Responding to requests for potentially inappropriate or futile therapies in adult intensive care unit

INTRODUCTION — Clinicians are sometimes faced with requests to provide treatments for patients in the intensive care unit (ICU) that they judge to be inappropriate. These requests often arise due to poor communication regarding prognosis and treatment goals between the treating team and the patient and/or their surrogates. Sometimes, such requests arise because of value disagreements between the clinician and the patient and/or their surrogates about what the goals of care should be in light of a serious medical situation.

Issues related to requests for futile interventions and potentially inappropriate treatments are reviewed in this topic. Details regarding other ethical issues that arise in the ICU, including communication with surrogates in ICUs, palliative care, informed consent, and withdrawal of care, are discussed separately.

●(See "Communication in the ICU: Holding a meeting with families and caregivers".)

●(See "Palliative care: Issues in the intensive care unit in adults".)

●(See "Informed procedural consent in the intensive care unit".)

●(See "Withholding and withdrawing ventilatory support in adults in the intensive care unit".)

TERMINOLOGY AND DEFINITIONS

Futile treatment — The term "futile" should be used only to describe treatments that cannot accomplish the intended goals [1]. Clinicians should not label interventions as futile because they believe the treatment is not cost-effective or think that the potential benefits are too unlikely or too small to outweigh the burdens.

Cases of futility are rare in the ICU. Examples of a futile treatment would be administering cardiopulmonary resuscitation to a patient with myocardial rupture or antifungal medication to treat bacterial pneumonia. An expanded description of futility is provided separately. (See "Palliative care: Medically futile and potentially inappropriate therapies of questionable benefit", section on 'Definitions of futility'.)

Potentially inappropriate — The term "potentially inappropriate" refers to treatments that have at least some chance of accomplishing the patient's intended goal but the clinician judges that the treatment is outside the boundaries of acceptable practice due to other ethical considerations. This could include that the treatment is exceedingly unlikely to accomplish the patient's goals, represents an unfair allocation of scarce resources, or is intended to achieve a goal that is contrary to accepted medical goals [2,3]. Most conflicts arise over potentially inappropriate treatments; disagreements occur over whether treatment goals are reasonable and whether the chances of success are high enough to warrant treatment.

Examples may include long-term mechanical ventilation in a patient with widely metastatic cancer and progressive multiorgan failure or performing a laparotomy on a patient with ischemic bowel who also has end stage liver disease, multiorgan failure, and high-dose vasopressor-dependent shock.

The term "potentially inappropriate" treatment makes explicit the value-laden nature of these judgments and thereby lessens the chance that clinicians will characterize the conflict as about objective facts or scientific knowledge.

Further details regarding the definition of potentially inappropriate treatment are provided separately. (See "Palliative care: Medically futile and potentially inappropriate therapies of questionable benefit", section on 'Potentially inappropriate treatment'.)

PREVALENCE — Several observational studies suggest that requests for inappropriate therapies is not uncommon in the ICU [4-6]. For example, one prospective study in five ICUs reported that among 1136 patients admitted to the ICU, 20 percent were perceived by ICU clinicians as receiving therapy that was probably futile (9 percent) or futile (11 percent) [5]. Two-thirds of those perceived as receiving futile therapy died before hospital discharge and the remaining one-third either died in the subsequent six months or remained in a severely compromised state of health. However, the definition of "futile" was broad (in contrast to what we recommend) and was more consistent with inappropriate therapy.

INITIAL EVALUATION TO ESTABLISH GOALS OF CARE — The principles of our approach are outlined in the algorithms (algorithm 1 and algorithm 2). We individualize the approach and incorporate unique aspects of each patient's condition and health-related values and preferences. In practice, it requires multiple conversations with the patient (if possible), their surrogate(s), and other clinicians involved in patient care. Our experience is that in most cases, skillful communication between the ICU team and family results in treatment plans that all can accept as reasonable.

Assess medical condition and prognosis — To evaluate whether a treatment is potentially inappropriate, the clinician needs to understand the patient's medical condition(s) and their prognosis. This involves taking a detailed history and examination and obtaining information from medical records and the primary medical team or subspecialty consultants. Despite such comprehensive information, prognostication remains one of the most challenging aspects of this evaluation. (See "Palliative care: Medically futile and potentially inappropriate therapies of questionable benefit", section on 'Complexity of prognostication'.)

