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Informed Consent

Informed Consent

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Informed Consent

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  1. Informed Consent Sandra A. Price, JD Risk Manager WVU Health Sciences Center 293-3584

  2. Informed Consent • Is it good for the patient or good for the provider or both?

  3. 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

  4. 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.

  5. 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?

  6. 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.

  7. 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.

  8. 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.

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

  10. 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.

  11. 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 patient’s questions • Assessing patient understanding

  12. 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)

  13. 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

  14. 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?

  15. Health Care Decisions Act • Methods to determine appropriate decisions and decision makers for patients that lack decision making capacity.

  16. Advanced Directives in WV • Living Will • Medical Power of Attorney • DNR Card • POST – Physician Orders for Scope of Treatment

  17. 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.

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

  19. 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 patient’s best interest?