Ignite Creation Date:
2024-05-06 @ 1:28 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01817712
Status:
COMPLETED
Last Update Posted:
2019-02-19
First Post:
2013-03-20
Brief Title:
Veterans Individual Placement and Support Towards Advancing Recovery
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 589 - Veterans Individual Placement and Support Towards Advancing Recovery
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIP-STAR
Brief Summary:
The primary objective of CSP589 VIP-STAR is to evaluate the effectiveness of Individual Placement Support IPS in unemployed Veterans with PTSD The primary hypothesis is that compared to those treated with transitional work program TWP unemployed Veterans with PTSD treated with IPS will be significantly more likely to become a steady worker A steady worker is defined as holding a competitive job for greater than or equal to 50 of the 18-month study follow-up period ie greater than or equal to 39 of the 78 weeks All participants will be followed for 18 months post-randomization
121412 Analytic plan augmented to allow for a sensitivity analysis of the primary outcome that would exclude the first 12 weeks post-randomization and evaluate between group proportion of steady worker status as defined by working in a competitive job for greater than or equal to 50 of the weeks during week 13-78
7113 Analysis plan has been augmented to include a logistic regression analysis of the primary outcome adjusted for participating medical center
10413 Addition of the IPS-25 Fidelity Scale The addition of the IPS-25 scale should increase the validity of study results
11515 Addition of an Interactive Voice RecognitionWeb-based IVRWeb System as an option for weekly data capture of the primary outcome data employment history
81715 Approval of Supplemental Data Collection at Participant Study Exit use of the data collected will supplement the study analysis plan and provide further insight into the impact of vocational rehab A Participant Satisfaction Survey will allow study participants to indicate their level of satisfaction with the study vocational rehabilitation intervention and suggestions for future research
121412 Analytic plan augmented to allow for a sensitivity analysis of the primary outcome that would exclude the first 12 weeks post-randomization and evaluate between group proportion of steady worker status as defined by working in a competitive job for greater than or equal to 50 of the weeks during week 13-78
7113 Analysis plan has been augmented to include a logistic regression analysis of the primary outcome adjusted for participating medical center
10413 Addition of the IPS-25 Fidelity Scale The addition of the IPS-25 scale should increase the validity of study results
11515 Addition of an Interactive Voice RecognitionWeb-based IVRWeb System as an option for weekly data capture of the primary outcome data employment history
81715 Approval of Supplemental Data Collection at Participant Study Exit use of the data collected will supplement the study analysis plan and provide further insight into the impact of vocational rehab A Participant Satisfaction Survey will allow study participants to indicate their level of satisfaction with the study vocational rehabilitation intervention and suggestions for future research
Detailed Description:
Posttraumatic stress disorder PTSD affects more than 600000 US Veterans and is the most common psychiatric condition for which Veterans seek VA disability benefits making up a substantial proportion of the 23 billion pensions and disability annual budget Although many Veterans with PTSD are college educated few have jobs almost 40 are impoverished and most report work role and social functioning scores below those of persons with serious mental illness Veterans returning from the Gulf War-era II conflicts defined as having served in the military since Sept 2001 often experience PTSD and confront unemployment upon their military discharge According to a March 2011 report from the US Department of Labor the 2010 unemployment rates were 115 for these Gulf War-era II Veterans 21 for service-connected disabled Gulf War-era II Veterans 13 for all service-connected Veterans of all eras combined and 94 for non Veterans The current methods used by the VA Compensated Work Therapy CWT programs do not sufficiently meet the employment rehabilitation needs of Veterans with PTSD In a VA Northeast Program Evaluation Center NEPEC study evaluating administrative data of 5862 Veterans from 122 CWT programs Veterans with PTSD were 19 less likely to be employed at discharge from the VA CWT program compared to those without a diagnosis of PTSD The rate of competitive employment at discharge was only 30 for Veterans with PTSD Similarly another VA study found that Veterans with PTSD involved in CWT were no more likely to be employed at 4 months follow-up compared to those who participated in a specialized PTSD treatment program
Over the past two decades of studies the Individual Placement and Support IPS model of Supported Employment has yielded remarkably robust and consistent employment outcomes for individuals with serious mental illness defined as schizophrenia schizoaffective disorder bipolar disorder and major depression with psychotic features Overall approximately two-thirds of participants in clinical trials with serious mental illness who received IPS achieved competitive employment However Veterans with PTSD have very different clinical characteristics and employment challenges compared to Veterans with SMI Serving as the first study in a PTSD population a recent single site pilot study found superior outcomes from IPS compared to the conventional VA vocational rehabilitation program VRP in unemployed Veterans with PTSD n85 During the 12-month study follow-up period 76 of the Veterans with PTSD randomized to IPS gained competitive employment compared to 28 of those randomized to VRP Together with the evidence base accumulated in the serious mentally ill population the positive results of the pilot study in PTSD support a VA Cooperative Study to definitively test the effectiveness of IPS in Veterans with PTSD
As the primary outcome the two groups will be compared in terms of the proportion of study participants who met the definition of steady worker ie hold competitive employment for at least 50 of the follow-up period Competitive employment is defined as a job receiving regular wages in a setting that is not set aside sheltered or enclaved that is the same job could be held by people without a mental illness or disability and is not a set-aside job in the TWP program Secondary outcomes will include change in other occupational outcomes PTSD symptoms self esteem community integration and quality of life We will explore the differences between groups in terms of occurrences of negative health outcomes
These findings would provide generalizable evidence of the effectiveness of differing employment support to the VHA stakeholders who inform policy and service delivery for Veterans with PTSD Given the number of Veterans with PTSD it is of critical importance for the VA to offer employment service programs based on the best evidence-based recovery-oriented model for this group Conducting a large multi-site study is the next logical step in confirming IPS as an evidence-based employment service for Veterans with PTSD
Over the past two decades of studies the Individual Placement and Support IPS model of Supported Employment has yielded remarkably robust and consistent employment outcomes for individuals with serious mental illness defined as schizophrenia schizoaffective disorder bipolar disorder and major depression with psychotic features Overall approximately two-thirds of participants in clinical trials with serious mental illness who received IPS achieved competitive employment However Veterans with PTSD have very different clinical characteristics and employment challenges compared to Veterans with SMI Serving as the first study in a PTSD population a recent single site pilot study found superior outcomes from IPS compared to the conventional VA vocational rehabilitation program VRP in unemployed Veterans with PTSD n85 During the 12-month study follow-up period 76 of the Veterans with PTSD randomized to IPS gained competitive employment compared to 28 of those randomized to VRP Together with the evidence base accumulated in the serious mentally ill population the positive results of the pilot study in PTSD support a VA Cooperative Study to definitively test the effectiveness of IPS in Veterans with PTSD
As the primary outcome the two groups will be compared in terms of the proportion of study participants who met the definition of steady worker ie hold competitive employment for at least 50 of the follow-up period Competitive employment is defined as a job receiving regular wages in a setting that is not set aside sheltered or enclaved that is the same job could be held by people without a mental illness or disability and is not a set-aside job in the TWP program Secondary outcomes will include change in other occupational outcomes PTSD symptoms self esteem community integration and quality of life We will explore the differences between groups in terms of occurrences of negative health outcomes
These findings would provide generalizable evidence of the effectiveness of differing employment support to the VHA stakeholders who inform policy and service delivery for Veterans with PTSD Given the number of Veterans with PTSD it is of critical importance for the VA to offer employment service programs based on the best evidence-based recovery-oriented model for this group Conducting a large multi-site study is the next logical step in confirming IPS as an evidence-based employment service for Veterans with PTSD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None