Implement and Test Visual Consent Template and Process

Not Applicable

Recruiting

• Conditions: Cancer; Alzheimer Disease

• Registration Number: NCT06804837
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-02-03
• Study Start: 2025-03-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 515

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Change in feasibility (FIM) of implementation (Research Staff only)	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)	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)	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)	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

Secondary Outcome Measures

Name	Time	Method
Knowledge of information provided in the consent (Participant only)	At time of consent review (day 1)	The investigators will ask up to7 true/false/unsure questions. Missing responses will be considered false/incorrect. An overall knowledge score will be calculated with the percentage of items correctly answered. Higher scores indicate greater participant understanding of the clinical trial.
Satisfaction of information provided in the consent (Participant only)	At time of consent review (day 1)	NIH Health Information National Trends Survey (HINTS); 5-items on a Likert scale (1=completely disagree, 3= neither agree nor disagree, 5= completely agree). Higher scores indicate higher satisfaction.
Decisional conflict (Participant only)	At time of consent review (day 1)	SURE measure; 4-item measure. Scores less than equal to 3 indicate the presence of decisional conflict
Number of enrollments to clinical trials (Participant only)	At time of consent review (day 1)	The investigators will document whether or not participants enroll in the trials.

Trial Locations

Locations (3)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University of North Carolina at Chapel Hill School of Medicine; 🇺🇸 Chapel Hill, North Carolina, United States

University of Utah Huntsman Cancer Institute (HCI); 🇺🇸 Salt Lake City, Utah, United States