Implement and Test Visual Consent Template and Process
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 266
- 试验地点
- 6
- 主要终点
- Change in feasibility (FIM) of implementation (Research Staff only)
研究概览
简要总结
The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level. Each participating research team member will begin in the standard consent arm of the study. Subsequently, they will be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.
- •Participant is willing and able to comply with study procedures based on the judgment of the investigator.
- •Age ≥ 18 years at the time of consent.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-
- •Consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
- •Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- •Washington University:
- •Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies (WeSHARE)
- •Participants of the Knight Alzheimer Disease Research Center.
- •Participants with available results from an Alzheimer Disease blood biomarker test.
- •Participants who agreed to be contacted for additional research studies.
- •University of Utah:
- •Huntsman Cancer Institute Total Cancer Care
- •Participants who have been diagnosed with any type of tumor or cancer.
- •Participants with genetic predispositions or family history of cancer or tumors.
- •Participant volunteers willing to share samples and data for research.
- •Eligibility Criteria for Research Staff:
- •Research staff/coordinators of one of the three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill.
排除标准
- 未提供
研究组 & 干预措施
Participants: Visual Consent
Participants will view the visual consent summary and will complete surveys with measures of knowledge, satisfaction with the information, decisional conflict, and potential covariates (i.e., demographics and health literacy).
干预措施: Visual consent (Other)
Research Staff: Standard Consent
Each participating research team member will begin in the standard consent arm of the study. The standard consent consists of a summary using text only.
干预措施: Standard consent (Other)
Participants: Standard Consent
Participants will view the standard consent consisting of summary text only and will complete surveys with measures of knowledge, satisfaction with the information, decisional conflict, and potential covariates (i.e., demographics and health literacy).
干预措施: Standard consent (Other)
Research Staff: Visual Consent
After beginning in the standard consent arm, the research staff will then be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study. Research staff will also complete a baseline survey to assess feasibility, acceptability, and appropriateness of using visual consent pages as well as their institution's willingness and ability to implement using visual key information pages into routine care. Research staff will also complete a post-study survey on attitudes toward consent, the intervention (feasibility, acceptability, appropriateness of the intervention), organizational readiness for participant engagement, and willingness to continue the invention.
干预措施: Visual consent (Other)
结局指标
主要结局
Change in feasibility (FIM) of implementation (Research Staff only)
时间窗: From baseline to end of study (estimated to be 4 months)
4 items on a Likert scale ranging from completely disagree to completely agree. Higher scores indicate greater feasibility. (1=completely disagree, 3= neither agree nor disagree, 5= completely agree)
Change in acceptability (AIM) of implementation measures (Research Staff only)
时间窗: From baseline to end of study (estimated to be 4 months)
4 items on a Likert scale ranging from completely disagree to completely agree. Higher scores indicate greater acceptability. (1=completely disagree, 3= neither agree nor disagree, 5= completely agree)
Change in appropriateness (IAM) of implementation measure (Research Staff only)
时间窗: From baseline to end of study (estimated to be 4 months)
4 items on a Likert scale ranging from completely disagree to completely agree. Higher scores indicate greater appropriateness. (1=completely disagree, 3= neither agree nor disagree, 5= completely agree)
Change in organizational willingness and ability to implement strategies (Research staff only)
时间窗: From baseline to end of study (estimated to be 4 months)
Measure of organizational readiness for engagement (MORE) measure; 4-point scale (1=not willing, 4=; willing) report mean and SD; higher scores indicate higher level of readiness
次要结局
- Knowledge of information provided in the consent (Participant only)(At time of consent review (day 1))
- Satisfaction of information provided in the consent (Participant only)(At time of consent review (day 1))
- Decisional conflict (Participant only)(At time of consent review (day 1))
- Number of enrollments to clinical trials (Participant only)(At time of consent review (day 1))