Pediatric Crohn's Disease
Conditions
Brief summary
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.
Interventions
OTHEREnhanced Pre-Consent Discussion
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.
OTHERStandard Pre-consent Discussion
Standard pre-consent discussion for a clinical trial
Sponsors
Patient-Centered Outcomes Research Institute
ImproveCareNow (ICN)
University of North Carolina, Chapel Hill
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Parent of a child who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965) * Patient who is eligible for the COMBINE trial (ClinicalTrials.gov Identifier: NCT02772965)
Exclusion criteria
* Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge Related to Trial Participation | prior to consent | Number correct on 5-item Knowledge Related to Trial Participation survey |
Secondary
| Measure | Time frame |
|---|---|
| Rate of enrollment | at consent |
| Support subscale of decision conflict scale | prior to consent |
Countries
United States
Outcome results
None listed