Interactive Informed Consent and Decision Conflict

University of Texas at Austin94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Upper Extremity Problem

Interventions

Interactive consentOTHER

They were randomized to complete an interactive consent.

Standard consentOTHER

They were randomized to complete a standard written consent.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Texas Health Austin (UTHA)

Austin, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: through study completion, an average of 6 months

Secondary Outcomes

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.

Time frame: through study completion, an average of 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.