Trial Outcomes & Findings for Do Consumer Providers Enhance Recovery? (NCT NCT00781079)
NCT ID: NCT00781079
Last Updated: 2018-10-11
Results Overview
The BASIS-R is a 24 item, comprehensive instrument assessing a range of psychiatric symptoms and problems. It is valid and reliable in both inpatient and outpatient settings in populations with SMI. All items have five response options ranging from 0 to 4, with higher scores indicating more problems (range in possible scores is 0 to 96).
COMPLETED
NA
285 participants
immediately before the intervention (BL), and 12 months post intervention (Post).
2018-10-11
Participant Flow
Participant milestones
| Measure |
Consumer Provider
Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
|
Care as Usual
Care as usual
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
133
|
|
Overall Study
COMPLETED
|
122
|
116
|
|
Overall Study
NOT COMPLETED
|
27
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Do Consumer Providers Enhance Recovery?
Baseline characteristics by cohort
| Measure |
Consumer Provider
n=149 Participants
Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
|
Care as Usual
n=133 Participants
Care as usual
|
Total
n=282 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.59 years
STANDARD_DEVIATION 9.19 • n=5 Participants
|
51.89 years
STANDARD_DEVIATION 11.13 • n=7 Participants
|
52.95 years
STANDARD_DEVIATION 10.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American non-Hispanic
|
39 participants
n=5 Participants
|
13 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White non hispanic
|
74 participants
n=5 Participants
|
78 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Bi racial non hispanic
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American Hispanic
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
18 participants
n=5 Participants
|
21 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
149 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: immediately before the intervention (BL), and 12 months post intervention (Post).The BASIS-R is a 24 item, comprehensive instrument assessing a range of psychiatric symptoms and problems. It is valid and reliable in both inpatient and outpatient settings in populations with SMI. All items have five response options ranging from 0 to 4, with higher scores indicating more problems (range in possible scores is 0 to 96).
Outcome measures
| Measure |
Consumer Provider
n=122 Participants
Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
|
Care as Usual
n=116 Participants
Care as usual on the case management teams
|
|---|---|---|
|
BASIS-R
baseline
|
26.15 units on a scale
Standard Deviation 14.28
|
29.34 units on a scale
Standard Deviation 14.24
|
|
BASIS-R
Post
|
24.57 units on a scale
Standard Deviation 14.05
|
26.76 units on a scale
Standard Deviation 15.11
|
SECONDARY outcome
Timeframe: immediately before the intervention (BL), and 12 months post intervention (Post).Population: comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.
The Mental Health Recovery Measure (MHRM) is a 30-item, 5-point behaviorally-anchored self-report measure based upon recovery experiences of persons with psychiatric disabilities. The MHRM total score has good validity, correlating strongly with the Empowerment Scale and Community Living Skills Scales, yet assessing unique aspects of recovery. Range of total score is 0 to 144, with higher scores meaning better recovery.
Outcome measures
| Measure |
Consumer Provider
n=122 Participants
Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
|
Care as Usual
n=116 Participants
Care as usual on the case management teams
|
|---|---|---|
|
Mental Health Recovery Measure (MHRM)
Baseline
|
85.00 units on a scale
Standard Deviation 17.88
|
78.3 units on a scale
Standard Deviation 18.79
|
|
Mental Health Recovery Measure (MHRM)
Post
|
85.66 units on a scale
Standard Deviation 15.9
|
80.52 units on a scale
Standard Deviation 16.54
|
SECONDARY outcome
Timeframe: immediately before the intervention (BL), and 12 months post intervention (Post).Population: comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.
The mental health version of the Patient Activation Measure (PAM) is a single 13-item scale designed to assess patient's knowledge, skill, and confidence in health self-management. Respondents endorse items (e.g., "I know what each of my prescribed medications do") on a scale from 1 ("disagree strongly") to 4 ("agree strongly"). Raw scores are converted using the established methodology for the PAM to an activation score from 0 (lowest)-100 (highest). Identifying levels of activation is based on whether an activation score falls within a previously determined range of scores. Level 1, the lowest level of activation, includes activation scores of 47 or lower; Level 2 includes scores of 47.1 to 55.1; Level 3 includes scores of 55.2 to 67.0; and Level 4 (the highest activation level) includes scores of 67.1 or above. This version has similar psychometric properties as the original 13-item PAM and correlates with related constructs in other samples of people with SMI.
Outcome measures
| Measure |
Consumer Provider
n=122 Participants
Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
|
Care as Usual
n=116 Participants
Care as usual on the case management teams
|
|---|---|---|
|
Patient Activation Measure
baseline
|
39.31 units on a scale
Standard Deviation 5.41
|
39.09 units on a scale
Standard Deviation 5.37
|
|
Patient Activation Measure
post
|
40.34 units on a scale
Standard Deviation 5.5
|
38.76 units on a scale
Standard Deviation 5.01
|
SECONDARY outcome
Timeframe: immediately before the intervention (BL), and 12 months post intervention (Post)Population: comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.
