Clinical Trial: Patient, Provider, and Healthcare System Factors Associated with in Suboptimal Prescribing for Older Patients with Epilepsy

This study is currently recruiting patients.
Verified by Department of Veterans Affairs August 2005

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00144001

Purpose

The past decade has witnessed a change in recommendations for epilepsy treatment due to findings from randomized clinical trials and the development of new antiepileptic drugs (AEDs). Early VA Cooperative Studies examining AEDs demonstrated that phenobarbital is unequivocally a suboptimal drug, but is particularly problematic for the elderly. The synthesis of clinical trials and clinical experience resulted in both systematically derived guidelines and informal consensus reports identifying phenytoin as a second-line AED for treating older patients newly diagnosed with epilepsy. Instead, carbamazepine, valproate, and newly developed AEDs (lamotrigine, gabapentin, and oxcarbazepine) are considered more appropriate first-line alternatives due to their equal efficacy and more favorable adverse effect profiles in elderly patients. Consistent recommendations to avoid phenytoin in the elderly suggest that it is important to determine the state of treatment for these patients in the VA. Our pilot work indicates that 68% of older veterans newly diagnosed with epilepsy receive phenytoin, and that 10% receive phenobarbital despite its increased potential for adverse effects. Nearly 2% of veterans >65 are actively treated for epilepsy, and the incidence is projected to increase with the aging of our society. Thus it is important to understand existing patterns of treatment for older veterans with epilepsy.
Condition Intervention Phase
Epilepsy
 Drug: Phenytoin
 Drug: Phenobarbital
 Drug: Carbamazepine
 Drug: Valproate
 Drug: Gabapentin
 Drug: Lamotrigine
 Drug: topiramate
 Drug: levetiracitam
 Drug: oxcarbazepine
 Drug: Zonisamide
Phase IV

MedlinePlus related topics:  Epilepsy

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Retrospective Study

Official Title: Effectiveness of Antiepileptic Drugs for Older Veterans: Old and New Drugs

Further Study Details: 

Expected Total Enrollment:  30000

Study start: October 2000;  Expected completion: June 2008
Last follow-up: September 2004;  Data entry closure: June 2006

Background:

The past decade has witnessed a change in recommendations for epilepsy treatment due to findings from randomized clinical trials and the development of new antiepileptic drugs (AEDs). Early VA Cooperative Studies examining AEDs demonstrated that phenobarbital is unequivocally a suboptimal drug, but is particularly problematic for the elderly. The synthesis of clinical trials and clinical experience resulted in both systematically derived guidelines and informal consensus reports identifying phenytoin as a second-line AED for treating older patients newly diagnosed with epilepsy. Instead, carbamazepine, valproate, and newly developed AEDs (lamotrigine, gabapentin, and oxcarbazepine) are considered more appropriate first-line alternatives due to their equal efficacy and more favorable adverse effect profiles in elderly patients. Consistent recommendations to avoid phenytoin in the elderly suggest that it is important to determine the state of treatment for these patients in the VA. Our pilot work indicates that 68% of older veterans newly diagnosed with epilepsy receive phenytoin, and that 10% receive phenobarbital despite its increased potential for adverse effects. Nearly 2% of veterans greater than 65 are actively treated for epilepsy, and the incidence is projected to increase with the aging of our society. Thus it is important to understand existing patterns of treatment for older veterans with epilepsy.

Objectives:

Using the framework developed by the Quality Enhancement Research Initiative (QUERI) this study will provide a major contribution to understanding optimal treatment of elderly patients with epilepsy by using national VA data in conjunction with Medicare data to address three objectives.

Objective 1: Identify patient, provider, and system factors predicting adoption of recommended AEDs for treatment of newly diagnosed older veterans (FY00-04).

Objective 2: Identify barriers to use of recommended AED in initial therapy for newly diagnosed older veterans with epilepsy.

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 (age, sex, race, disease burden), provider (specialty vs. primary care), and system (formulary restrictions) levels. We will use semi-structured interviews of primary care, neurology and emergency room providers to begin to identify barriers to use of recommended AED using qualitative and survey methods.

Findings:

No results at this time.

Status:

Project start date: July 1, 2005. We are in the process of obtaining pharmacy and Medicare data.

Impact:

The proposed study will enhance understanding of factors associated with adoption of clinical recommendations for newly diagnosed older patients with epilepsy, and will begin to identify barriers to their adoption. This aspect of the study will provide the foundation on which to develop interventions to improve care. The proposed study will also develop a foundation for research examining outcomes for patients with epilepsy. Ultimately, these efforts will improve the quality of care for older veterans diagnosed with epilepsy.

Eligibility

Ages Eligible for Study:  66 Years and above,  Genders Eligible for Study:  Both
Criteria

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:

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00144001


Massachusetts
      VA New England Health Care System, Bedford,  Massachusetts,  01730,  United States; Recruiting
Mary Jo V Pugh, PhD RN  210-617-5368    mjpugh@verdict.uthscsa.edu 
Dan R. Berlowitz, MD MPH,  Sub-Investigator

Texas
      VA South Texas Health Care System, San Antonio, San Antonio,  Texas,  78229,  United States; Recruiting
Mary Jo V Pugh, PhD RN  210-617-5368    mjpugh@verdict.uthscsa.edu 
Mary Jo V Pugh, PhD RN,  Principal Investigator

Study chairs or principal investigators

Mary Jo V Pugh, PhD RN,  Principal Investigator,  VA South Texas Health Care System, San Antonio   

More Information

Study ID Numbers:  IIR 02-274
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00144001
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-06

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