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OpenTrials
Completed

NCT Number: NCT00144001

Factors Associated With in Suboptimal Prescribing for Older Patients With Epilepsy

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.

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Key information

Age range

66 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, Bedford, Massachusetts, United States

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About this study

OBJECTIVE(S):

  • 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Type of Antiepileptic drug prescribed for individuals with new onset epilepsy

    Time frame: Within one year of first epilepsy diagnosis

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Appropriateness of Antiepileptic Drug Use for Older Veterans

Acronym: TIGER

Important dates

Study start
2000
Primary completion
2004
Study completion
2008
First posted
Sep 2, 2005
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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