NCT03582813

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 26, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

May 21, 2018

Results QC Date

January 8, 2020

Last Update Submit

March 12, 2020

Conditions

Keywords

self-directed caremental health servicesmental health recoverybehavioral health service financing

Outcome Measures

Primary Outcomes (1)

  • Recovery From Mental Illness

    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 Outcomes (6)

  • Change in Self-esteem

    Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)

  • Coping Mastery

    Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)

  • Perceived Autonomy Support

    Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)

  • Number of Participants With Employment

    Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)

  • Number of Participants Enrolled in Classes

    Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)

  • +1 more secondary outcomes

Study Arms (2)

Self-directed care

EXPERIMENTAL

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

Services as usual

ACTIVE COMPARATOR

Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers.

Behavioral: Services as usual

Interventions

Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system

Self-directed care

Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency

Services as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or older
  • able to understand spoken English.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Scanlan JN, Hancock N, Honey A. The Recovery Assessment Scale - Domains and Stages (RAS-DS): Sensitivity to change over time and convergent validity with level of unmet need. Psychiatry Res. 2018 Mar;261:560-564. doi: 10.1016/j.psychres.2018.01.042.

    PMID: 29407723BACKGROUND
  • Davis C, Kellett S, Beail N. Utility of the Rosenberg self-esteem scale. Am J Intellect Dev Disabil. 2009 May;114(3):172-8. doi: 10.1352/1944-7558-114.3.172.

    PMID: 19374464BACKGROUND
  • Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.

    PMID: 649936BACKGROUND
  • Williams GC, Deci EL. Internalization of biopsychosocial values by medical students: a test of self-determination theory. J Pers Soc Psychol. 1996 Apr;70(4):767-79. doi: 10.1037//0022-3514.70.4.767.

    PMID: 8636897BACKGROUND
  • Cook JA, Shore S, Burke-Miller JK, Jonikas JA, Hamilton M, Ruckdeschel B, Norris W, Markowitz AF, Ferrara M, Bhaumik D. Mental Health Self-Directed Care Financing: Efficacy in Improving Outcomes and Controlling Costs for Adults With Serious Mental Illness. Psychiatr Serv. 2019 Mar 1;70(3):191-201. doi: 10.1176/appi.ps.201800337. Epub 2019 Jan 11.

Results Point of Contact

Title
Dr. Judith A. Cook, Director
Organization
Center on Mental Health Services Research and Policy, University of Illinois at Chicago, Department of Psychiatry

Study Officials

  • Judith A Cook, PhD

    University of Illinois at Chicago, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research interviewers were blinded to study condition
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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..
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

May 21, 2018

First Posted

July 11, 2018

Study Start

March 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 26, 2020

Results First Posted

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share