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If my procedure or treatment requires Informed Consent, what exactly does that mean?

Informed Consent forms started as a formal way to for a provider to communicate the risks and benefits of a treatment that the patient was about to receive, as well as their alternative options. This was well intended, since it had become common for a paternalistically oriented physician (often in a rush to see other patients) to present a patient with their recommendation, often in medical language that the patient couldn’t hope to understand. Then to overstate the anticipated benefits and understate the possible side effects or negative consequences.

And in many cases, alternative options were never discussed. So after an uninterrupted diatribe of confident and assertive medical speak, the physician would ask the patient ‘Do you understand? Should we proceed?’ To which the patient almost invariably respond ‘Yes, Doctor’. Often with a deer in the headlights expression.

The essence of the problem was often clear when a family member who missed the physician’s recommendation conversation would ask the patient what the doc said, and the patient would be completely unable to replicate the essential points. Nor would they have a clear understanding of their options and the pros and cons of each. They simply went with the flow of the physician’s recommendation.

Informed consent was intended to fix this problem, by putting in writing a shared understanding (physician and patient) of what the condition was, what the intended procedure was, the anticipated outcomes, the anticipated risks or possible adverse outcomes, and what the alternatives were. Good idea, right?

If you are working with a hospital or specialty physician who has a conversation with you in advance of your treatment, talks to you in terms that you understand, makes clear to you what your options are and what the likely outcomes and possible adverse outcomes are, invites you to ask questions, then collaborates with you to pursue the option of your choice, THEN documents all of that in an Informed Consent document that you can review in advance, ask questions about, get comfortable with and sign … then you’re working with an outstanding physician or hospital. Tell everyone.

Unfortunately, in many provider organizations the informed consent process and document has devolved from that to become what may be the most clear example of where hospitals/surgeons and patient’s interests clash. In many cases, they have become the document that hospitals (and in some cases specialty physicians) give to a patient that says, in essence;

Really bad things could happen to you. We’ll try our best, but we’re ultimately not responsible for a bad outcome;

While we think we know the procedure we’re about to do, we’re not sure we won’t need to do something else once we get started, so you’re agreeing now that we can do whatever we think is best without seeking further approval from you or your advocates; and,

We’re going to get paid in full for everything we do. If your insurance doesn’t cover it, you are agreeing to pay the balance.

That, folks, is the ultimate CYA document.

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“With no requirement that hospitals and clinicians be candid with patients about risks and costs, informed consent is ‘a complete sham,'” says Harlan Krumholz, MD, speaking at the Lown Institute conference.   Krumholz, director of the Center for Outcome Research and Evaluation at Yale University School of Medicine, wants to know what would happen if the consent process included a period of time when a patient could consider all of the risks and benefits of a treatment whether they would be appropriate, and whether there were alternatives with lower risks but similar outcomes. “We have people undergoing procedures under assumptions of benefit that do not exist,” Krumholz said.

Cardiologist Blasts Informed Consent Process, Cheryl Clark, HealthLeaders March 12, 2015

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“Informed consent discussions are often devoid of details about the material risks, benefits, and alternatives that are critical to meaningful patient decision making. Informed consent documents for procedures, surgery, and medical treatments with material risks (eg, radiation therapy) tend to be generic, containing information intended to protect the physician or hospital from litigation. These documents are often written at a high reading level and sometimes presented in non-legible print, putting a premium on health literacy and proactive information-seeking behavior.  Moreover, informed consent documents are often signed minutes before the start of a procedure, a time when patients are most vulnerable and least likely to ask questions—hardly consistent with what a reasonable patient would deem acceptable.”

The New Era of Informed ConsentGetting to a Reasonable-Patient Standard Through Shared Decision MakingErica S. Spatz, MD, MHS; Harlan M. Krumholz, MD, SM; Benjamin W. Moulton, JD, MPH; Journal of the American Medical Association, 2016;315(10)

And what makes this even worse is that many hospitals and specialty physicians don’t tender an Informed Consent document in advance. They wait until the last possible moment (immediately before or even after admission, or well into a pre-procedure prep process) when the patient is both emotionally compromised and extremely hesitant to ‘disrupt’ the process by reading, let alone questioning, the unbalanced and hospital-favored nature of the language. This last element is compounded when the hospital or specialty provider has designed a process that includes having a relatively low-level staff member, such as a nurse’s assistant or an admissions clerk, tender the document to the patient. Under those circumstances, the only immediate answer to any patient question or challenge of the terms is ‘Oh, this is just a standard procedure’, or ‘I can’t answer your question, but we can’t proceed if you don’t want to sign the document’.

