ACCESS: AI-Driven Consent Simplification Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Quality of Informed Consent (QUIC)
研究概览
简要总结
The overarching goal of this pilot is to explore how generative artificial intelligence (genAI) can be used to improve the accessibility and understandability of informed consent materials in clinical research. The study will test the extent to which informed consent text can be improved by large language models (LLM; specifically, ChatGPT and NotebookLM) along with other AI tools (specifically, ElevenLabs) through qualitative and quantitative analyses.
Simplifying such forms using genAI may facilitate better comprehension, ensuring truly informed consent. Improving informed consent form (ICF) comprehension can lead to more informed and willing participation in clinical studies. This improved understanding may result in higher enrollment rates, better subject retention, and more accurate data collection as individuals will have a clearer understanding of study procedures and risks.
After reviewing the assigned consent information, participants will be asked a series of questions to capture their overall understanding. Then they will then be asked specific, multiple-choice questions about the content of the consent form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60 years and above
- •UCLA patient
- •English speaking
- •Ability to provide informed consent
- •UCLA investigators who are health providers that perform clinical trials
- •Must be clinical research investigatory and staff actively involved in research operations at UCLA
- •English speaking
- •Individuals involved in IRB activities (chairs, committee members, staff)
- •Must be a director or staff at UCLA
- •English speaking
排除标准
- •Group 1: None
- •Group 2: PI and co-PIs of the study "Donor Chimerism and Graft Survival Following Combined HLA-Identical Sibling Living Donor Kidney and Hematopoietic Stem Cell Transplantation Utilizing a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Rabbit Anti-Thymocyte Globulin (rATG)"
- •Group 3: Individuals from the IRB who have reviewed the study submission for "Donor Chimerism and Graft Survival Following Combined HLA-Identical Sibling Living Donor Kidney and Hematopoietic Stem Cell Transplantation Utilizing a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Rabbit Anti-Thymocyte Globulin (rATG)"
研究组 & 干预措施
Group 1 - Adult participants - Arm B
Will review the simplified ICF
干预措施: AI Simplified ICF (Behavioral)
Group 1- Adult participants - Arm C
Will listen to a podcast in conjunction to the original ICF
干预措施: Original ICF (Behavioral)
Group 1- Adult participants - Arm C
Will listen to a podcast in conjunction to the original ICF
干预措施: Podcast - Original ICF (Behavioral)
Group 1-Adult participants - Arm D
Will listen to a podcast in conjunction to the simplified ICF
干预措施: AI Simplified ICF (Behavioral)
Group 1-Adult participants - Arm D
Will listen to a podcast in conjunction to the simplified ICF
干预措施: Podcast - Simplified ICF (Behavioral)
Group 1-Adult participants - Arm A
Will review the original ICF
干预措施: Original ICF (Behavioral)
Group 3 - IRB individuals
Individuals involved in IRB activities (chairs, committee members, staff)
干预措施: Original ICF (Behavioral)
Group 3 - IRB individuals
Individuals involved in IRB activities (chairs, committee members, staff)
干预措施: AI Simplified ICF (Behavioral)
Group 2 - Investigators
PIs who are health providers that perform clinical trials
干预措施: Original ICF (Behavioral)
Group 2 - Investigators
PIs who are health providers that perform clinical trials
干预措施: AI Simplified ICF (Behavioral)
结局指标
主要结局
Quality of Informed Consent (QUIC)
时间窗: Day 1 (immediately after reviewing the ICF materials)
The QUIC measures knowledge recall. The summed score of 10 knowledge items comprising key concepts of informed consent will be calculated. The scores range between 0 and 22 with higher scores indicating higher knowledge.
次要结局
- Time to read and understand informed consent(Day 1)
- Participant understanding and comprehension of the study(Day 1)