When is Informed Consent Needed?
The rules and regulations surrounding Healthcare have changed drastically in the last 25 years. In the past, the common thought about informed consent for treatment was that it was required for surgery and other interventional treatments. Once intrusive diagnostic procedures came about, such as diagnostic images taken after the patient is injected with a contrast, healthcare providers and lawmakers decided there should be a consent to treatment process followed prior to the test. This decision was the result of changing technology and the general public’s awareness of their rights. It was also made based on the fact that the risk for adverse outcomes was higher with the contrast.
State legislation, regulations, and case law determines what types of treatment need an informed consent process. The “necessity” of the consent process also comes from recognized standards of practice from professionals who specialize in a particular test and recognize the importance of obtaining consent. Federal laws and requirements are also in place to protect patients and medical providers, but states are allowed to put their own laws in place, as long as they follow some basic federal guidelines.
What do patients need to know?
Informed consent is the process of having a two-way communication between the patient and the physician to discuss and agree upon a suitable treatment option. During this process, there is a lot of information passed between the two. Sometimes patients can become confused and frustrated when too much information is provided.
There are various levels of knowledge on certain treatments and procedures. Each patient will have his or her own threshold for knowledge retention and comprehension. Patients often have several health care providers participating in their care. The situation can be a bit overwhelming and confusing, even before they know everything about the treatment recommendation.
To keep it simple, there are some basic things that all patients should be informed about, whether it comes from the diagnostic technician, the nurse, or the physician, including:
- What is involved with the preparation for the procedure?
- How much time is needed for the preparation?
- What is the anticipated recovery time associated with the procedure?
- What restrictions will the patient have on normal daily activities?
- What follow up care is necessary for this procedure?
Should Every Medical Encounter Include an informed consent process?
Why not complete the process for obtaining consent for every treatment recommended, including non-intrusive diagnostic interventions like cardiac stress tests? Some providers may argue that there are time constraints and performing due diligence by speaking with the patient, researching medical history, and not delegating any of the “communications” to others, would take too much time. Providers also sometimes believe that there is a common knowledge that the majority of patients already have, so providing all of the information is not necessary. As wrong as that sounds, it is common practice in the industry.
Some people say that conducting the informed consent process is necessary for all treatment recommendations, even when the risk of negative outcomes are very low. From a patient safety perspective, this point of view has value. A better-informed patient can make appropriate decisions and a better-informed provider can make appropriate recommendations. The informed consent process becomes a win-win between doctor and patient.
What is the solution?
As with most people, healthcare providers will complete tasks that are easy and not time consuming. Building in the consent process into your standard work flows can help ensure that it gets done. Giving the healthcare providers time in their schedule to speak to the patient, all of the medical history information on file, and an easy way to have the patient read/view information can help complete the process in a timely manner, without intruding on the doctor’s time.
The consent process isn’t only for physicians; the other care providers must also complete the consent process to ensure all of the information is clear to both the provider and the patient. This includes the pre-treatment and the post-treatment providers. Pre-treatment providers, such as an anesthetics nurse who prepares the patient for anesthesia, need to speak to the patient, obtain information from them, provide information to them, and make sure there is an understanding between them before providing the service. Post-treatment providers, such as occupational therapists, also have a responsibility to obtain and provide the appropriate information for the patient to make an informed decision about their post treatment care.
Each and every provider, each and every time, without exception, should have an active two-way conversation with the patient (or representative) and ensure there is an understanding between the two of them on all of the aspects involved with the treatment. Consent should go along with all providers who participate in the continuum of care.
When hospitals require only a consent for treatment process be conducted by the physician, they are essentially saying that consent is a form that needs to be signed and not a process of communication between all providers of this patient’s care. This is what needs to be fixed, there are gaps in the communication and it can put people’s lives at risk.
Side Note: Consent for medical photographs
Healthcare providers occasionally feel that there are benefits for the medical community to take a photograph of the patient’s body. In this case, the consent process should be followed, resulting in an agreed protocol and signed consent form documented in the patient’s chart. The patient should be informed about how and if there will be any identifying of the patient in the photograph. They should be informed if the photo is published and where. Notes regarding the taking and using of photos must be properly documented in the patient’s chart.