October 20, 2015
Best Practices for Informed Consent

Are your patients truly providing informed consent, or are they simply agreeing to treatment? There’s a critical difference, and a new study indicates that patients aren’t getting enough information from their doctors to choose among care options.

In the study, researchers listened to 59 conversations between cardiologists and patients about elective percutaneous coronary intervention (PCI), to open the arteries and relieve chronic stable angina. Because this kind of chest pain can be triggered by exercise or stress, rest and medication are other options. However, in the analysed conversations, cardiologists discussed the alternatives just 25% of the time. They were even less likely to explain the pros and cons of stents used in PCI, and to verbally confirm that patients understood what information they were being given.

In fact, just 2 of the conversations included all elements of informed consent. Yet, most of the time, cardiologists recommended the procedure, and patients followed along. That’s pretty much the definition of “agreeing” and not truly consenting.

Defining informed consent

It’s easy to think of informed consent as the “document a patient signs to verify that he has engaged in a dialog with a health care practitioner about a proposed medical treatment” — however, it’s not the document but the discussion that constitutes informed consent. The signed document is the official confirmation that all the elements of the discussion have taken place. Those elements are:

  • Discuss the patient’s role in the decision-making process — stress that it is, ultimately, their choice
  • Describe the medical issue and the typically suggested treatment
  • Offer alternatives to the suggested treatment, including choosing to not have treatment
  • Explain the risks and benefits of the suggested treatment, as well as the risks and benefits of the alternatives, and compare those with the patient’s goals and preferences
  • Discuss uncertainties — rather than making the patient less sure, this full disclosure will build trust
  • Assess the patient’s understanding of the information provided
  • Elicit the patient’s preference and the treatment they’re consenting to, and confirm this with the signing of the informed consent document.

Tips for achieving informed consent

The ways in which you approach each of the elements of informed consent can make the difference between agreement and consent. It’s recommended that the form for each treatment be adapted from a consistent template, to ensure all points are included for all treatments. But even tailored forms should be used as an outline for discussion, not simply repeated verbatim. To this end, it could be helpful to use medical scribes to document the discussion, so that the physician can fully engage with the patient, explaining options, pros and cons, and answering any questions the patient has.

It’s important to recognize differences in education or literacy levels and provide more help to patients with less education or low literacy. Speak in terminology patients can understand, and have other staff (such as nurses) also reinforce or additionally explain the information that has been presented. Use graphics, webcasts, websites podcasts or DVDs to provide messages in a variety of formats — not all patients learn by listening, and these supplemental materials can help reach such patients. In addition, it’s a good idea to have forms and education materials with lower reading levels and shorter lengths, uncluttered by unnecessary information, on hand.

Sometimes patients need time and space to decide — don’t pressure them to choose on the day if they’re not ready. Instead, give patients information or fact sheets, or multimedia materials or options that can be used at home. When patients are ready to choose a treatment, use a “teach back” method, in which patients are asked to repeat back the information that has been presented to them, to ensure that they understand what they’re consenting to. And, finally, make sure patients are aware they’re allowed to decline treatment, and give them the opportunity to do so.

A boost for patient satisfaction

Informed consent isn’t a panacea. There’s actually no evidence that shows it improves adherence to medication or self-care regimens, prevents medical errors, or even improves overall health outcomes. But it does improve patient-physician communication, increase patient satisfaction, create more realistic expectations, and reduce malpractice claims — all of which are worthwhile pursuits.