Mental Illness PersistentSDC-RCTNCT03582813
Efficacy of Mental Health Self-Directed Care Financing
A study testing Self-directed care and Services as usual in people with Mental Illness Persistent, run by University of Illinois Chicago.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness Persistent
- What is being tested?
- Self-directed care and Services as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2009to 1 Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- receiving mental health services at a Texas Department of State Health Services-funded mental health program
- diagnosis of serious mental illness consistent with federal Public Law 102-32
- assigned to a level of care eligible for a package of comprehensive clinical and rehabilitation services known as Service Package 3
- 18 years or older
- able to understand spoken English.
Who cannot join
- cognitive impairment
- homeless at time of recruitment
- history of violent behavior resulting in arrest and conviction in the past 10 years
- active substance use in the absence of substance use treatment
- enrollment in Medicare or dual beneficiary
- finances controlled by a third party (e.g., representative payee)
About this study
Official title: Randomized Controlled Trial of Mental Health Self-Directed Care Financing in Texas
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.
Read the detailed description
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.
- Conditions
- Mental Illness Persistent
- Being tested
- Self-directed care, Services as usual
- Keywords
- self-directed care, mental health services, mental health recovery, behavioral health service financing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-directed careBehavioural
Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system
Services as usualBehavioural
Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
| Study group | Role | What they receive |
|---|---|---|
| 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.. Receives: Behavioral: Self-directed care |
| Services as usual | Active comparator | Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Receives: Behavioral: Services as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
Secondary outcomes (6)
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.
Measured: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First 12 months of study participation; Second 12 months of study participation; total 24 months of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start1 Mar 2009
- Primary completion1 Mar 2013
- Study completion1 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental Illness PersistentStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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..
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Principal investigator, Judith A. Cook, University of Illinois Chicago
- Investigators
- Judith A Cook, PhD, Principal investigator, University of Illinois at Chicago, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582813
- Sponsor's protocol ID
- 2008-0970
- Other IDs
- H133B050003
- Acronym
- SDC-RCT
- Status last verified
- Mar 2020
- First submitted
- 21 May 2018
- Last updated
- 26 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29407723Davis 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.
PubMed 19374464Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
PubMed 649936Williams 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.
PubMed 8636897Cook 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.
PubMed 30630401
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Mental Health Self-Directed Care Financing in Texas
- ClinicalTrials.gov ID
- NCT03582813
- Acronym / sponsor ID
- SDC-RCT / 2008-0970
- Conditions
- Mental Illness Persistent
- Keywords
- self-directed care, mental health services, mental health recovery, behavioral health service financing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 1 Mar 2009 (actual)
- Primary completion
- 1 Mar 2013 (actual)
- Study completion
- 1 Mar 2013 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Posted 26 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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..
| Arm | Type | Receives |
|---|---|---|
| Self-directed care | Experimental | Behavioral: Self-directed careSubjects 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.. |
| Services as usual | Active comparator | Behavioral: Services as usualSubjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- receiving mental health services at a Texas Department of State Health Services-funded mental health program
- diagnosis of serious mental illness consistent with federal Public Law 102-32
- assigned to a level of care eligible for a package of comprehensive clinical and rehabilitation services known as Service Package 3
- 18 years or older
- able to understand spoken English.
Key exclusion criteria (6 listed)
- cognitive impairment
- homeless at time of recruitment
- history of violent behavior resulting in arrest and conviction in the past 10 years
- active substance use in the absence of substance use treatment
- enrollment in Medicare or dual beneficiary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-directed careTraditional and non-traditional behavioral health services are chosen from within and outside the public mental health system | Behavioural | Self-directed care |
| Services as usualTraditional behavioral health services are chosen from along those delivered at the patient's community mental health agency | Behavioural | Services as usual |
Primary outcome
Recovery From Mental Illness
Time frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.
6 secondary outcomes
Change in Self-esteem
Time frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
Coping Mastery
Time frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
Perceived Autonomy Support
Time frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
Number of Participants With Employment
Time frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
Number of Participants Enrolled in Classes
Time frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
Change in Mental Health Service Cost
Time frame: First 12 months of study participation; Second 12 months of study participation; total 24 months of study participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29407723Scanlan 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.
- Background: PubMed 19374464Davis 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.
- Background: PubMed 649936Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
- Background: PubMed 8636897Williams 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.
- Results publication: PubMed 30630401Cook 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith A Cook, PhD principal investigator
University of Illinois at Chicago, Department of Psychiatry
Questions about this trial
What is this clinical trial studying?
A study testing Self-directed care and Services as usual in people with Mental Illness Persistent, run by University of Illinois Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery From Mental Illness (time frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03582813, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.