NCT06053346

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
652

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

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

August 1, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

6.4 years

First QC Date

August 20, 2023

Last Update Submit

September 22, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (27)

  • Total cost of Barbara Arons Pavilion (BAP) Acute Inpatient Psychiatric Care (12 months)

    12 months post-enrollment

  • Total cost of Barbara Arons Pavilion (BAP) Acute Inpatient Psychiatric Care (24 months)

    24 months post-enrollment

  • Total cost of Barbara Arons Pavilion (BAP) Acute Inpatient Psychiatric Care (36 months)

    36 months post-enrollment

  • Total cost of Emergency Psychiatric Services (EPS) - 12 months

    12 months post-enrollment

  • Total cost of Emergency Psychiatric Services (EPS) - 24 months

    24 months post-enrollment

  • +22 more secondary outcomes

Study Arms (2)

Pay For Performance (PFP)

EXPERIMENTAL

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.

Behavioral: Pay For Performance (PFP)

Usual Care (UC)

ACTIVE COMPARATOR

Participants receive the usual array of mental health and psychosocial services offered by Santa Clara County.

Behavioral: Usual Care (UC)

Interventions

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.

Pay For Performance (PFP)
Usual Care (UC)BEHAVIORAL

Outpatient and inpatient mental health and psychosocial services delivered by Santa Clara County services and systems.

Usual Care (UC)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic DisordersBipolar DisorderSubstance-Related Disorders

Interventions

Reimbursement, Incentive

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Reimbursement MechanismsInsurance, Health, ReimbursementFinancing, OrganizedEconomicsHealth Care Economics and Organizations

Study Officials

  • Keith Humphreys, PhD

    Professor of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2023

First Posted

September 25, 2023

Study Start

August 1, 2016

Primary Completion

December 31, 2022

Study Completion

July 1, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share