| Primary | Steady Worker | Participants were categorized as a steady worker if they held a competitive job for 50% or more of the 12-month follow-up (i.e. 26 or more weeks out of 52 weeks). | 119 randomized Veterans who were followed in a primary care Patient Aligned Care Team, who had a diagnosis of at least one mental disorder, and were unemployed or under-employed. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
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| OG000 | Individual Placement and Support (IPS) | Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. | | OG001 | Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR) | Treatment as Usual Vocational Rehabilitation could include pre-vocational counseling, Community Based Supported Employment, and most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: TW specialist does not provide long-term follow-up after the first job is obtained. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Using SamplePower 3.0 to estimate the statistical power, the target sample size of 120 (60 per group) provided 84% power to detect a 25% or greater absolute difference between groups in the percent of participants achieving 'steady worker' status (e.g., 40% in IPS vs. 15% in control arm), at the .05 level of significance, assuming a 10% attrition. | Chi-squared | | 0.02 | a priori threshold for statistical significance p \ | Odds Ratio (OR) | 2.49 | | | 2-Sided | 95 | 1.14 | 5.43 | | | | | Superiority | |
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| Secondary | Weeks Worked in a Competitive Job | Number of weeks out of 52 week follow-up in which the participant worked at least one hour in a competitive job. | 119 randomized Veterans who were followed in a primary care Patient Aligned Care Team, who had a diagnosis of at least one mental disorder, and were unemployed or under-employed. | Posted | | Mean | Standard Deviation | weeks | | 12 months | | | | ID | Title | Description |
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| OG000 | Individual Placement and Support (IPS) | Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. | | OG001 | Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR) | |
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| Secondary | Time to First Competitive Job | The number of weeks from randomization until the participant worked in a competitive job. | 119 randomized Veterans who were followed in a primary care Patient Aligned Care Team, who had a diagnosis of at least one mental disorder, and were unemployed or under-employed. | Posted | | Mean | Standard Deviation | weeks | | 12 months | | | | ID | Title | Description |
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| OG000 | Individual Placement and Support (IPS) | Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. | | OG001 | Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR) | Treatment as Usual Vocational Rehabilitation could include pre-vocational counseling, Community Based Supported Employment, and most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: TW specialist does not provide long-term follow-up after the first job is obtained. |
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| Secondary | Income Earned From Competitive Jobs | For those participants, the income earned from any competitive jobs was added for the 52-week follow-up period. | | Posted | | Mean | Standard Deviation | US dollars | | 12 months | | | | ID | Title | Description |
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| OG000 | Individual Placement and Support (IPS) | Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. | | OG001 | Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR) | Treatment as Usual Vocational Rehabilitation could include pre-vocational counseling, Community Based Supported Employment, and most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: TW specialist does not provide long-term follow-up after the first job is obtained. |
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| Secondary | Symptom Checklist-90-Revised Change From Baseline to Month 12. | Symptom Checklist-90-Revised (SCL-90-R): 90-item self-report survey; assesses nine dimensions. Each item is self-rated for level of discomfort/distress on scale of 0 "not at all" to 4 "extremely" for somatization (range 0 to 48), obsessive-compulsive symptoms (range 0 to 40), interpersonal sensitivity (range 0 to 36), depression (range 0 to 52), anxiety (range 0 to 40), hostility (range 0 to 24), phobic-anxiety (range 0 to 28), paranoid ideation (range 0 to 24), and psychoticism (range 0 to 40). Total score for a dimension is the sum of items and the distress score for each dimension is the sum divided by number of items in that dimension (range = 0 to 4). Global Severity Index is a mean of all items, calculated by dividing the sum of scores by the number of items (range 0 to 4). Higher score indicates greater distress and increase in score over time indicates worse outcome. | 119 randomized Veterans who were followed in a primary care Patient Aligned Care Team, who had a diagnosis of at least one mental disorder, and were unemployed or under-employed. | Posted | | Mean | Standard Deviation | score on a scale | | Change from baseline to month 12 (value at 12 months minus value at baseline) is shown below. Additionally, all relevant time points used in the calculation timeframe from baseline to 12 months (baseline, months 4, 6, 8, and 12) included in analysis. | | | | ID | Title | Description |
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| OG000 | Individual Placement and Support (IPS) | Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. |
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| Secondary | Income Earned From All Sources | All income earned from competitive, transitional work, and other sources over the 12-month follow-up. | 119 randomized Veterans who were followed in a primary care Patient Aligned Care Team, who had a diagnosis of at least one mental disorder, and were unemployed or under-employed. | Posted | | Mean | Standard Deviation | US dollars | | 12 months | | | | ID | Title | Description |
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| OG000 | Individual Placement and Support (IPS) | Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. | | OG001 | Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR) | Treatment as Usual Vocational Rehabilitation could include pre-vocational counseling, Community Based Supported Employment, and most commonly Transitional Work assignments (TW) which involves 1) time-limited set-aside work experiences: short-term transitional work experiences in a brokered or set-aside work setting; 2) no strict entrance criteria other than general medical clearance; 3) limited integration of TW and clinical Services; 4) not patient-centered: TW jobs are pre-arranged, set-aside jobs are less likely to have a meaningful relationship to the Veterans' preferences; 5) personalized benefits counseling; 6) limited job search: TW specialists provide variable and limited guidance for competitive job search; 7) no job development: TW specialists do not engage in community based job development; 8) time limited: TW specialist does not provide long-term follow-up after the first job is obtained. |
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| Secondary | Rosenberg Self-Esteem Scale Change From Baseline to 12 Months. | Rosenberg Self-Esteem Scale (RSES) is a 10-item self-report Likert-type questionnaire that asks participants to indicate the degree of their agreement or disagreement with statements about their self-esteem and self-depreciation from 0 = "strongly agree" to 3 = "strongly disagree". The items are summed and the scoring ranges from 0 to 30, with higher scores indicating a higher degree of self-esteem; a positive change in score over time indicates improved self esteem. A score less than 15 may indicate low self esteem. | 119 randomized Veterans who were followed in a primary care Patient Aligned Care Team, who had a diagnosis of at least one mental disorder, and were unemployed or under-employed. | Posted | | Mean | Standard Deviation | score on a scale | | Change from baseline to month 12 (value at 12 months minus value at baseline) is shown below. Additionally, all relevant time points used in the calculation timeframe from baseline to 12 months (baseline, months 4, 6, 8, 12) were included in mixed model. | | | | ID | Title | Description |
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| OG000 | Individual Placement and Support (IPS) | Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. |
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| Secondary | Income Earned From Competitive Jobs in Participants Who Held a Competitive Job | Income earned ($) from competitive jobs over 12 months was compared between groups for all randomized participants who held a competitive job at some point. | All randomized participants who held a competitive job during the 12-month follow-up | Posted | | Mean | Standard Deviation | US dollars | | 12 months | | | | ID | Title | Description |
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| OG000 | Individual Placement and Support (IPS) | .Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. | | OG001 | Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR) | |
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| Other Pre-specified | Community Reintegration of Service Members | Community Reintegration of Service Members (CRIS) is a self-report instrument used to evaluate the Veteran's reintegration into the community. The correlations between the CRIS and the 36-Item Short Form Health Survey scales of role physical, role emotional, and social functioning were 0.44-0.80 and the CRIS has strong reliability, conceptual integrity, and construct validity. In pilot studies with 126 veterans, working subjects had better CRIS scores then unemployed subjects. Items on the CRIS cover 9 aspects of participation: Learning and Applying Knowledge, General Tasks and Demands, Communication, Mobility, Self-care, Domestic Life, Interpersonal Relationships, Major Life Areas, and Community, Social and Civic Life. Subscale scores for 1) extent of participation, 2) perceived limitations, and 3) satisfaction with participation are calculated. For each of the 3 subscales, the minimum score is 10, the maximum score is 70. Higher scores are indication of better outcomes. | All subjects randomized; intent-to-treat analysis | Posted | | Mean | Standard Deviation | units on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Individual Placement and Support (IPS) | Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the PACT; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. Individual Placement and Support (IPS): Individual Placement and Support (IPS) is the evidenced based model of supported employment. |
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| Post-Hoc | Proportion of Weeks Unencumbered by Transitional Work in Which Competitive Job Was Held | The number of weeks in which the participant was engaged in a transitional work assignment in the treatment as usual arm was subtracted from the 52 week follow-up and used as denominator in deriving the proportion of weeks worked in a competitive job. The IPS group did not engage in transitional work, so 52 weeks was the denominator in deriving the proportion of weeks worked in a competitive job. | 119 randomized Veterans who were followed in a primary care Patient Aligned Care Team, who had a diagnosis of at least one mental disorder, and were unemployed or under-employed. | Posted | | Mean | Standard Deviation | percentage of 52 weeks | | 12 months | | | | ID | Title | Description |
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| OG000 | Individual Placement and Support (IPS) | Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. |
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| Post-Hoc | Held a Full-time Competitive Job | Participant held a full-time competitive job during the 12-month follow-up. Full time was defined as working at least 30 hours per week. | 119 randomized Veterans who were followed in a primary care Patient Aligned Care Team, who had a diagnosis of at least one mental disorder, and were unemployed or under-employed. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
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| OG000 | Individual Placement and Support (IPS) | Individual Placement and Support (IPS) is supported employment and involves the following domains: 1) competitive Employment: IPS assists participants to enter into competitive jobs; 2) eligibility based on client choice, i.e. "zero exclusion"; 3) integration of IPS and treatment team, i.e. the Patient Aligned Care Team; 4) patient-centered job match for competitive employment; 5) personalized benefits counseling: IPS specialists help Veterans obtain information about their VA, Social Security, Medicaid, and other government entitlements; 6) rapid job search: IPS specialists use a rapid job search, rather than providing lengthy pre-employment assessment, training, counseling; 7) job development: IPS specialists build an employer network based on Veterans' interests; 8) time-unlimited and individualized support: follow-along IPS supports are individualized and continue for as long as needed during the 12-month study. | | OG001 | Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR) | |
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