Transition of Inflammatory Bowel Disease (IBD) Patients From Pediatric to Adult Gastroenterologist (GI)

NCT ID: NCT00360022

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2011-02-28

Brief Summary

The purpose of this study is to determine if the program that has been made to ease the transition of care for adolescent patients with IBD from pediatric gastroenterology to adult gastroenterology is effective to reduce the risk of disease flare during this period. Patient satisfaction with this program will also be assessed.

Detailed Description

Approximately 15 to 25% of patients with inflammatory bowel disease are diagnosed prior to the age of 18. The chronic course of this disease means that approximately one quarter of all IBD patients will need to transition from being cared for by a pediatric gastroenterologist to an adult gastroenterologist. Studies in other chronic disease states have identified several problems with the current means of transitioning care from a pediatrician to the adult caregiver including lack of adherence with the proposed treatment, lack of knowledge about the disease, and limited self-care skills. Even without IBD, this can be a time of tremendous turmoil for the adolescent patient. For the chronically ill IBD patient, this stress is further intensified by the underlying illness. Several studies have shown that the risk of flare is increased by non-adherence with medical treatment. The main factors associated with poor adherence include young age and either being under the doctor's care for less than one year or being a new patient for that doctor. Therefore, young adults transferring care from a pediatric gastroenterologist to an adult gastroenterologist are at the highest risk for a bad outcome.

Several recommendations have been published on how to best transition the adolescent IBD patient from pediatric to adult care. The general consensus is that there should be a gradual age specific increase in patient autonomy and involvement in their care prior to being transitioned to an adult gastroenterologist. No study however has incorporated combined clinic visits for the patient with both the pediatric and adult IBD specialist. Furthermore, although these recommendations make logical sense, they have not been assessed objectively.

Conditions

Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Joint Visits

Transition patients will have 2 joint visits performed with the pediatric GI specialist and the adult GI specialist as they transfer care to an adult GI provider.

Group Type: EXPERIMENTAL

Joint visits

Intervention Type: OTHER

Both the pediatric GI specialist and the adult GI specialist will see the patient together at 2 different visits. The first joint visit is lead by the pediatric MD and the second joint visit is lead by the adult MD.

Control

Transition patients in the control group will transfer care to adult GI provider in typical manner.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Joint visits

Both the pediatric GI specialist and the adult GI specialist will see the patient together at 2 different visits. The first joint visit is lead by the pediatric MD and the second joint visit is lead by the adult MD.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

A patient may be considered for study participation if all of the following apply:

1. Outpatient of either sex aged ≥ 16 years or older.

2. The patient has a confirmed diagnosis of IBD.

3. No plans to move > 200 miles from Nashville in the subsequent 12 months.

4. The patient has read, understood and signed a written informed consent form. Permission of a minor participant will be obtained via a parent consent form.

Exclusion Criteria

The patients will be excluded from the study if one or more of the following apply:

1. Unable to give consent.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Schwartz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A Schwartz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

The Vanderbilt Clinic

Nashville, Tennessee, United States

Vanderbilt Childrens Hospital/ Pediatric Gastroenterology Clinic

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

060580

Identifier Type: -

Identifier Source: org_study_id