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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
90
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.
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.
BC Children's Hospital
Vancouver, British Columbia, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
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.
Time frame: 3 years
Transition Readiness Assessment Questionnaire (TRAQ)
Transition Readiness
Time frame: 3 years
Transition Readiness Assessment Questionnaire (TRAQ)
Transition Readiness
Time frame: Up to 24 months (at time of transfer to adult care)
Transition Success Scores (TSS)
Transition Readiness
Time frame: 3 years
Transition Success Scores (TSS)
Transition Readiness
Time frame: Up to 24 months (at time of transfer to adult care)
Pediatric IBD INTERMED
Biopsychosocial Risk Profile
Time frame: 3 years
Pediatric IBD INTERMED
Biopsychosocial Risk Profile
Time frame: Up to 24 months (at time of transfer to adult care)
IBD-KID2
Disease-related knowledge
Time frame: 3 years
IBD-KID2
Disease-related knowledge
Time frame: Up to 24 months (at time of transfer to adult care)
IBDQ-32
Quality of life
Time frame: 3 years
IBDQ-32
Quality of life
Time frame: Up to 24 months (at time of transfer to adult care)
IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)
Self-Efficacy
Time frame: 3 years
IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)
Self-Efficacy
Time frame: Up to 24 months (at time of transfer to adult care)
Physician Global Assessment (PGA)
Physician assessment of disease activity
Time frame: 3 years
Physician Global Assessment (PGA)
Physician assessment of disease activity
Time frame: Up to 24 months (at time of transfer to adult care)
Fecal calprotectin
Measure of gut inflammation
Time frame: 3 years
Modified Harvey-Bradshaw Index (HBI) for Crohn's disease
Disease activity in Crohn's disease patients
Time frame: 3 years
Modified Harvey-Bradshaw Index (HBI) for Crohn's disease
Disease activity in Crohn's disease patients
Time frame: Up to 24 months (at time of transfer to adult care)
Pediatric Ulcerative Colitis Activity Index (PUCAI)
Disease activity in ulcerative colitis patients
Time frame: 3 years
Pediatric Ulcerative Colitis Activity Index (PUCAI)
Disease activity in ulcerative colitis patients
Time frame: Up to 24 months (at time of transfer to adult care)
Emergency department visit after 18th birthday (yes/no)
Health services utilization
Time frame: 3 years
Number of emergency department visits after 18th birthday
Health services utilization
Time frame: 3 years
Hospitalization after 18th birthday (yes/no)
Health services utilization
Time frame: 3 years
Number of outpatient visits to a gastroenterologist after 18th birthday
Health services utilization
Time frame: 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.
Time frame: Up to 24 months (at time of transfer to adult care)
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