Factors Associated With in Suboptimal Prescribing for Older Patients With Epilepsy (TIGER)
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|ClinicalTrials.gov Identifier: NCT00144001|
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : April 7, 2015
|Condition or disease|
- Identify patient, provider, and system factors predicting adoption of recommended AEDs for treatment of newly diagnosed older veterans (FY00-04).
- Identify barriers to use of recommended AED in initial therapy for newly diagnosed older veterans with epilepsy.
- Assess and compare effectiveness of long-term use of various AED.
Using existing national VA outpatient, inpatient, and pharmacy databases in conjunction with Medicare inpatient and outpatient standard analytic files, the 1999 National Health Survey of VA Enrollees, American Hospital Association data, and primary data collection, we will identify the extent to which treatment for older veterans newly diagnosed with epilepsy changed between FY00-FY04, and identify predictors of change at the patient, provider, and system levels. We will begin to identify barriers to use of recommended AED using structured interviews with primary care and general neurology providers in sites with high and low use of suboptimal AEDs in incident cases. Finally, we will compare hospitalizations, emergency room visits, and fall-related injuries (including fractures) for patients on different AED regimens.
We have identified 72,638 patients who are at least 66 years of age, have a diagnosis of epilepsy in VA or Medicare files, and who also received AEDs from the VA; 9,682 of of these are incident cases, 41,867 are chronic cases, and 21,089 have been defined as having unknown onset. We found wide variations in prescribing, an high rates of use of suboptimal AEDs (70%). We identified sites with high and low use of suboptimal and new AEDs. We have finalized provider interview protocols, and are in the process of gaining approval at individual sites.
The proposed study will enhance understanding of factors associated with adoption of clinical recommendations for newly diagnosed older patients with epilepsy, begin to identify barriers to their adoption, and assess outcomes of epilepsy patients on chronic AED therapy. This study will provide the foundation on which to develop interventions to improve care and will improve the quality of care for older veterans diagnosed with epilepsy.
|Study Type :||Observational|
|Actual Enrollment :||9682 participants|
|Official Title:||Appropriateness of Antiepileptic Drug Use for Older Veterans|
|Study Start Date :||October 2000|
|Primary Completion Date :||September 2004|
|Study Completion Date :||September 2008|
- Type of Antiepileptic drug prescribed for individuals with new onset epilepsy [ Time Frame: Within one year of first epilepsy diagnosis ]
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): NCT00144001
|United States, Massachusetts|
|Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA|
|Bedford, Massachusetts, United States, 01730|
|United States, Texas|
|South Texas Health Care System, San Antonio, TX|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Mary Jo Pugh, PhD RN||South Texas Health Care System, San Antonio, TX|