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

Summary

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.

Conditions

• Inflammatory Bowel Diseases
• Crohn Disease
• Ulcerative Colitis
• Adolescent Development
• Transition
• Mental Health Wellness 1

Interventions

BEHAVIORAL

Multimodal intervention consisting of four core components

Core Component 1: Individualized Assessment: Each participant will undergo individualized assessment of their biopsychosocial risk profile (PIBD INTERMED), self-efficacy (IBD-SES-A), function (IBD-DI), transition readiness (TRAQ) and IBD knowledge (IBD-KID2), and depression, anxiety and activation. Core Component 2: Transition Navigator: Participants will be assigned a transition navigators, who will have knowledge of IBD, an understanding of the care pathway involved in transitioning IBD patients, and the skills and ability to provide psychosocial support. Core Component 3: Participant Skills-building: Skills-building materials delivered virtually. Navigators will also be trained as motivational coaches and will lead separate personalized virtual sessions targeting individual skills that have been identified as deficient during the assessment phase. Core Component 4: eLearning Curriculum: Organized online eLearning modules with reinforcement of knowledge by the navigators.

BEHAVIORAL

Standard of care

The control group will be provided a standardized version of routine care for transition. In addition to recruiting centers' standard of care, all participating centers will implement the following transition interventions: 1. A written letter explaining the goals of transition to the patient and family. 2. Completion of age-appropriate checklists to ensure adolescents are meeting milestones of transition (developed by the TRACC Network).51 3. Annual online live educational webinars on transition and adolescent issues (hosted by the CIDsCaNN Education Committee). 4. Completion of the Pediatric INTERMED,52 with appropriate biopsychosocial intervention. 5. Completion of a transfer-of-care summary letter sent to the receiving adult gastroenterologist using a standardized letter template.53 The Control Group may also receive any interventions currently in place in their participating care center, but will not receive the formal 4-component intervention described below.

Sponsors & Collaborators

• Crohn's and Colitis Canada

  collaborator OTHER

• The Leona M. and Harry B. Helmsley Charitable Trust

  collaborator OTHER

• The Canadian Children Inflammatory Bowel Disease Network: A Partnership with the CH.I.L.D. Foundation

  collaborator UNKNOWN

• The CH.I.L.D. Foundation - Children with Intestinal & Liver Disorders

  collaborator UNKNOWN

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Eric I Benchimol, MD, PhD · The Hospital for Sick Children

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-25

Primary Completion

2026-04-01

Completion

2026-12-31

Countries

• Canada

Study Locations