Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interactive consent | Experimental | They were randomized to complete an interactive consent |
|
| Standard written consent | Active Comparator | They were randomized to complete a standard written consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive consent | Other | They were randomized to complete an interactive consent. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
People with cognitive deficits were excluded.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Ring, MD | Professor of orthopedic surgery at The university of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Austin (UTHA) | Austin | Texas | 78701 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard consent |
| Other |
They were randomized to complete a standard written consent. |
|