Improving OutcoMes in the Pediatric to Adult Care Transition in Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease; Crohn Disease; Colitis, Ulcerative
MeSH terms: Crohn Disease; Colitis; Intestinal Diseases; Inflammatory Bowel Diseases; Colitis, Ulcerative
Study type: Interventional

Summary: 
      The transition from pediatric to adult IBD care can be stressful and wrought with challenges
      including access to care and establishment of new physician-patient relationships. There a
      few studies which characterize patterns of healthcare utilization during this critical period
      and its impact on outcomes. We hypothesize that uninterrupted healthcare utilization in
      academic centers and optimized communication with patients during the pediatric-adult
      transition period is associated with lower hospitalizations and surgery. This hypothesis will
      be addressed by a randomized clinical trial to determine the impact of monthly regular
      telephone contact with an IBD Registered Nurse versus standard of care during the
      pediatric-adult transition period. Outcomes will include healthcare utilization,
      health-related quality of life, patient satisfaction, and treatment adherence over 12 months
      of follow-up. Randomization and analyses will be stratified by whether subjects were
      transferred to adult care in an academic center or in a community practice. We hope that this
      research will facilitate optimal delivery of healthcare during the pediatric-adult
      transition.
    

Detailed description: 
      Rationale: The years marking the transition from pediatric-to-adult transition can be
      particularly difficult and transitioning patients with IBD may be at increased risk for loss
      to follow-up. As patient advocates, we need an intervention that would enable continuity of
      care especially among young adults who may face obstacles in accessing regular office visits.
      An intervention such as regular email contact with an IBD nurse may especially benefit those
      who are transitioning to community gastroenterology practices or to geographic regions where
      there is difficulty in accessing gastroenterology care. The lack of continuity of care may
      lead to delayed treatment which may be associated with poor clinical outcomes.

      Research Question and Hypothesis: Our primary question is whether regular email contact with
      an IBD nurse can improve health outcomes. We hypothesize that such interaction, through
      augmented continuity of care will lead to increased patient satisfaction, increased medical
      adherence, improved transition readiness, decreased disease activity, and consequently
      decreased costly visits to the emergency department and hospitalizations.

      Study Design: Multi-center randomized controlled clinical trial

      Study population and inclusion/exclusion criteria: This study comprise adolescent subjects
      recruited from the IBD clinics of the Hospital for Sick Children, McMaster Children's
      Hospital or Children's Hospital of Eastern Ontario who meet the following inclusion criteria:
      (1) diagnosis of IBD; (2) at least age 16 years or older; (3) planning to undergo transition
      of care and will be followed by a gastroenterologist in either an academic center or the
      community; (4) have access to email or other means of telecommunication. We will exclude any
      subjects who will not be residing in Canada or who will not be enrolled in the Ontario Health
      Insurance Plan after exiting pediatric care. Registration with OHIP, even if residing in a
      different province, is required for monitoring of health utilization.

      Health Implications: Our study may demonstrate cost-savings from decreased non-routine
      healthcare utilization coupled with improvement in health outcomes that may support the more
      widespread use of routine email-based interactions with IBD allied health providers in the
      pediatric-adult transition period.
    

Intervention name(s): Telephone and email correspondence with an Inflammatory Bowel Disease Nurse; Minimal Intervention Arm
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The IBD pediatric-adult transition nurse will send an email each month containing:
Brief Questionnaire: A link to a secured website will be provided where participants will respond to a questionnaire.
Direct Nurse Contact: Telephone and email correspondence with an Inflammatory Bowel Disease Nurse
Educational module: Every other month, we will include in the email another link to an optional educational module that will be part of a curriculum to facilitate transition readiness.
MyHealth Passport
Study Questionnaire: A personalized link to a more comprehensive study questionnaire similar to the baseline questionnaire will be emailed in the 6th and 12th (final) email.; Patients randomized to the control group will have receive email based questionnaires and information relating to the MyHealth Passport application. This intervention is not expected to significantly improve outcomes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Inflammatory Bowel Disease; Transition; Adolescent; Chronic Disease; Colitis, Ulcerative