Trial of Enhanced Pre-Consent Discussion

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Pediatric Crohn's Disease

Treatments: Other: Standard Pre-consent Discussion; Other: Enhanced Pre-Consent Discussion

Study type: Interventional

Funder types: Other

Identifiers

NCT02869880

2015-9033

Details and patient eligibility

About

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.

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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241 participants in 2 patient groups

Standard Pre-consent Discussion

Active Comparator group

Description:

Standard pre-consent discussion for a clinical trial.

Treatment:

Other: Standard Pre-consent Discussion

Enhanced Pre-consent Discussion

Experimental group

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.

Treatment:

Other: Enhanced Pre-Consent Discussion