Elements of Informed Consent
What are the elements of informed consent
What is Context, information, comprehension, and voluntariness
Information:
What can subjected standard need for information be affected by:
What is:
Culture, ethnicity, values
Risk adversity
Personality and education
Prior experiences with disease/illness or treatment options
Life-style considerations
Ensure patient understanding of the information provided describes what term?
What is comprehension
Name the different parts of Consent
What is Part A: Health Literacy
Part B: Minors Healthcare Decision making Rights
Part C: when you do not need to obtain consent
When you obtain consent from someone else
Part D: How to help a patient make an informed decision
When a patient is unable to make or communicate a healthcare decision or when a partient doesn't want to make a decision who is assigned?
What is a medical power of attorney or health care agent
Context of informed consent:
Consent Discussion is equal to
What is delivering bad news
Information
What should you discuss for each treatment option ( including non treatment)
What is
Its purpose
What is involved ( procedure, length, frequency, recovery time, and how it will affect their lives
The prognosis
Whether time is of the essence
What are some examples of how you can ensure the patient is comprehending?
What is
Have the patient repeat major points (diagnosis, options, risks, etc.).
Have the patient describe how the potential benefits and harms would affect them given their goals, values, life-style, etc.
Have the patient state what will happen without treatment.
Have the patient repeat medication information and instructions.
What are circumstances under which a minor is allowed to make confidential healthcare decisions under Georgia law. Minors of any age may consent to treatment for :
What is substance abuse, STD's , reproductive heath, and minor parents can consent to all healthcare for their children
What authority do a medical power of attorney have?
What is make all decision regarding medical treatment, care, and custody including those that extend being the patients death
Request, examine, or copy the patients medical record
Consent or refuse consent, to disclosure of the patient's healthcare information
Context of Informed Consent
High levels of ____ negatively affect how education is received by newly diagnosed patients with disease by decreasing comprehension, retention, and patient satisfaction
What is anxiety
Information
Pharmacist must offer to discuss the medication including but not limited to:
What is
Name and description of the drug.
Dosage form, dose, route of administration and duration of therapy.
Intended use of the drug and expected action or result.
Common severe side effects, adverse effects or interactions.
Therapeutic contraindications that may be encountered.
Techniques for self-monitoring of drug therapy.
Proper storage of the drug.
Prescription refill information.
Action to be taken in the event of a missed dose.
Directions or precautions for preparation, administration or use by the patient.
Voluntariness:
A patient nt makes a choice they would not have otherwise made if not for being deceived or someone using excessive/improper pressure
What is Undue influence
Physicians may treat a minor without parental consent in medical emergencies when and what is it based on?
What is
Immediate treatment is necessary. Delay would risk death, serious injury, or permanent harm. This is based on the doctrine of presumed consent.
This person has decision-making authority if the patient is unable to make or communicate a healthcare decision and has not appointed a healthcare agent
What is a healthcare representative
Information
What standard is what a "reasonable prudent patient" would need to know to make an informed decision or information that would be substantial factor in a patients decision - making process
What is objective standard
Information:
HARMS; Pharmacist must discuss these with the patient, what do they include
Discuss the PROBABILITY, MAGNITUDE & DURATION of each harm along with how you will try to prevent it and what you will do if it does happen.
Explain the difficulty in extrapolating from research to individual patients; openly acknowledge uncertainty.
Discuss the various kinds of harms that may be experienced such as physical, psychological, economic (e.g., employment), familial and social
Voluntariness
Threat of harm that can be physical, financial or relational (abandonment, involuntary commitment, financial threats for “signing out” AMA, telling patients they can’t leave, etc.)
What is Coercion
True or False: In medical emergencies informed consent is required based on the presumption that a reasonable prudent person would want to be saved
What is false
True or False: A healthcare representative has the same authority as a healthcare agent and court approval is not required
What is true
Information:
What standard is what the particular patient in front of you needs to know to make an informed decision.
What is subjective standard
What obligation increases in relation to the probability, magnitude or duration of harm
What is comprehension
What are three main points for voluntariness
What is
Respect for autonomy doesn't mean you can’t try to persuade your patient.
Patients can change their mind at any time, and if the situation is not emergent suggest that they take some time to make a decision.
Ensure the patient is able to make a voluntary decision, free from undue influence and coercion.
When the informed consent (exception) does not apply
What is to a patient who have previously stated their wishes to have life- sustaining / life saving treatment withheld whether verbally or by way of an advance directive, DNR order or declaration of Faith
Describe emotional, intellectual and clinical factors that can adversely affect a patients ability to make healthcare decisions
What is:
Emotional Factors: Anxiety, Fear, Stress, Shock after diagnosis
High emotional distress can reduce comprehension and retention of information.
Intellectual Factors: Education level, Health literacy, Cultural beliefs, Personality differences (e.g., desire for detailed information)
These factors influence how much information a patient needs to make a decision.
Clinical Factors: Severe illness, Cognitive impairment, Delirium or confusion, Pain or medication effects
These conditions may impair decision-making capacity.