- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06053346
Partners in Wellness: Evaluation of a Pay for Performance Program for High-Utilizers of Mental Health Services
Evaluation of the Santa Clara County Mental Health Service Pay for Performance Quality Improvement Initiative
Healthcare systems in the United States (U.S.) have long faced the considerable challenge of managing budgetary pressures while at the same time helping people with serious mental illness and/or addiction. One potential way to address this challenge is to offer community-based services for individuals who are high-utilizers of expensive emergency and inpatient psychiatric services. Due to the decentralized nature of California governance, responsibility for mental health services falls primarily to the individual counties. The County of Santa Clara, CA invests significantly in community-based services as well as 24-hour care settings. This County adopted an innovative Pay for Performance (PFP) model and contracted with a new care provider to better meet the needs of this patient population and, in turn, reduce demand on the County's 24-hour psychiatric services. Whether this innovative contracting framework will help individuals who thus far have not responded well to mental health services is unknown. The purpose of this study was to determine whether the quality of care for these high-need patients was improved and at a sustainable cost. To this end, a randomized clinical trial (RCT) was conducted to determine whether this innovative quality improvement initiative, referred to as "Partners in Wellness", was successful at reducing the total cost of 24-hour psychiatric care used by enrollees compared to individuals who concurrently received services from the county. Individuals were randomly assigned to the Usual Care (UC) or Pay-For-Performance (PFP) conditions. The primary outcome of this evaluation was reduction in the total cost of 24-hour psychiatric services in the target population.
the primary outcome of this evaluation was reduction in the total cost of 24-hour psychiatric services in the target population.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals with a history of extensive utilization of 24-hour psychiatric services in Santa Clara County, CA and a likelihood of continuing to use them in the future.
Exclusion Criteria:
- Age 17 or younger
- Born before 1952
- Not current resident of the County
- Currently residing in a state hospital
- Registered sex offender with legally imposed residency restrictions
Have a DSM-V diagnosis of (or meet diagnostic criteria for):
- Dementia
- Autism Spectrum Disorder
- Catatonia
- Brief Psychotic Disorder
- Traumatic head injury resulting in severe cognitive impairment
- IQ of 69 or lower
- Eating disorders, including Pica, Anorexia Nervosa and Bulimia Nervosa, or
- Pyromania, or Psychogenic Polydipsia paired with life threatening behaviors in the past 12 months.
- Serious risk to self (i.e., suicidal intent with specific plan OR command hallucinations for self-harm that were acted on in the last 30 days and resulted in significant physical injury, or without staff intervention would have resulted in significant physical injury.
- Risk to others (e.g., sexual aggression or other violent, assaultive behavior toward clinical staff in the past 12 months).
- Serious medical diagnoses that either require intensive and regular home health care (e.g., Cystic Fibrosis, Parkinson's, Cancer), imminent risk of placement in a Skilled Nursing Facility or nursing home (e.g., non-ambulatory; needing would care), or are terminal or are life-threatening.
- Significant functional impairments (e.g., unable to toilet, incontinent and refuse to wear diaper, refuse to eat or drink, refuse to dress self or wear clothes, unable to transfer in/out of bed)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pay For Performance (PFP)
Participants receive a tailored mix of assertive case management, crisis intervention, substance use counseling, mental health treatment, peer support, skill-building and care coordination, among other services delivered by a provider agency contracted by Santa Clara County.
Individual and organizational performance incentives relative to traditional contracted service arrangements were also included.
Specifically, the agreement between the contracted provider and the County included an agreed schedule of financial rewards and penalties for the contracted provider based on whether its enrollees utilized more or less care than had a historical cohort of patients enrolled before the program began.
|
Wraparound mental health, psychosocial, and addiction treatment services provided by contractor under an schedule of rewards or penalties that was agreed to with Santa Clara County.
|
Active Comparator: Usual Care (UC)
Participants receive the usual array of mental health and psychosocial services offered by Santa Clara County.
|
Outpatient and inpatient mental health and psychosocial services delivered by Santa Clara County services and systems.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total cost of 24-hour psychiatric services (12 months)
Time Frame: 12 months post-enrollment
|
Total cost of the following care types beginning from enrollment until 12 months post-enrollment: Emergency Psychiatric Services (EPS), Barbara Arons Pavilion (BAP) Acute Psychiatric Inpatient, Contract Hospital, Institutes of Mental Disease (IMD), State Hospital, Crisis Residential, Transitional Residential, Super Board and Care, and Residential Care Facility.
Days of utilization for each service were multiplied by estimates of the average costs per client, per day provided by the County.
To create the primary outcome measure, costs from all of these sources were summed.
|
12 months post-enrollment
|
Total cost of 24-hour psychiatric services (24 months)
Time Frame: 24 months post-enrollment
|
Total cost of the following care types beginning from enrollment until 24 months post-enrollment: Emergency Psychiatric Services (EPS), Barbara Arons Pavilion (BAP) Acute Psychiatric Inpatient, Contract Hospital, Institutes of Mental Disease (IMD), State Hospital, Crisis Residential, Transitional Residential, Super Board and Care, and Residential Care Facility.
Days of utilization for each service were multiplied by estimates of the average costs per client, per day provided by the County.
To create the primary outcome measure, costs from all of these sources were summed.
|
24 months post-enrollment
|
Total cost of 24-hour psychiatric services (36 months)
Time Frame: 36 months post-enrollment
|
Total cost of the following care types beginning from enrollment until 36 months post-enrollment: Emergency Psychiatric Services (EPS), Barbara Arons Pavilion (BAP) Acute Psychiatric Inpatient, Contract Hospital, Institutes of Mental Disease (IMD), State Hospital, Crisis Residential, Transitional Residential, Super Board and Care, and Residential Care Facility.
