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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| ImproveCareNow (ICN) | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Pre-consent Discussion | Active Comparator | Standard pre-consent discussion for a clinical trial. |
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| Enhanced Pre-consent Discussion | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Pre-Consent Discussion | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge Related to Trial Participation | Number correct on 5-item Knowledge Related to Trial Participation survey | prior to consent |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of enrollment | at consent | |
| Support subscale of decision conflict scale | prior to consent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Lipstein, MD, MPH | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| C536215 | Pediatric Crohn's disease |
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| Standard Pre-consent Discussion | Other | Standard pre-consent discussion for a clinical trial |
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