Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN #1205)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 46
- 主要终点
- Quality of Informed Consent Part A (QuIC-A) Score
研究概览
简要总结
The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and (2) Evaluation Study to understand barriers to implementation of ETRIC.
详细描述
A two-arm, randomized study will be conducted in patients about to undergo consent discussion for participation in two large, multicenter BMT CTN clinical trials. Once they agree to participate in this Easy-to-Read Informed Consent (ETRIC) study, they will go through the consent process for the parent trial using either a standard or the ETRIC consent form. The content of both forms will be similar but the ETRIC form will incorporate a two-column format with specific attention towards enhanced readability and processability. Following the consent discussion for the BMT CTN parent trial, patients will complete assessments of health literacy, comprehension of the parent trial and satisfaction and anxiety related to the consent process. These assessments will be completed within 7 business days of the consent discussion of the parent trial.
Notes: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on April 18, 2014. Enrollment on the BMT CTN 1203 trial (NCT02208037) completed accrual on May 13, 2016.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Quality of Informed Consent Part A (QuIC-A) Score
时间窗: Within 7 days of consent discussion
The primary objective of the trial is to compare objective comprehension scores on the Quality of Informed Consent (part A) instrument between subjects randomized to the ETRIC versus the standard consent arms. The QuIC-A is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of comprehension.
次要结局
- Quality of Informed Consent Part B (QuIC-B) Score(Within 7 days of consent discussion)
- Modified Deaconess Informed Consent Comprehension Test (DICCT)(WIthin 7 days of consent discussion)
- REALM-R Score(Within 7 days of consent discussion)
- Newest Vital Sign (NVS) Score(Within 7 days of consent discussion)
- Participant Satisfaction With Consent Process(Within 7 days of consent discussion)
- State Trait Anxiety Inventory (STAI) Score(Within 7 days of consent discussion)
- Participant Information Location Time(Within 7 days of consent discussion)
- Consent Rate on Parent Trial(Within 7 days of consent discussion)