Days of utilization for each service were multiplied by estimates of the average costs per client, per day provided by the County.
To create the primary outcome measure, costs from all of these sources were summed.
|
36 months post-enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total cost of Barbara Arons Pavilion (BAP) Acute Inpatient Psychiatric Care (12 months)
Time Frame: 12 months post-enrollment
|
Total cost of Barbara Arons Pavilion (BAP) Acute Psychiatric Inpatient Care in the 12 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
12 months post-enrollment
|
Total cost of Barbara Arons Pavilion (BAP) Acute Inpatient Psychiatric Care (24 months)
Time Frame: 24 months post-enrollment
|
Total cost of Barbara Arons Pavilion (BAP) Acute Psychiatric Inpatient Care in the 24 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
24 months post-enrollment
|
Total cost of Barbara Arons Pavilion (BAP) Acute Inpatient Psychiatric Care (36 months)
Time Frame: 36 months post-enrollment
|
Total cost of Barbara Arons Pavilion (BAP) Acute Psychiatric Inpatient Care in the 36 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
36 months post-enrollment
|
Total cost of Emergency Psychiatric Services (EPS) - 12 months
Time Frame: 12 months post-enrollment
|
Total cost of Emergency Psychiatric Services (EPS) in the 12 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
12 months post-enrollment
|
Total cost of Emergency Psychiatric Services (EPS) - 24 months
Time Frame: 24 months post-enrollment
|
Total cost of Emergency Psychiatric Services (EPS) in the 24 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
24 months post-enrollment
|
Total cost of Emergency Psychiatric Services (EPS) - 36 months
Time Frame: 36 months post-enrollment
|
Total cost of Emergency Psychiatric Services (EPS) in the 36 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
36 months post-enrollment
|
Total cost of Contract Hospital (12 months)
Time Frame: 12 months post-enrollment
|
Total cost of Contract Hospitals in the 12 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
12 months post-enrollment
|
Total cost of Contract Hospital (24 months)
Time Frame: 24 months post-enrollment
|
Total cost of Contract Hospitals in the 24 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
24 months post-enrollment
|
Total cost of Contract Hospital (36 months)
Time Frame: 36 months post-enrollment
|
Total cost of Contract Hospitals in the 36 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
36 months post-enrollment
|
Total cost of Crisis Residential Facility (12 months)
Time Frame: 12 months post-enrollment
|
Total cost of Crisis Residential Facility care in the 12 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
12 months post-enrollment
|
Total cost of Crisis Residential Facility (24 months)
Time Frame: 24 months post-enrollment
|
Total cost of Crisis Residential Facility care in the 24 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
24 months post-enrollment
|
Total cost of Crisis Residential Facility (36 months)
Time Frame: 36 months post-enrollment
|
Total cost of Crisis Residential Facility care in the 36 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
36 months post-enrollment
|
Total cost of Transitional Residential (12 months)
Time Frame: 12 months post-enrollment
|
Total cost of Transitional Residential care in the 12 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
12 months post-enrollment
|
Total cost of Transitional Residential (24 months)
Time Frame: 24 months post-enrollment
|
Total cost of Transitional Residential care in the 24 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
24 months post-enrollment
|
Total cost of Transitional Residential (36 months)
Time Frame: 36 months post-enrollment
|
Total cost of Transitional Residential care in the 36 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
36 months post-enrollment
|
Total cost of Residential Care Facility (12 months)
Time Frame: 12 months post-enrollment
|
Total cost of Residential Care Facilities in the 12 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
12 months post-enrollment
|
Total cost of Residential Care Facility (24 months)
Time Frame: 24 months post-enrollment
|
Total cost of Residential Care Facilities in the 24 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
24 months post-enrollment
|
Total cost of Residential Care Facility (36 months)
Time Frame: 36 months post-enrollment
|
Total cost of Residential Care Facilities in the 36 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
36 months post-enrollment
|
Total cost of Institutes of Mental Disease (12 months)
Time Frame: 12 months post-enrollment
|
Total cost of Institutes of Mental Disease in the 12 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
12 months post-enrollment
|
Total cost of Institutes of Mental Disease (24 months)
Time Frame: 24 months post-enrollment
|
Total cost of Institutes of Mental Disease in the 24 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
24 months post-enrollment
|
Total cost of Institutes of Mental Disease (36 months)
Time Frame: 36 months post-enrollment
|
Total cost of Institutes of Mental Disease in the 36 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
36 months post-enrollment
|
Total cost of Custody Health (12 months)
Time Frame: 12 months post-enrollment
|
Total cost of Jail-based mental health care in the 12 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
12 months post-enrollment
|
Total cost of Custody Health (24 months)
Time Frame: 24 months post-enrollment
|
Total cost of Jail-based mental health care in the 24 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
24 months post-enrollment
|
Total cost of Custody Health (36 months)
Time Frame: 36 months post-enrollment
|
Total cost of Jail-based mental health care in the 36 months post-enrollment.
Days of utilization for this service was multiplied by estimates of the average costs per client, per day provided by the County.
|
36 months post-enrollment
|
Incarceration (12 months)
Time Frame: 12 months post-enrollment
|
Proportion of patients who had any days of incarceration during the 12 months post-enrollment.
|
12 months post-enrollment
|
Incarceration (24 months)
Time Frame: 24 months post-enrollment
|
Proportion of patients who had any days of incarceration during the 24 months post-enrollment.
|
24 months post-enrollment
|
Incarceration (36 months)
Time Frame: 36 months post-enrollment
|
Proportion of patients who had any days of incarceration during the 36 months post-enrollment.
|
36 months post-enrollment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Keith Humphreys, PhD, Professor of Psychiatry
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30530
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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