Table 5 Primary and Secondary Outcome Measures. Note: Primary and secondary outcomes will be measured at enrollment (T1), at the time of transfer to adult care (T2), and at the end of the study period (1–2 years after transfer) (T3), unless otherwise specified
Domain | Measure | Timing of administration |
|---|---|---|
Primary outcome | ||
Disability and function | T1, T2, T3 | |
Secondary outcomes | ||
Transition readiness | Transition Readiness Assessment Questionnaire (TRAQ) [28] Transition Success Scores (TSS) | T1, T2, T3 |
Bio-psychosocial risk | Pediatric IBD INTERMED [24] | T1, T2, T3 |
Disease-related knowledge | IBD-KID2[29] | T1, T2, T3 |
Quality of life | IBDQ-32[57] | T1, T2, T3 |
Self-efficacy | IBD Self-Efficacy Scale—Adolescent (IBD-SES-A) [58] | T1, T2, T3 |
Mental Health | Patient Health Questionnaire-9 (PHQ-9) Generalized Anxiety Disorder-7 (GAD-7) | T1, T2, T3 |
Disease activity | Physician global assessment (PGA) of disease activity Modified Harvey Bradshaw Index (HBI) Assessment for CD Activity [44] Pediatric Ulcerative Colitis Activity Index (PUCAI) for UC Activity [45] Fecal calprotectin (at enrollment and study termination only) | T1, T2, T3 T1, T3 |
Health services utilization | Emergency department visit after 18th birthday (yes/no) Number of emergency department visits after 18th birthday Hospitalization after 18th birthday (yes/no) Number of outpatient visits to GI after 18th birthday | T3 |