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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05980078
Other study ID # 2017-05-0033
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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