Efficacy of Mental Health Self-Directed Care Financing

Mental Illness Persistent Clinical Trial

— SDC-RCT  

Official title:

Randomized Controlled Trial of Mental Health Self-Directed Care Financing in Texas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582813
• Other study ID #: 2008-0970
• Secondary ID: H133B050003
• Status: Completed
• Phase: N/A
• Start date: March 1, 2009
• Est. completion date: March 1, 2013

Study information

• Verified date: March 2020
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: March 1, 2013
• Est. primary completion date: March 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness Persistent

Intervention

Behavioral:
• Self-directed care
Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system
• Services as usual
Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute on Disability, Independent Living, and Rehabilitation Research, Substance Abuse and Mental Health Services Administration (SAMHSA)

References & Publications (5)

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 — View 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. — View Citation

Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.	Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.	Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.	Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.	Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.	Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.	First 12 months of study participation; Second 12 months of study participation; total 24 months of study participation