Transition of Inflammatory Bowel Disease (IBD) Patients From Pediatric to Adult Gastroenterologist (GI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00360022|
Recruitment Status : Terminated (problems with subject accrual)
First Posted : August 3, 2006
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Diseases Crohn's Disease Ulcerative Colitis||Other: Joint visits||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Actual Study Start Date :||August 2006|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Experimental: 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.
Other: 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.
No Intervention: Control
Transition patients in the control group will transfer care to adult GI provider in typical manner.
- Decrease IBD flare at 1 year [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360022
|United States, Tennessee|
|The Vanderbilt Clinic|
|Nashville, Tennessee, United States, 37232-5280|
|Vanderbilt Childrens Hospital/ Pediatric Gastroenterology Clinic|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||David A Schwartz, M.D.||Vanderbilt University|