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Testing Self-Directed Care in Florida

Primary Purpose

Mental Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
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 Disorder focused on measuring self-directed care

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois at Chicago, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

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.

Subjects receive routine mental health care from community agencies consisting of outpatient services coordinated at community behavioral health programs.

Outcomes

Primary Outcome Measures

Change in perceived competence for mental health self-management
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.

Secondary Outcome Measures

Change in met and unmet needs related to multiple life domains
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.
Change in perception of service providers as supportive of client autonomy
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.
Change in self-rated recovery from mental illness
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.
Change in employment status
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.
Change in service costs
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.

Full Information

First Posted
December 5, 2022
Last Updated
May 8, 2023
Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT05649449
Brief Title
Testing Self-Directed Care in Florida
Official Title
Money Follows the Person Through Self-Directed Care in Florida
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
March 26, 2020 (Actual)
Study Completion Date
March 26, 2020 (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

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder
Keywords
self-directed care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Self-directed care is a recovery-oriented model of community mental health 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.
Masking
Outcomes Assessor
Masking Description
Research interviewers are blinded to study condition.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects receive routine mental health care from community agencies consisting of outpatient services coordinated at community behavioral health programs.
Intervention Type
Behavioral
Intervention Name(s)
Self-Directed Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Services as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in perceived competence for mental health self-management
Description
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.
Time Frame
study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)
Secondary Outcome Measure Information:
Title
Change in met and unmet needs related to multiple life domains
Description
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.
Time Frame
study entry (pre-intervention), 6-months (intervention mid-point), 12 months (immediate post-intervention)
Title
Change in perception of service providers as supportive of client autonomy
Description
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.
Time Frame
study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)
Title
Change in self-rated recovery from mental illness
Description
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.
Time Frame
study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)
Title
Change in employment status
Description
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.
Time Frame
study entry (pre-intervention), 6-months (intervention mid-point), 12-months (immediate post-intervention)
Title
Change in service costs
Description
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.
Time Frame
12-month period of study participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Illinois at Chicago, Department of Psychiatry
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Testing Self-Directed Care in Florida

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