Trial Outcomes & Findings for Supported Employment in Patient Aligned Care Teams (NCT NCT02400736)
NCT ID: NCT02400736
Last Updated: 2022-03-09
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
12 months
Results posted on
2022-03-09
Participant Flow
502 veterans were considered for this study, 140 were consented, 19 were not eligible, 2 were randomized in error, and 119 were randomized and included in the analyses. Of the 119 randomized participants, 100 (84%) participants completed the study.
Participant milestones
| Measure |
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 (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.
|
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: The TW specialist does not provide long-term follow-up after the first job is obtained.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
61
|
|
Overall Study
COMPLETED
|
47
|
53
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
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 (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.
|
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: The TW specialist does not provide long-term follow-up after the first job is obtained.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Moved from the area
|
3
|
1
|
Baseline Characteristics
Supported Employment in Patient Aligned Care Teams
Baseline characteristics by cohort
| Measure |
Individual Placement and Support (IPS)
n=58 Participants
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 Participants
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.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
37.8 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
38.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Mental Disorder
Major depression, past
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Mental Disorder
Major depression, current
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Mental Disorder
Agoraphobia
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Mental Disorder
Panic Disorder (lifetime)
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Mental Disorder
Post-traumatic stress disorder
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Mental Disorder
Alcohol Use Disorder, past year
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Mental Disorder
Substance Used Disorder
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=58 Participants
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 Participants
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.
|
|---|---|---|
|
Steady Worker
|
26 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Number of weeks out of 52 week follow-up in which the participant worked at least one hour in a competitive job.
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=58 Participants
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 Participants
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.
|
|---|---|---|
|
Weeks Worked in a Competitive Job
|
38.6 weeks
Standard Deviation 14.8
|
24.6 weeks
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
The number of weeks from randomization until the participant worked in a competitive job.
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=58 Participants
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 Participants
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.
|
|---|---|---|
|
Time to First Competitive Job
|
8.7 weeks
Standard Deviation 8.8
|
17.6 weeks
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Randomized participants
For those participants, the income earned from any competitive jobs was added for the 52-week follow-up period.
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=58 Participants
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 Participants
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.
|
|---|---|---|
|
Income Earned From Competitive Jobs
|
11,106 US dollars
Standard Deviation 12,792
|
6,605 US dollars
Standard Deviation 10,150
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=58 Participants
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 Participants
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.
|
|---|---|---|
|
Symptom Checklist-90-Revised Change From Baseline to Month 12.
|
0.036 score on a scale
Standard Deviation 0.14
|
0.042 score on a scale
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
All income earned from competitive, transitional work, and other sources over the 12-month follow-up.
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=58 Participants
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 Participants
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.
|
|---|---|---|
|
Income Earned From All Sources
|
17,960 US dollars
Standard Deviation 11,310
|
11,168 US dollars
Standard Deviation 9,682
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=58 Participants
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 Participants
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.
|
|---|---|---|
|
Rosenberg Self-Esteem Scale Change From Baseline to 12 Months.
|
1.23 score on a scale
Standard Deviation 5.16
|
0.31 score on a scale
Standard Deviation 6.33
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All randomized participants who held a competitive job during the 12-month follow-up
Income earned ($) from competitive jobs over 12 months was compared between groups for all randomized participants who held a competitive job at some point.
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=36 Participants
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=31 Participants
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.
|
|---|---|---|
|
Income Earned From Competitive Jobs in Participants Who Held a Competitive Job
|
18,945 US dollars
Standard Deviation 10,792
|
13,813 US dollars
Standard Deviation 10,809
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: All subjects randomized; intent-to-treat analysis
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.
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=58 Participants
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 Participants
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.
|
|---|---|---|
|
Community Reintegration of Service Members
Baseline (Extent of Participation)
|
46.8 units on a scale
Standard Deviation 8.15
|
48.6 units on a scale
Standard Deviation 7.75
|
|
Community Reintegration of Service Members
4-month (Extent of Participation)
|
48.6 units on a scale
Standard Deviation 6.32
|
48.5 units on a scale
Standard Deviation 7.98
|
|
Community Reintegration of Service Members
8-month (Extent of Participation)
|
48.1 units on a scale
Standard Deviation 7.51
|
46.3 units on a scale
Standard Deviation 8.55
|
|
Community Reintegration of Service Members
12-month (Extent of Participation)
|
46.1 units on a scale
Standard Deviation 8.61
|
47.6 units on a scale
Standard Deviation 9.50
|
|
Community Reintegration of Service Members
Baseline (Perceived Limitations)
|
47.1 units on a scale
Standard Deviation 8.77
|
48.0 units on a scale
Standard Deviation 7.34
|
|
Community Reintegration of Service Members
4-month (Perceived Limitations)
|
49.9 units on a scale
Standard Deviation 7.96
|
48.7 units on a scale
Standard Deviation 8.81
|
|
Community Reintegration of Service Members
8-month (Perceived Limitations)
|
47.8 units on a scale
Standard Deviation 8.97
|
47.7 units on a scale
Standard Deviation 9.01
|
|
Community Reintegration of Service Members
12-month (Perceived Limitations)
|
46.7 units on a scale
Standard Deviation 9.21
|
48.1 units on a scale
Standard Deviation 9.82
|
|
Community Reintegration of Service Members
Baseline (Satisfaction with Participation)
|
48.6 units on a scale
Standard Deviation 9.89
|
50.6 units on a scale
Standard Deviation 9.91
|
|
Community Reintegration of Service Members
4-Month (Satisfaction with Participation)
|
52.6 units on a scale
Standard Deviation 8.62
|
51.7 units on a scale
Standard Deviation 9.34
|
|
Community Reintegration of Service Members
8-month (Satisfaction with Participation)
|
50.3 units on a scale
Standard Deviation 10.11
|
50.2 units on a scale
Standard Deviation 10.92
|
|
Community Reintegration of Service Members
12-month (Satisfaction with Participation)
|
47.7 units on a scale
Standard Deviation 10.11
|
50.4 units on a scale
Standard Deviation 11.45
|
POST_HOC outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=58 Participants
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 Participants
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.
|
|---|---|---|
|
Proportion of Weeks Unencumbered by Transitional Work in Which Competitive Job Was Held
|
40 percentage of 52 weeks
Standard Deviation 13.7
|
25 percentage of 52 weeks
Standard Deviation 16.7
|
POST_HOC outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Individual Placement and Support (IPS)
n=58 Participants
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 Participants
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.
|
|---|---|---|
|
Held a Full-time Competitive Job
|
25 Participants
|
12 Participants
|
Adverse Events
Individual Placement and Support (IPS)
Serious events: 6 serious events
Other events: 17 other events
Deaths: 1 deaths
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Individual Placement and Support (IPS)
n=58 participants at risk
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Seizure
|
1.7%
1/58 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
0.00%
0/61 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Psychiatric disorders
Suicidal Ideation
|
3.4%
2/58 • Number of events 2 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
1.6%
1/61 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Renal and urinary disorders
Kidney Stone
|
1.7%
1/58 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
0.00%
0/61 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Skin and subcutaneous tissue disorders
Gun Shot Wound
|
1.7%
1/58 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
0.00%
0/61 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.00%
0/58 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
1.6%
1/61 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Cardiac disorders
Death
|
1.7%
1/58 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
0.00%
0/61 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/58 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
1.6%
1/61 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Cardiac disorders
Chest Pain
|
1.7%
1/58 • Number of events 2 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
0.00%
0/61 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Reproductive system and breast disorders
Hysterectomy
|
0.00%
0/58 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
1.6%
1/61 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
Other adverse events
| Measure |
Individual Placement and Support (IPS)
n=58 participants at risk
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.
|
Treatment as Usual Vocational Rehabilitation/Transitional Work (TAU-VR)
n=61 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular Skeletal Pain or Problem
|
13.8%
8/58 • Number of events 10 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
14.8%
9/61 • Number of events 11 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Infections and infestations
Infection
|
5.2%
3/58 • Number of events 3 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
9.8%
6/61 • Number of events 7 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Psychiatric disorders
Mental health
|
3.4%
2/58 • Number of events 2 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
1.6%
1/61 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Eye disorders
Eye
|
1.7%
1/58 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
1.6%
1/61 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Nervous system disorders
Neurological
|
3.4%
2/58 • Number of events 2 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
6.6%
4/61 • Number of events 4 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Cardiac disorders
Cardiovascular
|
1.7%
1/58 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
1.6%
1/61 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Reproductive system and breast disorders
Reproductive system
|
1.7%
1/58 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
1.6%
1/61 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Gastrointestinal disorders
GI, including dental
|
1.7%
1/58 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
3.3%
2/61 • Number of events 2 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Ear and labyrinth disorders
Ear
|
1.7%
1/58 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
0.00%
0/61 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Respiratory, thoracic and mediastinal disorders
Pmonary
|
0.00%
0/58 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
4.9%
3/61 • Number of events 3 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Injury, poisoning and procedural complications
Accidents, insects, dog bites
|
3.4%
2/58 • Number of events 2 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
4.9%
3/61 • Number of events 3 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
|
Metabolism and nutrition disorders
Diabetes
|
0.00%
0/58 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
1.6%
1/61 • Number of events 1 • 12 months
Participants self-reported adverse events were collected over 12-months and definition did not differ from clinical trials site. Adverse events were monitored without regard to the specific adverse event term.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place