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Completed

NCT Number: NCT03582813

Efficacy of Mental Health Self-Directed Care Financing

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.

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Key information

Conditions

Mental Illness Persistent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Self-directed care

Behavioral

Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system

Services as usual

Behavioral

Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research
  • Substance Abuse and Mental Health Services Administration (SAMHSA)

Registry information

Official study title

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

Acronym: SDC-RCT

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2018
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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