IBD Shared Decision Making Intervention

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228615
• Other study ID #: 2016-8792
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 19, 2019

Study information

• Verified date: July 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

Other:
• SDM Intervention
Intervention Component A: letter to activate families; Intervention Component B: in-clinic decision support; Intervention Component C: follow-up phone call

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Crohn's and Colitis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of multi-component intervention: OPTION scale	Measures observed shared decision making based on review of the video-recorded visit	Baseline
Primary	Feasibility of multi-component intervention: Receipt of intervention components	The percentage of participants who receive each individual component (i.e., pre-visit email/letter, in-clinic decision support, follow-up phone call)	1 month post baseline
Primary	Feasibility of multi-component intervention: Length of clinic visit	Measures the length of the clinic visit with in-clinic decision support intervention	Baseline