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

Primary Purpose

Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Joint visits
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammatory Bowel Diseases

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A patient may be considered for study participation if all of the following apply: Outpatient of either sex aged ≥ 16 years or older. The patient has a confirmed diagnosis of IBD. No plans to move > 200 miles from Nashville in the subsequent 12 months. 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: Unable to give consent. Does not meet inclusion criteria above.

Sites / Locations

  • The Vanderbilt Clinic
  • Vanderbilt Childrens Hospital/ Pediatric Gastroenterology Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Joint Visits

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Decrease IBD flare at 1 year

Secondary Outcome Measures

Full Information

First Posted
August 2, 2006
Last Updated
April 1, 2017
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00360022
Brief Title
Transition of Inflammatory Bowel Disease (IBD) Patients From Pediatric to Adult Gastroenterologist (GI)
Official Title
Improving the Transition of Care From Pediatric GI to Adult GI for Patients With IBD: A Prospective Randomized Trial of a New Model
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
problems with subject accrual
Study Start Date
August 2006 (Actual)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Joint Visits
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Transition patients in the control group will transfer care to adult GI provider in typical manner.
Intervention Type
Other
Intervention Name(s)
Joint visits
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease IBD flare at 1 year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A patient may be considered for study participation if all of the following apply: Outpatient of either sex aged ≥ 16 years or older. The patient has a confirmed diagnosis of IBD. No plans to move > 200 miles from Nashville in the subsequent 12 months. 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: Unable to give consent. Does not meet inclusion criteria above.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Schwartz, M.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Vanderbilt Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5280
Country
United States
Facility Name
Vanderbilt Childrens Hospital/ Pediatric Gastroenterology Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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