If courts are not involved with a patient’s ability to make decisions, health care providers commonly invoke the term “medical competence,” but they are really referring to the patient’s capacity. In contrast to legal competence, decision-making capacity is a clinical judgment, which specifically describes the patient’s ability to make medical decisions. The physician’s need to assess capacity arises when there is reason to question whether a patient can make decisions about care (44). When assessing the patient’s capacity, i.e., what most observers refer to imprecisely as whether the patient is competent to consent to care, the examining physician must determine whether the patient understands the five basic elements of capacity (Table 4.1) (45). During an interview, if a patient demonstrates satisfactory understanding of these five facts, it can reasonably be inferred the patient possesses adequate decision-making capacity.
Informal Assessments
Informal assessments of a patient’s cognitive abilities typically occur throughout physician–patient interactions. In the critically ill patient, mental status may fluctuate during the course of hospitalization or even during the course of the day. Unless presented with evidence to suspect otherwise, the treating physician should assume the default position that the patient remains capable of independent choice. If this ability is in question, the health care provider is obliged to demonstrate that the patient cannot make medical decisions. When the clinical situation suggests the patient is incapable of independent choice, a more formal evaluation may be initiated (46).
Physicians may be more likely to question the patient’s mental capacity if the patient’s choices appear unreasonable or contradict the physician’s personal values. The patient who refuses a relatively low-risk, high-benefit intervention, or a terminally ill patient who insists on pursuing a painful intervention with little proven benefit, are both scenarios that may prompt a physician to question the patient’s decision-making capacity. In these situations, the physician must first attempt to decipher whether the patient’s seemingly illogical behavior is actually part of a rational thought process. A critically hemorrhaging patient who refuses a blood transfusion may be medically frustrating to care for, but this refusal becomes understandable once it is revealed the patient is a Jehovah’s Witness. Similarly, the patient with end-stage metastatic cancer who has failed multiple rounds of chemotherapy may appear irrational for insisting on pursuing invasive experimental procedures. This seemingly irrational insistence may become more understandable in the context of an upcoming family event, anniversary, or graduation.
External and Emotional Factors
In the ICU, external factors, including sundowning, sedation, pain medication, or altered sleep patterns, may contribute to transient, reversible episodes of incapacity. Whenever possible, attempts should be made to minimize the impact of these influences and optimize the patient’s cognitive status prior to making a capacity assessment. The patient’s judgment is often compromised by emotional factors—anger, fear, denial, depression, or pain—this is especially true in both the ICU and in the emergency department. The common scenario of the 50-year-old executive with crushing substernal chest pain who denies he is having a heart attack and wants to sign out of the hospital is an example of how denial may compromise a patient’s judgment.
Health care providers should recognize that the patient’s decisions under those conditions may not be the same ones they would choose in a less stressful environment. The physician must attempt to ensure that external factors do not unduly influence the patient. True informed consent requires the patient’s unhindered judgment; when that judgment appears to be unduly compromised, the physician should use appropriate measures such as family intervention, psychiatric consultation, or medication aimed at treating the specific problem. The frightened patient who refuses necessary medical care is often grateful if, after appropriate intervention, proper care is provided.
For particularly high-risk interventions or close-call scenarios, a second physician, generally someone with expertise in this area such as a psychiatrist or neurologist, may be consulted to evaluate the patient. In such cases, the physician should inform the consultant in advance about the situation so the consultant can conduct a focused interview and provide the necessary information.
Legal Interventions
In rare circumstances, questioning a patient’s capacity means seeking a court determination of legal incompetence. In practice, resorting to court is rarely necessary. Rather than deferring to the court system, most states recognize the authority of a spouse, family member, or friend to make decisions in the best interest of the patient. However, when family members and health care providers cannot agree about the most appropriate course of action after attempts at resolution, a legal opinion may be the only option. Courts are generally reluctant to get involved in health care decisions, so this should generally be the last option.
SURROGATE DECISION-MAKING
Signing out of the Hospital Against Medical Advice
One of the most difficult situations for the ICU staff is the extremely uncooperative, combative patient. In most cases, these patients are reacting to fear, pain, illicit drug ingestion, or alcohol withdrawal. Usually, after appropriate sedation or analgesia, care can be rendered although occasionally a patient must be physically restrained. The indication for physical restraint is when patients present a risk to themselves or to others. In rare circumstances, despite the best efforts of the staff, a patient may refuse all treatments and demand to leave the hospital. The staff is then forced to reconcile the conflict between respecting the patient’s rights and their duty to care for, and protect the patient from harm; there may be no easy resolution of this problem.
