Feasibility of a Care Team-Focused Action Plan to Improve Quality of Care for Children and Adolescents With Inflammatory Bowel Disease

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this interventional study is to test the feasibility of a new communication tool, call MyIBD, in youth ages 13 to 19 years with inflammatory bowel disease. The main question\[s\] it aims to answer are: * Is the MyIBD communication tool feasible to use in everyday clinical practice? * Does the MyIBD tool have potential to improve patients' self-management skills and the quality of care they receive? Participants who receive the MyIBD intervention will complete surveys about their care at three times points - at study enrollment, at 6 months, and at 12 months. The surveys will help the research team learn about the feasibility of using MyIBD in practice and about any effects on patients' self-management skills and quality of care. Researchers will compare those receiving a MyIBD document to a randomly selected control group (patients receiving usual care for pediatric inflammatory bowel disease) to see if self-management skills and quality of care differ between the groups.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 19
Healthy Volunteers: f
View:

• age 13-19 years old at time of recruitment; AND

• diagnosis at least 3 months earlier of Crohn's disease, ulcerative colitis, or indeterminate colitis (to exclude families who have not had sufficient time to become familiar with condition and/or clinic personnel); AND

• receiving ongoing care at UNC (at least one visit in the past year)

Locations
United States
North Carolina
University of North Carolina-Chapel Hill School of Medicine
RECRUITING
Chapel Hill
Contact Information
Primary
Neal deJong, MD
dejong@med.unc.edu
919-966-2504
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2026-03
Participants
Target number of participants: 60
Treatments
Experimental: MyIBD
Each participant randomized to the intervention arm (MyIBD) will receive an individually tailored MyIBD document within a week of a scheduled outpatient clinic visit. The MyIBD document will be prepared by the patient's usual, assigned nurse coordinator together with the study's clinical champion (a nurse practitioner in the IBD program). Participants will receive a copy of the MyIBD document with language suggesting that they use it to guide decisions about care in between appointments. Each participant's primary care provider will also receive a copy of the MyIBD document. The nurse coordinator will send reminder messages to intervention-group participants (using the electronic patient portal) to access and use their MyIBD document at 1-2 months, 3-4 months, 7-8 months, and 11-12 months after initial plan creation.
No_intervention: Usual Care
Each participant randomized to the control group will receive usual care in the pediatric IBD program. They will be eligible to receive a MyIBD document after completing the study (12 months after enrollment).
Related Therapeutic Areas
Sponsors
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov