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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06053346
Other study ID # 30530
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2016
Est. completion date July 1, 2023

Study information

Verified date September 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 652
Est. completion date July 1, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Behavioral:
Pay For Performance (PFP)
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.
Usual Care (UC)
Outpatient and inpatient mental health and psychosocial services delivered by Santa Clara County services and systems.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Outcome

Type Measure Description Time frame Safety issue
Primary Total cost of 24-hour psychiatric services (12 months) 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
Primary Total cost of 24-hour psychiatric services (24 months) 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
Primary Total cost of 24-hour psychiatric services (36 months) 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 Total cost of Barbara Arons Pavilion (BAP) Acute Inpatient Psychiatric Care (12 months) 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
Secondary Total cost of Barbara Arons Pavilion (BAP) Acute Inpatient Psychiatric Care (24 months) 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
Secondary Total cost of Barbara Arons Pavilion (BAP) Acute Inpatient Psychiatric Care (36 months) 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
Secondary Total cost of Emergency Psychiatric Services (EPS) - 12 months 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
Secondary Total cost of Emergency Psychiatric Services (EPS) - 24 months 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
Secondary Total cost of Emergency Psychiatric Services (EPS) - 36 months 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
Secondary Total cost of Contract Hospital (12 months) 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
Secondary Total cost of Contract Hospital (24 months) 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
Secondary Total cost of Contract Hospital (36 months) 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
Secondary Total cost of Crisis Residential Facility (12 months) 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
Secondary Total cost of Crisis Residential Facility (24 months) 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
Secondary Total cost of Crisis Residential Facility (36 months) 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
Secondary Total cost of Transitional Residential (12 months) 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
Secondary Total cost of Transitional Residential (24 months) 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
Secondary Total cost of Transitional Residential (36 months) 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
Secondary Total cost of Residential Care Facility (12 months) 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
Secondary Total cost of Residential Care Facility (24 months) 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
Secondary Total cost of Residential Care Facility (36 months) 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
Secondary Total cost of Institutes of Mental Disease (12 months) 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
Secondary Total cost of Institutes of Mental Disease (24 months) 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
Secondary Total cost of Institutes of Mental Disease (36 months) 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
Secondary Total cost of Custody Health (12 months) 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
Secondary Total cost of Custody Health (24 months) 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
Secondary Total cost of Custody Health (36 months) 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
Secondary Incarceration (12 months) Proportion of patients who had any days of incarceration during the 12 months post-enrollment. 12 months post-enrollment
Secondary Incarceration (24 months) Proportion of patients who had any days of incarceration during the 24 months post-enrollment. 24 months post-enrollment
Secondary Incarceration (36 months) Proportion of patients who had any days of incarceration during the 36 months post-enrollment. 36 months post-enrollment
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