Upper Extremity Problem
Conditions
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.
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.
Interventions
OTHERInteractive consent
They were randomized to complete an interactive consent.
OTHERStandard consent
They were randomized to complete a standard written consent.
Sponsors
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision Conflict Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Jefferson Scale of Patient's Perceptions of Physician Empathy | 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. |
Countries
United States
Outcome results
None listed