Interactive Informed Consent and Decision Conflict

Upper Extremity Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05980078
• Other study ID #: 2017-05-0033
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: May 1, 2023

Study information

• Verified date: August 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 1, 2023
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Exclusion Criteria:

People with cognitive deficits were excluded.

Related Conditions & MeSH terms

• Upper Extremity Problem

Intervention

Other:
• Interactive consent
They were randomized to complete an interactive consent.
• Standard consent
They were randomized to complete a standard written consent.

Locations

Country	Name	City	State
United States	University of Texas Health Austin (UTHA)	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision Conflict Scale	The Decision Conflict Scale consists of sixteen 4- point items regarding comfort with decision-making.	through study completion, an average of 6 months
Secondary	Jefferson Scale of Patient's Perceptions of Physician Empathy	The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five 7-point scale questions and higher scores indicated greater perceived clinician empathy.	through study completion, an average of 6 months