More than a piece of paper


More than a piece of paper

A piece of paper which states ‘the patient refused treatment’ is not a substitute for a proper conversation that confirms an understanding of the probable benefits and risks of treatment, says Fay Rozovsky, president of The Rozovsky Group.

An informed refusal of care merits a thoughtful conversation with the patient to make certain that he or she understands the nature and consequences of such a decision. Sometimes referred to as the “matching bookend” of the consent communication process, an informed refusal conversation may lead to a salutary treatment alternative for the patient. A case example highlights this point.

"Care providers should be attuned to cost sensitivity among patients with high-deductible health plans."

The case of Don Clark

Forty-three-year-old Don Clark worked as a food service manager at a restaurant. He was happy to obtain a high deductible “bronze” healthcare plan through the federal exchange. Until he had obtained healthcare coverage Mr. Clark had avoided seeking treatment for sudden, recurrent pain and swelling in his knees and feet, choosing instead to use over-the-counter pain medication. With his new health plan he decided to see his primary care provider, Dr. Elliot.

After examining Mr. Clark, and discussing his symptoms, Dr. Elliot ordered some blood tests and diagnostic imaging of Mr. Clark’s knees and feet. When the results came back he met with Mr. Clark to discuss next steps.

Dr. Elliot said, “Mr. Clark, the test results confirm what I thought may be the cause of your problem. I am very confident that you have been experiencing gout.” 

Dr. Elliot explained the possible causes of gout and the complications attributed to it. “In terms of lifestyle changes you will need to stop eating all those rich steaks and lobsters at the restaurant and you will definitely need to cut back on your intake of alcohol. Losing about 25 pounds will also help,” said Dr. Elliot.

“What about medication? Can you give me something?” asked Mr. Clark.

“There are a number of medications that can help with pain during an acute flare-up, but you will have to be careful to limit the length of time that you use these over-the-counter preparations since there are potentially serious complications. 

“Meantime, I am sending an electronic prescription to the pharmacy for a medication that should help reduce the frequency of the gout attacks. Try it for a month and come back to see the nurse practitioner for a follow-up visit,” said Dr. Elliott. 

That afternoon Mr. Clark received a statement for more than $1,500 for the X-rays and blood tests. The explanation of benefits indicated that he had $400 remaining in his deductible that would need to be satisfied before his 80:20 co-pay would take effect.

Three days later, Mr. Clark went to the pharmacy to pick up his prescription. When he saw the price he thought that there must be a mistake. He asked the pharmacy clerk to re-check the purchase price. He told Mr. Clark, “It is your health plan, sir. You are required to pay 40 percent of the cost of this tiered drug. This price is already reduced.”

Mr. Clark declined to purchase the drug. He told the nurse practitioner during the follow-up visit that he had decided not to take the medication. He said, “I am not convinced I need that medication.”

The nurse practitioner responded, “Well that is your choice. I will let Dr. Elliot know. Please sign this medication refusal statement. Ask the receptionist to schedule an appointment for you in six months.”

In Mr. Clark’s electronic record the nurse practitioner documented, “Patient refused to take the prescription medication. See his signed medication refusal statement.”

His refusal was not ‘informed’ 

Put simply, the nurse practitioner did not complete an informed refusal of medication management. He did not discuss with Mr. Clark the potential consequences of refusing the prescription medication. Further, he did not attempt to ascertain why the patient had made this decision. At no time did the nurse practitioner offer alternative types of treatment. Instead, the nurse practitioner asked Mr. Clark to sign an informed refusal statement. 

A piece of paper is not a substitute for a cogent conversation with a patient that confirms an understanding of the indications for the prescription medication, the probable benefits and risks as well as treatment alternatives and related probable benefits and risks. The consequences of refusing either recommended or alternative treatment should be part of the conversation. 

From a patient safety standpoint, a “teach-back” helps to confirm that the refusal is informed. Once completed, it is appropriate to document that the patient refused to give consent to recommended or alternative forms of care. Such documentation should be consistent with applicable law.

Effective informed refusal 

The informed refusal discussion with the patient is a good opportunity to find out if the individual really understands the consequences of his or her choice. Moreover, when used effectively, the discussion may tease out the real reasons for the patient declining a test or treatment. 

