Clinical trial NCT05221281: Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care
Official title: Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Adolescent Development
Transition
Mental Health Wellness 1
Keywords: Transition from Pediatric to Adult Care
Health Services Research
Adolescent Medicine
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Crohn's and Colitis Canada
name: The Leona M. and Harry B. Helmsley Charitable Trust
name: The Canadian Children Inflammatory Bowel Disease Network: A Partnership with the CH.I.L.D. Foundation
name: The CH.I.L.D. Foundation - Children with Intestinal & Liver Disorders
First posted: 2022-02-02
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: IBD Disability Index (IBD-DI)
timeFrame: 3 years
Secondary outcomes:
measure: Transition Readiness Assessment Questionnaire (TRAQ)
timeFrame: 3 years
measure: Transition Readiness Assessment Questionnaire (TRAQ)
timeFrame: Up to 24 months (at time of transfer to adult care)
measure: Transition Success Scores (TSS)
timeFrame: 3 years
measure: Transition Success Scores (TSS)
timeFrame: Up to 24 months (at time of transfer to adult care)
measure: Pediatric IBD INTERMED
timeFrame: 3 years
measure: Pediatric IBD INTERMED
timeFrame: Up to 24 months (at time of transfer to adult care)
measure: IBD-KID2
timeFrame: 3 years
measure: IBD-KID2
timeFrame: Up to 24 months (at time of transfer to adult care)
measure: IBDQ-32
timeFrame: 3 years
measure: IBDQ-32
timeFrame: Up to 24 months (at time of transfer to adult care)
measure: IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)
timeFrame: 3 years
measure: IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)
timeFrame: Up to 24 months (at time of transfer to adult care)
measure: Physician Global Assessment (PGA)
timeFrame: 3 years
measure: Physician Global Assessment (PGA)
timeFrame: Up to 24 months (at time of transfer to adult care)
measure: Fecal calprotectin
timeFrame: 3 years
measure: Modified Harvey-Bradshaw Index (HBI) for Crohn's disease
timeFrame: 3 years
measure: Modified Harvey-Bradshaw Index (HBI) for Crohn's disease
timeFrame: Up to 24 months (at time of transfer to adult care)
measure: Pediatric Ulcerative Colitis Activity Index (PUCAI)
timeFrame: 3 years
measure: Pediatric Ulcerative Colitis Activity Index (PUCAI)
timeFrame: Up to 24 months (at time of transfer to adult care)
measure: Emergency department visit after 18th birthday (yes/no)
timeFrame: 3 years
measure: Number of emergency department visits after 18th birthday
timeFrame: 3 years
measure: Hospitalization after 18th birthday (yes/no)
timeFrame: 3 years
measure: Number of outpatient visits to a gastroenterologist after 18th birthday
timeFrame: 3 years
measure: IBD Disability Index (IBD-DI)
timeFrame: Up to 24 months (at time of transfer to adult care)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Eric I Benchimol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.