So what happens if you suffer the result of a preventable error? Or the provider decides, mid procedure, to do another procedure that happens to be an excluded benefit under your insurance plan? Or, mid procedure, another physician is asked to consult, and that physician isn’t in your insurance network?

The hospital and specialty physician’s lawyers will be standing there with a copy of your signed ‘Informed Consent’ form, reminding you that they told you in advance that all of these things might happen, and you agreed to them.

So they are not responsible.

And pay up.

 

What can you do to make the Informed Consent process work for you?

Make sure you understand the process, it’s goal, and how to use the process to your benefit

Never forget that the original intent of Informed Consent process was to help you, as a patient, make a balanced and informed decision about your treatment options based on your treatment goals.  You deserve to know all of your options and, for each of them, their likelihood to helping you achieve your goal, their likelihood to harm you, and any uncertainties involved.  Go to our one-page-review-of-treatment-options for a simple form you can use with your physician to achieve this.

Make sure your doctor knows you understand what Informed Consent means, and that you want to complete the process with them while you have the chance to ask questions, do your own research, and possibly get a second opinion.  You can even refer them to this National Institute of Health article on how doctors can do Informed Consent well or poorly.

 

Consider getting a second opinion

Ultimately, you are the one who has the most to gain and the most to loose by your treatment decision.  Getting a second opinion is likely to have one of two results;  either;

a.) you’ll continue on the treatment path you agreed to with your original physician, but with greater confidence;  or,

b.) you’ll learn something in your second opinion that will cause you to choose a different treatment option with a better chance of helping you achieve your goal, with less chance of harm, with less uncertainty, at a lower cost, or some combination of all of these.

Either way, you win.

If you’re interested in a second opinion, try The Cleveland Clinic’s My Consult.  Or check out more options here.

 

Completely avoid procedures that are unlikely to help you

If you’ve collaborated with your physician leading up to your conscious choice of treatment after fully understanding your options, their respective chances of getting you to your treatment goal (as opposed to being ineffective or causing you harm), and their costs, then hopefully you’ve avoided getting to a procedure that is unlikely to benefit you.

 

Prepare in advance and don’t get caught by surprise

If you’re admitted to a hospital or undergoing a surgical procedure, you’re likely to be asked to sign their informed consent form. Ask to see all informed consent forms, and any other forms you will be expected to sign, when you schedule your procedure and specifically state that you expect to see all documents, from all providers, and do not want to be surprised by requests for additional signatures just prior to your procedure. Read them in advance and understand clearly what they mean.   If they are unbalanced or they make you uncomfortable in any way, you can try to challenge them but it is unlikely that you will be able to find anyone willing to amend them. They’re too deeply ingrained. Your best shot is to try to find another provider with less onerous terms. See the steps you can take to protect yourself in the section on Estimating Costs.

 

Establish a personal connection with your lead surgeon/physician in advance

Let them know that, regardless of what’s in your informed consent document, that you have planned for the procedure in question and you’re counting on their help to engage your Proxy if the question of additional procedures or involving additional surgeons/consultants/other providers comes up during the procedure, unless it is an absolute life threatening emergency. Specifically tell them that you have financially planned for this procedure, but the unnecessary addition of additional procedures or providers (especially if they’re out of network or excluded benefits) could financially ruin you.

 

Provide copies of your Limited Healthcare Power of Attorney in advance

Make sure your provider team knows who your Proxy is.

 

Remember:  We coach, support, educate, and empower.  We illuminate options you may not have known you had.  But we don't decide what's right for you in your unique circumstances; only you can do that.  And we don't provide medical, financial, or legal advice; nor do we replace the valuable counsel of those who do.