NCT06564948

Brief Summary

The proposed Center will leverage burgeoning real-time data linkage capabilities among health systems, Medicaid payors, and criminal legal (e.g., jail booking data, jail release data) systems, to identify individuals coming in and out of jail for suicide assessment and prevention, and to better coordinate care across these disparate systems. This Center will advance the fields of suicide prevention and criminal legal system-based mental health by solving a well-known, central problem in both fields: the inability to track and intervene with individuals moving in and out of both and often multiple systems. The goal is near-term reductions in the U.S. suicide rate.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,040

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress47%
Feb 2025Sep 2027

First Submitted

Initial submission to the registry

July 2, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

March 14, 2025

Status Verified

October 1, 2024

Enrollment Period

2.7 years

First QC Date

July 2, 2024

Last Update Submit

March 12, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Past-year medically treated suicide attempt at baseline and 12 months

    Number of participants with a past-year medically treated suicide attempt. This will be measured at baseline and 12 months will be collected using the electronic health record (EHR) data.

    Baseline and 12 months

  • Suicide Severity and Behaviors using Computerized Adaptive Test Suicide Scale (CAT-SS) at Baseline and 12 Months

    The CAT-SS measures Severity of Suicide Risk will be assessed using CAT-SS, providing severity on a 0-100 point scale, and risk-stratification to negligible, intermediate and high risk. It is highly sensitive and specific to the Columbia Suicide Severity Rating Scale, and predicts future suicide events with high precision and accuracy.

    Baseline and 12 months

Secondary Outcomes (3)

  • Number of Individual Interactions with the Criminal Legal System at Baseline and 12 Months

    From enrollment through 12 months

  • Number of Individual Interactions between Hospitals and the Criminal Justice System at Baseline and 12 Months

    From enrollment through 12 months

  • Frequency of Healthcare Services Used by Patients at Baseline and 12 Months

    From enrollment through 12 months

Study Arms (3)

Treatment as usual (TAU)

EXPERIMENTAL

This arm will consist of 2160 eligible individuals identified to have had criminal legal involvement in Cambridge Health Alliance catchment area cities other than Cambridge (Everett, Somerville, Malden, Medford, Chelsea, Revere, Winthrop). Police departments in these Treatment as Usual cities have no programs that link police officers and clinicians to follow up on safety planning and services. These individuals will be identified as having police involvement between 2009 and 2019.

Other: Treatment as usual (TAU)

Family and Social Justice Section (FSJS)

EXPERIMENTAL

Consists of 200 Cambridge Health Alliance Patients Ages 18-100 Individuals who have come into contact with the Cambridge Police Department (as identified in the Family and Social Justice Section data) between 2009 and 2019.

Other: Family and Social Justice

FSJS + Navigator

EXPERIMENTAL

40 patients recruited during the study period in the Cambridge Health Alliance Emergency Department (ED) Ages 18-100 Individuals who are brought into the ED under police supervision (excluding individuals currently incarcerated) involuntarily brought to the ED for psychiatric evaluation because they are considered to be a risk to themselves or others (MA Law 123(12)); or the subject of a police call for service for a mental health issue who are willingly admitted to the ED

Other: Family and Social Justice Service and Navigator (FSJS+Navigator) Intervention

Interventions

TAU patients will be identified using "targeted limited chart review methods" used in our prior studies, "scraping" clinical notes in the EHR for criminal justice involvement. Initial Identification terms, "police", "arrest", "court", "summons", "jail", and "crime" will be used to identify candidates for police involvement, downloading the sentence in which the keyword appeared and the sentence before and after. Next, an iterative process of editing of the search terms will be conducted to remove patients with negation of the keyword ("did not commit a crime"), and other sentence characteristics that generate false positives ("cardiac arrest"). Samples of the resulting dataset will be taken, accuracy assessed by examining the surrounding sentences, leading to further iterations and repetition of the process until a high level of accuracy is achieved.

Treatment as usual (TAU)

Documentation and follow-up by the Cambridge Police Department (CPD) for all mental health-related police calls, including involuntary and voluntary Emergency Department admissions; Established partnerships with city departments, healthcare systems, clergy, courts, businesses, and mental health advocates to ensure timely engagement in mental health treatment and community-based services; Required 40 hours of officer crisis intervention training (CIT), and additional sessions on trauma- informed policing, mental health, procedural justice, race, and crisis negotiation; and Staffing of sworn and civilian staff including specially-trained officers designated to work with individuals living with mental illness, homelessness, and substance abuse.

