Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- IBD Disability Index (IBD-DI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Do not speak English fluently
- •Intention to leave Canada after graduation from high school
研究组 & 干预措施
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
干预措施: Multimodal intervention consisting of four core components (Behavioral)
Control: Standard of care
Routine Care
干预措施: Standard of care (Behavioral)
结局指标
主要结局
IBD Disability Index (IBD-DI)
时间窗: 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.
次要结局
- Emergency department visit after 18th birthday (yes/no)(3 years)
- Number of emergency department visits after 18th birthday(3 years)
- IBD-KID2(Up to 24 months (at time of transfer to adult care))
- IBDQ-32(Up to 24 months (at time of transfer to adult care))
- Modified Harvey-Bradshaw Index (HBI) for Crohn's disease(Up to 24 months (at time of transfer to adult care))
- Transition Readiness Assessment Questionnaire (TRAQ)(Up to 24 months (at time of transfer to adult care))
- Pediatric IBD INTERMED(Up to 24 months (at time of transfer to adult care))
- Hospitalization after 18th birthday (yes/no)(3 years)
- Transition Success Scores (TSS)(Up to 24 months (at time of transfer to adult care))
- Pediatric Ulcerative Colitis Activity Index (PUCAI)(Up to 24 months (at time of transfer to adult care))
- Number of outpatient visits to a gastroenterologist after 18th birthday(3 years)
- IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)(Up to 24 months (at time of transfer to adult care))
- Physician Global Assessment (PGA)(Up to 24 months (at time of transfer to adult care))
- Fecal calprotectin(3 years)
- IBD Disability Index (IBD-DI)(Up to 24 months (at time of transfer to adult care))
- Transition Readiness Assessment Questionnaire (TRAQ)(3 years)
- Transition Success Scores (TSS)(3 years)
- Pediatric IBD INTERMED(3 years)
- IBD-KID2(3 years)
- IBDQ-32(3 years)
- IBD Self-Efficacy Scale - Adolescent (IBD-SES-A)(3 years)
- Physician Global Assessment (PGA)(3 years)
- Modified Harvey-Bradshaw Index (HBI) for Crohn's disease(3 years)
- Pediatric Ulcerative Colitis Activity Index (PUCAI)(3 years)
研究者
Eric Benchimol
Senior Scientist
The Hospital for Sick Children