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| Name | Class |
|---|---|
| Crohn's and Colitis Canada | OTHER |
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
| The Canadian Children Inflammatory Bowel Disease Network: A Partnership with the CH.I.L.D. Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Control: Standard of care | Other | Routine Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Transition Readiness Assessment Questionnaire (TRAQ) | Transition Readiness | 3 years |
| Transition Readiness Assessment Questionnaire (TRAQ) | Transition Readiness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric I Benchimol, MD, PhD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's Hospital | Vancouver | British Columbia | V6H 3N1 | Canada | ||
| Children's Hospital of Eastern Ontario |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40243391 | Derived | 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. | |
| 39382077 | 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. |
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| The CH.I.L.D. Foundation - Children with Intestinal & Liver Disorders | UNKNOWN |
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|
| 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:
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. |
|
|
| 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) |
| Ottawa |
| Ontario |
| K1H 8L1 |
| Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| 35585484 | 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. |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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