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

NCT02085083 | Completed

• 1 other identifier: IMPACT-IBD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Inflammatory Bowel Disease; Crohn Disease; Colitis, Ulcerative

Keywords

Inflammatory Bowel Disease; Transition; Adolescent; Chronic Disease; Colitis, Ulcerative

Outcome Measures

Primary Outcomes (4)

• 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).

• 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).

• 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.

• 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 Outcomes (3)

• Change in Quality of Life

  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).

• Change in Disease Activity

  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).

• Change in Knowledge of Disease

  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).

Study Arms (2)

Regular telephone and email access to an IBD Nurse

EXPERIMENTAL

The IBD pediatric-adult transition nurse will send an email to each individual randomized to the intervention arm each month. The email will include the following: Brief Questionnaire;The Option For Direct Nurse Contact; Educational modules; MyHealth Passport and a Comprehensive Study Questionnaire.

Behavioral: Telephone and email correspondence with an Inflammatory Bowel Disease Nurse

Minimal Intervention

ACTIVE COMPARATOR

The IBD pediatric-adult transition nurse will send an email to each individual randomized to the control arm every 3 months. The email will include the following: MyHealth Passport and Study Questionnaire. This intervention is not expected to significantly improve outcomes.

Behavioral: Minimal Intervention Arm

Interventions

Telephone and email correspondence with an Inflammatory Bowel Disease Nurse BEHAVIORAL

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.

Regular telephone and email access to an IBD Nurse

Minimal Intervention Arm BEHAVIORAL

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.

Minimal Intervention

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (3)

McMaster University Medical Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (7)

• 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.

  PMID: 22677118 BACKGROUND

• 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.

  PMID: 15605138 BACKGROUND

• 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.

  PMID: 11964946 BACKGROUND

• 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.

  PMID: 10227345 BACKGROUND

• 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.

  PMID: 18472377 BACKGROUND

• 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.

  PMID: 19172125 BACKGROUND

• 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.

  PMID: 19434722 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Chronic Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Geoffrey Nguyen, MD, PhD

  Mount Sinai Hospital, Canada

  PRINCIPAL INVESTIGATOR

• Anne Griffiths, MD

  The Hospital For Sick Children, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: March 12, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)