Do You Really Understand That Informed Consent Document You Signed?

Be honest – how closely do you read the informed consent documents that you’re given at your doctor’s office?  Even if you read it, do you really understand it?  Do you know what it means if you sign it?  If you answered no to any of these questions then you are not alone.  A 2005 study by the National Quality Forum revealed that 60 to 70% of patients do not read or do not understand these confusing forms.

 

In an attempt to make informed consent documents more readable, the Centers for Medicare and Medicaid Services (CMS) issued new guidelines last year challenging those in the medical profession to make their consent forms more patient-friendly.  Hospitals that don’t comply with these guidelines might lose their eligibility to bill Medicare for treatments.

 

It is about time that the medical profession took informed consent documents more seriously.  For years there seems to have been a prevailing mentality in the medical profession that “doctors know best” and patients should consider themselves lucky to receive treatment from such skilled and competent individuals.  Worse, some patients have felt like there is a perception that they are incapable of making their own medical decisions.  Most of us know what its like to be talked down to by a person with more knowledge than we have – it can be intimidating, and make us agree to things we ordinarily wouldn’t if we understood what was involved.  Informed consent documents are supposed to bridge the gap between the doctor’s knowledge and the patient’s desire to make the right decision for their health.

 

What is informed consent, exactly?

 

Informed consent means that you have agreed to surgery or other medical procedure with an understanding of the facts, alternatives, risks, and implications of the procedure.  In order to give informed consent, you have to be considered competent.  Your judgment cannot be impaired (i.e. drugs or alcohol) and you have to be of sound mind in order for your signature to be considered valid.

 

The Changing Face of Informed Consent

 

CMS states that at a minimum a well-design informed consent form will contain the following:

• Name of the hospital where the procedure or other type of medical treatment is to take place
• Name of the specific procedure, or other type of medical treatment for which consent is being given
• Name of the responsible practitioner who is performing the procedure or administering the medical treatment
• Statement that the procedure or treatment, including the anticipated benefits, material risks, and alternative therapies, was explained to the patient or the patient’s legal representative
• Signature of the patient or the patient’s legal representative
• Date and time the informed consent form is signed by the patient or the patient’s legal representative

 

CMS also recommends that informed consent forms include the following information:

• Name of the practitioner who conducted the informed consent discussion with the patient or the patient’s representative
• Date, time, and signature of the person witnessing the patient or the patient’s legal representative signing the consent form
• Indication or listing of the material risks of the procedure or treatment that were discussed with the patient or the patient’s representative
• Statement, if applicable, that physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery, in accordance with the hospital’s policies and, in the case of residents, based on their skill set and under the supervision of the responsible practitioner
• Statement, if applicable, that qualified medical practitioners who are not physicians who will perform important parts of the surgery or administration of anesthesia will be performing only tasks that are within their scope of practice, as determined under State law and regulation, and for which they have been granted privileges by the hospital.

 

Other recommendations for informed consent forms include writing the forms for a 6^th grade reading level, utilizing technology to present the forms electronically, and using the “teach back” method while reviewing forms with the patient.  A recent study showed that consent forms written at a 6^th grade level and reviewed with patients using the “teach back” method (where the patient is asked to repeat in their own words what they understand from the form) increased form comprehension from about 22% to 95%.  Other recommendations include using pictures, alternate languages, and for electronic forms, links to further information about the procedure and associated risks.

 

Is Technology the Answer?

 

One new computer program hospitals are using is the iMedConsent software package, manufactured by Dialog Medical.  iMedConsent is an electronic informed consent software package, which allows medical professionals and patients to review electronic copies of consent paperwork and additional information about the procedure stored in the software’s database.  Once the patient electronically signs the form, it can be stored with their medical records.

 

 

As a patient, you deserve to understand exactly what your doctor wants to do to your body, a clear outline of the alternatives available to you, and a comprehensive list of possible risks and issues that might arise if you chose to undergo the procedure – and the risks and issues if you do not.  Given that many malpractice lawsuits often stem from inadequate or insufficient consent forms, the medical profession needs to fix these forms.  We hope that this new technology and the changes proposed by CMS improve patient understanding and prevent accidents from occurring – accidents that could be prevented with better communication between patient and doctor.

 

If you or someone you love has been the victim of a medical mistake, then Peter Panas wants to help you get the justice you deserve.  Contact us today and find out how you could be eligible to receive compensation for lost wages, pain and suffering, lost future earnings, and medical expenses.

 

Law Office of Peter Panas, PC
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