Informed consent is the communication process that both demonstrates and protects a patient's self-determination by providing a patient with decision-making capacity with sufficient, understandable information and allowing the patient to make a voluntary, knowledgeable decision. There are five requirements that must be satisfied.13 These include the patient having decision-making capacity, the EP providing sufficient information, the patient understanding the information, the patient giving consent in a voluntary fashion without coercion, and the patient communicating their decision (Table 1-3).
While the terms “competence” and “decision-making capacity” are frequently used interchangeably, their strict meanings are different. Competence is a legal term with broader applications related to financial matters and the determination of personal choices. Decision-making capacity is a clinical term that speaks to the specific capacity to make a particular clinical decision. Many people who are legally “incompetent” retain healthcare decision-making capacity. If the patient does not have decision-making capacity, informed consent cannot be obtained and it must be obtained from a surrogate decision maker, or the patient may fall into an exception from informed consent.
Determining Decision-Making Capacity
The determination that a patient has decision-making capacity is at the core of informed consent. By default, EPs assume that a patient has capacity and confirm this through routine dialogue with the individual. There are six elements that should be confirmed when there is a question about a patient's capacity to make an informed decision about procedures or treatment.14 The patient must be able to: understand and process the options, weigh the benefits and risks, apply a set of values and goals to the decision, arrive at a decision, communicate a choice, and demonstrate capacity to make the decision (Table 1-4).
Table 1-4 Elements to Determine if a Patient has Decision-Making Capacity ||Download (.pdf)
Table 1-4 Elements to Determine if a Patient has Decision-Making Capacity
The patient is able to understand and process the options presented
The patient is able to weigh the relative benefits, burdens, and risks of the options
The patient is able to apply a set of values and goals to the decision
The patient is able to arrive at a decision that is consistent over time
The patient is able to communicate a choice
The patient demonstrates capacity appropriate and sufficient to make this decision
Determination of capacity is a clinical decision based on the judgment of the EP regarding the patient's actual level of functioning and appreciation of the ramifications of the clinical situation. The degree of capacity needed to understand risks and benefits of suturing a finger laceration differs from a cardiac catheterization. As such, a patient may be able to understand one choice, but not another. An Alzheimer patient (who is pleasant, oriented to place and year) may be unable to appreciate the consequences of a decision. While this patient may have capacity for some tasks, they may lack the capacity to consent for a specific procedure such as a lumbar puncture.
The EP needs to assess the ability for the individual to weigh the risks in light of their own values. An example would be the ramifications of a fracture reduction on the dominant hand. A construction worker or musician may make a decision different than an individual whose livelihood does not depend on perfect hand function.
A recognized element of decision-making capacity is whether the patient's decision is consistent over time. This is not necessarily applicable specifically to the ED. A possible heuristic is whether the decision is consistent with the person's narrative and values as expressed consistently over time in life choices. The decision-specific nature of capacity acknowledges that the level of capacity needed depends on the complexity of the decision, with greater capacity needed for decisions with graver consequences. The degree of capacity needed to consent does not necessary equal the degree of capacity needed to refuse a recommended intervention.10 Informed refusal will be discussed later in this chapter.
Decision-making capacity is a dynamic process and changes depending on the patient's evolving condition and task in question. The ED patient may be able to participate to a greater or lesser extent depending on fluctuations in their condition and alterations of their sensorium from the administration of medications. Efforts should be made whenever possible to enhance the patient's decision-making capacity (reduce pain medication temporarily or visit patients at optimal times) in order to engage them to the fullest extent possible in their care.
Emancipated minor and adolescent laws vary from state to state.9 It is important to note that emancipated minors are legally recognized as adults and responsible for their own finances and care. They are able to provide fully informed consent. It is important for EPs to know their local laws where minors who are not emancipated may give consent for sensitive conditions or procedures such as those of a reproductive nature or substance abuse.
Informed consent may not be possible with some populations, such as young children and elderly with dementia. It is still possible to inform these patients of the procedure and to engage their assent. Unlike consent, assent is not determinative. It does offer the possibility of the individual participating in their care.15
Patients Lacking Decision-Making Capacity
It is not possible to obtain informed consent when a patient lacks decision-making capacity. Necessary treatment may be provided to patients who lack decision-making capacity without obtaining the patient's informed consent. However, EPs should make every effort to learn the patient's previously stated preferences for treatment (e.g., written advance directive or communication with a primary care provider). Efforts should be made to obtain consent from a surrogate decision maker if prior preferences are not available. A surrogate decision maker is a person entrusted with making healthcare decisions because they know the patient best and can bring the patient's values and goals into the clinical decision process. This role can be challenging for even the most capable decision makers. It is not uncommon for surrogates to have a role conflict between applying their own values and/or wishes and those of the patient.