Determine goals of treatment — During this assessment, we also determine (and document) the goals of treatment by the patient and/or their surrogates as well as their health-related values and preferences. This involves a detailed discussion of sensitive issues including the following:

●Desire for prolongation of life

●Perception of their current quality of life and potential future quality of life

●Desire for relief of pain and suffering

●Attitude towards short-term need for or prolonged dependence on life support (including tracheostomy or feeding tube, inability to live an independent life, inability to participate in self-care or treasured hobbies)

●Opinion regarding life-sustaining therapies other than mechanical ventilation (eg, dialysis, transfusions, cardiopulmonary resuscitation [CPR])

●Feelings towards nursing home dependence

●Opinion regarding the circumstances of their death (eg, peaceful death versus CPR)

This discussion is key to understanding what the patient's values and preferences are and puts meaning to vague statements, such as "I want everything done." Further details regarding an effective goals of care discussion are provided separately. (See "Discussing goals of care".)

The clinician should be able to identify and respect any differences between their personal values and those of the patient, which can be challenging when personal opinions are strong. (See 'Value differences between patients and clinicians' below.)

Whenever possible, discussion about goals of care should be carried out before a crisis occurs, including documentation of advance directives and the substance of goals-of-care conversations. However, this is frequently not the case, and on occasion, time-pressured decisions need to be made in the absence of such discussions. The approach under a time constraint and advance directives are discussed separately. (See 'Time-pressured decisions' below and "Advance care planning and advance directives".)

Initial conversation with patient and/or surrogate — We next have a conversation with the patient and/or their surrogate. The patient's wishes should be given substantial weight when having this conversation.

Important aspects of the conversation that should be addressed include the following:

●A careful delineation of the patient's medical situation and prognosis using culturally sensitive and empathic language and making a special effort to avoid medical terminology. The term futility should not be misused since it introduces bias. (See "Communication of prognosis in palliative care" and "Communication in the ICU: Holding a meeting with families and caregivers", section on 'Sharing clinical information' and "Palliative care: Medically futile and potentially inappropriate therapies of questionable benefit", section on 'Risk of bias'.)

●Discussion of medically reasonable treatment options that are most consistent with the patient's goals of care and values. This should include a review of the risks and benefits of each treatment. This may be a difficult discussion given that clinicians and patients (or their surrogates) occasionally disagree about whether the risks of harm outweigh the chances of benefit. During these discussions, strictly futile interventions should not be offered (eg, adding a third or fourth vasopressor in the absence of data to suggest benefit). Further details regarding surrogate meetings are provided separately. (See "Communication in the ICU: Holding a meeting with families and caregivers".)

At the conclusion of this initial conversation, we determine whether the treatment requested by the patient or surrogate is appropriate, futile, or inappropriate. Further action based upon this decision is provided below. (See 'Appropriate therapy requested' below and 'Futile therapy requested' below and 'Potentially inappropriate therapy requested' below.)

When deemed inappropriate or futile, most hospitals have a policy to provide guidance for clinicians on how to manage such requests.

Managing conflict during such conversations is an important aspect of good ICU care, particularly for clinicians, because such conflicts are associated with moral distress and burnout [4,7]. In one study conducted across 82 ICUs, the provision of inappropriate care by clinicians was independently associated with the intent to leave their job (odds ratio 1.65, 95% CI 1.04-2.63) [4]. Strategies to avoid futility disputes are discussed separately. (See "Palliative care: Medically futile and potentially inappropriate therapies of questionable benefit", section on 'Strategies to avoid futility disputes'.)

Clinicians should not simply acquiesce to requests for treatments that they believe violate accepted medical practice since this violates the ethical obligations to practice with professional integrity and to refrain from harming patients.

In addition, clinicians should avoid making purely independent judgments about whether a requested treatment is inappropriate and case discussion with other clinicians is reasonable. There may be legitimate uncertainty about what is appropriate treatment, particularly in patients who are near the end of life, and individual clinicians may not be well-positioned to make such judgments independently.

APPROPRIATE THERAPY REQUESTED — If the clinician and patient/surrogate determine that the requested therapy is appropriate, then they should proceed with that therapy.

