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NCT Number: NCT05221281

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Adolescent Development Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Mental Health Wellness 1 Transition Ulcerative Colitis

Age range

16 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's Hospital, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal intervention consisting of four core components

Behavioral

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.

Standard of Care

Behavioral

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:

  • A written letter explaining the goals of transition to the patient and family.
  • Completion of age-appropriate checklists to ensure adolescents are meeting milestones of transition (developed by the TRACC Network).51
  • Annual online live educational webinars on transition and adolescent issues (hosted by the CIDsCaNN Education Committee).
  • Completion of the Pediatric INTERMED,52 with appropriate biopsychosocial intervention.
  • 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.

Other names: Control

Primary outcomes

  1. IBD Disability Index (IBD-DI)

    Time frame: 3 years

    Ordinal variable that measures participant functioning as the primary outcome. IBD-DI was selected as a validated measure of overall disability, functioning, and health. The primary outcome will be measured 3 years after enrollment.

Secondary outcomes

  1. Transition Readiness Assessment Questionnaire (TRAQ)

    Time frame: 3 years

    Transition Readiness

  2. Transition Readiness Assessment Questionnaire (TRAQ)

    Time frame: Up to 24 months (at time of transfer to adult care)

    Transition Readiness

  3. Transition Success Scores (TSS)

    Time frame: 3 years

    Transition Readiness

  4. Transition Success Scores (TSS)

    Time frame: Up to 24 months (at time of transfer to adult care)

    Transition Readiness

  5. Pediatric IBD INTERMED

    Time frame: 3 years

    Biopsychosocial Risk Profile

  6. Pediatric IBD INTERMED

    Time frame: Up to 24 months (at time of transfer to adult care)

    Biopsychosocial Risk Profile

  7. IBD-KID2

    Time frame: 3 years

    Disease-related knowledge

  8. IBD-KID2

    Time frame: Up to 24 months (at time of transfer to adult care)

    Disease-related knowledge

  9. IBDQ-32

    Time frame: 3 years

    Quality of life

  10. IBDQ-32

    Time frame: Up to 24 months (at time of transfer to adult care)

    Quality of life

  11. IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)

    Time frame: 3 years

    Self-Efficacy

  12. IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)

    Time frame: Up to 24 months (at time of transfer to adult care)

    Self-Efficacy

  13. Physician Global Assessment (PGA)

    Time frame: 3 years

    Physician assessment of disease activity

  14. Physician Global Assessment (PGA)

    Time frame: Up to 24 months (at time of transfer to adult care)

    Physician assessment of disease activity

  15. Fecal calprotectin

    Time frame: 3 years

    Measure of gut inflammation

  16. Modified Harvey-Bradshaw Index (HBI) for Crohn's disease

    Time frame: 3 years

    Disease activity in Crohn's disease patients

  17. Modified Harvey-Bradshaw Index (HBI) for Crohn's disease

    Time frame: Up to 24 months (at time of transfer to adult care)

    Disease activity in Crohn's disease patients

  18. Pediatric Ulcerative Colitis Activity Index (PUCAI)

    Time frame: 3 years

    Disease activity in ulcerative colitis patients

  19. Pediatric Ulcerative Colitis Activity Index (PUCAI)

    Time frame: Up to 24 months (at time of transfer to adult care)

    Disease activity in ulcerative colitis patients

  20. Emergency department visit after 18th birthday (yes/no)

    Time frame: 3 years

    Health services utilization

  21. Number of emergency department visits after 18th birthday

    Time frame: 3 years

    Health services utilization

  22. Hospitalization after 18th birthday (yes/no)

    Time frame: 3 years

    Health services utilization

  23. Number of outpatient visits to a gastroenterologist after 18th birthday

    Time frame: 3 years

    Health services utilization

  24. IBD Disability Index (IBD-DI)

    Time frame: Up to 24 months (at time of transfer to adult care)

    Ordinal variable that measures participant functioning as the primary outcome. IBD-DI was selected as a validated measure of overall disability, functioning, and health.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Crohn's and Colitis Canada
  • The CH.I.L.D. Foundation - Children with Intestinal & Liver Disorders
  • The Canadian Children Inflammatory Bowel Disease Network: A Partnership with the CH.I.L.D. Foundation
  • The Leona M. and Harry B. Helmsley Charitable Trust

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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