Upper Extremity ProblemNCT05980078
Interactive Informed Consent and Decision Conflict
A study testing Interactive consent and Standard consent in people with Upper Extremity Problem, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Extremity Problem
- What is being tested?
- Interactive consent and Standard consent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- People with cognitive deficits were excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Austin (UTHA)
Austin, Texas, 78701
About this study
Official title: A Computer-Based Interactive Informed Consent for Surgery Does Not Reduce 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.
Read the detailed 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.
- Conditions
- Upper Extremity Problem
- Being tested
- Interactive consent, Standard consent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive consentOther
They were randomized to complete an interactive consent.
Standard consentOther
They were randomized to complete a standard written consent.
| Study group | Role | What they receive |
|---|---|---|
| Interactive consent | Experimental | They were randomized to complete an interactive consent Receives: Other: Interactive consent |
| Standard written consent | Active comparator | They were randomized to complete a standard written consent Receives: Other: Standard consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
Jefferson Scale of Patient's Perceptions of Physician Empathy
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.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Nov 2017
- Primary completion1 Mar 2020
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ring, University of Texas at Austin
- Investigators
- David Ring, MD, Principal investigator, Professor of orthopedic surgery at The university of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980078
- Sponsor's protocol ID
- 2017-05-0033
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computer-Based Interactive Informed Consent for Surgery Does Not Reduce Decision Conflict
- ClinicalTrials.gov ID
- NCT05980078
- Acronym / sponsor ID
- 2017-05-0033
- Conditions
- Upper Extremity Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive consent | Experimental | Other: Interactive consentThey were randomized to complete an interactive consent |
| Standard written consent | Active comparator | Other: Standard consentThey were randomized to complete a standard written consent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- People with cognitive deficits were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive consentThey were randomized to complete an interactive consent. | Other | Interactive consent |
| Standard consentThey were randomized to complete a standard written consent. | Other | Standard written consent |
Primary outcome
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.
1 secondary outcome
Jefferson Scale of Patient's Perceptions of Physician Empathy
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ring, MD principal investigator
Professor of orthopedic surgery at The university of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive consent and Standard consent in people with Upper Extremity Problem, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision Conflict Scale (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.