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

Patient Decision Aids Before Informed Consent Conversations for Image-Guided Procedures: Controlled Trials at Two Institutions
Shanmukha Srinivas, Isabel G. Newton, Maciej Waradzyn, Nishita Kothary, Eric J. Keller
American Journal of Roentgenology, October 2022
Abstract
Background
Patient decision aids (PDAs) improve informed consent practices. Available PDAs for image-guided procedures are of limited quality.
Objective
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: January, 2021 to October, 2021). Patients were assigned systematically at site A, and randomly at site B, to electronically receive or not receive a 2-page PDA before the visit. PDAs described procedures and their benefits, risks, and alternatives at a 6th-8th grade health literacy level, and vetted by diverse patient focus groups. Patients completed a post visit survey (site A: phone; 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 male, 46 female; 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 not received, 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.