Interactive Informed Consent and Decision Conflict
A Computer-Based Interactive Informed Consent for Surgery Does Not Reduce Decision Conflict
1 other identifier
interventional
94
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 27, 2023
CompletedFirst Posted
Study publicly available on registry
August 7, 2023
CompletedJuly 31, 2025
July 1, 2025
2.3 years
July 27, 2023
July 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Decision Conflict Scale
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.
through study completion, an average of 6 months
Secondary Outcomes (1)
Jefferson Scale of Patient's Perceptions of Physician Empathy
through study completion, an average of 6 months
Study Arms (2)
Interactive consent
EXPERIMENTALThey were randomized to complete an interactive consent
Standard written consent
ACTIVE COMPARATORThey were randomized to complete a standard written consent
Interventions
They were randomized to complete a standard written consent.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- People with cognitive deficits were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Health Austin (UTHA)
Austin, Texas, 78701, United States
Study Officials
- PRINCIPAL INVESTIGATOR
David Ring, MD
Professor of orthopedic surgery at The university of Texas at Austin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery and Perioperative Care Department
Study Record Dates
First Submitted
July 27, 2023
First Posted
August 7, 2023
Study Start
November 1, 2017
Primary Completion
March 1, 2020
Study Completion
May 1, 2023
Last Updated
July 31, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share