Efficacy of Mental Health Self-Directed Care Financing (SDC-RCT)

• ClinicalTrials.gov Identifier: NCT03582813
• Recruitment Status: Completed
• First Posted: July 11, 2018
• Results First Posted: March 26, 2020
• Last Update Posted: March 26, 2020
• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research; Substance Abuse and Mental Health Services Administration (SAMHSA)
• Information provided by (Responsible Party): Judith A. Cook, University of Illinois at Chicago

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mental Illness Persistent	Behavioral: Self-directed care; Behavioral: Services as usual	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 216 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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..
• Masking: Single (Outcomes Assessor)
• Masking Description: Research interviewers were blinded to study condition
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Mental Health Self-Directed Care Financing in Texas
• Actual Study Start Date: March 1, 2009
• Actual Primary Completion Date: March 1, 2013
• Actual Study Completion Date: March 1, 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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..	Behavioral: Self-directed care; Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system
Active Comparator: Services as usual; Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers.	Behavioral: Services as usual; Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Change in Self-esteem [ Time Frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) ]
   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.
2. Coping Mastery [ Time Frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) ]
   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.
3. Perceived Autonomy Support [ Time Frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) ]
   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.
4. Number of Participants With Employment [ Time Frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) ]

   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.

5. 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 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.
6. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Sponsors and Collaborators

University of Illinois at Chicago

National Institute on Disability, Independent Living, and Rehabilitation Research

Substance Abuse and Mental Health Services Administration (SAMHSA)

Investigators

• Principal Investigator: Judith A Cook, PhD; University of Illinois at Chicago, Department of Psychiatry

More Information

Publications of Results:

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.

Other 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.

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.

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

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.

• Responsible Party: Judith A. Cook, Professor of Psychiatry, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT03582813
• Other Study ID Numbers: 2008-0970; H133B050003 ( Other Grant/Funding Number: US Dept of Educ-NIDRR Center for Mental Health Services Cooperative Agreement )
• First Posted: July 11, 2018
• Results First Posted: March 26, 2020
• Last Update Posted: March 26, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Judith A. Cook, University of Illinois at Chicago:

self-directed care; mental health services; mental health recovery; behavioral health service financing

Additional relevant MeSH terms:

Mental Disorders