Trial of Enhanced Pre-Consent Discussion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Knowledge Related to Trial Participation
研究概览
简要总结
Nested within the COMBINE pragmatic clinical trial, the investigators will conduct a cluster randomized controlled trial to determine whether, in parents (of children with Crohn's Disease) or patients > 18 years old being approached for trial participation, a pre-consent discussion enhanced with decision aids is more effective than the standard pre-consent discussion in transferring knowledge to parents/patients related to trial participation.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent of a child who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965)
- •Patient who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965)
排除标准
- •Non-English speaking
研究组 & 干预措施
Standard Pre-consent Discussion
Standard pre-consent discussion for a clinical trial.
干预措施: Standard Pre-consent Discussion (Other)
Enhanced Pre-consent Discussion
The enhanced pre-consent discussion intervention is a tool that includes both textual and graphical information regarding the trial and an interactive component designed to initiate and facilitate conversations between all parties in the decision-parent, patient, healthcare provider and research staff.
干预措施: Enhanced Pre-Consent Discussion (Other)
结局指标
主要结局
Knowledge Related to Trial Participation
时间窗: prior to consent
Number correct on 5-item Knowledge Related to Trial Participation survey
次要结局
- Rate of enrollment(at consent)
- Support subscale of decision conflict scale(prior to consent)
研究者
Ellen A. Lipstein MD, MPH
Assistant Professor of Pediatrics
Children's Hospital Medical Center, Cincinnati