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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inflammatory Bowel Disease Crohn Disease Colitis, Ulcerative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Regular telephone and email access to an IBD Nurse

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.

Group Type EXPERIMENTAL

Telephone and email correspondence with an Inflammatory Bowel Disease Nurse

Intervention Type 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.

Minimal Intervention

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.

Group Type ACTIVE_COMPARATOR

Minimal Intervention Arm

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No