FUTILE THERAPY REQUESTED — If it is determined that the requested treatment is futile (which is rare), then we advise that the treatment is futile and explain that there is no obligation to provide such care on the following grounds:

●Providing futile therapy goes against the ethical obligation of clinicians to act to benefit their patients and to refrain from harming them [1,8].

●Clinicians have a legitimate interest in safeguarding their profession's integrity and trustworthiness, which would be undermined if clinicians administered interventions that they knew cannot achieve the intended goals.

When faced with requests for futile therapies, we try to understand the reasons underlying such requests, address misperceptions, provide emotional support, and explain why we feel that the requested interventions should not be provided. The involvement of consultants or ancillary services, such as palliative care or ethics consultants or hospital chaplains, may be helpful during these discussions.

If this approach does not lead to consensus or if there is any uncertainty regarding whether a treatment is futile (expressed by any member of the treatment team), we seek a second opinion from a qualified and independent provider.

POTENTIALLY INAPPROPRIATE THERAPY REQUESTED — When a patient or surrogate requests a potentially inappropriate treatment despite the clinicians' (and consultants') best counseling efforts, we engage in a process of conflict resolution (algorithm 2 and algorithm 1 and table 1). This is a seven-step process that is grounded in both ongoing respectful, empathic communication and procedural fairness. (See 'Conflict resolution: Seven step process' below.)

Conflict resolution: Seven step process — The seven-step conflict resolution process was published as a joint policy statement by five North American and European professional societies, which is summarized below (table 1) [9]. The Society of Critical Care Medicine (SCCM) [10] and the American Medical Association (AMA) have issued similar statements [11]. A shared decision between the treatment team and the patient and their surrogates may occur following any step during this process. Importantly, not all states have legal language that adheres to this standard. It is therefore reasonable that clinicians be aware of local law practices. (See 'Legal aspects' below.)

Step 1: Expert consultation — Before initiation of and throughout the resolution process, clinicians should enlist expert consultation to aid in achieving a negotiated agreement. When feasible, we assemble a collaborative team that involves members of the health care team, palliative care or ethics consultants, and subspecialty clinicians with expertise or knowledge of the patient and their condition (eg, oncologist, neurologist, family practitioner).

Ongoing dialogue during this step is important. A mutually agreeable solution may be reached by encouraging clinicians and the patient and/or their surrogates to continue to talk together with the goal of resolution. This is particularly important as new information becomes available and the clinical condition of the patient evolves.

Studies suggest that most conflicts between the clinician and the patient/surrogate can be resolved collaboratively through ongoing dialogue [12,13] and with the help of expert consultation [14-18]. This is most likely because few of these disagreements arise from true value conflicts (ie, differences in deeply held values and beliefs about treatment goals) but are instead a result of inadequate communication and support in the face of a life-threatening illness [12,13].

Step 2: Inform the patient or surrogate about the conflict resolution process — The patient and/or surrogates should be informed in writing that a formal process-based resolution procedure has been initiated. They should also be informed about the steps involved in such a process and the anticipated timeline.

Step 3: Request a second opinion — A second opinion should be obtained to verify the prognosis and the judgement that the requested treatment is inappropriate.

Step 4: Review by a multidisciplinary hospital committee — The clinical team should also request that the case be reviewed by a multidisciplinary hospital committee, usually the hospital ethics committee. Such a committee should be interprofessional in nature and should strive to have community representation. Both the clinicians and the patient/surrogate should be asked to explain the reasons underlying their beliefs about the correct treatment plan. The opinions of the committee should be provided in writing to the treatment team and to the patient/surrogate and should include reasons for the committee's determination.

Although case review by a multidisciplinary hospital committee accomplishes the goal of gaining the perspective of individuals not directly involved in the patient's care, some have argued that this review may yield a biased conclusion in favor of the treatment team because the membership on such hospital committees tends to be dominated by employees of the hospital [19].

Step 5: No agreement – Offer to transfer the patient to a willing provider — If an agreement cannot be reached, the clinician should offer the patient and/or their surrogates the opportunity to transfer care to a willing clinician. This step is important because, with the exception of treatments that are strictly futile, there is often uncertainty about what are boundaries of acceptable practice in patients with advanced critical illness.

Clinicians and the institution should offer to share responsibility for seeking an alternative clinician because genuine efforts to facilitate transfer require expertise that patients and surrogates generally lack. This includes identifying and contacting alternative clinicians, explaining the clinical situation to them, and assisting with the logistics of the transfer process.

