Trial of Enhanced Pre-Consent Discussion
1 other identifier
interventional
241
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2016
CompletedFirst Posted
Study publicly available on registry
August 17, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJanuary 18, 2020
January 1, 2020
2.7 years
August 10, 2016
January 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Knowledge Related to Trial Participation
Number correct on 5-item Knowledge Related to Trial Participation survey
prior to consent
Secondary Outcomes (2)
Rate of enrollment
at consent
Support subscale of decision conflict scale
prior to consent
Study Arms (2)
Standard Pre-consent Discussion
ACTIVE COMPARATORStandard pre-consent discussion for a clinical trial.
Enhanced Pre-consent Discussion
EXPERIMENTALThe 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.
Interventions
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 for a clinical trial
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Non-English speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Medical Center, Cincinnatilead
- Patient-Centered Outcomes Research Institutecollaborator
- ImproveCareNow (ICN)collaborator
- University of North Carolina, Chapel Hillcollaborator
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen Lipstein, MD, MPH
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
August 10, 2016
First Posted
August 17, 2016
Study Start
October 1, 2016
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
January 18, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share