The right to leave the hospital against medical advice is the prerogative of the competent patient. If the patient meets the general test of medical competence as described in the five basic elements of capacity (see Table 4.1) (45), the patient must be permitted to leave the hospital, even if the staff disagrees with the decision or the decision seems irrational. However, all decisions by patients to leave against medical advice should be scrutinized by senior staff to ensure the patient truly is competent. Those decisions that appear irrational should be scrutinized with even more care. A classic example is the aforementioned 50-year-old male with an acute myocardial infarction, otherwise competent but who, in a fit of denial, demands to sign out of the hospital. All avenues should be used to get the patient to stay, including a detailed discussion of the situation and an appeal to family or friends who accompany the patient to the hospital. Ultimately, however, if the patient refuses to listen, because he is competent he must be permitted to leave. In such situations—very trying ones, indeed—health care providers must attempt to provide any appropriate care or workup before the patient leaves. Staff should avoid recriminations, and the patient should also be reassured he or she can return for care at any time.
Other situations are not so clear-cut. In many cases, the patient’s competence is in question. Possible physiologic causes for the patient’s condition, e.g., hypoxemia, electrolyte disturbances, sepsis, should be identified. If the patient cannot be deemed competent, staff may decide to institute treatment over the objection of the patient, which might even entail physical restraint. Failure to restrain when indicated carries a significant risk to both patient and health care providers. The classic counterpoint to the aforementioned myocardial infarction patient is the patient in a motor vehicle accident who appears intoxicated but wants to sign out of the hospital. If the physician suspects that the patient is intoxicated, based on clinical observation even before confirmation of blood alcohol concentration, the patient should not be allowed to leave until appropriate radiologic assessment of the head and neck have been performed.
Some health care providers are overly concerned with the liability they may incur by treating a patient against his or her wishes. When competence cannot be established with certainty, if the staff decides to restrain the patient, they may theoretically open themselves to charges of battery. Such an outcome, however, is extremely unlikely, and almost certainly less likely than the alternative of being charged with negligent discharge. The consequences of being responsible for the negligent death of unrestrained patients are far more serious than the responsibility for holding patients against their will for several hours. When the staff’s actions are medically reasonable, they are acting in good faith, and they document their decision (see below, Documentation), the likelihood of successful litigation against them is remote.
Documentation
Every situation of implied consent, or a decision to leave the hospital against medical advice, requires scrupulous and detailed documentation. The information that should be included in the medical record is listed in Table 4.2. Specialty consultations with neurology or psychiatry are not mandatory but may be useful in assessing the patient and documenting the situation. In difficult cases, it may be necessary to involve a representative of the hospital’s administration or legal counsel.
| TABLE 4.2 Documentation of Patients Who Leave the Hospital Against Medical Advice |
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PATIENT COMPREHENSION OF CONSENT FORMS
There is no medical or legal consensus regarding which procedures require formal consent. As a general guideline, the greater the risk of the procedure, the greater need to discuss the risks and benefits more formally (34). This standard results in consent policies that vary significantly from hospital to hospital. One survey of informed consent practices found that while over 90% of hospitals surveyed required formal consent for gastrointestinal endoscopy, fiberoptic bronchoscopy, or medical research, fewer than 10% required consent for nasogastric intubation or bladder catheterization (47). Of note, requirements for consent varied between medical and surgical services, even within the same institution.
Achieving satisfactory informed consent may not always be possible, even when physicians explain the procedures to patients. In one study of patients who consented to moderately invasive bedside procedures (thoracentesis, paracentesis, bone marrow aspirate, or lumbar puncture), 90% of the patients surveyed reported the physician had explained the indication for the procedure, although only 70% could correctly recall the reason for the procedure. Although 86% of patients reported the physician had informed them of the risks of the procedure, only 57% could later name any of the risks (48). This raises the question of how effectively information is communicated to patients and how accurately patients understand and recall information presented to them.