●If a willing provider is found and the patient is medically stable to permit it, the patient should be transferred.

●If no willing provider can be found after a diligent search, a stronger case can be made that the requested treatments are inappropriate.

Step 6: No willing provider – Inform surrogates of their right to seek legal intervention — If no willing clinician can be found at other institutions, the patient and/or their surrogate should be informed of their right to seek legal intervention by an independent appeals body. The rationale for this step is that a central element of procedural fairness is preserving the opportunity for appeal of the decision to a legitimate, impartial body, which may not always be achieved with existing institutional review processes.

In the United States, independent legal intervention has traditionally been filled by the courts, although other appeals processes are theoretically possible, such as nonjudicial appeals boards [20] or mechanisms similar to the Ontario Capacity and Consent Board [21].

Step 7: Take action — The last step is that action is taken:

●If no willing provider can be located and the hospital review committee or independent appeals body concurs with the clinician's judgment (or the patient/surrogate does not seek independent appeal), clinicians are ethically justified to refuse to provide the requested treatment. Treatments ensuring the patient's symptoms are well controlled and caregivers are supported should be continued. (See "Palliative care: Issues in the intensive care unit in adults".)

●If a willing provider is located or the review committee concurs with the patient or surrogate's judgment, the treatment in question should be initiated (or continued) or the patient transferred to a willing clinician.

Challenges

Legal aspects — Outside of the state of Texas [22], this procedural approach does not guarantee legal protection for clinicians. Therefore, it is important that the hospital leadership of the institution in which the patient is being cared for supports the dispute resolution process. As an example, the policy at Children's Hospital in Boston is to label such decisions as "institutional," rather than "individual" decisions made by a specific provider [23].

Value differences between patients and clinicians — Decisions about medical care in advanced illness often hinge on personal conceptions of what gives life meaning [24,25], about which there can be legitimate disagreement between clinicians and patients. These are value-laden judgments.

As an example, a clinician may believe that the most respectful way to care for a patient with advanced dementia and multiorgan failure is to pursue a course of treatment focused on comfort. However, a particular patient may have articulated a deeply held moral or religious belief that the best way to respect the sanctity of life is to attempt to extend life, even in end-stage disease. In such cases, the clinician should be able to identify and acknowledge these differences in values.

Conscientious objection — Occasionally, a clinician may have a personal conscientious objection to the treatment plan arrived at through the dispute resolution process. Such conscience-based objections by clinicians deserve respect and accommodation when possible, but should not be allowed to impose an undue burden on the patient, family, surrogate(s), or other clinical staff. We agree with the principles outlined by a policy statement from the American Thoracic Society (ATS) on managing clinicians' conscientious objections [26]. These principles are outlined in the algorithm (algorithm 3).

Time-pressured decisions — Occasionally, when medical issues require urgent treatment, there may be insufficient time to undertake a formal evaluation or undergo a conflict resolution process. We agree with the multiprofessional policy statement that states there are certain circumstances in which clinicians are permitted to refuse the provision of a requested treatment even if time pressures make it infeasible to complete the seven-step resolution [9]. (See 'Conflict resolution: Seven step process' above.).

Provisional conditions for such cases include the following:

●Clinicians should only use this pathway when there is a high degree of certainty that what is being requested is outside the boundaries of accepted practice.

●Treatment refusals over the objections of surrogates are managed using as much of the seven-step conflict resolution process as is possible given the clinical circumstances.

●All involved clinicians should reach a consensus on a specific decision prior to informing the patient and/or their surrogates and taking any action.

●There is retrospective review of such cases.

●This approach should only be used in exceptional circumstances and only as a last resort.

As an example, a surrogate may be present during an unexpected cardiopulmonary arrest that results in ongoing cardiopulmonary resuscitation (CPR) of their loved one. Despite multiple unsuccessful rounds of CPR, the surrogate may insist that CPR continue. In such a circumstance, we believe it is important that the treating team achieve a consensus on whether continuation of CPR is outside the boundaries of accepted practice. If the team agrees that continuing CPR would be inappropriate, a designated member of the clinical team should inform the surrogate of this decision and give the reasons behind the decision. Following this, resuscitative efforts should be ceased, and the case should be retrospectively reviewed to identify areas in which care process can be improved.

