Clinical trial NCT02085083: Improving OutcoMes in the Pediatric to Adult Care Transition in Inflammatory Bowel Disease
Official title: Improving OutcoMes in the Pediatric to Adult Care Transition in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Crohn Disease
Colitis, Ulcerative
Keywords: Inflammatory Bowel Disease
Transition
Adolescent
Chronic Disease
Colitis, Ulcerative
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Crohn's and Colitis Foundation
First posted: 2014-03-12
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* This study comprises adolescent subjects recruited from the IBD clinics of the Hospital for Sick Children and McMaster Children's Hospital 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.

Exclusion Criteria:

* We will exclude any subjects who will not be residing in Canada or who will not be enrolled in the Ontario Health Insurance Plan (OHIP) after exiting pediatric care. Registration with OHIP, even if residing in a different province, is required for the monitoring of health utilization.

Primary outcomes:
measure: Change in Patient Satisfaction
timeFrame: Patient satisfaction will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
measure: Change in Medication Adherence
timeFrame: Medication adherence will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
measure: Change in Non-Routine Healthcare Utilization
timeFrame: Non-routine healthcare utilization will be assessed retrospectively for 12 months prior to transfer of care and compared to 12 months post-transfer of care.
measure: Change in Transition Readiness
timeFrame: Transition readiness will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Quality of life will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
measure: Change in Disease Activity
timeFrame: Disease activity will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
measure: Change in Knowledge of Disease
timeFrame: Knowledge of disease will be assessed prior to transfer of care (within 3 months from the time of randomization) and again post-transfer of care (within 12 months from the time of randomization).
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Medical Center
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Canada
name: Geoffrey Nguyen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital For Sick Children, Toronto, Canada
name: Anne Griffiths, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bollegala N, Brill H, Marshall JK. Resource utilization during pediatric to adult transfer of care in IBD. J Crohns Colitis. 2013 Mar;7(2):e55-60. doi: 10.1016/j.crohns.2012.05.010. Epub 2012 Jun 5.
citation: Pinzon JL, Jacobson K, Reiss J. Say goodbye and say hello: the transition from pediatric to adult gastroenterology. Can J Gastroenterol. 2004 Dec;18(12):735-42. doi: 10.1155/2004/474232.
citation: Baldassano R, Ferry G, Griffiths A, Mack D, Markowitz J, Winter H. Transition of the patient with inflammatory bowel disease from pediatric to adult care: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2002 Mar;34(3):245-8. doi: 10.1097/00005176-200203000-00001. No abstract available.
citation: Scal P, Evans T, Blozis S, Okinow N, Blum R. Trends in transition from pediatric to adult health care services for young adults with chronic conditions. J Adolesc Health. 1999 Apr;24(4):259-64. doi: 10.1016/s1054-139x(98)00127-x.
citation: Dabadie A, Troadec F, Heresbach D, Siproudhis L, Pagenault M, Bretagne JF. Transition of patients with inflammatory bowel disease from pediatric to adult care. Gastroenterol Clin Biol. 2008 May;32(5 Pt 1):451-9. doi: 10.1016/j.gcb.2008.01.044. Epub 2008 May 8.
citation: Hait EJ, Barendse RM, Arnold JH, Valim C, Sands BE, Korzenik JR, Fishman LN. Transition of adolescents with inflammatory bowel disease from pediatric to adult care: a survey of adult gastroenterologists. J Pediatr Gastroenterol Nutr. 2009 Jan;48(1):61-5. doi: 10.1097/MPG.0b013e31816d71d8.
citation: Greenley RN, Stephens M, Doughty A, Raboin T, Kugathasan S. Barriers to adherence among adolescents with inflammatory bowel disease. Inflamm Bowel Dis. 2010 Jan;16(1):36-41. doi: 10.1002/ibd.20988.