Trial Outcomes & Findings for Efficacy of Mental Health Self-Directed Care Financing (NCT NCT03582813)

NCT ID: NCT03582813

Last Updated: 2020-03-26

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 216 participants
• Primary outcome timeframe: Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)
• Results posted on: 2020-03-26

Participant Flow

Eligible participants ( who were active Texas Department of State Health Services (DSHS) were recruited at community mental health agencies by local research staff between March 2009 and September 2010.

Participant milestones

Measure	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.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system	Services as Usual Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
Overall Study STARTED	114	102
Overall Study COMPLETED	95	81
Overall Study NOT COMPLETED	19	21

Reasons for withdrawal

Measure	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.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system	Services as Usual Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
Overall Study Lost to Follow-up	18	21
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Efficacy of Mental Health Self-Directed Care Financing

Baseline characteristics by cohort

Measure	Self-directed Care n=114 Participants 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.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system	Services as Usual n=102 Participants Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency	Total n=216 Participants Total of all reporting groups
Age, Continuous	41.6 Years STANDARD_DEVIATION 10.0 • n=5 Participants	41.6 Years STANDARD_DEVIATION 9.5 • n=7 Participants	41.6 Years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	58 Participants n=7 Participants	134 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	44 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants	11 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	92 Participants n=5 Participants	91 Participants n=7 Participants	183 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	51 Participants n=5 Participants	52 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants	47 Participants n=7 Participants	107 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
High school diploma/General Equivalency Degree	76 Participants n=5 Participants	66 Participants n=7 Participants	142 Participants n=5 Participants
Diagnosis Category Schizophrenia	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Diagnosis Category Major Depressive Disorder	43 Participants n=5 Participants	45 Participants n=7 Participants	88 Participants n=5 Participants
Diagnosis Category Bipolar I or II Disorder	33 Participants n=5 Participants	22 Participants n=7 Participants	55 Participants n=5 Participants
Diagnosis Category Co-Occurring Substance Abuse	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Mental Health services cost in year prior to study	4,390 Dollar Amount STANDARD_DEVIATION 3.29 • n=5 Participants	3,996 Dollar Amount STANDARD_DEVIATION 3.83 • n=7 Participants	4,204 Dollar Amount STANDARD_DEVIATION 3.55 • n=5 Participants

PRIMARY outcome

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

Population: The number reflected in the "Overall Number of Participants Analyzed" pertains to the number of participants who completed the baseline interview.

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.

Outcome measures

Measure	Self-directed Care n=114 Participants 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.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system	Services as Usual n=102 Participants Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
Recovery From Mental Illness T1 - Baseline (pre-intervention)	148.0 score on a scale Standard Deviation 20.45	152.81 score on a scale Standard Deviation 22.21
Recovery From Mental Illness T2 - 12 months later (intervention mid-point)	151.88 score on a scale Standard Deviation 21.77	154.56 score on a scale Standard Deviation 20.03
Recovery From Mental Illness T3 - 24 months later (end of intervention)	152.17 score on a scale Standard Deviation 21.18	153.62 score on a scale Standard Deviation 22.02

SECONDARY outcome

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

Population: The number reflected in the "Overall Number of Participants Analyzed" pertains to the number of participants who completed the baseline interview.

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.

Outcome measures

Measure	Self-directed Care n=114 Participants 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.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system	Services as Usual n=102 Participants Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
Change in Self-esteem T1 - Baseline (pre-intervention)	23.97 score on a scale Standard Deviation 5.78	24.57 score on a scale Standard Deviation 5.49
Change in Self-esteem T2 - 12 months later (intervention mid-point)	25.74 score on a scale Standard Deviation 5.64	25.74 score on a scale Standard Deviation 5.53
Change in Self-esteem T3 - 24 months later (end of intervention)	25.42 score on a scale Standard Deviation 5.75	25.19 score on a scale Standard Deviation 5.59

SECONDARY outcome

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

Population: The number reflected in the "Overall Number of Participants Analyzed" pertains to the number of participants who completed the baseline interview.

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.

