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OpenTrials
Completed

NCT Number: NCT02869880

Trial of Enhanced Pre-Consent Discussion

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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Key information

Conditions

Pediatric Crohn's Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Pre-consent Discussion

Other

Standard pre-consent discussion for a clinical trial

Primary outcomes

  1. Knowledge Related to Trial Participation

    Time frame: prior to consent

    Number correct on 5-item Knowledge Related to Trial Participation survey

Secondary outcomes

  1. Rate of enrollment

    Time frame: at consent

  2. Support subscale of decision conflict scale

    Time frame: prior to consent

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • ImproveCareNow (ICN)
  • Patient-Centered Outcomes Research Institute
  • University of North Carolina, Chapel Hill

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2016
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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