Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2008 |
| End Date: | September 2017 |
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.
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.
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.
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.
Inclusion Criteria:
- Veteran
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