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Factors Associated With in Suboptimal Prescribing for Older Patients With Epilepsy (TIGER)
This study has been completed.

First Received on August 31, 2005.   Last Updated on January 27, 2012   History of Changes
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

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)
Groups/Cohorts
1

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
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, 78229-5700
Sponsors and Collaborators
Investigators
Principal Investigator: Mary Jo Pugh, PhD RN VA South Texas Health Care System, San Antonio
  More Information

Publications:
Pugh MJ, Copeland LA, Zeber JE, Cramer JA, Amuan ME, Cavazos JE, Kazis LE. The impact of epilepsy on health status among younger and older adults. Epilepsia. 2005 Nov;46(11):1820-7.
Pugh MJ, Foreman PJ, Berlowitz DR. Prescribing antiepileptics for the elderly: differences between guideline recommendations and clinical practice. Drugs Aging. 2006;23(11):861-75. Review.
Berlowitz DR, Pugh MJ. Pharmacoepidemiology in community-dwelling elderly taking antiepileptic drugs. Int Rev Neurobiol. 2007;81:153-63. Review.
Pugh MJ, Berlowitz DR, Kazis L. The impact of epilepsy on older veterans. Int Rev Neurobiol. 2007;81:221-33.
Zeber JE, Copeland LA, Amuan M, Cramer JA, Pugh MJ. The role of comorbid psychiatric conditions in health status in epilepsy. Epilepsy Behav. 2007 Jun;10(4):539-46. Epub 2007 Apr 6.
Pugh MJ, Berlowitz DR, Montouris G, Bokhour B, Cramer JA, Bohm V, Bollinger M, Helmers S, Ettinger A, Meador KJ, Fountain N, Boggs J, Tatum WO 4th, Knoefel J, Harden C, Mattson RH, Kazis L. What constitutes high quality of care for adults with epilepsy? Neurology. 2007 Nov 20;69(21):2020-7. Epub 2007 Oct 10. Review.
Pugh MJ, Zeber JE, Copeland LA, Tabares JV, Cramer JA. Psychiatric disease burden profiles among veterans with epilepsy: the association with health services utilization. Psychiatr Serv. 2008 Aug;59(8):925-8.
Pugh MJ, Van Cott AC, Cramer JA, Knoefel JE, Amuan ME, Tabares J, Ramsay RE, Berlowitz DR; Treatment In Geriatric Epilepsy Research (TIGER) team. Trends in antiepileptic drug prescribing for older patients with new-onset epilepsy: 2000-2004. Neurology. 2008 May 27;70(22 Pt 2):2171-8.
Pugh MJ, Knoefel JE, Mortensen EM, Amuan ME, Berlowitz DR, Van Cott AC. New-onset epilepsy risk factors in older veterans. J Am Geriatr Soc. 2009 Feb;57(2):237-42.
Hope OA, Zeber JE, Kressin NR, Bokhour BG, Vancott AC, Cramer JA, Amuan ME, Knoefel JE, Pugh MJ. New-onset geriatric epilepsy care: Race, setting of diagnosis, and choice of antiepileptic drug. Epilepsia. 2008 Nov 17; [Epub ahead of print]
VanCott AC, Cramer JA, Copeland LA, Zeber JE, Steinman MA, Dersh JJ, Glickman ME, Mortensen EM, Amuan ME, Pugh MJ. Suicide-related behaviors in older patients with new anti-epileptic drug use: data from the VA hospital system. BMC Med. 2010 Jan 11;8:4.
Ettinger AB, Copeland LA, Zeber JE, Van Cott AC, Pugh MJ. Are psychiatric disorders independent risk factors for new-onset epilepsy in older individuals? Epilepsy Behav. 2010 Jan;17(1):70-4. Epub 2009 Nov 12.
Pugh MJ, Vancott AC, Steinman MA, Mortensen EM, Amuan ME, Wang CP, Knoefel JE, Berlowitz DR. Choice of initial antiepileptic drug for older veterans: possible pharmacokinetic drug interactions with existing medications. J Am Geriatr Soc. 2010 Mar;58(3):465-71.
Zeber JE, Copeland LA, Pugh MJ. Variation in antiepileptic drug adherence among older patients with new-onset epilepsy. Ann Pharmacother. 2010 Dec;44(12):1896-904. Epub 2010 Nov 2.
Pugh MJ, Berlowitz DR, Rao JK, Shapiro G, Avetisyan R, Hanchate A, Jarrett K, Tabares J, Kazis LE. The quality of care for adults with epilepsy: an initial glimpse using the QUIET measure. BMC Health Serv Res. 2011 Jan 3;11:1.
Copeland LA, Ettinger AB, Zeber JE, Gonzalez JM, Pugh MJ. Psychiatric and medical admissions observed among elderly patients with new-onset epilepsy. BMC Health Serv Res. 2011 Apr 19;11:84.
Pugh MJ, Tabares J, Finley E, Bollinger M, Tortorice K, Vancott AC. Changes in antiepileptic drug choice for older veterans with new-onset epilepsy: 2002 to 2006. J Am Geriatr Soc. 2011 May;59(5):955-6. No abstract available.

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

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 February 09, 2012