Nested within the COMBINE pragmatic clinical trial, the investigators will conduct a cluster randomized controlled trial to determine whether, in parents (of children with Crohn's Disease) or patients \> 18 years old being approached for trial participation, a pre-consent discussion enhanced with decision aids is more effective than the standard pre-consent discussion in transferring knowledge to parents/patients related to trial participation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
241
The enhanced pre-consent discussion intervention is a tool that includes both textual and graphical information regarding the trial and an interactive component designed to initiate and facilitate conversations between all parties in the decision-parent, patient, healthcare provider and research staff.
Standard pre-consent discussion for a clinical trial
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Knowledge Related to Trial Participation
Number correct on 5-item Knowledge Related to Trial Participation survey
Time frame: prior to consent
Rate of enrollment
Time frame: at consent
Support subscale of decision conflict scale
Time frame: prior to consent
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.