Interactive Informed Consent and Decision Conflict

NCT ID: NCT05980078

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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Upper Extremity Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Interactive consent

They were randomized to complete an interactive consent

Group Type EXPERIMENTAL

Interactive consent

Intervention Type OTHER

They were randomized to complete an interactive consent.

Standard written consent

They were randomized to complete a standard written consent

Group Type ACTIVE_COMPARATOR

Standard consent

Intervention Type OTHER

They were randomized to complete a standard written consent.

Interventions

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Interactive consent

They were randomized to complete an interactive consent.

Intervention Type OTHER

Standard consent

They were randomized to complete a standard written consent.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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David Ring

Professor of Surgery and Perioperative Care Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Ring, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of orthopedic surgery at The university of Texas at Austin

Locations

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University of Texas Health Austin (UTHA)

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2017-05-0033

Identifier Type: -

Identifier Source: org_study_id

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