294 SE2d 445 (WV 1982)

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Risk Disclosure

• Most common
• Worst case scenario
• Chance of permanent disfigurement, loss of sexual
  function or death
• Watch for complications
• When to come back or when to call you

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Other aspects of Informed Consent

• Who gets consent?
• Shared decisions making
• Written v. oral v. implied consent
• Informed Refusal
• Exceptions to general rule
• Mature minors
• Emergency circumstances
• Therapeutic privilege
• What if patient asks you to decide?

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Health Care Decisions Act

• Methods to determine appropriate decisions and
  decision makers for patients that lack decision
  making capacity.

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Advanced Directives in WV

• Living Will
• Medical Power of Attorney
• DNR Card
• POST Physician Orders for Scope of Treatment

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If there are no advanced directives that tell you
how the patient wants to be treated under these
circumstances, you must look to a substitute
decision maker for informed consent.
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Substitute Decision Makers

• Court Appointed Guardians
• Medical Power of Attorney Representatives
• Surrogate Decision Makers

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Standards for Substitute Decision Makers

• If they know, what does the patient want in this
  circumstance.
• Knowing the patient, their religious preferences
  and moral beliefs, can it be determined what the
  patient would want in this circumstance?
• What is in the patients best interest?