Impacting Risk Communication: Educating Providers to Improve Informed Consent Conversations in Procedural Sedation

Impacting Risk Communication: Educating Providers to Improve Informed Consent Conversations in Procedural Sedation
Book Chapter
Raquel M. Schears, Fernanda Bellolio
The New Science of Medicine, 25 July 2023; pp 237–249 [Springer]
Abstract
    Patients that require procedural sedation (PS) in the emergency department (ED) are at risk of complications from emergency medical conditions that bring them to the ED plus the need for pain and anxiety management to successfully accomplish an intervention or diagnostic procedure. Explanation of the purpose, risks and benefits of PS is part of the informed consent. To participate in informed consent, patients need to understand what it is that they are agreeing to, and what are the risks and benefits of the procedure. Common challenges in these scenarios are that clinicians might not know the research evidence surrounding the risks and adverse events of the procedure, and present harms and benefits in general terms. Another challenge is that patients might not understand medical evidence when it is shared. To perform informed consent patients and providers need to actively participate sharing information and answering questions. Patients must have sufficient information if they are to make decisions that reflect their own values and preferences, and physicians play a key role as educators in this process.

We identified a gap in our process of informed consent for PS. To fill this gap, we examined the prior literature to gain insight regarding incidence of adverse events in sedation when performed in the ED setting. Baseline provider knowledge was assessed with a pretest, thereafter didactic presentations on PS risks were provided and followed up with a posttest 6 months later. In the interim, we gave providers an evidence-based risk of adverse events card to facilitate informed consent conversations with patients undergoing PS in the ED. Because providers may find it difficult to strike a balance between too much and too little information, we also made a video on how to incorporate serious adverse events (SAEs) risks in an informed consent process for PS and made it available online for review.

Lastly, an evidence-based visual decision aid (DA) was developed out of a 3-round iterative process using a modified Delphi exercise, and created as an adjunct to supplement (rather than replace) clinician counselling about the spectrum of sedation risks for use by providers with identified patients. The visual aid became the focal point of the new informed consent process for PS implemented in 2017. The genesis of the DA, was based on PS survey feedback and patients and providers’ perceptions of evidence-based audiovisual aids utility (study card, didactic presentation, informed consent simulation) judged to be helpful in communicating sedation risks, when obtaining consent in the ED.

Visual aids help to increase the knowledge of providers and patients when communicating the risks of procedures. Risks can be estimated and consistently reported by trained providers and can help engage patients in relevant risk conversation in routine practice. In other acute settings, DAs have been shown to improve information recall, have clear potential to alter patient experience and likely impact their perception of quality of care. The sustainability of ED provider-facilitated use of an evidence-based visual DA for PS with patients requires ongoing investigation. If interactive repetition builds on the value of evidence-based communication, then the impact of patient understanding regarding the risks of sedation may actually translate validity to the informed consent process.