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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
515
Visual key information page
Summary text only
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGUniversity of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States
RECRUITINGUniversity of Utah Huntsman Cancer Institute (HCI)
Salt Lake City, Utah, United States
RECRUITINGChange in feasibility (FIM) of implementation (Research Staff only)
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)
Time frame: From baseline to end of study (estimated to be 4 months)
Change in acceptability (AIM) of implementation measures (Research Staff only)
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)
Time frame: From baseline to end of study (estimated to be 4 months)
Change in appropriateness (IAM) of implementation measure (Research Staff only)
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)
Time frame: From baseline to end of study (estimated to be 4 months)
Change in organizational willingness and ability to implement strategies (Research staff only)
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
Time frame: From baseline to end of study (estimated to be 4 months)
Knowledge of information provided in the consent (Participant only)
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.
Time frame: At time of consent review (day 1)
Satisfaction of information provided in the consent (Participant only)
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.
Time frame: At time of consent review (day 1)
Decisional conflict (Participant only)
SURE measure; 4-item measure. Scores less than equal to 3 indicate the presence of decisional conflict
Time frame: At time of consent review (day 1)
Number of enrollments to clinical trials (Participant only)
The investigators will document whether or not participants enroll in the trials.
Time frame: At time of consent review (day 1)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.