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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: Multimodal intervention consisting of four core components
* Behavioral: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Multimodal intervention consisting of four core components.<br>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<br>* 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.<br>|
| Other: Control: Standard of care<br>Routine Care | Behavioral: Standard of care<br>* 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.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transition Readiness Assessment Questionnaire (TRAQ) | Transition Readiness | 3 years | 
| Transition Readiness Assessment Questionnaire (TRAQ) | Transition Readiness | Up to 24 months (at time of transfer to adult care) | 
| Transition Success Scores (TSS) | Transition Readiness | 3 years | 
| Transition Success Scores (TSS) | Transition Readiness | Up to 24 months (at time of transfer to adult care) | 
| Pediatric IBD INTERMED | Biopsychosocial Risk Profile | 3 years | 
| Pediatric IBD INTERMED | Biopsychosocial Risk Profile | Up to 24 months (at time of transfer to adult care) | 
| IBD-KID2 | Disease-related knowledge | 3 years | 
| IBD-KID2 | Disease-related knowledge | Up to 24 months (at time of transfer to adult care) | 
| IBDQ-32 | Quality of life | 3 years | 
| IBDQ-32 | Quality of life | Up to 24 months (at time of transfer to adult care) | 
| IBD Self-Efficacy Scale - Adolescent (IBD-SES-A) | Self-Efficacy | 3 years | 
| IBD Self-Efficacy Scale - Adolescent (IBD-SES-A) | Self-Efficacy | Up to 24 months (at time of transfer to adult care) | 
| Physician Global Assessment (PGA) | Physician assessment of disease activity | 3 years | 
| Physician Global Assessment (PGA) | Physician assessment of disease activity | Up to 24 months (at time of transfer to adult care) | 
| Fecal calprotectin | Measure of gut inflammation | 3 years | 
| Modified Harvey-Bradshaw Index (HBI) for Crohn's disease | Disease activity in Crohn's disease patients | 3 years | 
| Modified Harvey-Bradshaw Index (HBI) for Crohn's disease | Disease activity in Crohn's disease patients | Up to 24 months (at time of transfer to adult care) | 
| Pediatric Ulcerative Colitis Activity Index (PUCAI) | Disease activity in ulcerative colitis patients | 3 years | 
| Pediatric Ulcerative Colitis Activity Index (PUCAI) | Disease activity in ulcerative colitis patients | Up to 24 months (at time of transfer to adult care) | 
| Emergency department visit after 18th birthday (yes/no) | Health services utilization | 3 years | 
| Number of emergency department visits after 18th birthday | Health services utilization | 3 years | 
| Hospitalization after 18th birthday (yes/no) | Health services utilization | 3 years | 
| Number of outpatient visits to a gastroenterologist after 18th birthday | Health services utilization | 3 years | 
| 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. | Up to 24 months (at time of transfer to adult care) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transition from Pediatric to Adult Care, Health Services Research, Adolescent Medicine