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Interactive Informed Consent and Decision Conflict

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Upper Extremity Problem

Treatments

Other: Interactive consent
Other: Standard consent

Study type

Interventional

Funder types

Other

Identifiers

NCT05980078
2017-05-0033

Details and patient eligibility

About

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.

Full 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.

Enrollment

94 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

94 participants in 2 patient groups

Interactive consent
Experimental group
Description:
They were randomized to complete an interactive consent
Treatment:
Other: Interactive consent
Standard written consent
Active Comparator group
Description:
They were randomized to complete a standard written consent
Treatment:
Other: Standard consent

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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