Transition Study of Inflammatory Bowel Disease (IBD) Patients From Pediatric Gastroenterologist to Adult Gastroenterologist
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Inflammatory Bowel Diseases Crohn's Disease Ulcerative Colitis |
Other: Transition program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| 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 |
- Decrease IBD flare at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: B
Group B transition patients will have 2 joint visits performed with the pediatric GI specialist and the adult GI specialist.
|
Other: Transition program
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.
|
|
No Intervention: A
Group A is control group who transfer care to adult GI provider in typical manner.
|
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Tonya F Givens, BSN | 615-936-1745 | tonya.givens@vanderbilt.edu |
| United States, Tennessee | |
| The Vanderbilt Clinic | Recruiting |
| Nashville, Tennessee, United States, 37232-5280 | |
| Contact: Tonya F Givens, BSN, RN 615-936-1745 tonya.givens@vanderbilt.edu | |
| Principal Investigator: David Schwartz, MD | |
| Vanderbilt Childrens Hospital/ Pediatric Gastroenterology Clinic | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Tonya F Givens, BSN, RN 615-936-1745 tonya.givens@vanderbilt.edu | |
| Sub-Investigator: Dedrick Moulton, MD | |
| Principal Investigator: | David A Schwartz, M.D. | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | David A. Schwartz MD / Principal Investigator, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00360022 History of Changes |
| Other Study ID Numbers: | 060580 |
| Study First Received: | August 2, 2006 |
| Last Updated: | July 14, 2011 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases Intestinal Diseases Ulcer |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013