EpilepsyTIGERNCT00144001
Factors Associated With in Suboptimal Prescribing for Older Patients With Epilepsy
An observational study of Epilepsy, run by US Department of Veterans Affairs at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 9,682 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2000to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older veterans (66 years and older) with a new diagnosis of epilepsy between 2000-2004
Who may be able to join
- Veterans 66 years and older receiving care from the Veterans Health Administration between fiscal years 2000-2004 Diagnosis of epilepsy and receiving anticonvulsant drugs
Who cannot join
- No VA pharmacy data the year prior to epilepsy diagnosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
About this study
Official title: Appropriateness of Antiepileptic Drug Use for Older Veterans
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.
Read the detailed description
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.
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Pharmacoepidemiology, Quality of Care, Outcomes
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of Antiepileptic drug prescribed for individuals with new onset epilepsy
Measured: Within one year of first epilepsy diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startOct 2000
- Primary completionSep 2004
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,682 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary Jo Pugh, PhD RN, Principal investigator, South Texas Health Care System, San Antonio, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144001
- Sponsor's protocol ID
- IIR 02-274
- Acronym
- TIGER
- Status last verified
- Sep 2008
- First submitted
- 31 Aug 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1345/aph.1P385. Epub 2010 Nov 2.
PubMed 21045168Pugh 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. doi: 10.1111/j.1532-5415.2011.03388.x. No abstract available.
PubMed 21568976Copeland 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. doi: 10.1186/1472-6963-11-84.
PubMed 21504584Pugh MJ, Starner CI, Amuan ME, Berlowitz DR, Horton M, Marcum ZA, Hanlon JT. Exposure to potentially harmful drug-disease interactions in older community-dwelling veterans based on the Healthcare Effectiveness Data and Information Set quality measure: who is at risk? J Am Geriatr Soc. 2011 Sep;59(9):1673-8. doi: 10.1111/j.1532-5415.2011.03524.x. Epub 2011 Aug 10.
PubMed 21831166Pugh 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. doi: 10.1186/1472-6963-11-1.
PubMed 21199575Brooks DR, Avetisyan R, Jarrett KM, Hanchate A, Shapiro GD, Pugh MJ, Berlowitz DR, Thurman D, Montouris G, Kazis LE. Validation of self-reported epilepsy for purposes of community surveillance. Epilepsy Behav. 2012 Jan;23(1):57-63. doi: 10.1016/j.yebeh.2011.11.002. Epub 2011 Dec 20.
PubMed 22189155VanCott 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. doi: 10.1186/1741-7015-8-4.
PubMed 20064226Ettinger 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. doi: 10.1016/j.yebeh.2009.10.010. Epub 2009 Nov 12.
PubMed 19913462Pugh 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. doi: 10.1111/j.1532-5415.2010.02732.x.
PubMed 20398114Pugh 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. doi: 10.1212/01.WNL.0000291947.29643.9f. Epub 2007 Oct 10.
PubMed 17928576Berlowitz DR, Pugh MJ. Pharmacoepidemiology in community-dwelling elderly taking antiepileptic drugs. Int Rev Neurobiol. 2007;81:153-63. doi: 10.1016/S0074-7742(06)81009-3.
PubMed 17433922Pugh MJ, Berlowitz DR, Kazis L. The impact of epilepsy on older veterans. Int Rev Neurobiol. 2007;81:221-33. doi: 10.1016/S0074-7742(06)81014-7.
PubMed 17433927Zeber 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. doi: 10.1016/j.yebeh.2007.02.008. Epub 2007 Apr 6.
PubMed 17416208Pugh 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. doi: 10.1111/j.1532-5415.2008.02124.x.
PubMed 19207140Hope 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. 2009 May;50(5):1085-93. doi: 10.1111/j.1528-1167.2008.01892.x. Epub 2008 Nov 17.
PubMed 19054416
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriateness of Antiepileptic Drug Use for Older Veterans
- ClinicalTrials.gov ID
- NCT00144001
- Acronym / sponsor ID
- TIGER / IIR 02-274
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Pharmacoepidemiology, Quality of Care, Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,682 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2000
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older veterans (66 years and older) with a new diagnosis of epilepsy between 2000-2004
Key inclusion criteria (1 listed)
- Veterans 66 years and older receiving care from the Veterans Health Administration between fiscal years 2000-2004 Diagnosis of epilepsy and receiving anticonvulsant drugs
Key exclusion criteria (1 listed)
- No VA pharmacy data the year prior to epilepsy diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type of Antiepileptic drug prescribed for individuals with new onset epilepsy
Time frame: Within one year of first epilepsy diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 21045168Zeber 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. doi: 10.1345/aph.1P385. Epub 2010 Nov 2.
- Results publication: PubMed 21568976Pugh 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. doi: 10.1111/j.1532-5415.2011.03388.x. No abstract available.
- Results publication: PubMed 21504584Copeland 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. doi: 10.1186/1472-6963-11-84.
- Results publication: PubMed 21831166Pugh MJ, Starner CI, Amuan ME, Berlowitz DR, Horton M, Marcum ZA, Hanlon JT. Exposure to potentially harmful drug-disease interactions in older community-dwelling veterans based on the Healthcare Effectiveness Data and Information Set quality measure: who is at risk? J Am Geriatr Soc. 2011 Sep;59(9):1673-8. doi: 10.1111/j.1532-5415.2011.03524.x. Epub 2011 Aug 10.
- Results publication: PubMed 21199575Pugh 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. doi: 10.1186/1472-6963-11-1.
- Results publication: PubMed 22189155Brooks DR, Avetisyan R, Jarrett KM, Hanchate A, Shapiro GD, Pugh MJ, Berlowitz DR, Thurman D, Montouris G, Kazis LE. Validation of self-reported epilepsy for purposes of community surveillance. Epilepsy Behav. 2012 Jan;23(1):57-63. doi: 10.1016/j.yebeh.2011.11.002. Epub 2011 Dec 20.
- Results publication: PubMed 20064226VanCott 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. doi: 10.1186/1741-7015-8-4.
- Results publication: PubMed 19913462Ettinger 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. doi: 10.1016/j.yebeh.2009.10.010. Epub 2009 Nov 12.
- Results publication: PubMed 20398114Pugh 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. doi: 10.1111/j.1532-5415.2010.02732.x.
- Results publication: PubMed 17928576Pugh 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. doi: 10.1212/01.WNL.0000291947.29643.9f. Epub 2007 Oct 10.
- Results publication: PubMed 17433922Berlowitz DR, Pugh MJ. Pharmacoepidemiology in community-dwelling elderly taking antiepileptic drugs. Int Rev Neurobiol. 2007;81:153-63. doi: 10.1016/S0074-7742(06)81009-3.
- Results publication: PubMed 17433927Pugh MJ, Berlowitz DR, Kazis L. The impact of epilepsy on older veterans. Int Rev Neurobiol. 2007;81:221-33. doi: 10.1016/S0074-7742(06)81014-7.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Jo Pugh, PhD RN principal investigator
South Texas Health Care System, San Antonio, TX
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of Antiepileptic drug prescribed for individuals with new onset epilepsy (time frame: Within one year of first epilepsy diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144001, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.