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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by (Responsible Party): | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00144001 |
Purpose
Nearly 2% of veterans >65 are actively treated for epilepsy, and the incidence is projected to increase with the aging of our society. Since commonly used antiepileptic drugs are considered suboptimal for older patients, it is important to understand existing patterns of treatment for older veterans with epilepsy.
| Condition |
|---|
|
Epilepsy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Appropriateness of Antiepileptic Drug Use for Older Veterans |
| Enrollment: | 9682 |
| Study Start Date: | October 2000 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
OBJECTIVE(S):
METHODS:
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.
RESULTS:
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.
IMPACT:
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.
Eligibility| Ages Eligible for Study: | 66 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Older veterans (66 years and older) with a new diagnosis of epilepsy between 2000-2004
Inclusion Criteria:
Veterans 66 years and older receiving care from the Veterans Health Administration between fiscal years 2000-2004 Diagnosis of epilepsy and receiving anticonvulsant drugs
Exclusion Criteria:
No VA pharmacy data the year prior to epilepsy diagnosis
Contacts and Locations| United States, Massachusetts | |
| VA New England Health Care System | |
| Bedford, Massachusetts, United States, 01730 | |
| United States, Texas | |
| VA South Texas Health Care System | |
| San Antonio, Texas, United States, 78229-5700 | |
| Principal Investigator: | Mary Jo Pugh, PhD RN | VA South Texas Health Care System, San Antonio |
More Information
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00144001 History of Changes |
| Other Study ID Numbers: | IIR 02-274 |
| Study First Received: | August 31, 2005 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Federal Government |
|
Epilepsy Pharmacoepidemiology Quality of Care Outcomes |
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |