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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05221281
• Other study ID #: 1000078476
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 25, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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: 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.

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (5)

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

Country where clinical trial is conducted

Canada, 

Outcome

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