Interactive Informed Consent and Decision Conflict

Study Overview
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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.

Official Title
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A Computer-Based Interactive Informed Consent for Surgery Does Not Reduce Decision Conflict

Conditions
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Upper Extremity Problem

Intervention / Treatment
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* Other: Interactive consent
* Other: Standard consent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: People with cognitive deficits were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive consent<br>They were randomized to complete an interactive consent | Other: Interactive consent<br>* They were randomized to complete an interactive consent.<br>|
| Active Comparator: Standard written consent<br>They were randomized to complete a standard written consent | Other: Standard consent<br>* They were randomized to complete a standard written consent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision Conflict Scale | The Decision Conflict Scale consists of sixteen 4- point items regarding comfort with decision-making. | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 7-point scale questions and higher scores indicated greater perceived clinician empathy. | through study completion, an average of 6 months |