Improving OutcoMes in the Pediatric to Adult Care Transition in Inflammatory Bowel Disease

Crohn Disease Clinical Trial

— IMPACT-IBD  

Official title:

Improving OutcoMes in the Pediatric to Adult Care Transition in Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085083
• Other study ID #: IMPACT-IBD
• Status: Completed
• Phase: N/A
• First received: December 23, 2013
• Last updated: April 14, 2018
• Start date: July 2014
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer

Intervention

Behavioral:
• Telephone and email correspondence with an Inflammatory Bowel Disease Nurse
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.
• Minimal Intervention Arm
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.

Locations

Country	Name	City	State
Canada	McMaster University Medical Center	Hamilton	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children (SickKids)	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Crohn's and Colitis Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Satisfaction	A comprehensive study questionnaire containing the CACHE questionnaire will be administered to assess patient satisfaction.; Reference: Casellas F, Ginard D, Vera I, Torrejón A. Development and testing of a new instrument to measure patient satisfaction with health care in inflammatory bowel disease: the CACHE questionnaire. Inflamm Bowel Dis. 2013 Mar;19(3):559-68.	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).
Primary	Change in Medication Adherence	Medication adherence will be assessed with a comprehensive study questionnaire containing the Morisky questionnaire.; Reference: Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986;24:67-74.	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).
Primary	Change in Non-Routine Healthcare Utilization	IBD related clinic visits, admissions to hospital, emergency department visits, endoscopy and operative procedures, imaging procedures will all be recorded via telephone interview with the patient and also via linkage to the Institute of Clinical and Evaluative Sciences Databases which record health claims by Ontario residents . The date of transfer of care to an adult gastroenterologist will be recorded as well as any continuing appointments with a pediatric gastroenterologist beyond the transfer date.	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.
Primary	Change in Transition Readiness	The Transition Readiness Assessment Questionnaire will be administered.; Reference: Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71.	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	Change in Quality of Life	Health Related Quality of Life will be monitored by the Inflammatory Bowel Disease Questionnaire (IBDQ) validated in IBD patients.; Reference: Inflammatory Bowel Disease Questionnaire - Guyatt G, Mitchell A, Irvine EJ, Singer J, Williams N, Goodacre R, Tompkins C. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology. 1989;96:804-10.	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).
Secondary	Change in Disease Activity	Disease activity will be monitored using the Harvey Bradshaw Index (HBI) for Crohn's Disease related disease activity and the Ulcerative Colitis Disease Activity Index (UCDAI) for UC-related disease activity; References: Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980;315(8167):514.; Sutherland LR, Martin F, Greer S, Robinson M, Greenberger N, Saibil F, Martin T, Sparr J, Prokipchuk E, Borgen L: 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology 1987, 92:1894-8.	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).
Secondary	Change in Knowledge of Disease	The Crohn's and Colitis Knowledge Questionnaire will be used to assess IBD specific knowledge.; Reference: Eaden JA, Abram K, Mayberry JF. The Crohn's and colitis knowledge score: a test for measuring patient knowledge in inflammatory bowel disease. Am J Gastroenterol; 1999: 94(12):3560 - 3566.	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).