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 ]

Percent correct on 6-item Knowledge Related to Trial Participation survey


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