Outcome measures

Measure	Self-directed Care n=114 Participants 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.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system	Services as Usual n=102 Participants Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
Coping Mastery T1 - Baseline (pre-intervention)	2.60 score on a scale Standard Deviation 0.50	2.66 score on a scale Standard Deviation 0.46
Coping Mastery T2 - 12 months later (intervention mid-point)	2.67 score on a scale Standard Deviation 0.52	2.69 score on a scale Standard Deviation 0.61
Coping Mastery T3 - 24 months later (end of intervention)	2.79 score on a scale Standard Deviation 0.51	2.60 score on a scale Standard Deviation 0.60

SECONDARY outcome

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

Population: The number reflected in the "Overall Number of Participants Analyzed" pertains to the number of participants who completed the baseline interview.

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.

Outcome measures

Measure	Self-directed Care n=114 Participants 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.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system	Services as Usual n=102 Participants Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
Perceived Autonomy Support T1 - Baseline (pre-intervention)	4.74 score on a scale Standard Deviation 1.72	4.65 score on a scale Standard Deviation 1.82
Perceived Autonomy Support T2 - 12 months later (intervention mid-point)	5.56 score on a scale Standard Deviation 1.33	4.85 score on a scale Standard Deviation 1.57
Perceived Autonomy Support T3 - 24 months later (end of intervention)	5.44 score on a scale Standard Deviation 1.54	4.83 score on a scale Standard Deviation 1.84

SECONDARY outcome

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

Population: The number reflected in the "Overall Number of Participants Analyzed" pertains to the number of participants who completed the baseline interview.

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.

Outcome measures

Measure	Self-directed Care n=114 Participants 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.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system	Services as Usual n=102 Participants Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
Number of Participants With Employment T1 - Baseline (pre-intervention)	16 Participants	13 Participants
Number of Participants With Employment T2 - 12 months later (intervention mid-point)	18 Participants	6 Participants
Number of Participants With Employment T3 - 24 months later (end of intervention)	19 Participants	6 Participants

SECONDARY outcome

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

Population: The number reflected in the "Overall Number of Participants Analyzed" pertains to the number of participants who completed the baseline interview.

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.

Outcome measures

Measure	Self-directed Care n=114 Participants 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.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system	Services as Usual n=102 Participants Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
Number of Participants Enrolled in Classes T1 - Baseline (pre-intervention)	7 Participants	10 Participants
Number of Participants Enrolled in Classes T2 - 12 months later (intervention mid-point)	5 Participants	5 Participants
Number of Participants Enrolled in Classes T3 - 24 months later (end of intervention)	11 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Self-directed Care n=114 Participants 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.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system	Services as Usual n=102 Participants Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
Change in Mental Health Service Cost Psychotherapy: Year 2	133 Dollar Amount Standard Deviation 346	12 Dollar Amount Standard Deviation 70
Change in Mental Health Service Cost Skills Training: Year 1	4 Dollar Amount Standard Deviation 19	27 Dollar Amount Standard Deviation 71
Change in Mental Health Service Cost Substance Abuse Treatment: Year 1	44 Dollar Amount Standard Deviation 227	203 Dollar Amount Standard Deviation 1029
Change in Mental Health Service Cost Substance Abuse Treatment: Year 2	55 Dollar Amount Standard Deviation 385	90 Dollar Amount Standard Deviation 504
Change in Mental Health Service Cost Medication Management: Year 1	182 Dollar Amount Standard Deviation 205	303 Dollar Amount Standard Deviation 229
Change in Mental Health Service Cost Medication Management: Year 2	111 Dollar Amount Standard Deviation 162	200 Dollar Amount Standard Deviation 282
Change in Mental Health Service Cost Diagnostic services: Year 1	36 Dollar Amount Standard Deviation 67	26 Dollar Amount Standard Deviation 54
Change in Mental Health Service Cost Diagnostic services: Year 2	14 Dollar Amount Standard Deviation 43	14 Dollar Amount Standard Deviation 43
Change in Mental Health Service Cost Psychotherapy: Year 1	229 Dollar Amount Standard Deviation 454	23 Dollar Amount Standard Deviation 118
Change in Mental Health Service Cost Psychosocial Rehab: Year 1	311 Dollar Amount Standard Deviation 783	646 Dollar Amount Standard Deviation 1394
Change in Mental Health Service Cost Psychosocial Rehab: Year 2	130 Dollar Amount Standard Deviation 421	177 Dollar Amount Standard Deviation 416
Change in Mental Health Service Cost Case Management: Year 1	26 Dollar Amount Standard Deviation 165	31 Dollar Amount Standard Deviation 141
Change in Mental Health Service Cost Case Management: Year 2	3 Dollar Amount Standard Deviation 15	39 Dollar Amount Standard Deviation 149
Change in Mental Health Service Cost Peer Services: Year 1	11 Dollar Amount Standard Deviation 64	9 Dollar Amount Standard Deviation 41
Change in Mental Health Service Cost Peer Services: Year 2	15 Dollar Amount Standard Deviation 101	13 Dollar Amount Standard Deviation 89
Change in Mental Health Service Cost Inpatient Care: Year 1	223 Dollar Amount Standard Deviation 1270	344 Dollar Amount Standard Deviation 1405
Change in Mental Health Service Cost Inpatient Care: Year 2	72 Dollar Amount Standard Deviation 476	269 Dollar Amount Standard Deviation 1385
Change in Mental Health Service Cost Psychiatric Crisis Services:Year 1	121 Dollar Amount Standard Deviation 453	168 Dollar Amount Standard Deviation 407
Change in Mental Health Service Cost Psychiatric Crisis Services: Year 2	70 Dollar Amount Standard Deviation 269	162 Dollar Amount Standard Deviation 574
Change in Mental Health Service Cost Residential Support: Year 1	58 Dollar Amount Standard Deviation 336	23 Dollar Amount Standard Deviation 166
Change in Mental Health Service Cost Residential Support: Year 2	58 Dollar Amount Standard Deviation 371	69 Dollar Amount Standard Deviation 386
Change in Mental Health Service Cost Medications: Year 1	1071 Dollar Amount Standard Deviation 2047	1387 Dollar Amount Standard Deviation 2574
Change in Mental Health Service Cost Medications: Year 2	902 Dollar Amount Standard Deviation 2414	1218 Dollar Amount Standard Deviation 2993
Change in Mental Health Service Cost Non-Traditional Services: Year 1	679 Dollar Amount Standard Deviation 516	0 Dollar Amount Standard Deviation 0
Change in Mental Health Service Cost Non-Traditional Services: Year 2	667 Dollar Amount Standard Deviation 658	0 Dollar Amount Standard Deviation 0
Change in Mental Health Service Cost Total Including Non-Traditional Services: Year 1	2998 Dollar Amount Standard Deviation 3128	3189 Dollar Amount Standard Deviation 4608
Change in Mental Health Service Cost Total Including Non-Traditional Services: Year 2	2241 Dollar Amount Standard Deviation 2960	2303 Dollar Amount Standard Deviation 4266
Change in Mental Health Service Cost Total Excluding Non-Traditional Services: Year 1	2319 Dollar Amount Standard Deviation 3316	3189 Dollar Amount Standard Deviation 4608
Change in Mental Health Service Cost Total Excluding Non-Traditional Services: Year 2	1574 Dollar Amount Standard Deviation 2938	2303 Dollar Amount Standard Deviation 4266

Adverse Events

Self-directed Care

Serious events: 1 serious events

Other events: 12 other events

Deaths: 3 deaths

Services as Usual

Serious events: 0 serious events

Other events: 11 other events

Deaths: 2 deaths

Serious adverse events

Measure	Self-directed Care n=114 participants at risk 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.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system	Services as Usual n=102 participants at risk Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
Immune system disorders Adverse events were monitored without regard to the specific adverse event term	0.88% 1/114 • Number of events 1 • The time frame over which adverse event data were collected was 3 years. For other serious adverse events, we included incarcerations.	0.00% 0/102 • The time frame over which adverse event data were collected was 3 years. For other serious adverse events, we included incarcerations.

Other adverse events

Measure	Self-directed Care n=114 participants at risk 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.. Self-directed care: Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system	Services as Usual n=102 participants at risk Subjects receive traditional behavioral health services as usual via the traditional service delivery system and its network of providers. Services as usual: Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
Psychiatric disorders Adverse events were monitored without regard to the specific adverse event term	10.5% 12/114 • Number of events 12 • The time frame over which adverse event data were collected was 3 years. For other serious adverse events, we included incarcerations.	9.8% 10/102 • Number of events 10 • The time frame over which adverse event data were collected was 3 years. For other serious adverse events, we included incarcerations.

Additional Information

Dr. Judith A. Cook, Director

Center on Mental Health Services Research and Policy, University of Illinois at Chicago, Department of Psychiatry

Phone: 312-355-3921

Email: jcook@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place