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

+ Affiliations:
1Division of Interventional Radiology, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92093

2Division of Interventional Radiology, Stanford University, 300 Pasteur Drive, H3630, Stanford, CA 94305

Citation: American Journal of Roentgenology: -. 10.2214/AJR.22.28165

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 postvisit 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.

Clinical Impact: PDAs can be implemented effectively without requiring additional clinician time or effort.

Corresponding Author: Eric J. Keller, MD, MA, Division of Interventional Radiology, Stanford University, 300 Pasteur Drive, H3630, Stanford, CA 94305; ; (650) 203-3281; @IR_Ethics

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