Family and Social Justice Section (FSJS)

The FSJS+Navigator intervention adds an Emergency Department (ED)-based Systems Navigator, a community health worker with lived experience (as family member or patient) with criminal justice and mental health systems, to the FSJS. This navigator will enhance communication between Cambridge Police Department (CPD), Cambridge Health Alliance (CHA), and community agencies by being the needed "point person" within the healthcare system (the FSJS intervention only has a CPD-based social worker) to maintain communication to improve mental health services and prevent deeper justice involvement. The Navigator engages with the FSJS process in step i) of the above sequence, engaging the patient in the CHA ED and obtaining consent. The Navigator then discusses the case with the presenting CPD officer, and relays critical information about the context of the service call to ED staff. Next, the Navigator will administer the baseline CAT-MH/SS and assess additional needs (employment, housing, food).

FSJS + Navigator

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Treatment as Usual (TAU) arm
  • Cambridge Health Alliance (CHA) patients from the cities other than Cambridge considered to be in the "catchment area" of CHA (Everett, Chelsea, Somerville, Medford, Malden, and Winthrop)
  • Ages 18-100
  • Identified as having police involvement between 2009 and 2019. Treatment as Usual patients will be identified using "targeted limited chart review methods" used in our prior studies, "scraping" clinical notes in the Electronic Health Records for criminal justice involvement. Initial Identification terms, "police", "arrest", "court", "summons", "jail", and "crime" will be used to identify candidates for police involvement, downloading the sentence in which the keyword appeared and the sentence before and after. Next, an iterative process of editing of the search terms will be conducted to remove patients with negation of the keyword ("did not commit a crime"), and other sentence characteristics that generate false positives ("cardiac arrest"). Samples of the resulting dataset will be taken, accuracy assessed by examining the surrounding sentences, leading to further iterations and repetition of the process until a high level of accuracy is achieved.
  • Family and Social Justice Section (FSJS) arm
  • Cambridge Health Alliance patients from Cambridge
  • Ages 18-100
  • Individuals who have come into contact with the Cambridge Police Department (as identified in the Family and Social Justice Section data) between 2009 and 2019.
  • Family and Social Justice Section plus Navigator (FSJS+Navigator) arm
  • Recruited during the study period in the CHA ED
  • Ages 18-100
  • Individuals who are brought into the Emergency Department under police supervision (excluding individuals currently incarcerated)
  • involuntarily brought to the Emergency Department for psychiatric evaluation because they are considered to be a risk to themselves or others (MA Law 123(12)); or
  • the subject of a police call for service for a mental health issue who are willingly admitted to the Emergency Department

You may not qualify if:

  • Treatment as Usual (TAU) arm
  • Cambridge Health Alliance patients residing in the City Cambridge are excluded from the TAU arm
  • Under the age of 18
  • Individuals with no identified criminal legal system contact during the study time period (no criminal legal involvement found in the targeted limited chart review method).
  • Any individual incarcerated at the Middlesex Jail/Prison that has not been released by the end of the period of data collection (December 31, 2019).
  • Family and Social Justice Section (FSJS) arm
  • Cambridge Health Alliance patients outside of Cambridge will be excluded from the FSJS arm
  • Under the age of 18
  • Any individual incarcerated at the Middlesex Jail/Prison that has not been released by the end of the period of data collection (December 31, 2019)
  • Family and Social Justice Section plus Navigator (FSJS+Navigator) arm
  • Under the age of 18
  • Any individual who becomes incarcerated during the course of the study
  • Individuals who enter the Emergency Department not under police supervision
  • For example, individuals will be excluded who voluntarily come to the ED seeking psychiatric care because they feel they may be a risk to themselves or others
  • Individuals brought to the ED from a jail or court ordered to the ED as an alternative to jail or prison

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02141, United States

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Interventions

TherapeuticsSocial JusticeMethods

Intervention Hierarchy (Ancestors)

Human RightsSocial Control, FormalHealth Care Economics and OrganizationsPrinciple-Based EthicsEthicsHealth Care Quality, Access, and EvaluationInvestigative Techniques

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Preliminary effectiveness of FSJS+Navigator model on suicide severity and clinical outcomes using CAT-SS/MH, mental health, and mental health treatment/criminal legal outcomes will be assessed. Assessments occur at baseline, 1, 3, and 6 months, providing key statistics (distribution, correlation of outcome over time, missingness) needed to inform a fully-powered Hybrid II trial. Improvement in medically treated suicide attempts and CAT-SS indicators will be assessed over time using repeated measures ANOVA. This study is a non-experimental longitudinal design comparing treatment group (FSJS+Navigator) to 2 control groups (FSJS Only and Treatment As Usual). We will assess the following as moderators of intervention effects: sex, race/ethnicity, past suicide attempt, past behavioral health treatment, Area Deprivation index, mental health professional shortage area score, per capita incarceration, and other area-level social determinants of health variables using stratified and DDD models.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2024

First Posted

August 21, 2024

Study Start

February 1, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

March 14, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations