Trial of Enhanced Pre-Consent Discussion

Not Applicable

Completed

• Conditions: Pediatric Crohn's Disease
• Interventions: Other: Standard Pre-consent Discussion; Other: Enhanced Pre-Consent Discussion

• 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

Study Timeline

• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-17
• Study Start: 2016-10
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-18

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

Arm && Interventions

Group	Intervention	Description
Standard Pre-consent Discussion	Standard Pre-consent Discussion	Standard pre-consent discussion for a clinical trial.
Enhanced Pre-consent Discussion	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.

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