Placing limits on treatment — It is sometimes appropriate for clinicians and surrogates to agree on a plan for a time-limited trial of intensive treatment (eg, short-term intubation for two to three weeks, but no tracheostomy and feeding tube). This approach has the advantage of giving the patient and their surrogate the time needed to accept a poor prognosis and understand that aggressive level of treatment was administered and pursuing it is unlikely to achieve the long-term goal of the patient.

When surrogates object to the act of withdrawing life support, a plan to not further escalate treatment, also known as do-not-escalate-treatment order (DNET), may also be appropriate (eg, not adding additional vasopressors or not initiating hemodialysis if kidney function worsens). (See "Palliative care: Medically futile and potentially inappropriate therapies of questionable benefit", section on 'Do-not-escalate-treatment orders'.)

The ATS promote a "time-limited trial" approach and define it as a collaborative plan among clinicians and a patient and/or their surrogate decision makers to use life-sustaining therapy for a defined duration, after which the patient's response to therapy informs the decision to continue care directed toward recovery, transition to care focused exclusively on comfort, or extend the trial's duration [27]. They describe 16 core elements (figure 1) in four phases (consider, plan, support, and reassess). The approach is generally intensivist-led without the need for an ethics consultation, although palliative consultation may be useful. If inappropriately implemented, time-limited trials may worsen conflict between the health care team and the patient/surrogate.

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Intensive care unit ethics".)

SUMMARY AND RECOMMENDATIONS

●Definitions – The definition of futile and potentially inappropriate are as follows (see 'Terminology and definitions' above and "Palliative care: Medically futile and potentially inappropriate therapies of questionable benefit", section on 'Definitions of futility'):

•The term "futile treatment" should be reserved for rare cases in which the treatment cannot accomplish the intended goal. (See 'Futile treatment' above.)

•The term "potentially inappropriate treatments" refers to treatments that have at least some chance of accomplishing the patient's intended goal. However, the clinician judges that providing the treatment is outside the boundaries of acceptable practice (eg, treatment that is exceedingly unlikely to accomplish the patient's goals, represents an unfair allocation of scarce resources, or is intended to achieve a goal that is contrary to accepted medical goals). (See 'Potentially inappropriate' above.)

●Initial evaluation – The principles of our approach are outlined in the algorithm (algorithm 1 and algorithm 2). (See 'Initial evaluation to establish goals of care' above.)

•To fully understand the patient's medical condition and prognosis, the clinician should take a detailed history and examination and obtain information from medical records and the primary medical team or subspecialty consultants. (See 'Assess medical condition and prognosis' above.)

•The goals of treatment desired by the patient and/or their surrogate should also be determined (and documented). (See 'Determine goals of treatment' above.)

•A conversation with the patient and/or their surrogate should begin by delineating the patient's medical situation and prognosis, then discuss medically reasonable treatment options that are consistent with the patient's values and determine whether the requested treatment(s) is appropriate, futile, or inappropriate. (See 'Initial conversation with patient and/or surrogate' above.)

●Approach to requests for futile or potentially inappropriate therapy – Our approach is the following:

•Request for strictly futile treatment – If it is determined that the requested treatment is futile, then the clinician explains that they are not obligated to provide such care. If conflict persists, they should seek input from other colleagues to aid in the resolution process. (See 'Futile therapy requested' above.)

•Requests for potentially inappropriate treatment – If patients/surrogates request potentially inappropriate therapy after careful goals-of-care conversations with clinicians, the clinician should engage in the seven-step conflict resolution process, which is outlined in the table (table 1). (See 'Conflict resolution: Seven step process' above.)

●Conscientious objections and time-pressured decisions – Clinicians' personal conscience-based objections to providing treatment should be managed according to the principles listed in the algorithm (algorithm 3). (See 'Conscientious objection' above.)

In situations where a time-pressured decision is required, clinicians may refuse to provide a requested treatment, provided that there is a high degree of certainty that the request is outside the boundaries of accepted practice, attempts are made (when feasible) to engage in as much of the conflict resolution process as possible, there is consensus among the clinical team, and there is retrospective review of the case. (See 'Time-pressured decisions' above.)

ACKNOWLEDGMENT — The UpToDate editorial staff acknowledges John Kellum, MD, who contributed to earlier versions of this topic review.