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Psychotic DisordersNCT06053346

Partners in Wellness: Evaluation of a Pay for Performance Program for High-Utilizers of Mental Health Services

A study testing Pay For Performance (PFP) in people with Psychotic Disorders and Bipolar Disorder, run by Stanford University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Pay For Performance (PFP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
652 participants
Where
No sites listed yet
Study dates
1 Aug 2016to 1 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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):
Show all 18Show fewer
  • 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)

About this study

Official title: 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.

Being tested
Pay For Performance (PFP), Usual Care (UC)
Medical subject headings
Psychotic Disorders, Bipolar Disorder, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pay For Performance (PFP)Behavioural

    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)Behavioural

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

Study groups in NCT06053346
Study groupRoleWhat they receive
Pay For Performance (PFP)ExperimentalParticipants 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.
Receives: Behavioral: Pay For Performance (PFP)
Usual Care (UC)Active comparatorParticipants receive the usual array of mental health and psychosocial services offered by Santa Clara County.
Receives: Behavioral: Usual Care (UC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months post-enrollment

  2. 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.

    Measured: 24 months post-enrollment

  3. 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.

    Measured: 36 months post-enrollment

Secondary outcomes (27)
  1. 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.

    Measured: 12 months post-enrollment

  2. 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.

    Measured: 24 months post-enrollment

  3. 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.

    Measured: 36 months post-enrollment

  4. 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.

    Measured: 12 months post-enrollment

  5. 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.

    Measured: 24 months post-enrollment

  6. 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.

    Measured: 36 months post-enrollment

  7. 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.

    Measured: 12 months post-enrollment

  8. 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.

    Measured: 24 months post-enrollment

  9. 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.

    Measured: 36 months post-enrollment

  10. 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.

    Measured: 12 months post-enrollment

  11. 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.

    Measured: 24 months post-enrollment

  12. 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.

    Measured: 36 months post-enrollment

  13. 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.

    Measured: 12 months post-enrollment

  14. 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.

    Measured: 24 months post-enrollment

  15. 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.

    Measured: 36 months post-enrollment

  16. 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.

    Measured: 12 months post-enrollment

  17. 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.

    Measured: 24 months post-enrollment

  18. 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.

    Measured: 36 months post-enrollment

  19. 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.

    Measured: 12 months post-enrollment

  20. 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.

    Measured: 24 months post-enrollment

  21. 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.

    Measured: 36 months post-enrollment

  22. 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.

    Measured: 12 months post-enrollment

  23. 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.

    Measured: 24 months post-enrollment

  24. 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.

    Measured: 36 months post-enrollment

  25. Incarceration (12 months)

    Proportion of patients who had any days of incarceration during the 12 months post-enrollment.

    Measured: 12 months post-enrollment

  26. Incarceration (24 months)

    Proportion of patients who had any days of incarceration during the 24 months post-enrollment.

    Measured: 24 months post-enrollment

  27. Incarceration (36 months)

    Proportion of patients who had any days of incarceration during the 36 months post-enrollment.

    Measured: 36 months post-enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2023
  2. Study start1 Aug 2016
  3. Primary completion31 Dec 2022
  4. Study completion1 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
652 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06053346
Sponsor's protocol ID
30530
Status last verified
Sep 2023
First submitted
20 Aug 2023
Last updated
25 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Blonigen DM, Humphreys K. A Randomized Controlled Trial of a Pay-for-Performance Initiative to Reduce Costs of Care for High-Need Psychiatric Patients. Psychiatr Serv. 2024 Sep 1;75(9):863-871. doi: 10.1176/appi.ps.20230481. Epub 2024 Apr 3.

    PubMed 38566562

Questions about this trial

What is this clinical trial studying?

A study testing Pay For Performance (PFP) in people with Psychotic Disorders and Bipolar Disorder, run by Stanford University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total cost of 24-hour psychiatric services (12 months) (time frame: 12 months post-enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06053346, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.

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