Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care

The Hospital for Sick Children

Status: Active, not recruiting

Conditions: Adolescent Development; Transition; Mental Health Wellness 1; Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Behavioral: Multimodal intervention consisting of four core components; Behavioral: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT05221281

1000078476

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 16 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 16-17.5 years
• Diagnosed with IBD diagnosed using standard criteria
• Ability to speak/read English at a functional (Grade 8) level
• Intention to reside in Canada after transfer to adult care
• Ability to use a smartphone or personal computer for the virtual intervention

Exclusion criteria

• Do not speak English fluently
• Intention to leave Canada after graduation from high school

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Intervention: Multimodal intervention consisting of four core components.

Experimental group

Description:

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

Treatment:

Behavioral: Multimodal intervention consisting of four core components

Control: Standard of care

Other group

Description:

Routine Care

Treatment:

Behavioral: Standard of care