Capacity (Competence) Determination and Informed Consent
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Basics
- Personal autonomy in decision making is a fundamental personal freedom.
- Capacity determination is an inherent element of the informed consent process.
- It is universally presumed that patients 18 years and older (or an emancipated minor under individual state laws) have legal and clinical capacity to give informed consent for health care testing, interventions, and treatment or to refuse same no matter the harm or benefit until proven otherwise.
Description
- Capacity:
- A clinical evaluation; determined by an authorized health care provider
- Focuses on perceived ability of patient to participate in informed consent
- Competence:
- A legal determination of abilities, performed by a court judge
- Involves medical information, but not limited to medical issues
- Capacity is the currently preferred term to competence: Legal Capacity and Medical Capacity
- A capacity determination is needed when arriving at a health care decision for testing, treatment, or an intervention involving risk of serious harm or no improvement.
- Any treating health care provider can evaluate capacity, including the provider also obtaining informed consent or a psychiatrist or neuropsychiatric consultant
- Medical capacity is determined by:
- Clinical observation and response to questions
- Capacity assessment tool(s)
- Cognitive assessment tool
- Interviews with a guardian or designated health care power of attorney (if indicated)
- The four “C”s of capacity are:
- Adequate cognition is a fundamental component, but not the sole determinant of capacity.
Epidemiology
Being near “end of life” increases the chance of having an advanced directive:
- Among almost 800,000 U.S. adults studied, approximately 1/3 have completed an advanced directive (2).
- As many as 1/3 of seriously ill geriatric patients near end of life do not have advanced directives (3).
Need for capacity determination has been increased due to:
- Increasing patient longevity
- Prolonged chronic disease states
- Better patient rehabilitation opportunities
- Safer anesthetics and advanced postsurgery care
Prevalence varies based on the patient risk factors (pretest probability) and physician experience:
Etiology and Pathophysiology
- Dementia is the most likely cause for individuals to be found incapable of making health care decisions in the outpatient setting.
- Capacity is a dynamic state; reassessment is necessary with each significant health care decision and informed consent
Risk Factors
- For incapacity:
- Longevity, multiple comorbidities, in hospital for medical reasons
- Never married, never worked outside home
- Insufficient informed consent:
- Patient factors:
- Health illiteracy
- Language and cultural barriers
- Excessive information
- Provider factors:
- Inexperience with process (e.g., house staff)
- Insufficient discussion time
- Use of medical terminology
- Patient factors:
General Prevention
Early assessment and periodic reassessment of capacity in:
- Dynamic patient conditions, like electrolyte imbalance, closed head injuries, delirium states
- After procedures with anesthesia or analgesics
- Enhancement and dissipation of mind-altering substances
Commonly Associated Conditions
- Dementia/Alzheimer disease, Parkinson disease, and traumatic brain injury
- Schizophrenia, depression, and substance abuse
- Acute illness, metabolic derangement
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Basics
- Personal autonomy in decision making is a fundamental personal freedom.
- Capacity determination is an inherent element of the informed consent process.
- It is universally presumed that patients 18 years and older (or an emancipated minor under individual state laws) have legal and clinical capacity to give informed consent for health care testing, interventions, and treatment or to refuse same no matter the harm or benefit until proven otherwise.
Description
- Capacity:
- A clinical evaluation; determined by an authorized health care provider
- Focuses on perceived ability of patient to participate in informed consent
- Competence:
- A legal determination of abilities, performed by a court judge
- Involves medical information, but not limited to medical issues
- Capacity is the currently preferred term to competence: Legal Capacity and Medical Capacity
- A capacity determination is needed when arriving at a health care decision for testing, treatment, or an intervention involving risk of serious harm or no improvement.
- Any treating health care provider can evaluate capacity, including the provider also obtaining informed consent or a psychiatrist or neuropsychiatric consultant
- Medical capacity is determined by:
- Clinical observation and response to questions
- Capacity assessment tool(s)
- Cognitive assessment tool
- Interviews with a guardian or designated health care power of attorney (if indicated)
- The four “C”s of capacity are:
- Adequate cognition is a fundamental component, but not the sole determinant of capacity.
Epidemiology
Being near “end of life” increases the chance of having an advanced directive:
- Among almost 800,000 U.S. adults studied, approximately 1/3 have completed an advanced directive (2).
- As many as 1/3 of seriously ill geriatric patients near end of life do not have advanced directives (3).
Need for capacity determination has been increased due to:
- Increasing patient longevity
- Prolonged chronic disease states
- Better patient rehabilitation opportunities
- Safer anesthetics and advanced postsurgery care
Prevalence varies based on the patient risk factors (pretest probability) and physician experience:
Etiology and Pathophysiology
- Dementia is the most likely cause for individuals to be found incapable of making health care decisions in the outpatient setting.
- Capacity is a dynamic state; reassessment is necessary with each significant health care decision and informed consent
Risk Factors
- For incapacity:
- Longevity, multiple comorbidities, in hospital for medical reasons
- Never married, never worked outside home
- Insufficient informed consent:
- Patient factors:
- Health illiteracy
- Language and cultural barriers
- Excessive information
- Provider factors:
- Inexperience with process (e.g., house staff)
- Insufficient discussion time
- Use of medical terminology
- Patient factors:
General Prevention
Early assessment and periodic reassessment of capacity in:
- Dynamic patient conditions, like electrolyte imbalance, closed head injuries, delirium states
- After procedures with anesthesia or analgesics
- Enhancement and dissipation of mind-altering substances
Commonly Associated Conditions
- Dementia/Alzheimer disease, Parkinson disease, and traumatic brain injury
- Schizophrenia, depression, and substance abuse
- Acute illness, metabolic derangement
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