Trial of Enhanced Pre-Consent Discussion

Pediatric Crohn's Disease Clinical Trial

Official title:

Trial of Enhanced Pre-Consent Discussion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869880
• Other study ID #: 2015-9033
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: July 2019

Study information

• Verified date: January 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Pediatric Crohn's Disease

Intervention

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.
• Standard Pre-consent Discussion
Standard pre-consent discussion for a clinical trial

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	ImproveCareNow (ICN), Patient-Centered Outcomes Research Institute, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge Related to Trial Participation	Number correct on 5-item Knowledge Related to Trial Participation survey	prior to consent
Secondary	Rate of enrollment		at consent
Secondary	Support subscale of decision conflict scale		prior to consent