To anticipate patients’ needs and to simplify the consent process, many institutions use standardized consent forms that include essential information regarding particular procedures or interventions. The use of a standardized ICU admission consent package, describing and requesting consent for the most commonly performed procedures, can enhance the informed consent process (49). Standardized forms, however, do not necessarily guarantee clear communication. As a response to defensive medicine concerns, standardized consent forms may describe every possible adverse consequence instead of actually trying to inform the patient (50). Moreover, standardized lists of complications may fail to communicate the risks most relevant to any particular patient, especially in the ICU, where a patient’s changing medical condition can present a dynamic series of risks and benefits. The risk of an iatrogenic pneumothorax from central venous catheter placement during mechanical ventilation carries different implications than the same complication when the catheter is simply placed for fluid replacement.
Despite these caveats, standardized consent forms for common procedures may be useful in initiating dialogue between patient and physician. Standardized consent forms may also be necessary for especially complex ICU surgical procedures such as organ transplantation or experimental surgery. In these situations, a detailed informational document provides patient and health care providers with a ready reference. The language of such forms should be reviewed periodically to ensure simplicity and reader-friendly, understandable language. Even when standardized forms are used, health care providers should enter a note in the patient’s medical record detailing the conversation between the patient and physician.
RESEARCH CONSENT IN THE ICU
Like every specialty, critical care medicine has achieved progress through research involving the participation of volunteers (51). Critically ill patients represent a particularly vulnerable population, which raises concerns about their ability to give voluntary, autonomous consent to participate in clinical research (52). Ongoing critical care research recognizes a corresponding obligation to protect this vulnerable population. Requesting consent for voluntary participation in research differs fundamentally from discussing informed consent for therapeutic interventions. When discussing the risks, benefits, and alternatives of any therapeutic or diagnostic intervention, both the clinician and patient seek a course of action that would maximally benefit the patient. In contrast, the goal of research is to generate information that may benefit future patients but does not necessarily benefit the individual research participant (53). This creates a potential conflict of interest between researcher and patient, and thus, researchers must exercise particular caution in protecting patients’ rights (54). Federal regulations, known as “the common rule,” have been designed to protect this vulnerable population of research participants (55).
Patients participating in clinical research may misunderstand or overestimate the individual benefits of participation; alternatively, they may not fully recognize the potential risks (56). Although the possibility for personal benefit does exist, a patient might be randomized to a nontreatment arm of a trial or may alternatively receive experimental therapy with unexpected, hazardous side effects (54,57). Researchers are obligated to ensure that research participants recognize the additional risks and benefits of participation. Occasionally, this means a researcher may ask a research participant to accept a disproportionate share of risk with no prospect of additional individual gain. The precise limits of risk a vulnerable patient may be asked to accept have not been specifically defined (58).
The research consent process should clearly delineate the nature of the research and structure of the trial, specifically including details on any randomization process (59). In contrast to therapeutic interventions, informed consent for research represents a process that continues throughout the course of a clinical study. Consequently, routine updates for the patient may be necessary. Standardized consent forms may be helpful in communicating the relevant information, and the physician should ensure that information is clearly explained. During the study, clinical research consent forms may be used as reference documents. Because of concerns regarding literacy and language comprehension, the complexity of language should generally target comprehension for no higher than a sixth-grade reading level.
Since few patients are likely to have voiced their previous preferences regarding research participation, proxy decision-makers are left to infer the most appropriate actions in certain situations for patients without decision-making capacity. Emergency situations where patients cannot consent, and surrogates cannot be located, raise concerns about the ethics of conducting research in these cases. Although regulations have sought to protect potential research subjects, those regulations acknowledge that denying research participation to patients who cannot give consent may also deny them potentially beneficial therapy. A 1996 amendment to the Code of Federal Regulations for the Protection of Human Subjects permits emergency research with certain provisions if consent cannot be obtained (54,60). Clinical trials describe waivers of consent based on implied consent (61). Delayed consent is another mechanism that has been employed for clinical trials comparing two clinically acceptable therapies (62).
The Emancipated Minor Exception
Emancipated minors are children younger than 18 years of age (or whatever the age of majority is in the state of residence) who can decide their own medical care. The specific criteria for emancipated minors vary from state to state, but generally pertain to minors who are either married, pregnant, a parent, in the military, financially independent and living apart from their parents, or those who have been legally declared emancipated by the court. Pediatric critical care practitioners should be familiar with laws concerning the age of majority and emancipated minors in the state where they practice.
