A Computer-Based Interactive Informed Consent for Surgery Does Not Reduce Decision Conflict
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Decision Conflict Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •People with cognitive deficits were excluded.
研究组 & 干预措施
Interactive consent
They were randomized to complete an interactive consent
干预措施: Interactive consent (Other)
Standard written consent
They were randomized to complete a standard written consent
干预措施: Standard consent (Other)
结局指标
主要结局
Decision Conflict Scale
时间窗: 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.
Decision Conflict Scale
时间窗: 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.
次要结局
- Jefferson Scale of Patient's Perceptions of Physician Empathy(through study completion, an average of 6 months)
- Jefferson Scale of Patient's Perceptions of Physician Empathy(through study completion, an average of 6 months)
研究者
David Ring
Professor of Surgery and Perioperative Care Department
University of Texas at Austin