NCT03228615

IBD Shared Decision Making Intervention

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
OTHER	SDM Intervention	Intervention Component A: letter to activate families; Intervention Component B: in-clinic decision support; Intervention Component C: follow-up phone call

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-07-19
• Completion: 2019-07-19
• First posted: 2017-07-25
• Last updated: 2021-07-13

Locations

1 site across 1 country: United States