The Vital Importance of Documenting Informed Refusal Conversations

A MICA-insured physician once called a MICA Risk Team Consultant and asked, “If my patient refuses colon cancer screening, can she sue me if she develops colon cancer that is not timely detected and treated? And MICA’s Risk Team responded, “Yes, she can, so make sure the patient’s refusal is ‘informed’ and well documented.” 

From a risk management and patient safety perspective, informed refusal is just as critical as informed consent. Unfortunately, informed refusal receives far less attention than the concept of informed consent, both in medical and legal literature and medical education programs.  

As a result, physicians and advanced practice providers (collectively, “clinicians”) frequently do not engage patients in effective informed refusal discussions and often fail to document informed refusals in the medical record. One emergency medicine physician framed the problem this way: 

“[The concept of informed refusal] is not routinely represented in medical school curriculums, is not entrenched in medical practice, and is left unaddressed by many hospital standard operating procedures. Furthermore, when refusals are obtained, they frequently do not comport with the doctrine of informed consent. Simply accepting a patient’s decision to forego the proposed treatment, test, or procedure, or having the patient sign an against medical advice (“AMA”) form, is not adequate.” 

To help you improve your informed refusal process, in this article MICA explains: 

• Why effective informed refusal conversations and documentation are crucial for the defense of malpractice claims and board complaints;
   
• The elements of an effective informed refusal conversation;
   
• What to include in informed refusal documentation; and
   
• The importance of an informed refusal policy and procedure. 

Defending Informed Refusal Malpractice Claims with Effective Documentation 

In malpractice cases involving lack of informed consent allegations, courts have ruled that physicians have a duty to disclose to patients pertinent or material information about a recommended procedure or treatment plan. In these cases, expert witnesses from both sides will testify about what information the physician should have provided to the patient to meet the standard of care. 

Informed refusal claims are similar. In these cases, a plaintiff will assert that the clinician failed to adequately disclose pertinent information about the risks or consequences of not undergoing the recommended treatment. Some examples of scenarios that could trigger this kind of claim include: 

• During a telemedicine encounter, a PCP told a patient with chest pain he should go immediately to the emergency room for evaluation. The patient refused, saying wait times will be long and it will be expensive. The patient would only agree to an outpatient evaluation, so the physician scheduled a stress test for the next week. Days later, the patient suffered a heart attack. 
   
• A 30-year-old patient refused her physician’s recommendations for regular pap smears. Years later, she was diagnosed with cervical cancer too far advanced to be surgically treated.
   
• Every year for seven years, a patient refused his PCP’s recommendation for colon cancer screening. The PCP never documented the recommendations or refusals. In the eighth year, the patient was diagnosed with colon cancer during a hospitalization, but by then he was not a surgical candidate. [For more detail on this closed claim from the malpractice insurer of Harvard-affiliated entities, read this summary]. 

To effectively defend informed refusal claims, it is vital to present evidence which demonstrates that the clinician did, in fact, explain to the patient the risks of refusing treatment. The defense lawyer will use this evidence to convince jurors that the clinician met his or her obligation, and the patient, understanding the potential consequences, decided to take the risk and forego the recommended treatment. 

A clinician’s detailed informed refusal documentation, made at the time of the informed refusal discussion, is crucial in these lawsuits. Without effective documentation of the clinician-patient conversation, it is difficult if not impossible for the defense attorney to persuade jurors that the clinician provided adequate material information to the patient. When such documentation is missing, informed refusal lawsuits often settle because going to trial would be too risky. 

The Informed Refusal Conversation 

The clinician-patient relationship is a partnership involving shared decision making. Clinicians are obligated, when recommending a procedure or treatment, to explain the nature and purpose, material risks and benefits, reasonable alternatives, and the risks of refusing care. The clinician must provide this information in terms the patient can understand. After a patient receives this information, he or she has the right to refuse treatment.  

When a patient refuses treatment, the clinician should engage in an informed refusal conversation. Without this conversation, informed refusal is not “informed.” One goal of the conversation is to protect the patient, by exploring reasons for refusal and testing patient understanding of the consequences.  

The conversation, when thoroughly documented, also protects the clinician in the event of a later lawsuit or board complaint. During an informed refusal discussion, clinicians should: 

• Restate the patient’s diagnosis, risk factors, co-morbidities, risks and benefits of recommended treatment 
   
• Convey interest in and explore the patient’s reasons for refusing treatment
   
• Demonstrate empathy and encourage the patient to discuss fears/concerns/questions
   
• Attempt to gauge the patient’s understanding of the risks of refusal
   
• Discuss alternative treatment options, including risks/benefits
   
• Invite the patient to return anytime for additional care
   
• Use an interpreter when necessary for effective communication 

Documenting Informed Refusal Effectively 

Documenting informed refusal following the clinician-patient conversation is vital. Because lawsuits play out years after the care at issue, the clinician usually cannot remember the conversation by the time he or she testifies in deposition or trial. While the clinician could testify about what he or she “usually” tells patients, this type of testimony is not nearly as credible or convincing to jurors as detailed documentation in the medical record made at the time of the events.   

Effective informed refusal documentation memorializes the details of the clinician-patient conversation. When documenting, clinicians may want to consider how it would sound to a jury. Does it adequately convey the details of the discussion?  

At a minimum, an effective informed refusal note should include: 

• The clinician’s assessment and recommended treatment;
   
• A list of risks and benefits discussed;
   
• A list of alternatives discussed;
   
• A statement that the patient refused treatment;
   
• A statement that the patient had the opportunity to ask questions and a list of any questions asked;
   
• Patient’s reasons for refusal; and 
   
• The clinician’s observations about whether the patient displayed understanding of the information. 

In addition to the clinician’s note, it can be helpful to have patients sign a form confirming their decision to refuse. When using forms, consider: 

• Customizable forms that provide space to insert patient-specific and procedure-specific text are ideal.
   
• In the absence of a documented informed refusal conversation, a patient’s signature on a one-sentence, generic form is worthless.
   
• Using forms may emphasize to patients the weight and significance of their decision. Effective forms can strengthen the defense of a later lawsuit. 
   
• Forms are not a substitute for a descriptive chart note written by the clinician.  

Standardize the Process 

Practices should consider developing an informed refusal policy and procedure to standardize patient-clinician conversations and subsequent documentation. When developing documentation templates or forms for patients to sign, they should be customizable so clinicians can insert details specific to the patient or conversation.