Healthcare experts are increasingly acknowledging the importance of using the medical informed consent as a valuable tool for advancing patient safety, improving patient communication and reducing risk. Offering patients more information about their healthcare journey not only creates a stronger partnership between providers and patients, it improves compliance with treatment plans, and gives patients the information they need to play a specific role in reducing risk on multiple fronts.

Informed consents first appeared in 1957, but it was not until 1972 that the idea evolved into more specific guidelines that focused on the physician or medical researcher’s obligation to disclose information, not only about the quality of a patient’s understanding of a recommended treatment plan or procedure, but also about their right to authorize or refuse the plan.

Informed Consent is a Critical Component of the Healthcare Journey

Today the informed consent process is a nondelegable duty of healthcare providers to effectively communicate with patients by providing general education information and reinforcing specifics the provider and/or their staff has reviewed with the patient. It’s a critical component of the healthcare journey, and can significantly reduce risk if a proper process is in place.

It’s not uncommon, however, for providers to have the misconception that a signed consent form demonstrates consent by itself. The written, signed consent only documents one phase of the informed consent process. For the patient to be truly and adequately ‘informed’, they also need to review and understand the information the provider has offered.

So when it comes to informed consents, healthcare practitioners should consider the patient’s overall capacity to understand their condition and the proposed treatment plan, as well as take into account any communication, language or cultural barriers that could hinder the consent process.

Every informed consent should also have the following elements:

  • Patient name
  • Condition description
  • Description of the proposed treatment plan and procedure(s) in both medical and layman’s terms
  • Risks and benefits of the proposed treatment plan and/or procedure
  • Treatment and alternative options, including risks associated with doing nothing
  • Patient signature memorializing their understanding and providing consent
  • Witness signature

Leveraging well-thought out informed consent steps can actually reduce the provider’s risk in surprising ways that may be somewhat counter intuitive at first glance, but in fact, end up improving the patient experience while reducing risk in the process.

So be sure your practice or institution takes into account the following three recommendations when considering your own informed consent process.

  1. Make your informed refusal process as clear and robust as your informed consent process. Although an informed refusal is identical to informed consent, this process ensures the patient refusing the recommended treatment plan or procedure is well aware of the potential risks and complications that could occur as a result of the refusal. Your informed refusal should be documented via patient-signed documents and/or by clear documentation in the patient’s health record.Having an explicit informed refusal as part of your whole consent process will help you reduce risk of medical malpractice lawsuits stemming from patients who could claim they were not properly informed of the risks associated with not performing the recommended procedure.
  2. Use video to enhance the informed consent communication process. Help patients focus on the most important information by recording informed consents on video. That way patients feel more engaged and you can deliver information in a clear, concise way. Your patients get all of the information they need and feel like important details of their care plan have not been neglected.It’s best to map out the required content first, then prepare any needed visual aids that will help clarify explanations and descriptions visually. Ensure the quality of your recording device, microphone and lighting are well suited for recording your video. Using a video recording app on your tablet device can make the process much easier, and reduce your risk of errors.
  3. Avoid information overload and simplify the content for your patients by writing at or below a sixth grade reading level. Limit content to what patients really need to know, and put the most important information first. If you avoid information overload, and instead, present information in a logical order by grouping related information together, patients are more easily able to process, digest and retain the necessary information. Such retention helps reduce the risk of malpractice lawsuits.Use descriptive headings and subheadings to help patients more easily navigate the content in your written consent forms, and format with short, single topic paragraphs. Use words that are well known to individuals without medical training, and avoid any jargon and technical terms.  For example, use “high blood pressure” instead of “hypertension.”Keeping language simple, clear and well-organized means patients are more likely to easily digest details of the consent and what it means to them. That, in turn, means they are less likely to have post-care questions, more likely to comply with post procedure instructions, and less likely to file claims against their provider.

Challenges and Benefits Built Into One

The informed consent process can create challenges for practitioners as they look for ways to ensure patients understand the information they receive and are able to make well-informed decisions about their healthcare journey. That aside, it can also improve patient communication and engagement while reducing risk, in many cases, significantly.

Providing the information patients need while incorporating health literacy considerations into the process will ultimately improve compliance while reducing the risk of claims and suits related to “lack of informed consent’ allegations. Any time healthcare practitioners can improve compliance while reducing risk is time well spent, so more time can be focused on delivering quality care.