Trial of Enhanced Pre-Consent Discussion
Not Applicable
Completed
- Conditions
- Pediatric Crohn's Disease
- Registration Number
- NCT02869880
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 241
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Knowledge Related to Trial Participation prior to consent Number correct on 5-item Knowledge Related to Trial Participation survey
- Secondary Outcome Measures
Name Time Method Rate of enrollment at consent Support subscale of decision conflict scale prior to consent
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center🇺🇸Cincinnati, Ohio, United States