Informed refusal: When patients decline treatment

Many physicians associate “informed refusal” with the patient who leaves the ED abruptly or discharges himself or herself from the hospital. Yet, a patient’s refusal to consent to a recommended intervention can occur under a variety of circumstances, and can lead to lawsuits involving allegations of failure to treat or failure to inform.

All patients have the right, after full disclosure, to refuse medical treatment. This can include patients who decline medication, routinely miss office visits, defer diagnostic testing, or refuse hospitalization. Physicians are then prohibited from proceeding with the intervention.

“Problems can arise when the patient or the patient’s family later argue that they were not given enough information to make an informed decision, or that the patient lacked the capacity to make the decision,” says Tanya Babitch, assistant vice president of risk management at TMLT.

 
The process of informed refusal

Informed refusal is a process, not a signed document. “Physicians need to show that the patient’s decision to decline treatment was based on a full understanding of all the facts necessary to make that decision,” says Babitch “Physicians cannot force a treatment on a patient, all they can do is educate.”

Circumstances in which informed refusal should be obtained can include “everyday” occurrences such as when a patient refuses to take blood pressure medication or declines a screening colonoscopy. It can also involve the patient who refuses life-saving surgery.

Reasons for the patient’s refusal should also be discussed. Reasons may include denial of the seriousness of the medical condition; lack of confidence in the treament; disagreement with the treatment plan; conflicts between hospitalization and personal obligations; and financial concerns. Understanding why a patient refused an intervention is important because the decision could be irrational or based on misinformation.

 
Assessing decision-making capacity

“Although the concept of patient autonomy requires that patients be permitted to make even idiosyncratic decisions, it remains the responsibility of the clinician to assure that no decision is the result of a problem with decision-making capacity or some misunderstanding that needs to be resolved.” (1)

With regard to obtaining consent for medical interventions, competence and decision-making capacity are often confused. A patient’s competence or incompetence is a legal designation determined by a judge. Decision-making capacity is clinically determined by physician assessment. (2)

“All adults are presumed competent legally unless determined incompetent judicially. An adult who possesses legal competence, however, may lack the capacity to make specific treatment decisions. Specific decision-making capacity should be determined by a physician's evaluation rather than by the courts.” (2)

Some patients are clearly unable to make medical decisions. Other patients may be suffering from impaired decision-making capacity caused by intoxication, hypoxia, sedation, stress, or fever. “Every effort should be made to reverse potential impairments in capacity, to assure that the patient is making the most rational, autonomous choice.” (3)

Physicians should not conclude that patients lack decision-making capacity because they decline a recommended intervention. “Determining decision-making capacity involves assessing the process the patient uses to arrive at a decision, not whether the decision he or she arrives at is the one preferred or recommended by the healthcare practitioner.” (1)
 

Documenting informed refusal

As with the informed consent process, informed refusal should be documented in the medical record and include the following:

• describe the intervention offered;
• identify the reasons the intervention was offered;
• identify the potential benefits and risks of the intervention;
• note that the patient has been told of the risks — including possible jeopardy to life or health — in not accepting the intervention;
• clearly document that the patient has unequivocally and without condition refused the intervention; and
• identify why the patient refused, particularly if the patient’s decision was rational and one that could not be overcome.
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“All cases of informed refusal should be thoroughly documented. Also, families watching the clinical demise of their loved one due to therapy refusal may demand inappropriate care, and even threaten to sue if such care is not provided, thus the heightened importance of thorough documentation.

Notes of the discussion with the patient (and family, if possible) should be recorded, as well as consultation notes from bioethics, social work and psychiatry specialty services. These notes should also comment on the patient’s mental status and decision making capacity.” (4)

 
Other risk management considerations

In addition to documenting the informed refusal discussion, the following recommendations may help minimize the risk of lawsuits related to patient refusals.

• As part of routine care, inquire about and encourage patients to complete advance directives before serious illness or capacity questions arise.
• Under federal and state regulations, a physician is legally prohibited from discussing a patient's medical history with anyone unless the patient permits it. Ask permission to involve the patient's family — as opposed to assuming the permission would be denied — when dealing with a patient who declines treatment. If the patient refuses to involve a family member, ask if any other confidant could be brought into the discussion.
• Use any community resources available — bioethics, social work and mental health or psychiatry services.  Having the patient obtain a second opinion may be effective, as hearing the same concerns strongly voiced by two physicians may convince the patient to proceed.
• If the patient persists in the refusal, it is important for the physician to leave the door open for the patient to return. Instruct the patient about symptoms or signs that would prompt a return. Provide an appropriate referral and detailed discharge or follow-up instructions.
• In addition to documenting the patient's refusal at the time it is given, document the refusal again if the patient returns. “This may apply more to primary care physicians who see the patient routinely. It may be necessary to address the intervention that the patient refused at each subsequent visit,” says Babitch. Document this discussion in the medical record, “again discussed with patient the need for cholesterol-lowering drugs . . . patient declined.”
 

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Sources

1. Ganzini L, Volicer L, Nelson W, Fox E, Derse A. Ten myths about decision-making capacity. J Am Med Dir Assoc. 2005 May-June;6(3 Suppl): S100-104. Available at https://pubmed.ncbi.nlm.nih.gov/15228638/. Accessed February 3, 2025.

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2. Barstow C, Shahan B, Roberts M. Evaluating medical decision-making capacity in practice. Am Fam Physician. 2018;98(1):40-46. Available at https://www.aafp.org/pubs/afp/issues/2018/0701/p40.html. Accessed February 3, 2025.

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3. Pugh J. Informed Consent, Autonomy, and Beliefs. Autonomy, Rationality, and Contemporary Bioethics. Oxford (UK): Oxford University Press. 2020. Available at https://www.ncbi.nlm.nih.gov/books/NBK556864/ . Accessed February 3, 2025.

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4. Bramstedt K, Nash P. When death is the outcome of informed refusal: dilemma of rejecting ventricular assist device therapy. J Heart Lung Transplant. 2005 Feb;24(2): 229-230. Available at https://www.jhltonline.org/article/S1053-2498(03)00977-X/abstract . Accessed February 3, 2025.

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