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? 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 patient autonomy and encourages self determination It promotes shared decision making It promotes shared decision making It is a communication tool It is a communication tool It is a tool to encourage patient compliance It is a tool to encourage patient compliance It is a legal document 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. 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? Does the patient have decision making capacity? If yes, how is informed consent obtained? If yes, how is informed consent obtained? If not, who can/should make decisions for the patient? 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 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. 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 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. 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. 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 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 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. She was lucid on some matters and confused on others and her train of thought wandered. Her reasons for refusing to consent were: 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. Her daughter petitioned the court and was appointed guardian. Mrs. Candura’s lawyer appealed. Did Mrs. Candura have decision making capacity? Did Mrs. Candura have decision making capacity? Did she give informed refusal to the surgery? 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 Do what you think will most benefit the patient; or Appoint a surrogate decision maker; or Appoint a surrogate decision maker; or Coerce the patient into accepting your recommendation; or Coerce the patient into accepting your recommendation; or Persuade the patient to accept your recommendation through education. Persuade the patient to accept your recommendation through education.

11. Elements of Informed Consent Diagnosis Diagnosis Nature and purpose of treatment Nature and purpose of treatment Person performing procedure Person performing procedure Benefits and risks Benefits and risks Realistic probability of success Realistic probability of success Alternatives Alternatives Their benefits and risks Their benefits and risks Prognosis if no treatment Prognosis if no treatment Answering patient’s questions Answering patient’s questions Assessing patient understanding 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? 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) Cross v. Trapp, 294 SE2d 445 (WV 1982)

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

14. Other aspects of Informed Consent Who gets consent? Who gets consent? Shared decisions making Shared decisions making Written v. oral v. implied consent Written v. oral v. implied consent Informed Refusal Informed Refusal Exceptions to general rule Exceptions to general rule –Mature minors –Emergency circumstances –Therapeutic privilege What if patient asks you to decide? 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. Methods to determine appropriate decisions and decision makers for patients that lack decision making capacity.

16. Advanced Directives in WV Living Will Living Will Medical Power of Attorney Medical Power of Attorney DNR Card DNR Card POST – Physician Orders for Scope of Treatment 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 Court Appointed Guardians Medical Power of Attorney Representatives Medical Power of Attorney Representatives Surrogate Decision Makers Surrogate Decision Makers

19. Standards for Substitute Decision Makers If they know, what does the patient want in this circumstance. 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? 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? What is in the patient’s best interest?