Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care
- Conditions
- Ulcerative ColitisMental Health Wellness 1Crohn DiseaseAdolescent DevelopmentTransitionInflammatory Bowel Diseases
- Interventions
- Behavioral: Multimodal intervention consisting of four core componentsBehavioral: Standard of care
- Registration Number
- NCT05221281
- Lead Sponsor
- The Hospital for Sick Children
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- Do not speak English fluently
- Intention to leave Canada after graduation from high school
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention: Multimodal intervention consisting of four core components. Multimodal intervention consisting of four core components 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 Control: Standard of care Standard of care Routine Care
- Primary Outcome Measures
Name Time Method IBD Disability Index (IBD-DI) 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 Outcome Measures
Name Time Method Emergency department visit after 18th birthday (yes/no) 3 years Health services utilization
IBDQ-32 Up to 24 months (at time of transfer to adult care) Quality of life
IBD-KID2 Up to 24 months (at time of transfer to adult care) Disease-related knowledge
Modified Harvey-Bradshaw Index (HBI) for Crohn's disease Up to 24 months (at time of transfer to adult care) Disease activity in Crohn's disease patients
Number of emergency department visits after 18th birthday 3 years Health services utilization
Transition Readiness Assessment Questionnaire (TRAQ) Up to 24 months (at time of transfer to adult care) Transition Readiness
Pediatric IBD INTERMED Up to 24 months (at time of transfer to adult care) Biopsychosocial Risk Profile
Hospitalization after 18th birthday (yes/no) 3 years Health services utilization
Transition Success Scores (TSS) Up to 24 months (at time of transfer to adult care) Transition Readiness
Pediatric Ulcerative Colitis Activity Index (PUCAI) Up to 24 months (at time of transfer to adult care) Disease activity in ulcerative colitis patients
Number of outpatient visits to a gastroenterologist after 18th birthday 3 years Health services utilization
IBD Self-Efficacy Scale - Adolescent (IBD-SES-A) Up to 24 months (at time of transfer to adult care) Self-Efficacy
Physician Global Assessment (PGA) Up to 24 months (at time of transfer to adult care) Physician assessment of disease activity
Fecal calprotectin 3 years Measure of gut inflammation
IBD Disability Index (IBD-DI) 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.
Trial Locations
- Locations (3)
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
BC Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada