Tailored Transition for IBD Adolescents
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Background: Smooth transition of adolescent patients diagnosed with inflammatory bowel
      diseases (IBD) to adult care is necessary in order to secure continues clinical management
      and to prevent possible deleterious clinical and psychosocial implications. In recent years
      there is an emphasis on successful transition, however, there are no standardized models or
      consensus guidelines incorporating both clinical and psychosocial aspects of transition.
      Objectives: To examine the effect a comprehensive clinical and psychosocial transition
      package on clinical management and patients outcomes in adolescents with IBD. Design: A
      prospective, trans-sectional study. Setting: The Schneider Children's Medical Center and the
      Rabin Medical Center. Participants: Children 17 year to 18 years who are diagnosed with IBD
      and are planned to initiate transition process to adult care. Main outcome measures: Change
      in clinical management as a result of tailored re-evaluation as a part of tailored transition
      package. Secondary outcome measures: a. The effect of a tailored transition package on
      patients' self-efficacy perception and readiness for transition. b. The effect of a tailored
      transition package on patient's outcomes (disease activity, flares, hospitalizations) during
      the first year following transition.
    

Detailed description: 
      General intervention scheme:

      Patients with an established diagnosis of IBD (crohn's disease, ulcerative colitis or
      IBD-unclassified) will be enrolled between the age of 17 and 17.5 years. Patients are
      eligible for enrollment 6 months following diagnosis and onward.

      Following enrollment each patient will undergo a structured re-evaluation as follows:

      Each patient will be thoroughly examined and have height ,weight, body mass index performed
      as well as comprehensive laboratory examinations. Fecal sample for fecal calprotectin will be
      obtained as well. Extent of disease will be registered using the Montreal classification.
      Disease activity indices will be calculated according to the Harvey-Bradshaw Index (HBI) for
      crohn's and Partial Mayo Score (PMS) for UC.

      Serum of patients treated with biologic medications will be analyzed for drug trough levels
      and anti-drug antibodies. Patients treated with thiopurines will have their blood analyzed
      for thiopurines metabolites. Patients will complete a "self-efficacy" and Transition
      Readiness Assessment Questionnaire (TRAQ). Both questionnaires were linguistically validated
      by bi-directional translation. Patients diagnosed with ileal or ileo-colonic crohn's will
      undergo an MR Enterography (MRE). In crohn's patients, MRE was shown to have a higher impact
      on patient management than colonoscopy. Patients diagnosed with either UC, IBD-U or Crohn's
      colitis will undergo a flexible sigmoidoscopy. Flexible sigmoidoscopy was recently shown to
      have a high degree of correlation with complete colonoscopy in assessments of UC activity.

      Treating physicians are entitled to offer the patient a more extensive endoscopic evaluation
      (complete colonoscopy, gastroscopy) or radiologic evaluation (pelvic MRI, liver ultra-sound)
      if deemed necessary according to clinical indications.

      Following the completion of clinical, laboratory and endoscopic/imaging evaluation a
      re-evaluation visit with both treating pediatric gastroenterologist and receiving adult
      gastroenterologist will be set. During this visit physicians will discuss the current
      treatment plan with the patient and the need for changes in therapeutic regimens (including
      step-up, step-down, adding or withdrawing optional treatments).

      A transition visit with both treating gastroenterologists will be set 3-6 months following
      the re-evaluation visit (around 18 years of age) in order to assess the efficacy of the
      therapeutic plan and to complete the transition process. During the transition visit patients
      will, again, complete a "self-efficacy" and TRAQ questionnaires. In between the reevaluation
      visit and the transition visit the patients will be followed according to clinical
      indications by the treating pediatric gastroenterologist.

      Prior to the transition visit each patient and parents will perform a transition preparation
      meeting with a multi-disciplinary team including a pediatric IBD nurse, an adult IBD nurse
      and a social worker. During this meeting the team will discuss practical issues concerning
      transition, instruct the patient on subjects specifically related to disease implications
      during late adolescence and early adulthood (substance abuse, alcohol, contraceptives,
      pregnancy, high education, work) and address special psycho-social needs/concerns. According
      to the team discretion, if a need for a meeting with the institute's psychologist is
      necessary, such meeting will be set within 30 days.

      At 12 months following transition data on disease activity and outcomes including flares,
      hospitalizations and surgical interventions since transition will be collected. Data will be
      compared with an "historic" cohort of matched patients (case-controlled) who completed
      routine transition in the time period prior to the study in which transition was performed
      following 1-2 visits of the patient with both pediatric and adult gastroenterologists.
    

Intervention name(s): Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluation
Intervention type(s): Procedure
Intervention description(s): All patients will be assessed for drug levels and metabolites. Patients diagnosed with ileal or ileo-colonic crohn's will undergo an MR Enterography (MRE). In crohn's patients, MRE was shown to have a higher impact on patient management than colonoscopy. Patients diagnosed with either UC, IBD-U or Crohn's colitis will undergo a flexible sigmoidoscopy.
Following re-evaluation each patient will undergo 2 transition meetings with pediatric and adult gastroenterologist as well as a meeting with IBD nurses and social worker.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment