| ID | Type | Description | Link |
|---|---|---|---|
| Promis Number 0052 | Other Grant/Funding Number | TVAMC | |
| MIRB 00033 | Other Identifier | TVAMC - reference number | |
| TVAMC 03-19 | Other Identifier | TVAMC - Year/project number |
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To study the impact of Individual Placement and Support (IPS) supported employment (SE) compared to treatment-as-usual vocational rehabilitation program (VRP) for veterans with posttraumatic stress disorder (PTSD).
Objectives: to study the impact of Individual Placement and Support (IPS) supported employment (SE) compared to treatment-as-usual vocational rehabilitation program (VRP) for veterans with posttraumatic stress disorder (PTSD).
Research Design: This prospective randomized study evaluates the impact of IPS-SE compared to VRP on occupational, sobriety, psychiatric, and quality of life outcomes and health care costs for veterans with chronic PTSD who enter the Tuscaloosa VA Medical Center's (TVAMC) vocational rehabilitation program.
Methodology: Occupational functioning is determined primarily by whether the veteran can obtain and maintain competitive employment, and, secondarily, by time worked and wages earned for those employed. Veterans who meet inclusion criteria will be randomized to either IPS-SE or VRP. Outcomes will be assessed over a fixed 12-month observation period (beginning at randomization and computed for the entire 12-month observation period) as percent subjects employed at least one week (employed rate), and monthly employment rates (maintained employed rate). In addition, PTSD symptoms and other health-related quality of life measures will be evaluated. This strategy uses all available data during the 1-year period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vocational Rehabilitation Program (VRP) | Active Comparator | Vocational Rehabilitation Program (VRP). VRP is the treatment as usual, which mostly consisted of transitional work program (TWP) in which client is placed in a set-aside noncompetitive job for time-limited period and then pursues competitive employment at time of discharge from VRP. Limited integration with treatment team and limited follow-along supports that are time-limited |
|
| Individual Placement and Support (IPS) | Experimental | Inidividual Placement and Support (IPS). IPS Supported Employment involves an IPS specialists working with client to identify job preferences, rapidly begin community-based job search, engage in competitive employment, sustain employment via open-ended IPS follow-along supports, and integrate IPS within the PTSD treatment team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vocational Rehabilitation Program (VRP) | Behavioral | Vocational Rehabilitation Program (VRP) is a treatment-as-usual method using traditional train-place approaches, such as prevocational work skills training , compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist |
| Measure | Description | Time Frame |
|---|---|---|
| Obtain Competitive Employment | The primary outcome: competitive employment (Yes or No). Competitive employment was defined as a job for regular wages in a setting that was not set aside, or sheltered, that is, the job could be held by people without a mental illness or disability and was not a set-aside job in the VRP. Day labor (babysitting, manual labor by the day, drill, temporary work for family or friends) was not considered competitive employment. | 1 calendar year |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD, Depression, Disability Outcomes | Clinician Administered PTSD Scale for DSM-IV (CAPS) score range 0-136 with higher=more severe; Quick Inventory of Depression Scale - Clinician-rated (QIDS-CR) score range 0-27 with higher=more severe; Clinical Global Impression-Severity (CGI-S) score range 1-7 with higher=more severe; Davidson Trauma Scale (DTS) score range 0-136 with higher=more severe; and World Health Organization Disability Assessment Scale (WHODAS-II) 36-items rated on 5-point scale, from 1 (no difficulty) to 5 (extreme difficulty/cannot do) in 6 domains of life; domain scores are transformed from the total raw score (sum of items) of each domain according to the following formula: Transformed score=[(actual raw score - lowest possible raw score) / (possible raw score range)] x 100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori Lynne Davis, MD AB | Tuscaloosa VA Medical Center, Tuscaloosa, AL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tuscaloosa VA Medical Center, Tuscaloosa, AL | Tuscaloosa | Alabama | 35404-5015 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22307881 | Result | Davis LL, Leon AC, Toscano R, Drebing CE, Ward LC, Parker PE, Kashner TM, Drake RE. A randomized controlled trial of supported employment among veterans with posttraumatic stress disorder. Psychiatr Serv. 2012;63(5):464-70. doi: 10.1176/appi.ps.201100340. | |
| 24708195 | Result | Davis LL, Pilkinton P, Poddar S, Blansett C, Toscano R, Parker PE. Impact of social challenges on gaining employment for veterans with posttraumatic stress disorder: an exploratory moderator analysis. Psychiatr Rehabil J. 2014 Jun;37(2):107-9. doi: 10.1037/prj0000058. Epub 2014 Apr 7. |
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100 Veterans were enrolled; 85 were randomized to IPS-SE (n=42) or VRP (n=43) and followed 12-months. 15 participants were excluded: 2 did not have PTSD, 2 lived >100 miles away, 3 withdrew consent, 4 had exclusionary diagnosis, and 4 were not eligible to be enrolled in the VRP. Participants were allowed to continue all other treatments for PTSD.
From 2006 to 2010 Veterans with PTSD at the Tuscaloosa VA Medical Center were enrolled in a 12-month, prospective randomized comparison of IPS Supported Employment and treatment-as-usual Vocational Rehabilitation Program (VRP).
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| ID | Title | Description |
|---|---|---|
| FG000 | Vocational Rehabilitation Program (VRP) | VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training , compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist |
| FG001 | Individual Placement and Support (IPS) | Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Veterans with PTSD were randomly assigned to a treatment goup.
