Interactive Informed Consent and Decision Conflict

Not Applicable

Completed

• Conditions: Upper Extremity Problem
• Interventions: Other: Standard consent; Other: Interactive consent

• Registration Number: NCT05980078
• Lead Sponsor: University of Texas at Austin

Brief 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.

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2020-03-01
• Study Completion: 2023-05-01
• Study First Submitted: 2023-07-27
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-03
• Study First Posted: 2023-08-07
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

1. English and Spanish-speaking adults
2. Older than 18 years of age
3. One of six common upper extremity conditions including carpal tunnel release, cubital tunnel release, trigger finger release, plate and screw fixation of a distal radius fracture, removal of a benign lump including a ganglion cyst, and Dupuytren contracture release.

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Exclusion Criteria

People with cognitive deficits were excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard written consent	Standard consent	They were randomized to complete a standard written consent
Interactive consent	Interactive consent	They were randomized to complete an interactive consent

Primary Outcome Measures

Name	Time	Method
Decision Conflict Scale	through study completion, an average of 6 months	The Decision Conflict Scale consists of sixteen 4- point items regarding comfort with decision-making.

Secondary Outcome Measures

Name	Time	Method
Jefferson Scale of Patient's Perceptions of Physician Empathy	through study completion, an average of 6 months	The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five 7-point scale questions and higher scores indicated greater perceived clinician empathy.

Trial Locations

Locations (1)

University of Texas Health Austin (UTHA); 🇺🇸 Austin, Texas, United States