View Clinical Trial (Medical Research Study)
Improving the Transition of Care From Pediatric GI to Adult GI for Patients With IBD: A Prospective Randomized Trial of a New Model
| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37232 |
| Conditions: |
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Inflammatory Bowel Diseases - Crohn's Disease - Ulcerative Colitis |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
2. Does not meet inclusion criteria above.
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| NCT ID: |
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NCT00360022 |
| Primary Contact: |
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Principal Investigator
David A Schwartz, M.D.
Vanderbilt University
Tonya F Givens, BSN
Phone: 615-936-1745
Email: tonya.givens@vanderbilt.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Nashville, Tennessee 37232
United States
Tonya F Givens, BSN, RN
Phone: 615-936-1745
Email: tonya.givens@vanderbilt.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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