Testing Self-Directed Care in Florida

May 8, 2023 updated by: Judith A. Cook, University of Illinois at Chicago

Money Follows the Person Through Self-Directed Care in Florida

This study tests a psychosocial intervention called mental health self-directed care by assessing its impact on recovery, mental health status, rehabilitation outcomes, and service costs in the state of Florida.

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

With additional funding from the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR), a new cohort of 40 study subjects will be recruited in the state of Florida to test mental health self-directed care (SDC). SDC is a self-directed model of service delivery in which participants manage a personal budget from which they purchase goods and services, including specific types of mental health care, social supports, and items that allow them to recover their health and emotional wellness and live independently. Investigators are studying the impact of SDC on recovery, mental health status, rehabilitation outcomes, and service costs. Working with Lutheran Services Florida, a public managing entity coordinating mental health care management in northeastern and central Florida, adults with mental health conditions will be recruited into the study and randomly assigned to receive SDC for one year or continue receiving services as usual. Assessments will occur at baseline, 6- and 12-month followup.

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.
42

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago, Department of Psychiatry

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 and older
  • Serious mental illness
  • Receiving services coordinated by behavioral health managing entity

Exclusion Criteria:

  • Cognitive impairment preventing informed consent
  • Enrollment in Medicaid/Medicare
  • Representative payeeship
  • Court-mandated treatment
  • Recent substance disorder crisis
  • In residential treatment
  • History of violent behavior in the past 10 years

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 Assignment
  • 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: Experimental
Participants meet with self-directed care program staff called brokers to receive a program orientation, share perceptions of their current life situation and mental health status, and review past year behavioral health service use as well as participants' views of service helpfulness. This culminates in participants' choice of recovery goals and development of an individual budget to pay for for services and material goods directly related to recovery goals. After budget approval by the program supervisor, brokers make purchases. At quarterly meetings, brokers and participants discuss the latter's progress toward recovery goals and create the next quarter's budget. After receiving 12 months of SDC services, participants are helped to transition back to usual community mental health services.
Behavioral: Self-Directed Care
Participants meet with self-directed care program staff called brokers to receive a program orientation, share perceptions of their current life situation and mental health status, and review past year behavioral health service use as well as participants' views of service helpfulness. This culminates in participants' choice of recovery goals and development of an individual budget to pay for for services and material goods directly related to recovery goals. After budget approval by the program supervisor, brokers make purchases. At quarterly meetings, brokers and participants discuss the latter's progress toward recovery goals and create the next quarter's budget. After receiving 12 months of SDC services, participants are helped to transition back to usual community mental health services.
Active Comparator: Control
Subjects receive routine mental health care from community agencies consisting of outpatient services coordinated at community behavioral health programs.
Behavioral: Services as usual
Participants receive usual outpatient psychiatric care delivered at community programs from which the person can choose from an array of services negotiated with the state mental health authority.

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
Change in perceived competence for mental health self-management
Time Frame: study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)
Perceived competence is measured with the Perceived Competence Scale that includes 4 items that assess subjects' self-rated ability to manage their mental health and recovery, with scores ranging from 4 to 28, with higher scores indicating greater perceived competence for mental health self-management.
study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-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 met and unmet needs related to multiple life domains
Time Frame: study entry (pre-intervention), 6-months (intervention mid-point), 12 months (immediate post-intervention)
Change in met and unmet needs is measured with the Camberwell Assessment of Need Short Appraisal Schedule with 22 items that assess needs across multiple life domains such as psychological distress, general health, and finances, which results in 2 scores, each ranging from 0-22, with higher scores indicating more met needs or more unmet needs.
study entry (pre-intervention), 6-months (intervention mid-point), 12 months (immediate post-intervention)
Change in perception of service providers as supportive of client autonomy
Time Frame: study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)
Change in provider support for client autonomy is measured by the Health Care Climate Questionnaire with 6 items that assess the degree to which subjects rate their services providers as encouraging autonomy by providing information, encouraging choice, and acknowledging subjects' emotions, with scores ranging from 6 to 42, with higher scores indicating more perceived autonomy support.
study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)
Change in self-rated recovery from mental illness
Time Frame: study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)
Change in self-rated recovery is measured by the Recovery Assessment Scale with 41 items that assess perceived level of recovery from mental illness, with higher scores indicating greater recovery.
study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)
Change in employment status
Time Frame: study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)
Assessment of employment status using the U.S. Bureau of Labor Statistics definition of paid employment which ranges from 0 (no) to 1 (employed) where a higher score indicates employment.
study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)
Change in service costs
Time Frame: 12-month period of study participation
Service cost is measured by the dollar amount of reimbursement paid by the behavioral health managing entity to a service provider or program for a paid claim for a discrete service with scores ranging from 0 dollars to no upper limit of dollars where higher scores indicate greater cost.
12-month period 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

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.
September 5, 2017

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 26, 2020

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 26, 2020

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).
December 5, 2022

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.
December 12, 2022

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.
December 14, 2022

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.
May 9, 2023

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.
May 8, 2023

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.
May 1, 2023

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.
  • STUDY2008-0970

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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