Trial of Enhanced Pre-Consent Discussion
Primary Purpose
Pediatric Crohn's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Pre-Consent Discussion
Standard Pre-consent Discussion
Sponsored by
About this trial
This is an interventional other trial for Pediatric Crohn's Disease
Eligibility Criteria
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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Pre-consent Discussion
Enhanced Pre-consent Discussion
Arm Description
Standard pre-consent discussion for a clinical trial.
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.
Outcomes
Primary Outcome Measures
Knowledge Related to Trial Participation
Number correct on 5-item Knowledge Related to Trial Participation survey
Secondary Outcome Measures
Rate of enrollment
Support subscale of decision conflict scale
Full Information
NCT ID
NCT02869880
First Posted
August 10, 2016
Last Updated
January 13, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Patient-Centered Outcomes Research Institute, ImproveCareNow (ICN), University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT02869880
Brief Title
Trial of Enhanced Pre-Consent Discussion
Official Title
Trial of Enhanced Pre-Consent Discussion
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Patient-Centered Outcomes Research Institute, ImproveCareNow (ICN), University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Crohn's Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
241 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Pre-consent Discussion
Arm Type
Active Comparator
Arm Description
Standard pre-consent discussion for a clinical trial.
Arm Title
Enhanced Pre-consent Discussion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Pre-Consent Discussion
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Pre-consent Discussion
Intervention Description
Standard pre-consent discussion for a clinical trial
Primary Outcome Measure Information:
Title
Knowledge Related to Trial Participation
Description
Number correct on 5-item Knowledge Related to Trial Participation survey
Time Frame
prior to consent
Secondary Outcome Measure Information:
Title
Rate of enrollment
Time Frame
at consent
Title
Support subscale of decision conflict scale
Time Frame
prior to consent
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Lipstein, MD, MPH
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trial of Enhanced Pre-Consent Discussion
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