Trial of Enhanced Pre-Consent Discussion

January 13, 2020 updated by: Ellen A. Lipstein MD, MPH, Children's Hospital Medical Center, Cincinnati
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Pre-consent Discussion
Standard pre-consent discussion for a clinical trial.
Other: Standard Pre-consent Discussion
Standard pre-consent discussion for a clinical trial
Experimental: Enhanced Pre-consent Discussion
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.
Other: Enhanced Pre-Consent Discussion
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge Related to Trial Participation
Time Frame: prior to consent
Number correct on 5-item Knowledge Related to Trial Participation survey
prior to consent

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of enrollment
Time Frame: at consent
at consent
Support subscale of decision conflict scale
Time Frame: prior to consent
prior to consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

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

Investigators

  • Principal Investigator: Ellen Lipstein, MD, MPH, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-9033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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