Perceptions of the recovery orientation of the program were assessed with the Recovery Self-Assessment (RSA), a 36 item survey that assesses domains of recovery-orientated practice (e.g., focus on life goals, involvement of patients in their own care). The RSA has high internal consistency and is thought to represent a more recovery-oriented or recovery-supportive environment. Each item ranges from 1 to 5. The total score (all 36 items averaged together) also is reported on that scale, with higher meaning more recovery.
Outcome measures
| Measure |
Consumer Provider
n=122 Participants
Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
|
Care as Usual
n=116 Participants
Care as usual on the case management teams
|
|---|---|---|
|
Recovery Self-Assessment: Person in Recovery Version
Baseline
|
3.86 units on a scale
Standard Deviation .53
|
3.81 units on a scale
Standard Deviation .61
|
|
Recovery Self-Assessment: Person in Recovery Version
Post
|
3.93 units on a scale
Standard Deviation .61
|
3.83 units on a scale
Standard Deviation .52
|
SECONDARY outcome
Timeframe: 12 months prior to the intervention (BL1), immediately before the intervention (BL2), and 12 months post intervention (Post).Population: comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.
The Illness Management and Recovery Scale (IMR) has 15 items (rated on 5-point behaviorally anchored scales) that assess progress toward goals, knowledge about mental illness, involvement with significant others and self-help, time in structured roles, impairment in functioning, symptom distress and coping, relapse prevention and hospitalizations, use of medications, and alcohol and drug use. A total IMR score is made of the mean of the items and has demonstrated good internal consistency, stability (test-retest after two weeks), and convergent validity, correlating with the Recovery Assessment Scale and the Colorado Symptom Index. The total score is reported on the scale of 1 to 5 with higher scores mean better recovery.
Outcome measures
| Measure |
Consumer Provider
n=122 Participants
Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
|
Care as Usual
n=116 Participants
Care as usual on the case management teams
|
|---|---|---|
|
Illness Management and Recovery Scale: Client Self-Rating
Baseline
|
3.51 units on a scale
Standard Deviation .58
|
3.39 units on a scale
Standard Deviation .56
|
|
Illness Management and Recovery Scale: Client Self-Rating
Post
|
3.56 units on a scale
Standard Deviation .56
|
3.48 units on a scale
Standard Deviation .54
|
SECONDARY outcome
Timeframe: immediately before the intervention (BL), and 12 months post intervention (Post).Population: comparisons between the PS and Usual Care groups used a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.
Subjective ratings of overall quality of life and the quality of social relationships, daily life, and family interactions was assessed using a combination of selected scales from the Quality of Life Instrument-Brief Version (QOLI), which been used extensively with a wide range of populations including those who are homeless, have a dual diagnosis, and are ethnic minorities. Because of low internal consistencies of subscales in our sample, a factor analysis was conducted which indicated that a larger scale that included the items from the overall quality of life, social relationships, daily life, and family interactions scales would be more reliable (all items averaged together). The score ranges from 1 to 5, with 1 meaning more quality of life.
Outcome measures
| Measure |
Consumer Provider
n=122 Participants
Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
|
Care as Usual
n=116 Participants
Care as usual on the case management teams
|
|---|---|---|
|
Quality of Life Interview, Brief Version
Baseline
|
4.64 units on a scale
Standard Deviation 1.04
|
4.54 units on a scale
Standard Deviation 1.03
|
|
Quality of Life Interview, Brief Version
Post
|
4.72 units on a scale
Standard Deviation 1.04
|
4.71 units on a scale
Standard Deviation .9
|
Adverse Events
Consumer Provider
Case as Usual
Serious adverse events
| Measure |
Consumer Provider
n=149 participants at risk
Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
|
Case as Usual
n=133 participants at risk
Care as usual on case management teams
|
|---|---|---|
|
Cardiac disorders
Death
|
6.7%
10/149 • Number of events 10 • 1 year
|
2.3%
3/133 • Number of events 3 • 1 year
|
|
Psychiatric disorders
Psychiatric
|
27.5%
41/149 • Number of events 105 • 1 year
|
17.3%
23/133 • Number of events 74 • 1 year
|
|
Cardiac disorders
Cardiac
|
16.1%
24/149 • Number of events 45 • 1 year
|
7.5%
10/133 • Number of events 12 • 1 year
|
|
General disorders
other hospitalizations
|
6.7%
10/149 • Number of events 40 • 1 year
|
14.3%
19/133 • Number of events 19 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place