Clinical Trial: Trial of Enhanced Pre-Consent Discussion
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Trial of Enhanced Pre-Consent Discussion
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 Summary:
Sponsor: Children's Hospital Medical Center, Cincinnati
Current Primary Outcome: Knowledge Related to Trial Participation [ Time Frame: prior to consent ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Rate of enrollment [ Time Frame: at consent ]
- Support subscale of decision conflict scale [ Time Frame: prior to consent ]
Original Secondary Outcome: Same as current
Information By: Children's Hospital Medical Center, Cincinnati
Dates:
Date Received: August 10, 2016
Date Started: August 2016
Date Completion: May 2020
Last Updated: August 12, 2016
Last Verified: August 2016