Clinical Informed Consent Format Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 主要终点
- Hypothetical trial enrollment as assessed by a likelihood of enrollment question
研究概览
简要总结
This study evaluates the effectiveness of a patient-centered short written informed consent form and a patient-centered short video informed consent in a randomized controlled trial (control = traditional informed consent ). Primary outcome measures include critical knowledge acquisition, risk and benefit judgments, and desired enrollment in a hypothetical clinical trial. The investigators hypothesized that the patient-centered patient-designed consent forms (video and written format) would do as well as or outperform the traditional consent form on the primary outcomes.
详细描述
Traditional informed consent documents tend to be lengthy and technical, often too dense to facilitate proper patient-engagement. In this study, the investigators test the effectiveness of a previously developed patient-centered, short informed consent document and a patient-centered, short informed animated consent video as compared to a lengthy traditional informed consent document for the same clinical condition (i.e. severe asthma)
In this study, self-identified asthma patients, aged 18 or older, attending an experimental session in a university computer laboratory will be randomly assigned to read either the full informed consent document (control) or the short, patient-centered informed consent document or to view the short patient-centered informed consent video. Participants will also complete a follow-up survey at 1-week.
The main outcome measures are:
Engagement in the information (1=not at all engaged, 2=not very engaged, 3= somewhat engaged, 4=very engaged, 5=completely engaged).
Intention to enroll in the clinical trial
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
- Double (Participant, Investigator)
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
- •at least 18 years of age
- •fluent in English
- •self-identifying as asthma patients
排除标准
- 未提供
结局指标
主要结局
Hypothetical trial enrollment as assessed by a likelihood of enrollment question
时间窗: immediately after intervention
Trust in physician as assessed by a composite of likert scale questions measuring trust
时间窗: immediately after intervention
Perceived Risk and Benefit as assessed by a series of judgment questions
时间窗: immediately after intervention
Engagement as assessed by a likert scale engagement question
时间窗: immediately after intervention
Trial Knowledge as assessed by a composite of 12 true/false questions
时间窗: immediately after intervention
次要结局
- Change in trust in physician as assessed by a composite of likert scale questions measuring trust at 1 week from intervention(1-week follow-up)
- Change in hypothetical trial enrollment as assessed by a likelihood of enrollment question at 1 week from intervention(1-week follow-up)
- Change in hypothetical trial trial knowledge as assessed by a composite of 12 true/false questions at 1 week from intervention(1-week follow-up)
- Change in Perceived Risk and Benefit as assessed by a series of judgment questions at 1 week from intervention(1-week follow-up)
研究者
Tamar Krishnamurti
Research Scientist
Carnegie Mellon University