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Informed Consent

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									Informed Consent & Advance Directives
Jennifer L. Peel, Ph.D.

What is ―Consent?‖
• Defined as permission, approval, or assent • Touching a person without consent constitutes a battery, and putting a person in fear of being touched without consent is assault.

What is ―INFORMED Consent?‖
• Consent given by the patient based on knowledge of the procedure to be performed, including its risks and benefits, as well as alternatives to the proposed treatment.

Types of Consent
• Expressed consent=either oral or written consent by the patient to undergo a specific procedure or treatment. • Implied consent=inferred from the circumstances. It is rarely documented and is relied upon for care or treatment that is routine and does not involve significant risk.

Who obtains consent?
• The individual who will be performing the procedure or administering the treatment in question is responsible for engaging the patient in the consent process.

What must be disclosed?
• The probable outcome • The likely benefits • An explanation of what is involved, including probably complications and any temporary discomfort, disfigurement or disability

• Any permanent results, including scarring or creation of a stoma, and required care • Risks reasonably foreseeable at the time the consent is obtained • Reasonable alternative procedures

What is ―Therapeutic Privilege?‖
A legal principle that allows the practitioner to withhold certain information from the patient based upon the potential adverse effects of the disclosure on the patient

What should be documented when exercising therapeutic privilege?
• The practitioner’s observations of the patient • Reasons why the practitioner believes certain details should be withheld • Information that was not disclosed • Details that were disclosed to the patient • A summary of medical findings used to justify use of the therapeutic privilege

Who may consent?
• Competent adult patients • Competence=ability to understand the proposed treatment and make an informed decision • Competence is usually assumed unless there are indications to the contrary

Evaluating Decision-Making Capacity
1. Ability to understand-Does the patient have the ability to understand the basic information needed to make a decision? 2. Ability to evaluate-Can the patient reason and weigh the consequences of the decision? Does the patient make a decision? Is the decision reasonably consistent over time? 3. Ability to communicate-Can the patient communicate the decision?

What about the incapacitated or comatose adult patient?
• Executed medical power of attorney
Obtain consent from the named proxy* Make a reasonable effort to inform the patient of the proposed treatment

• Did not execute medical power of attorney
•Obtain consent from one of the following:

•Spouse •Reasonably available adult children
•Parents •Nearest living relative

*The law prohibits the proxy decisionmaker from consenting to voluntary inpatient mental health services, convulsive treatment, psychosurgery, abortion or ―neglect of the patient through the omission of care primarily intended to provide for the comfort of the patient.‖

Terminology of Advance Directives
• Advance Care Planning=the process of discussion, documentation, and implementation of wishes • Advance Directives=instructional statement
– Living will/durable power of attorney – Values history – Personal letter – Medical directive

Five Steps for Successful Advance Care Planning
1. 2. 3. 4. 5. Introduce the topic Engage in structured discussions Document patient preferences Review, update Apply directives when need arises

1. Introduce the topic
• • • • • Be straightforward and routine Determine patient familiarity Explain the process Determine comfort level Determine proxy

Role of the Proxy
• Entrusted to speak for the patient • Involved in the discussions • Must be willing, able to take the proxy role

Patient & Proxy Education
• Define key medical terms • Who should they inform of the directive
– Family (with location) – Lawyer – Physicians

• Explain benefits, burdens of treatments
– Life support may only be short-term – Any intervention can be refused – Recovery cannot always be predicted

2. Engage in structured discussions
• Proxy decision maker(s) present • Describe scenarios, options for care • Elicit patient’s values, goals • Use a worksheet • Check for inconsistencies Consumer’s Toolkit for Healthcare Advance Planning

3. Document patient preferences
• • • • • Review advance directive Sign the documentation Enter into the medical record Recommend statutory documents Ensure portability

4. Review, update
• Follow up periodically • Note major life events • Discuss, document changes

5. Apply directives
1. Determine applicability 2. Read and interpret the advance directive 3. Consult with the proxy 4. Ethics committee for disagreements 5. Carry out the treatment plan

Common Pitfalls
• • • • • • Failure to plan Proxy absent for discussions Unclear patient preferences Focus too narrow Communicative patients are ignored Making assumptions

Some minors can consent: • Active duty with the U.S. Armed Forces • 16 years of age or older who reside away from their parents, managing conservators, or guardians, with or without consent, and if the minors are managing their own financial affairs

Texas Advance Directives Act (1999)
• Replaced three prior laws • Provides uniform definitions:
– Artificial nutrition and hydration – Competent – Irreversible condition – Life-sustaining treatment – Terminal condition

• Consenting to the diagnosis and treatment any infectious, contagious, or communicable diseases, including all sexually transmitted diseases • Unmarried and pregnant who consent to treatment other than abortion related to their pregnancies • Seeking treatment for conditions related to chemical use

Sedated Patients
• As a rule, consent should not be obtained from a sedated or anesthetized patient for an elective procedure—let the sedative wear off! • If delay is not feasible, consent should be obtained from a surrogate.

Mentally Handicapped and Mentally Ill Patients
• May be competent to give consent • Do not presume incompetence

Emergency Treatment without Consent
• The patient is in immediate need of medical treatment as determined by a physician or other health care practitioner; • The patient is unable to consent because of physical or mental impairment or because the patient is a minor;

• No surrogate of the patient is available to give consent; • Delay in treatment would increase the risk to the patient’s life or health; and • Proposed treatment is limited to that necessary to treat the emergency; and • There is no evidence that the patient would oppose treatment.

Refusal of Treatment
The courts may order competent adults to submit to treatment in these situations: • Refusal endangers the general public • Refusal endangers a viable fetus • Refusal of treatment may result in death leaving a minor dependent child a ward of the state

In general, surrogates may not refuse medically necessary and reasonable care for incompetent patients.

Revocation of Consent
• Patient may revoke at any time, either orally or in writing. • If revoked during a procedure, the procedure should be terminated as soon as reasonably possible.

Non-English Speakers or the Hearing Impaired
• Get an interpreter! • Suggested that a witness be present to counter-sign the progress note documenting the information that was provided to the translator • Translator’s name should be noted in the medical record

• Telephone consents are acceptable, but they must be well documented.

Obtaining Informed Consent in a Teaching Situation
1. Have the attending physician and house staff visit the patient together, prior to the procedure. Clarify the resident’s role in the procedure to the patient and his/her family. 2. Spell out the resident’s qualifications to reinforce patient confidence. Emphasis a relationship of peers.

3. Clarify that the attending physician will be present at all times in a directly supervisory capacity and that he/she is the responsible doctor. 4. Inform the patient of the identity of personnel in the operating room. 5. Prepare for some patients to insist on the attending physician performing the procedure.

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