NCT02869880

Trial of Enhanced Pre-Consent Discussion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Crohn's Disease

Interventions

Type	Name	Description
OTHER	Enhanced 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.
OTHER	Standard Pre-consent Discussion	Standard pre-consent discussion for a clinical trial

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2016-08-17
• Last updated: 2020-01-18

Locations

1 site across 1 country: United States