When the Parents or Surrogate and Health Care Team Disagree on the Care of a Critically Ill Child
This situation arises most commonly in end-of-life situations regarding the propriety and timing of providing care (63,64). These are obviously emotionally wrenching circumstances when health care professionals and parents or surrogates disagree. Health care providers may anticipate the termination of ventilator support in a severely brain-injured patient or a terminal cancer patient days, or even weeks, before parents or surrogates reach an understanding that this is the proper decision. Parents or surrogates may hold out unreasonable hope, however understandable, in the face of a child’s impending death. Patience is usually the best approach, as time and reasoned discussion generally resolve these issues. This strategy requires the understanding that those involved may be at different stages of acceptance. Collegial communication eventually brings the concerned parties to an acceptable conclusion. It is imperative that critical care practitioners offer parents or surrogates sufficient opportunity to discuss their feelings and emotions. A distant, emotionally detached approach by the critical care provider is inappropriate and complicates the delivery of care.
When there is neither common ground nor hope of agreement between the critical care provider and parents or surrogates, the final resort is to resort to the courts. Practitioners should not undertake formal legal action lightly. Experience has shown that in most cases, attorneys, courts, and judges, rather than hearing such cases, prefer resolution outside the courtroom. Besides being expensive, the legal process requires time and energy, both physical and emotional, on the part of everyone involved. In this adversarial process between the critical care provider and parents or surrogates involving end-of-life decisions, medical professionals should keep in mind that, in some cases, courts have ruled against the medical team who originally instituted the proceedings (65). Whenever pediatric critical care practitioners consider going to court for resolution, they should consult the hospital’s legal staff and ethics committee to explore other options and coordinate an optimal strategy for all parties involved. They should remember that the best interests of the pediatric patient are their paramount concern.
Key Points
- Rooted in principles of autonomy and self-determination, the courts have long upheld that one’s body may not be violated without proper approval.
- A corollary to the right to consent to medical treatment is a patient’s right to not consent (to refuse) medical treatment.
- The Saikewicz court developed a four-pronged test to evaluate the “state’s interest” and has been widely adopted by the courts in determining when an individual patient’s ability to exercise her or his constitutional right to refuse treatment can be circumscribed:
- The preservation of life
- The protection of the interests of innocent third parties
- The prevention of suicide
- Maintaining the ethical integrity of the medical profession
- The preservation of life
- In a patient who at no time had capacity, the Court identified four key points that continue to provide us with guidance today:
- A patient’s common-law right to determine the course of his own medical treatment is paramount to the doctor’s obligation to provide needed medical care.
- Clear and convincing proof is required in cases where it is claimed that a person, now incompetent, left instructions to terminate life-sustaining procedures when there is no hope of recovery.
- An individual who was never competent at any time in his life is considered still a child and a parent may not deprive a child of life-saving treatment, however, well intentioned.
- Neither the common law nor existing state statutes require persons to seek prior court approval in cases involving discontinuance of life-sustaining treatment for incompetent.
- A patient’s common-law right to determine the course of his own medical treatment is paramount to the doctor’s obligation to provide needed medical care.
- In the Cruzan “right to die” case, the Court:
- Recognized a “right to die” but carefully noted that this was not guaranteed by the Constitution
- Set out rules for what was required in order for a third party to refuse treatment on behalf of an incompetent person
- Established that, absent a living will or clear and convincing evidence of what the incompetent person would have wanted, the state’s interests in preserving life outweigh the individual’s rights to refuse treatment
- Left it to the states to determine their own right to die standards, rather than creating a uniform national standard
- Recognized a “right to die” but carefully noted that this was not guaranteed by the Constitution
- The roots of informed consent are to be found in the case of Schloendorff v New York Hospital, the Nuremberg Code, and the Tuskegee Syphilis Study.
- The ethical foundations of informed consent encompass the classic principles of autonomy, beneficence, and justice.
- The standards for informed consent vary.
- Under the professional community standard, the physician asks, “What should I tell the patient?”
- Under the reasonable person standard, the physician asks, “What does a reasonable person want to know?”
- Under the individual person standard, the physician asks, “What does this patient want to know?”
- Under the professional community standard, the physician asks, “What should I tell the patient?”
- Emancipated minors are children younger than 18 years of age (or whatever the age of majority is in the state of residence) who can decide their own medical care. Specific criteria include minors who are married, pregnant, a parent, in the military, financially independent and living apart from their parents, or those who have been legally declared emancipated by the court.
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