Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03582813
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
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

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.

Layout table for study information
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 : May 1, 2009
Actual Primary Completion Date : May 1, 2013
Actual Study Completion Date : May 1, 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in perceived degree of recovery from mental illness measured by the Recovery Assessment Scale of Corrigan & Giffort [ Time Frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) ]
    Perceived level of recovery from mental illness regarding personal confidence, ability to ask for help, goal orientation, reliance on others, and tolerable symptom levels. For total score and subscale scores, higher values equal better recovery. For summed total score, minimum = 41 and maximum = 205. For summed personal confidence subscale, minimum = 9 and maximum = 45. For summed willingness to ask for help subscale, minimum = 3 and maximum = 15. For summed goal and success orientation subscale, minimum = 5 and maximum = 25. For summed reliance on others subscale, minimum = 4 and maximum = 20. For summed tolerable symptom levels subscale, minimum = 3 and maximum = 15.


Secondary Outcome Measures :
  1. Change in perceived self-esteem measured by the Rosenberg Self-Esteem Scale [ 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. Higher vales equal better self=esteem. Minimum = 10 and maximum = 40.

  2. Feeling of mastery regarding emotional coping measured by the Pearlin & Schooler Coping Mastery Scale [ 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. Higher values equal better coping mastery. Minimum = 7 and maximum = 49.

  3. Perceived support for autonomously motivated change measured by the Learning Climate Questionnaire of Williams & Deci [ Time Frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) ]
    Change in perception that service environment is supportive of autonomy to make decisions and choices. Higher score equals better autonomy support. Minimum = 15 and maximum = 105.

  4. Change in employment status measured by Bureau of Labor Statistics definition of paid employment [ Time Frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) ]
    Working for pay versus not. Higher value equals working for pay. Minimum = 0 and maximum = 1.

  5. Change in education participation status measured by U.S. Department of Education definition of school enrollment [ Time Frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) ]
    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 utilization measured by a paid claim from the Texas Department of State Health Services Data Warehouse [ Time Frame: First 12 months of study participation; Second 12 months of study participation; total 24 months of study participation ]
    Receipt of a discrete behavioral health service. Higher value = received service. Minimum = 0 and maximum = 1.

  7. Change in mental health service cost measured by the amount of reimbursement for a paid claim from the Texas Department of State Health Services Data Warehouse [ Time Frame: First 12 months of study participation; Second 12 months of study participation; total 24 months of study participation ]
    Amount of dollars paid for delivery of a discrete behavioral health service. Higher value = higher cost. Minimum = 1 and maximum = 5,000.

  8. Change in service satisfaction measured by the Client Satisfaction Questionnaire of Atkisson & Zwick [ Time Frame: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention) ]
    Subjects' reported level of satisfaction with mental health services received. Higher value = better satisfaction. Minimum = 8 and maximum = 32.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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)

Publications:
Layout table for additonal information
Responsible Party: Judith A. Cook, Professor of Psychiatry, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03582813     History of Changes
Other Study ID Numbers: H133B050003c
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Mental Disorders