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OpenTrials
Completed

NCT Number: NCT05980078

Interactive Informed Consent and Decision Conflict

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.

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Key information

Conditions

Upper Extremity Problem

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Austin (UTHA)

Austin, Texas, 78701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English and Spanish-speaking adults
  • Older than 18 years of age
  • 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.

Treatment and study plan

Interactive consent

Other

They were randomized to complete an interactive consent.

Standard consent

Other

They were randomized to complete a standard written consent.

Primary outcomes

  1. Decision Conflict Scale

    Time frame: through study completion, an average of 6 months

    The Decision Conflict Scale (DCS) consists of sixteen items rated on a 4-point scale (1 = strongly agree to 4 = strongly disagree), with total scores ranging from 0 to 100. Higher scores indicate greater decisional conflict and therefore a worse outcome.

Secondary outcomes

  1. Jefferson Scale of Patient's Perceptions of Physician Empathy

    Time frame: through study completion, an average of 6 months

    The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five items rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with total scores ranging from 5 to 35. Higher scores indicate greater perceived physician empathy, representing a better outcome.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2023
First posted
Aug 7, 2023
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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