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

NCT05221281 | Active Not Recruiting

• 1 other identifier: 1000078476
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Transition from Pediatric to Adult Care; Health Services Research; Adolescent Medicine

Outcome Measures

Primary Outcomes (1)

• IBD Disability Index (IBD-DI)

  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.

  3 years

Secondary Outcomes (24)

• Transition Readiness Assessment Questionnaire (TRAQ)

  3 years

• Transition Readiness Assessment Questionnaire (TRAQ)

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

• Transition Success Scores (TSS)

  3 years

• Transition Success Scores (TSS)

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

• Pediatric IBD INTERMED

  3 years

Study Arms (2)

Intervention: Multimodal intervention consisting of four core components.

EXPERIMENTAL

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

Behavioral: Multimodal intervention consisting of four core components

Control: Standard of care

OTHER

Routine Care

Behavioral: Standard of care

Interventions

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.

Intervention: Multimodal intervention consisting of four core components.

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: 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.

Also known as: Control

Control: Standard of care

Eligibility Criteria

• Age: 16 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (3)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (3)

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

• Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.

  PMID: 39382077 DERIVED

• Bollegala N, Barwick M, Fu N, Griffiths AM, Keefer L, Kohut SA, Kroeker KI, Lawrence S, Lee K, Mack DR, Walters TD, de Guzman J, Tersigni C, Miatello A, Benchimol EI. Multimodal intervention to improve the transition of patients with inflammatory bowel disease from pediatric to adult care: protocol for a randomized controlled trial. BMC Gastroenterol. 2022 May 18;22(1):251. doi: 10.1186/s12876-022-02307-9.

  PMID: 35585484 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Eric I Benchimol, MD, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 2, 2022
• Study Start: February 25, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)