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| ID | Type | Description | Link |
|---|---|---|---|
| H133B050003 | Other Grant/Funding Number | US Dept of Educ-NIDRR Center for Mental Health Services Cooperative Agreement |
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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
| Substance Abuse and Mental Health Services Administration (SAMHSA) | FED |
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Self-directed care (SDC) programs give people with disabilities control over public funds to purchase traditional behavioral health and non-traditional services in order to remain outside of institutional settings. The purpose of this study is to determine the effects of this model on participant outcomes, service costs, and user satisfaction among people with serious mental illness.
Self-directed care (SDC) programs give people with disabilities control over public funds to purchase traditional behavioral health and non-traditional services in order to remain outside of institutional settings. The purpose of this study is to determine the effects of this model on participant outcomes, service costs, and user satisfaction among people with serious mental illness. Adults with serious mental illness served in the Texas public health system will be randomly assigned to SDC versus services as usual and assessed at baseline, 12-month, and 24-month follow-up. Mixed effects random-regression analysis will test for longitudinal changes in outcomes between the two study conditions. Differences in service costs will be analyzed using generalized linear models with negative binomial and zero-inflated negative binomial distribution. Non-traditional expenditures by the SDC participants will be examined descriptively. Service satisfaction in both study conditions will be assessed at one- and two-year follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-directed care | Experimental | Subjects receive traditional behavioral health and non-traditional services via a self-directed care model in which they develop a person-directed plan and create a budget for the purchase of medically necessary goods and services. Program staff acting as service brokers help them secure needed goods and services from within or outside the public behavioral health provider system. A fiscal intermediary manages financial resources to pay providers and enable the purchase of approved goods.. |
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| Services as usual | Active Comparator | Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-directed care | Behavioral | Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system |
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| Measure | Description | Time Frame |
|---|---|---|
| Recovery From Mental Illness | This outcome is measured by the Recovery Assessment Scale (RAS). Recovery is a psychosocial outcome assessed via patient self-ratings on a 41-item scale using a 5-point Likert-Response format ranging from "strongly disagree" to "strongly agree". The minimum value for the RAS is 41 and the maximum is 205, with higher scores indicating a better outcome. Dimensions of recovery include personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and not being dominated by one's residual psychiatric symptoms. | Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-esteem | Feelings of self-worth and confidence in general abilities as measured by the Rosenberg Self-Esteem Scale . Higher vales equal better self=esteem. Minimum = 10 and maximum = 40. | Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith A Cook, PhD | University of Illinois at Chicago, Department of Psychiatry | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29407723 | Background | Scanlan JN, Hancock N, Honey A. The Recovery Assessment Scale - Domains and Stages (RAS-DS): Sensitivity to change over time and convergent validity with level of unmet need. Psychiatry Res. 2018 Mar;261:560-564. doi: 10.1016/j.psychres.2018.01.042. | |
| 19374464 | Background | Davis C, Kellett S, Beail N. Utility of the Rosenberg self-esteem scale. Am J Intellect Dev Disabil. 2009 May;114(3):172-8. doi: 10.1352/1944-7558-114.3.172. |
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Eligible participants ( who were active Texas Department of State Health Services (DSHS) were recruited at community mental health agencies by local research staff between March 2009 and September 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-directed Care | Subjects receive traditional behavioral health and non-traditional services via a self-directed care model in which they develop a person-directed plan and create a budget for the purchase of medically necessary goods and services. Program staff acting as service brokers help them secure needed goods and services from within or outside the public behavioral health provider system. A fiscal intermediary manages financial resources to pay providers and enable the purchase of approved goods.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system |
| FG001 | Services as Usual | Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-directed Care | Subjects receive traditional behavioral health and non-traditional services via a self-directed care model in which they develop a person-directed plan and create a budget for the purchase of medically necessary goods and services. Program staff acting as service brokers help them secure needed goods and services from within or outside the public behavioral health provider system. A fiscal intermediary manages financial resources to pay providers and enable the purchase of approved goods.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recovery From Mental Illness | This outcome is measured by the Recovery Assessment Scale (RAS). Recovery is a psychosocial outcome assessed via patient self-ratings on a 41-item scale using a 5-point Likert-Response format ranging from "strongly disagree" to "strongly agree". The minimum value for the RAS is 41 and the maximum is 205, with higher scores indicating a better outcome. Dimensions of recovery include personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and not being dominated by one's residual psychiatric symptoms. | The number reflected in the "Overall Number of Participants Analyzed" pertains to the number of participants who completed the baseline interview. | Posted | Mean | Standard Deviation | score on a scale | Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) |
|
The time frame over which adverse event data were collected was 3 years.
