search
Back to results

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

Primary Purpose

Mental Illness Persistent

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-directed care
Services as usual
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Illness Persistent focused on measuring self-directed care, mental health services, mental health recovery, behavioral health service financing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Self-directed care

    Services as usual

    Arm Description

    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..

    Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    May 21, 2018
    Last Updated
    March 12, 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)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03582813
    Brief Title
    Efficacy of Mental Health Self-Directed Care Financing
    Acronym
    SDC-RCT
    Official Title
    Randomized Controlled Trial of Mental Health Self-Directed Care Financing in Texas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2009 (Actual)
    Primary Completion Date
    March 1, 2013 (Actual)
    Study Completion Date
    March 1, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Illinois at Chicago
    Collaborators
    National Institute on Disability, Independent Living, and Rehabilitation Research, Substance Abuse and Mental Health Services Administration (SAMHSA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Illness Persistent
    Keywords
    self-directed care, mental health services, mental health recovery, behavioral health service financing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Outcomes Assessor
    Masking Description
    Research interviewers were blinded to study condition
    Allocation
    Randomized
    Enrollment
    216 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Self-directed care
    Arm Type
    Experimental
    Arm Description
    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..
    Arm Title
    Services as usual
    Arm Type
    Active Comparator
    Arm Description
    Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-directed care
    Intervention Description
    Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system
    Intervention Type
    Behavioral
    Intervention Name(s)
    Services as usual
    Intervention Description
    Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
    Primary Outcome Measure Information:
    Title
    Recovery From Mental Illness
    Description
    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.
    Time Frame
    Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
    Secondary Outcome Measure Information:
    Title
    Change in Self-esteem
    Description
    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.
    Time Frame
    Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
    Title
    Coping Mastery
    Description
    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.
    Time Frame
    Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
    Title
    Perceived Autonomy Support
    Description
    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.
    Time Frame
    Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
    Title
    Number of Participants With Employment
    Description
    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.
    Time Frame
    Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
    Title
    Number of Participants Enrolled in Classes
    Description
    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.
    Time Frame
    Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
    Title
    Change in Mental Health Service Cost
    Description
    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.
    Time Frame
    First 12 months of study participation; Second 12 months of study participation; total 24 months of study participation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Judith A Cook, PhD
    Organizational Affiliation
    University of Illinois at Chicago, Department of Psychiatry
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29407723
    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.
    Results Reference
    background
    PubMed Identifier
    19374464
    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.
    Results Reference
    background
    PubMed Identifier
    649936
    Citation
    Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
    Results Reference
    background
    PubMed Identifier
    8636897
    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.
    Results Reference
    background
    PubMed Identifier
    30630401
    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.
    Results Reference
    result

    Learn more about this trial

    Efficacy of Mental Health Self-Directed Care Financing

    We'll reach out to this number within 24 hrs