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

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 Overview

• Status: Active, not recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Mental Health Wellness 1; Adolescent Development; Transition
• Intervention / Treatment: Behavioral: Multimodal intervention consisting of four core components; Behavioral: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • BC Children's Hospital
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital of Eastern Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: 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	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.
Other: Control: Standard of care; Routine Care	Behavioral: 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.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transition Readiness Assessment Questionnaire (TRAQ)	Transition Readiness	3 years
Transition Readiness Assessment Questionnaire (TRAQ)	Transition Readiness	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)

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust; 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
• Investigators: Principal Investigator: Eric I Benchimol, MD, PhD, The Hospital for Sick Children

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 22, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Health Services Research; Adolescent Medicine; Transition from Pediatric to Adult Care
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 1000078476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Location of the repository - OSF.io or journal (planned); Administrators for the repository Since we are not sure which journals we will submit to at this time, we cannot comment on the location/administrators for the repository.; De-identified study data plans - At a minimum, research journals are asking that authors share a 'minimal data set' for submission. This is normally defined as the minimal data set to consist of the data required to replicate all study findings reported in the article, as well as related metadata and methods. This is what will be shared with journals upon submission.; Privacy protections for stored study data - Only de-identified study data will be shared with the open access repository. Submission to research journals has been outlined on the participant consent form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No