For other serious adverse events, we included incarcerations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-directed Care | Subjects receive traditional behavioral health and non-traditional services via a self-directed care model in which they develop a person-directed plan and create a budget for the purchase of medically necessary goods and services. Program staff acting as service brokers help them secure needed goods and services from within or outside the public behavioral health provider system. A fiscal intermediary manages financial resources to pay providers and enable the purchase of approved goods.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse events were monitored without regard to the specific adverse event term | Immune system disorders | Systematic Assessment | Subject was admitted to hospice care for HIV infection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse events were monitored without regard to the specific adverse event term | Psychiatric disorders | Systematic Assessment | One participant became very upset and frustrated due to problems with mental health service provider (i.e., reported they violated her privacy and that she was treated disrespectfully). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Judith A. Cook, Director | Center on Mental Health Services Research and Policy, University of Illinois at Chicago, Department of Psychiatry | 312-355-3921 | jcook@uic.edu |
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Self-directed care is a model of service delivery in which service recipients are allocated a individual budget from which they purchase mental health and other services and material goods needed to help them recover from their mental illness and remain outside of restrictive settings such as hospitals..
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Research interviewers were blinded to study condition
| Services as usual | Behavioral | Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency |
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| Coping Mastery |
Change in subjects' sense of personal control over important life outcomes as measured by the Coping Mastery Scale. Higher values equal better coping mastery. Minimum = 2 and maximum = 49. |
| Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) |
| Perceived Autonomy Support | Perceived support for autonomously motivated change measured by the Learning Climate Questionnaire of Williams & Deci. Measures change in perception that service environment is supportive of autonomy to make decisions and choices. Higher score equals better autonomy support. Minimum = 4 and maximum = 105. | Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) |
| Number of Participants With Employment | Change in employment status as measured by Bureau of Labor Statistics definition of paid employment: with paid employment versus without paid employment. Higher value equals with paid employment. Minimum = 0 and maximum = 1. | Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) |
| Number of Participants Enrolled in Classes | Change in education participation status as measured by U.S. Department of Education's definition of school enrollment: enrolled in classes requiring registration and fee payment versus not enrolled in classes. Higher value = enrolled in classes. Minimum = 0 and maximum = 1. | Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) |
| Change in Mental Health Service Cost | Mental health service cost is measured by the amount of reimbursement for a paid claim from the Texas Department of State Health Services Data Warehouse, It represents the amount of dollars paid for delivery of a discrete behavioral health service. Higher value = higher cost. Minimum = 1 and maximum = 5,493. | First 12 months of study participation; Second 12 months of study participation; total 24 months of study participation |
| 649936 | Background | Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available. |
| 8636897 | Background | Williams GC, Deci EL. Internalization of biopsychosocial values by medical students: a test of self-determination theory. J Pers Soc Psychol. 1996 Apr;70(4):767-79. doi: 10.1037//0022-3514.70.4.767. |
| 30630401 | Result | Cook JA, Shore S, Burke-Miller JK, Jonikas JA, Hamilton M, Ruckdeschel B, Norris W, Markowitz AF, Ferrara M, Bhaumik D. Mental Health Self-Directed Care Financing: Efficacy in Improving Outcomes and Controlling Costs for Adults With Serious Mental Illness. Psychiatr Serv. 2019 Mar 1;70(3):191-201. doi: 10.1176/appi.ps.201800337. Epub 2019 Jan 11. |
| BG001 | Services as Usual | Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| High school diploma/General Equivalency Degree | Count of Participants | Participants |
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| Diagnosis Category | Count of Participants | Participants |
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| Mental Health services cost in year prior to study | Mean | Standard Deviation | Dollar Amount |
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Subjects receive traditional behavioral health and non-traditional services via a self-directed care model in which they develop a person-directed plan and create a budget for the purchase of medically necessary goods and services. Program staff acting as service brokers help them secure needed goods and services from within or outside the public behavioral health provider system. A fiscal intermediary manages financial resources to pay providers and enable the purchase of approved goods..
Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system
| OG001 | Services as Usual | Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency |
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| Secondary | Change in Self-esteem | Feelings of self-worth and confidence in general abilities as measured by the Rosenberg Self-Esteem Scale . Higher vales equal better self=esteem. Minimum = 10 and maximum = 40. | The number reflected in the "Overall Number of Participants Analyzed" pertains to the number of participants who completed the baseline interview. | Posted | Mean | Standard Deviation | score on a scale | Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) |
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| Secondary | Coping Mastery | Change in subjects' sense of personal control over important life outcomes as measured by the Coping Mastery Scale. Higher values equal better coping mastery. Minimum = 2 and maximum = 49. | The number reflected in the "Overall Number of Participants Analyzed" pertains to the number of participants who completed the baseline interview. | Posted | Mean | Standard Deviation | score on a scale | Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) |
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| Secondary | Perceived Autonomy Support | Perceived support for autonomously motivated change measured by the Learning Climate Questionnaire of Williams & Deci. Measures change in perception that service environment is supportive of autonomy to make decisions and choices. Higher score equals better autonomy support. Minimum = 4 and maximum = 105. | The number reflected in the "Overall Number of Participants Analyzed" pertains to the number of participants who completed the baseline interview. | Posted | Mean | Standard Deviation | score on a scale | Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) |
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| Secondary | Number of Participants With Employment | Change in employment status as measured by Bureau of Labor Statistics definition of paid employment: with paid employment versus without paid employment. Higher value equals with paid employment. Minimum = 0 and maximum = 1. | The number reflected in the "Overall Number of Participants Analyzed" pertains to the number of participants who completed the baseline interview. | Posted | Count of Participants | Participants | Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) |
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| Secondary | Number of Participants Enrolled in Classes | Change in education participation status as measured by U.S. Department of Education's definition of school enrollment: enrolled in classes requiring registration and fee payment versus not enrolled in classes. Higher value = enrolled in classes. Minimum = 0 and maximum = 1. | The number reflected in the "Overall Number of Participants Analyzed" pertains to the number of participants who completed the baseline interview. | Posted | Count of Participants | Participants | Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) |
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| Secondary | Change in Mental Health Service Cost | Mental health service cost is measured by the amount of reimbursement for a paid claim from the Texas Department of State Health Services Data Warehouse, It represents the amount of dollars paid for delivery of a discrete behavioral health service. Higher value = higher cost. Minimum = 1 and maximum = 5,493. | Posted | Mean | Standard Deviation | Dollar Amount | First 12 months of study participation; Second 12 months of study participation; total 24 months of study participation |
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| 3 |
| 114 |
| 1 |
| 114 |
| 12 |
| 114 |
| EG001 | Services as Usual | Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency | 2 | 102 | 0 | 102 | 11 | 102 |
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| Adverse events were monitored without regard to the specific adverse event term | Psychiatric disorders | Systematic Assessment | Incarceration of research subjects entirely unrelated to the research |
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| T2 - 12 months later (intervention mid-point) |
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| T3 - 24 months later (end of intervention) |
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| T2 - 12 months later (intervention mid-point) |
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| T3 - 24 months later (end of intervention) |
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| T2 - 12 months later (intervention mid-point) |
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| T3 - 24 months later (end of intervention) |
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| T2 - 12 months later (intervention mid-point) |
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| T3 - 24 months later (end of intervention) |
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| T2 - 12 months later (intervention mid-point) |
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| T3 - 24 months later (end of intervention) |
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| Psychotherapy: Year 1 |
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| Psychotherapy: Year 2 |
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| Skills Training: Year 1 |
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| Psychosocial Rehab: Year 1 |
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| Psychosocial Rehab: Year 2 |
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| Case Management: Year 1 |
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| Case Management: Year 2 |
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| Peer Services: Year 1 |
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| Peer Services: Year 2 |
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| Inpatient Care: Year 1 |
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| Inpatient Care: Year 2 |
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| Psychiatric Crisis Services:Year 1 |
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| Psychiatric Crisis Services: Year 2 |
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| Residential Support: Year 1 |
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| Residential Support: Year 2 |
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| Substance Abuse Treatment: Year 1 |
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| Substance Abuse Treatment: Year 2 |
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| Medication Management: Year 1 |
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| Medication Management: Year 2 |
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| Medications: Year 1 |
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| Medications: Year 2 |
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| Non-Traditional Services: Year 1 |
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| Non-Traditional Services: Year 2 |
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| Total Including Non-Traditional Services: Year 1 |
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| Total Including Non-Traditional Services: Year 2 |
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| Total Excluding Non-Traditional Services: Year 1 |
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| Total Excluding Non-Traditional Services: Year 2 |
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