NCT05980078

Interactive Informed Consent and Decision Conflict

A Computer-Based Interactive Informed Consent for Surgery Does Not Reduce Decision Conflict

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Informed consent for surgery can address the legal aspects while also being simple, informative, and empathic. It can help people confirm that the potential harms are acceptable in light of the potential benefits. Standard consent forms just document this process, while a computer-based, interactive consent process can also standardize and potentially enhance it.

Detailed description

It's not clear that the current informed consent process adequately addresses common misconceptions and adequately confirms patient understanding of potential harms and potential benefits. Thoughtful patient consideration of potential benefits and potential harms of surgery might be facilitated by a step-by-step, iterative, interactive electronic consent process designed to help patients: 1) become aware of their values, 2) understand the actual and potential harms of surgery, 3) understand the potential benefits of surgery, and 4) guide people away from common misconceptions and towards decisions based on their values.

Conditions

• Upper Extremity Problem

Interventions

Type	Name	Description
OTHER	Interactive consent	They were randomized to complete an interactive consent.
OTHER	Standard consent	They were randomized to complete a standard written consent.

Timeline

• Start date: 2017-11-01
• Primary completion: 2020-03-01
• Completion: 2023-05-01
• First posted: 2023-08-07
• Last updated: 2025-07-31

Locations

1 site across 1 country: United States