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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
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease

Detailed Description:


  1. Identify patient, provider, and system factors predicting adoption of recommended AEDs for treatment of newly diagnosed older veterans (FY00-04).
  2. Identify barriers to use of recommended AED in initial therapy for newly diagnosed older veterans with epilepsy.
  3. 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
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Group 1

Primary Outcome Measures :
  1. Type of Antiepileptic drug prescribed for individuals with new onset epilepsy [ Time Frame: Within one year of first epilepsy diagnosis ]

Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

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
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Mary Jo Pugh, PhD RN South Texas Health Care System, San Antonio, TX

Van Cott AC, Pugh MJ. Epilepsy and the elderly. Annals of Long-Term Care: Clinical Care and Aging. 2008 Jan 1; 16(1):28-32.

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00144001     History of Changes
Other Study ID Numbers: IIR 02-274
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: September 2008

Keywords provided by VA Office of Research and Development:
Quality of Care

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases