Clinical trial NCT06564948: Treatment for Individuals Interacting with the Criminal Justice System
Official title: Improving Mental Health Treatment for Individuals in Crisis Interacting with the Criminal Justice System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide Risk
Psychiatric Disorders
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: Michigan State University
name: Mount Auburn Hospital
First posted: 2024-08-21
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Treatment as Usual (TAU) arm

   1. 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)
   2. Ages 18-100
   3. 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.
2. Family and Social Justice Section (FSJS) arm

   1. Cambridge Health Alliance patients from Cambridge
   2. Ages 18-100
   3. 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.
3. Family and Social Justice Section plus Navigator (FSJS+Navigator) arm

   1. Recruited during the study period in the CHA ED
   2. Ages 18-100
   3. 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

Exclusion Criteria

1. Treatment as Usual (TAU) arm

   1. Cambridge Health Alliance patients residing in the City Cambridge are excluded from the TAU arm
   2. Under the age of 18
   3. 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).
   4. 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).
2. Family and Social Justice Section (FSJS) arm

   1. Cambridge Health Alliance patients outside of Cambridge will be excluded from the FSJS arm
   2. Under the age of 18
   3. 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)
3. Family and Social Justice Section plus Navigator (FSJS+Navigator) arm

   1. Under the age of 18
   2. Any individual who becomes incarcerated during the course of the study
   3. 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

Primary outcomes:
measure: Past-year medically treated suicide attempt at baseline and 12 months
timeFrame: Baseline and 12 months
measure: Suicide Severity and Behaviors using Computerized Adaptive Test Suicide Scale (CAT-SS) at Baseline and 12 Months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Number of Individual Interactions with the Criminal Legal System at Baseline and 12 Months
timeFrame: From enrollment through 12 months
measure: Number of Individual Interactions between Hospitals and the Criminal Justice System at Baseline and 12 Months
timeFrame: From enrollment through 12 months
measure: Frequency of Healthcare Services Used by Patients at Baseline and 12 Months
timeFrame: From enrollment through 12 months
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
References: