Factors Associated With in Suboptimal Prescribing for Older Patients With Epilepsy (TIGER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00144001
First received: August 31, 2005
Last updated: April 25, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Type of Antiepileptic drug prescribed for individuals with new onset epilepsy [ Time Frame: Within one year of first epilepsy diagnosis ] [ Designated as safety issue: No ]

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)

Detailed Description:

OBJECTIVE(S):

  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.

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
Study Population

Older veterans (66 years and older) with a new diagnosis of epilepsy between 2000-2004

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:

No VA pharmacy data the year prior to epilepsy diagnosis

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144001

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
Sponsors and Collaborators
Investigators
Principal Investigator: Mary Jo Pugh, PhD RN VA South Texas Health Care System, San Antonio
  More Information

Publications:
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: 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: April 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Epilepsy
Pharmacoepidemiology
Quality of Care
Outcomes

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014