Improving Consent Experiences in Clinical Trials at Siteman Cancer Center
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 300
- 主要终点
- Patient's knowledge of consent
研究概览
简要总结
This is a study to evaluate the impact of evidence-based visual key information (VKI) pages on participant's experiences with informed consent for research, enrollment in high-accruing studies that choose to use VKIs as part of their consent process, and research team perceptions of the implementation potential of VKIs in studies. Unlike in previous pilots conducted at Siteman Cancer Center, this study will assess changes in outcomes before and after a VKI is implemented in a study consent process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Patient Eligibility Criteria:
- •Patient must be 18 years or older
- •Patients must be English-speaking
- •Able to understand an IRB-approved written consent document
- •Must go through the consent process for one of the parent studies
- •Research Team Eligibility Criteria:
- •Member of a parent study research team
- •Engaged in the study consent processes, including creating and reviewing consents or enrolling participants
排除标准
- 未提供
结局指标
主要结局
Patient's knowledge of consent
时间窗: Time of consent completion for parent study (day 1)
Knowledge of consent will be measured by patient's responses to 6-items on the patient consent experience survey. The 6-items are customized for each parent study and have three answers for patient to choose: true, false, and unsure. Responses will be reported via descriptive statistics and between group differences will be examined via chi-square tests.
Patient's anxiety about enrolling
时间窗: Time of consent completion for parent study (day 1)
Anxiety about enrolling will be captured by patient's answers to a single item on the patient consent experience survey adapted from the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The item is measured by a 5-point Likert scale as follows: Not at all, A little, Somewhat, A lot, and Extremely. Responses be will scored as appropriate for the validated measure and between group differences will be examined via t-tests.
次要结局
- Patient's trust in information(Time of consent completion for parent study (day 1))
- Patient's perceptions of patient centered care(Time of consent completion for parent study (day 1))
- Parent study enrollment rates(Completion of enrollment (estimated total time is 9-13 months))