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

March 12, 2020 updated by: Judith A. Cook, University of Illinois at Chicago

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.
Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.
Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.
Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.
Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
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.
First 12 months of study participation; Second 12 months of study participation; total 24 months of study participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Disability, Independent Living, and Rehabilitation Research
Substance Abuse and Mental Health Services Administration (SAMHSA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Judith A Cook, PhD, University of Illinois at Chicago, Department of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2008-0970
  • H133B050003 (OTHER_GRANT: US Dept of Educ-NIDRR Center for Mental Health Services Cooperative Agreement)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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