- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649449
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
42
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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.
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)
September 5, 2017
Primary Completion (Actual)
March 26, 2020
Study Completion (Actual)
March 26, 2020
Study Registration Dates
First Submitted
December 5, 2022
First Submitted That Met QC Criteria
December 12, 2022
First Posted (Actual)
December 14, 2022
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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