Informed Consent Formats by Information Preference and Priority
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Score for high impact questions
研究概览
简要总结
This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials. The study will be primarily run through an online survey.
详细描述
The goal of this study is to investigate whether the same information can be communicated in different formats of an informed consent document in ways that improve participant understanding and confidence. Participants will review one of several different versions of the same informed consent document, and will be asked to complete a survey after reading the documents. The survey will ask participants their willingness to enroll in the clinical trial discussed in the document and their confidence in their decision. The survey will also test participants recollection of information from the informed consent document. Researchers will look at this data to see if there are ways to improve knowledge about the clinical trial and confidence in decisions without necessarily changing enrollment preferences.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 Years Old or Older
- •Read and agreed to informed consent
- •Indicated desire to participate
- •Diagnosed with asthma
- •US resident
排除标准
- •Participants from whom we receive multiple responses will be dropped from analysis (but will be compensated for participation)
研究组 & 干预措施
Original
Participants will review the full-length, original consent form for the clinical trial.
干预措施: Original consent form (Behavioral)
Shortened
Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study.
干预措施: Shortened consent form (Behavioral)
Reordered
Participants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section).
干预措施: Reordered, shortened consent form (Behavioral)
Highlighted
Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study.
干预措施: Shortened consent form with a highlights box (Behavioral)
Interactive
Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section.
干预措施: Interactive, shortened consent form (Behavioral)
结局指标
主要结局
Score for high impact questions
时间窗: through study completion, an average of 30 minutes
Sum of correct answers (T/F) for any item relating to material that was rated as 50 or higher on impact on willingness to enroll in a previous study.
次要结局
- Perception of investigator transparency(through study completion, an average of 30 minutes)
- Interaction effect of format and importance on likelihood of correct answer(through study completion, an average of 30 minutes)
- Scores for different information categories(through study completion, an average of 30 minutes)
- Effect of location on score(through study completion, an average of 30 minutes)
- Decision to enroll(through study completion, an average of 30 minutes)
- Confidence in enrollment decision(through study completion, an average of 30 minutes)
- Satisfaction with consent structure(through study completion, an average of 30 minutes)
- Score for low impact questions(through study completion, an average of 30 minutes)
- Total score for all questions(through study completion, an average of 30 minutes)
- Perception of investigator concern for well being(through study completion, an average of 30 minutes)
- Participant's probability estimate of the likelihood that the treatment would help control their asthma(through study completion, an average of 30 minutes)