Multimodal Intervention for Crohn's Disease Transition Care

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byEric I Benchimol, MD, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The Hospital for Sick Children

No Placebo Group

Trial Summary

What is the purpose of this trial?

Background: Transition in care is defined as the "purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers." Currently, there is no Level 1 evidence of an intervention to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the efficacy and impact of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada. Methods: This multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0 to 17.5 years. The intervention program consists of 4 core components: 1) individualized assessment, 2) transition navigator, 3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and 4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness, anxiety and depression scales, and health service utilization rates. Additionally, we will identify the effectiveness of an evidence-based implementation approach and related barriers and facilitators for the intervention program. Discussion: The type 1 hybrid effectiveness-implementation design will allow us to develop a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will not depend on individual hospital resources, allowing centralization of interventions and funding. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach.

Research Team

Eric I Benchimol, MD, PhD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

This trial is for English-speaking adolescents aged 16 to 17.5 years with Inflammatory Bowel Disease (IBD), planning to stay in Canada after transitioning to adult care, and who can use a smartphone or computer for virtual interventions.

Inclusion Criteria

I am between 16 and 17.5 years old.

I have been diagnosed with inflammatory bowel disease.

Ability to use a smartphone or personal computer for the virtual intervention

See 2 more

Exclusion Criteria

Intention to leave Canada after graduation from high school

I am not fluent in English.

Treatment Details

Interventions

Multimodal intervention consisting of four core components (Behavioral Intervention)
Standard of care (Behavioral Intervention)

Trial OverviewThe study tests a multimodal intervention against standard care in improving the transition of young IBD patients from pediatric to adult healthcare. The program includes individual assessments, a transition navigator, virtual skills-building, and an education program.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Intervention: Multimodal intervention consisting of four core components.Experimental Treatment1 Intervention

Core Component 1: Individualized Assessment Core Component 2: Transition Facilitation with a Navigator Core Component 3: Participant Skills-building Core Component 4: Structured Educational eLearning Curriculum

Group II: Control: Standard of careExperimental Treatment1 Intervention

Routine Care