Emergency Physicians must pay attention to the language used when asking a surrogate decision maker for consent. Frame the discussion with phrases asking what the patient would want in the situation such as “How would your father view this situation?” or “What would your father's preference be based on his values?” Avoid general phrases such as “What should we do?”, “What do you want us to do?”, or “What do you think he would want?” If the decision seems to stem from a role conflict, an EP can ask the surrogate “Why do you think he would choose that?” No prior conversation covers every clinical scenario perfectly and the gravity of the decision can frequently be overwhelming for the surrogate.10
The choice of a surrogate decision maker may be quite obvious in some cases such as the parent or legal guardian of a child. The choice can be more complex in other cases. Who may serve as a surrogate and their scope of authority varies by state. What if the appropriate surrogate is in question and there is no statutory guidance? A useful guide is that the surrogate's authority arises from a close relationship to the patient that affords accurate and informed communication of the patient's values. Challenges in resolving conflict between potential surrogates (e.g., siblings with different opinions regarding parental care) should be referred to an ethics committee or other institutional mechanisms to offer guidance unless emergent conditions make that impractical.
The EP must relate sufficient information about the procedure to the patient. This raises the questions of what information to present and how much to present. Relevant information includes the risks and benefits of the procedure, any alternatives to the proposed course of action, and the consequences of nonaction. The question remains how much information needs to be disclosed to patients, particularly in light of the potential that legal action may be taken if an EP does not obtain informed consent properly.16
There are two standards that are commonly used, and these standards vary by state. The traditional “professional standard” requires the EP to provide information based on what the profession's standard of practice would deem necessary to disclose for a patient to be informed. The more common “reasonable person standard” requires the EP to include all the information that a reasonable patient would want to know in order to make a knowledgeable decision. Information that should be communicated includes: the patient's current medical condition and how will it progress if no treatment is given, the treatment alternatives, the risks and benefits of each potential treatment and their probabilities, and the financial costs of each if those estimates exist. Finally, the EP should provide a personal recommendation as to the best alternative.17
Understandable Presentation of Information
Information must be given in a way that is understandable. The patient must be able to adequately weigh the benefits, burdens, and risks of the treatment in the context of their own beliefs, life, values, and goals. The obvious differential in knowledge and understanding between patients and EPs may be exacerbated by language barriers, literacy, numeracy, and low educational levels.18 Such barriers may be overcome by: speaking at a level easy for the patient to comprehend, being sensitive to patients who may be unable to read, and being sensitive of patients who may not be highly educated. Understanding is bidirectional and necessitates that EPs confirm that the patient understands what they are told.19 Communicating numbers, such as risk and probabilities, is the most complex task asked of EPs.20 Frame numbers in multiple ways and present outcomes in both positive and negative contexts to enhance informed consent.20 For example, “3 out of 4 children have no side effect but one in four will have nightmares from this medication.”
Language barriers are frequent in the ED and pose significant concern in obtaining and documenting informed consent.21 Understanding languages is situational. Although some EPs may have additional language (non-English) proficiency, it is imperative to know when to call an interpreter. Limited language skills allow the EP to extract critical clinical information. Patients may need more information than the EP's skills allow. Calling an interpreter may be essential for meeting a minimum standard of care.22
Voluntary Nature of the Decision
Forced treatment where any real choice is removed from the patient being involved in the decision-making process violates the doctrine of informed consent. Any form of coercion based on threats or intolerable consequences, such as the withholding of pain medication, would fall into this category. Emergency Physicians cannot manipulate patient decisions by withholding or distorting information that the EP believes may sway the patient toward a preferred course. Persuasion is permissible, and it is an obligation as trained professionals to synthesize the information and recommend a course of action. An appropriate recommendation includes laying out the risks, benefits, and reasoning behind one's recommendation as well as explaining the reasoning for not selecting an alternate approach. Emergency Physicians can also utilize the resources of the patient's family or significant others to provide arguments in favor of a particular course of treatment. The EP must be careful to avoid overwhelming the patient as the goal should be a shared solution by consensus and not forcing the patient to surrender to the wants of others.23 Strategies to approach a patient's refusal are discussed in depth later in this chapter.
Effective Informed Consent and Refusal
There is a difference between the autonomous authorization informed consent (information and dialogue) and the effective informed consent (to meet legal and institutional requirements). The EP should document the discussion of the benefits, burdens, risks, and alternatives addressed in the discussion with the patient in order for an autonomous authorization to be recognized as effective and, thus, the entire informed consent valid. Local institutional policies should be referenced to confirm an effective informed consent or refusal.7
Some hospitals have patients sign “blanket” consent forms agreeing to all emergency tests and treatments on their registration in the ED. Such consent forms provide no information regarding specific individual procedures. These forms are not acceptable because they fail to respect patient autonomy. Blanket consent forms cannot substitute for the usual informed consent process for procedures in the ED, where a dialogue with the patient is required.24