IBD Shared Decision Making Intervention



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any - 100
Updated:2/10/2019
Start Date:September 1, 2017
End Date:July 2019
Contact:Ellen A Lipstein, MD, MPH
Email:ellen.lipstein@cchmc.org
Phone:513-803-1626

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Pilot Trial of a Multi-Component Decision Making Intervention in IBD

The purpose of this clinical trial is to implement a multi-component shared decision making
intervention for families of children with IBD. The main objective of this research will be
to assess the acceptability, feasibility and clinical and decision outcomes of a
multi-component decision support intervention targeted at families of children with IBD who
are making decisions about treatment with TNFαi agents.

Research has shown that when making decisions about treatment with anti-tumor necrosis
factor-α (TNFαi) agents, parents of children with inflammatory bowel disease (IBD) experience
high levels of decisional conflict. This extreme level of conflict is due to the challenge of
considering an effective treatment that has potentially serious side-effects. Elevated levels
of decisional conflict have been associated with delays in decision making and failures to
implement treatment plans. Given that such delays may lead to worse clinical outcomes, there
is an urgent need to improve the decision-making process around TNFαi therapy. The use of
structured decision support to help inform and guide parents through this challenging
decision may improve the decision-making process. Such structure facilitates high-quality
decision making by providing balanced, accurate information, helping individuals clarify what
is most important to them, and facilitating conversations between families and healthcare
providers. Based the investigators' prior research into the TNFαi decision process, the
investigators developed a multi-component decision support intervention designed to improve
the TNFαi decision process. This intervention will be tested in a controlled pilot trial
designed to assess the acceptability and feasibility of a multi-component intervention and to
determine the effect size of the multi-component intervention on both clinical and decision
outcomes in children and adolescents with IBD and their parents.

Inclusion Criteria:

- Clinician anticipates discussing TNFai treatment at clinic visit; parent and patient
willing to have visit video-recorded

Exclusion Criteria:

- patient over age 17; prior use of TNFai; unable to read and speak English; clinic
visit not conducted in English; previous participation in this study; known major
mental illness in parent or adolescent patient; medical instability at scheduled
visit; patient's gastroenterologist is a study investigator
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-803-3144
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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