Clinical trial NCT03582813: Efficacy of Mental Health Self-Directed Care Financing
Official title: Randomized Controlled Trial of Mental Health Self-Directed Care Financing in Texas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness Persistent
Keywords: self-directed care
mental health services
mental health recovery
behavioral health service financing
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
name: Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted: 2018-07-11
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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..
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Recovery From Mental Illness
timeFrame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
Secondary outcomes:
measure: Change in Self-esteem
timeFrame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
measure: Coping Mastery
timeFrame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
measure: Perceived Autonomy Support
timeFrame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
measure: Number of Participants With Employment
timeFrame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
measure: Number of Participants Enrolled in Classes
timeFrame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
measure: Change in Mental Health Service Cost
timeFrame: First 12 months of study participation; Second 12 months of study participation; total 24 months of study participation
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois at Chicago, Department of Psychiatry
name: Judith A Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
citation: 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.
citation: 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.