Some care providers are reluctant to engage the patient in such a discussion. They do not want to appear to be bullying or browbeating the patient by asking “why” he or she has chosen not to pursue recommended tests or treatment. 

With Mr. Clark, the nurse practitioner might have continued the conversation by saying, “I am curious why you have decided not to use the prescription medication” or “Could you help me understand why you do not want to take the medication prescribed for you?” 

Alternatively, the nurse practitioner might say, “Before you firm up your decision, I would like you to spend a few minutes discussing your choice with Dr. Elliot. He is in the office. Let me get him for you.”

Why take this extra step? The nurse practitioner might think the patient would be more comfortable discussing the decision with Dr. Elliot. Moreover, it was the physician who decided upon the recommended course of care.

At this stage, Dr. Elliot has a good opportunity to use a stylized “teach-back” approach to affirm that the patient understands the consequences of declining recommended medication management. However, in approaching the patient he should be respectful and understanding without trying to intimidate Mr. Clark into changing his mind. 

Consider this example of the follow-up discussion.

“Hello Mr. Clark. I am pleased that you came back for your follow-up visit. The nurse practitioner tells me that you decided not to take the prescription medication. It will be helpful for me to understand why you have made this decision.”

The doctor then asks a series of questions and gives the patient time to respond.

Tell me what you recall of our discussion about the reason for prescribing this medication.

What do you remember about the probable benefits and risks of this course of treatment?

Tell me what you recall about treatment alternatives? 

We discussed what the consequences might be if you declined to use the medication. Can you tell me what might occur?

If the patient responses are accurate, there is a complete, informed refusal teach-back process that should be documented in the patient’s medical record. If the answers are inaccurate, it is a good opportunity to reiterate the consent communication process.

There is nothing improper about the physician going further and saying, “Mr. Clark a number of my new patients decide against certain tests or treatment because of cost factors. This is particularly of concern for those who have high deductible bronze plans that require considerable out-of-pocket costs for tests and medication. If this is one of the factors that has led you to decline the medication treatment, we can discuss some less expensive, beneficial medications. Would you like to do so?” 

If the patient responds, “Yes,” the door is open to a renewed consent communication about medication-specific treatment alternatives. The decision may not be to decline care, but rather, to accept a different medication regimen. The conversation would be documented in the patient’s medical record.

Lessons learned

Patients who are surprised or shocked by the cost of tests and medication may respond viscerally and refuse such diagnostic studies or expensive prescription drugs. Anecdotal information suggests that many patients with so-called bronze health plans do not fully appreciate their out-of-pocket costs. Once they realize the financial costs, they may be reluctant to agree to expensive tests and medication.

Care providers should be attuned to cost sensitivity among patients with high-deductible health plans. Rather than waiting until a patient declines a test or drug treatment, the issue is best addressed during the consent communication regarding treatment options.

Care providers and healthcare clinics can be forthright about the cost of care. Post signage and provide written information that encourages patients to express their concern regarding diagnostic tests, medications or treatments that are not financially feasible or that are beyond their means of transportation. 

With such information in hand, healthcare providers can refine care plans to meet the realities of their patients. By taking such steps, the need may be reduced for informed refusal conversations. For risk managers, the process may reduce liability exposure for consent claims.

I recently underwent an outpatient procedure and, after signing the consent form provided by the receptionist, I began to think about consent in all its dimensions. The process was not sufficient in several respects. The physician never actually sat with me to explain the risks and benefits of the procedure and the form was inadequate. Only when I pushed the issue did the kind of conversation that should have taken place actually happen to my satisfaction. Do you think this is uncommon? Think again!n

About Fay A. Rozovsky

Fay A. Rozovsky, JD, MPH, is president of The Rozovsky Group, a healthcare risk management firm that provides a full range of education and consulting services for healthcare providers and entities across the continuum of care. She is the author ofConsent to Treatment: A Practical Guide, 5th Edition, a book published with regular updates by Wolters Kluwer Law and Business. She can be contacted at: 

Fay A Rozovsky, The Rozovsky Group, Dr Elliot, US