Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00657787 |
| Other study ID # |
PT075235 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2008 |
| Est. completion date |
September 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Boston VA Research Institute, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The overall objective of this project is to develop the first longitudinal registry of
combat-exposed men and women with PTSD. This registry will provide essential data on the
natural history, including progression and remission, and outcomes associated with PTSD in
military service men and women who have utilized the Department of Veterans Affairs (VA)
health care system. Additional goals of this project are to determine risk factors for PTSD
among combat-exposed service men and women (by incorporating a combat-exposed non-PTSD group
of veterans into analyses), and to assess the joint effects of combat exposure and PTSD on a
broad range of outcome measures (by incorporating a non-combat-exposed group of veterans into
analyses). Thus, the registry will allow an evaluation of current theoretical models of
symptom development and progression in a large sample of service men and women who utilize
the VA medical system.
In addition to the PTSD registry, we will collect information on two comparison groups of
OIF/OEF-era veterans to conduct nested case control studies within the general VA health care
utilization database. First, a comparison group of combat veterans who are high utilizers of
VA medical care, but who have not received a diagnosis of PTSD will be identified. This group
will be used in analyses to identify risk factors for PTSD. Additionally, the rate of PTSD
symptoms will be evaluated in this comparison group to estimate the prevalence of missed PTSD
diagnoses among combat veterans with high rates of service utilization, and the resulting
impact on utilization and outcomes. A second comparison group will consist of veterans with
similar service record and demographic backgrounds, who were not deployed to the OIF/OEF war
zones. Thus, the proposed project will create a PTSD registry from the VA database to assess
the natural history and progression of PTSD in combat veterans from OIF/OEF and also to
conduct case-control studies nested within the VA database. The case-control comparisons will
be used to evaluate key hypotheses related to the specific aims of the overall project.
Description:
This project will be designed to address a range of research questions within the registry
itself, as well as in the comparisons with non-registry groups. Specific aims of this project
can be divided into the following major research areas.
1. Epidemiology of PTSD Aim 1. To evaluate the natural history of PTSD, including
progression and remission of symptoms over time, and the long-term psychosocial, medical
and quality of life outcomes associated with the disorder Aim 2. To identify predictors
of recovery or remission from PTSD, including treatment utilization, psychiatric and
medical comorbidities, and sociodemographic factors Aim 3. To identify clinical
characteristics, risk factors and comorbidities of PTSD, including disparities by
gender, race/ethnicity, social support, and socioeconomic status, by comparing PTSD
patients to a "control" group of veterans without PTSD
2. PTSD Treatment and Outcomes Aim 4. To identify current treatment approaches and outcomes
of treatment through time, particularly among service members who are often excluded
from clinical trials due to comorbidities and therefore remain unexamined and possibly
under-treated Aim 5. To estimate the joint effects of combat exposure and PTSD on
long-term psychosocial well-being and quality of life measures, by comparing PTSD
patients to a "control" group of veterans who were not deployed to combat/war zones
during the same time period
3. Health Services Research Aim 6. To establish the prevalence of PTSD in a comparison
group of service men and women who had not received the PTSD diagnosis in their patient
record but are high utilizers of the VA medical system, and to identify risk factors for
missed PTSD diagnoses Aim 7. To provide data that are immediately useful for determining
future health services policy, costs, and needs for upcoming research, manpower and
training, by assessing current referral and utilization patterns. Both direct and
indirect (e.g., productivity loss, pharmacological burden) costs of treatment will be
assessed Aim 8. To develop a large database of servicemen and women with PTSD and
network of treatment sites that are potentially available for further observational and
interventional studies, as well as concurrent ancillary studies, such as qualitative
studies on caregiver/family burden.
The proposed project will be conducted in three phases over three years using both existing
data from the VA medical record database and prospective data to be collected by a structured
interview in the third phase of the study, as well as periodic data transfers from the
medical records. During the first phase (months 1-9), the data de-identification procedures
for the study will be pre-tested (months 1-2), the data will be prepared for abstraction
(months 2-4), and the study protocol and research interview will be reviewed and finalized
(months 6-9). During Phase II (months 4-12), the preliminary PTSD database will be created by
data transfer (month 4), query reports/resolutions (month 5). Also during this phase,
analyses of existing data extracted from the VA medical record system will be conducted
(months 10-12) and target cohorts for follow-up assessment will be identified. Phase III
(months 12-36) will include subject recruitment for the PTSD registry and two comparison
groups, and the structured telephone interviews will be conducted in all three groups (months
12-24). Data collected in the telephone interview will be coded, de-identified and merged
with the overall study database. Analyses will be conducted during this phase (months 24-36)
related to the Specific Aims of the study. The PTSD registry database will be updated as new
VA electronic medical records for registry participants appear during the course of this
project, thereby capturing the trajectory of PTSD patients.
