Patient Decision Aids Before Informed Consent Conversations for Image-Guided Procedures: Controlled Trials at Two Institutions.

Abstract

<b>BACKGROUND.</b> Patient decision aids (PDAs) improve informed consent practices. Available PDAs for image-guided procedures are of limited quality. <b>OBJECTIVE.</b> The purpose of this article was to evaluate the impact of PDAs on understanding and satisfaction among patients undergoing informed consent conversations before outpatient image-guided procedures. <b>METHODS.</b> This prospective study included patients awaiting an interventional radiology clinic visit to discuss and obtain informed consent for an image-guided procedure. The study was conducted at two academic medical centers (site A, visits from August 2020 to July 2021; site B, visits from January 2021 to October 2021). Patients were assigned systematically at site A and randomly at site B to electronically receive or not receive a two-page PDA before the visit. PDAs described procedures and their benefits, risks, and alternatives at a sixth- to eighth-grade health literacy level and were vetted by diverse patient focus groups. Patients completed a postvisit survey (site A, by telephone; site B, online) assessing understanding of the procedure and satisfaction with the consent conversation using 5-point scales. Data were pooled between sites. <b>RESULTS.</b> The study included 105 patients (59 men, 46 women; median age, 67 years; 51 from site A, 54 from site B; 53 who received PDA, 52 who did not). Survey response rate was 100% (51/51) at site A and 67% (62/92) at site B. Patients who received, versus did not receive, a PDA reported greater understanding of benefits (4.5 vs 4.0, <i>p</i> < .001), risks (4.4 vs 3.6, <i>p</i> < .001), and alternatives (4.0 vs 3.3, <i>p</i> < .001), and of what procedures involved (4.4 vs 4.1, <i>p</i> = .02) and were more likely to feel that they were provided with enough time with the clinician (4.7 vs 4.5, <i>p</i> = .03), listened to carefully (4.8 vs 4.4, <i>p</i> < .001), free to choose any option including not to have the procedure (4.7 vs 4.3, <i>p</i> < .001), given enough time to make a decision (4.8 vs 4.3, <i>p</i> < .001), encouraged to ask questions (4.8 vs 4.5, <i>p</i> < .001), and had questions answered (4.8 vs 4.4, <i>p</i> = .001). <b>CONCLUSION.</b> Well-vetted plain-language PDAs provided before image-guided procedure consent conversations improve patients' self-perceived understanding of the procedure and satisfaction with the conversation. <b>CLINICAL IMPACT.</b> PDAs can be implemented effectively without requiring additional clinician time or effort.