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| ID | Title | Description |
|---|---|---|
| BG000 | VA Vocational Rehabilitation Program (Treatment-as-usual) | VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Obtain Competitive Employment | The primary outcome: competitive employment (Yes or No). Competitive employment was defined as a job for regular wages in a setting that was not set aside, or sheltered, that is, the job could be held by people without a mental illness or disability and was not a set-aside job in the VRP. Day labor (babysitting, manual labor by the day, drill, temporary work for family or friends) was not considered competitive employment. | All randomized participants were included in the analysis (intent-to-treat) | Posted | Number | participants | 1 calendar year |
|
Serious adverse events were carefully reviewed with the patients during their participation in the study (1 year), regardless of cause. All serious adverse events were reported to the IRB within 48 hours from the time the PI learned of the event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VA Vocational Rehabilitation Program (Treatment-as-usual) | VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe migraine headache | General disorders | Systematic Assessment |
The elements of the study that limit generalizability include the single-site design, the small number of IPS interventionists, low number of women in the sample, and the exclusion of nonveterans.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori Davis, MD | Tuscaloosa VA Medical Center | 205-554-3819 | lori.davis@va.gov |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
|
| Individual Placement and Support (IPS) | Behavioral | Individual Placement and Support (IPS) is an evidence--based model of supported employment that emphasizes rapid job search within client preferences, community job development, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of the IPS specialist within the treatment team. |
|
|
| one-year |
| Employment Outcomes (Weeks Competitively Employed) | Number of weeks employed for any time in a competitive job (not set-aside job) | one year |
| Employment Outcomes (Days Competitively Employed | Number of days employed in a competitive job (not set-aside job) | one year |
| Employment Outcomes (Hours Competitively Employed) | hours employed in a competitive (not set-aside) job | one year |
| Employment Outcomes (Gross Income Competitive) | total gross income (US dollars) from all competitive wages, salary, commissions | one year |
| Employment Outcomes (Total Gross Income From All Sources | total gross income from all sources of work including noncompetitive and competitive jobs | one year |
| Incarcerated |
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| Withdrawal by Subject |
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| BG001 |
| Individual Placement and Support (IPS) Supported Employment |
Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Individual Placement and Support (IPS) Supported Employment | Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team. |
|
|
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| Secondary | PTSD, Depression, Disability Outcomes | Clinician Administered PTSD Scale for DSM-IV (CAPS) score range 0-136 with higher=more severe; Quick Inventory of Depression Scale - Clinician-rated (QIDS-CR) score range 0-27 with higher=more severe; Clinical Global Impression-Severity (CGI-S) score range 1-7 with higher=more severe; Davidson Trauma Scale (DTS) score range 0-136 with higher=more severe; and World Health Organization Disability Assessment Scale (WHODAS-II) 36-items rated on 5-point scale, from 1 (no difficulty) to 5 (extreme difficulty/cannot do) in 6 domains of life; domain scores are transformed from the total raw score (sum of items) of each domain according to the following formula: Transformed score=[(actual raw score - lowest possible raw score) / (possible raw score range)] x 100. | All randomized participants (intent-to-treat) | Posted | Mean | Standard Deviation | units on a scale | one-year |
|
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|
|
| Secondary | Employment Outcomes (Weeks Competitively Employed) | Number of weeks employed for any time in a competitive job (not set-aside job) | All randomized participants (intent-to-treat) | Posted | Mean | Standard Deviation | weeks | one year |
|
|
|
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| Secondary | Employment Outcomes (Days Competitively Employed | Number of days employed in a competitive job (not set-aside job) | All randomized participants (intent-to-treat) | Posted | Mean | Standard Deviation | days | one year |
|
|
|
| Secondary | Employment Outcomes (Hours Competitively Employed) | hours employed in a competitive (not set-aside) job | All randomized participants (intent-to-treat) | Posted | Mean | Standard Deviation | hours | one year |
|
|
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| Secondary | Employment Outcomes (Gross Income Competitive) | total gross income (US dollars) from all competitive wages, salary, commissions | All randomized participants (intent-to-treat) | Posted | Mean | Standard Deviation | US dollars | one year |
|
|
|
| Secondary | Employment Outcomes (Total Gross Income From All Sources | total gross income from all sources of work including noncompetitive and competitive jobs | All randomized participants (intent-to-treat) | Posted | Mean | Standard Deviation | US dollars | one year |
|
|
|
| 11 |
| 43 |
| 7 |
| 43 |
| EG001 | Individual Placement and Support (IPS) Supported Employment | Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team. | 5 | 42 | 2 | 42 |
| Severe Staph Infection | Infections and infestations | Systematic Assessment |
|
| Surgical procedure | Surgical and medical procedures | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Motor Vehicle Accident complications | General disorders | Systematic Assessment |
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| Medical Stabilization | General disorders | Systematic Assessment |
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| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Abnormally high blood pressure | Cardiac disorders | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Injury to finger | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypertrophy adnoids | Ear and labyrinth disorders | Systematic Assessment |
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| Neck swelling | General disorders | Systematic Assessment |
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| Alcohol withdrawal | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cyst underarm | Infections and infestations | Systematic Assessment |
|
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| CGI-S |
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| DTS |
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| WHODAS II |
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