Participants and Sampling Strategy The source of participants will be the VA in/outpatient
electronic medical records of all new utilizers of the VA medical system from FY 2002 through
2007. According to data from the DOD Defense Manpower Data Center (DMDC) received by the VA
Environmental Epidemiology Service (EES) on April 17, 2007, from FY 2002 through February
2007, there had been a total of 717,196 unique OIF/OEF veterans (excluding 3,303 who died in
theater) who had been separated from active duty following deployment, and were therefore
eligible for VA benefits. Of these, 252,095 (35%) had obtained VA health care by March 2007.
More recent healthcare data through September 2007 indicate that 263,909 individuals have
accessed VA health care. The VA health administrative database rigorously records all
in-patient and out-patient visits, and includes basic information regarding each visit, such
as the patient name, SSN, DOB, gender, and ICD-9 diagnostic codes to describe the purpose of
the visit (EES database).
The overarching objective of this project-the creation of a PTSD registry-will be
accomplished by identifying male and female OIF/OEF veterans from the entire VA medical
records database of new utilizers with a diagnosis of PTSD (as defined by ICD-9 code 309.81)
in the electronic medical record. We will sample from the VA database to recruit participants
for a structured telephone interview to obtain details on exposures and outcomes of interest
that are not captured in the existing database. A sample of 800 PTSD patients with OIF/OEF
war zone experience, 400 patients without the PTSD diagnosis but with OIF/OEF experience and
high utilization of VA services, and 400 individuals matched by age, gender, race/ethnicity,
and year of entry into the VA EES database, who were not sent to the war zones of OIF/OEF
will be recruited to participate in the telephone interview. To be representative of all
veterans from the OIF/OEF era, the sampling will be stratified by year of entry into the VA
database.
Creation of the PTSD Registry Database Patient registries, as defined by the AHRQ and World
Health Organization, are organized systems containing information about individual persons,42
and the patient registry database is defined as a file (or files) derived from the registry.
A patient-based database is necessary to allow direct access to information on diagnoses of
interest and treatment outcomes, as well as to longitudinally track follow-up visits,
progress, and treatment courses.
In contrast to these criteria, the current database of utilizers of the VA healthcare system
is structured by chronological in-patient and out-patient visits, rather than unique patient
identifiers or diagnoses. Thus, with the existing database, there is no readily accessible
way to identify unique patients with PTSD or to assess their longitudinal outcomes and
utilization of VA healthcare. Therefore, a fundamental objective of this proposal is to
establish a registry of patients with PTSD from the existing VA utilization database.
Electronic medical records such as those in the VA database are increasingly important
sources of data, but data must be extracted, transformed into registry format, and loaded
into the registry, where they will reside in the registry database, together with
registry-specific data that is imported from other sources. The other sources of data for the
PTSD registry will be the OIF/OEF veteran roster (particularly for military specific data,
e.g., branch, rank, deployment dates, etc.) and, in Phase III, the proposed telephone
interview.
During Phase I of this project, a cumulative roster of unique OIF/OEF veterans who have been
separated from active duty following deployment and who have become eligible for VA
healthcare will be matched with VA inpatient (PTF) and outpatient (OPC) databases for fiscal
year (FY) 2004 through FY 2007. For identification of a potential PTSD patient, any veteran
patient with a diagnosis of ICD-9 CM, 308.81 will be selected. The PTSD registry will
encompass utilizers of the VA medical system. Each unique patient with a visit record
indicating a PTSD diagnosis will be included. The registry creation will involve a multi-step
process, including steps to identify all PTSD diagnoses, to identify unique patients within
the PTSD diagnoses, and to identify each additional visit made by each PTSD patient. For
identification of OIF/OEF veteran non-PTSD patients who are high VA healthcare users (sample
#2), we will review in/outpatient records of OIF/OEF veteran patients and identify those who
have been hospitalized or treated as outpatients more than 11 times during the post
deployment period. A similar step will be taken to identify a non-combat comparison group of
patients (sample #3). All veteran patients for three groups will be stratified by year of
first entry to VA healthcare data bases (FY 2004-2007) and equal number of veteran patients
will be randomly selected for each fiscal year for sample #1 and sample #2. For sample #3,
additional matching variables such as age, gender, and ethnicity/race will be used in
addition to the year of entry to VA healthcare databases. Ultimately, during Phase II, all
existing VA medical utilization data and OIF/OEF veterans' roster data for each veteran
patient will be merged and de-identified to ensure privacy and confidentiality.
During Phase III, data obtained from a telephone interview will be merged with the existing
data in the PTSD registry database. The PTSD registry will continue to be updated at 6-month
intervals during the course of this project as new or updated electronic medical records are
entered into the VA in/outpatient healthcare database for registry participants.
