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

BACKGROUND. Patient decision aids (PDAs) improve informed consent practices. Available PDAs for image-guided procedures are of limited quality. OBJECTIVE. 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. METHODS. 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. RESULTS. 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, p < .001), risks (4.4 vs 3.6, p < .001), and alternatives (4.0 vs 3.3, p < .001), and of what procedures involved (4.4 vs 4.1, p = .02) and were more likely to feel that they were provided with enough time with the clinician (4.7 vs 4.5, p = .03), listened to carefully (4.8 vs 4.4, p < .001), free to choose any option including not to have the procedure (4.7 vs 4.3, p < .001), given enough time to make a decision (4.8 vs 4.3, p < .001), encouraged to ask questions (4.8 vs 4.5, p < .001), and had questions answered (4.8 vs 4.4, p = .001). CONCLUSION. 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. CLINICAL IMPACT. PDAs can be implemented effectively without requiring additional clinician time or effort.