- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06564948
Improving Mental Health Treatment for Individuals in Crisis Interacting With the Criminal Justice System
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Benjamin Cook
- Phone Number: 617-806-8741
- Email: bcook@cha.harvard.edu
Study Contact Backup
- Name: Taylor Witkowski
- Phone Number: 617-806-8751
- Email: twitkowski@challiance.org
Study Locations
-
-
Massachusetts
-
Cambridge, Massachusetts, United States, 02141
- Recruiting
- Cambridge Health Alliance
-
Contact:
- Benjamin Cook
- Phone Number: 617-806-8741
- Email: bcook@cha.harvard.edu
-
Contact:
- Taylor Witkowski
- Phone Number: 617-806-8751
- Email: twitkowski@challiance.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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 2025.
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
Exclusion Criteria
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment as usual (TAU)
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.
|
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.
|
|
Experimental: FSJS + Navigator
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
|
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).
|
|
Experimental: Family and Social Justice Section (FSJS)
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 2025.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Past-year medically treated suicide attempt at baseline and 12 months
Time Frame: 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
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Individual Interactions with the Criminal Legal System at Baseline and 12 Months
Time Frame: From enrollment through 12 months
|
Number of calls about each individual to the Cambridge Police Department (CPD) Number of arrests Number of admissions to the Middlesex County Jail Repeat admission to the Middlesex County Jail
|
From enrollment through 12 months
|
|
Number of Individual Interactions between Hospitals and the Criminal Justice System at Baseline and 12 Months
Time Frame: From enrollment through 12 months
|
Number of involuntary hospitalizations that require Cambridge Police Department (CPD) interaction
|
From enrollment through 12 months
|
|
Frequency of Healthcare Services Used by Patients at Baseline and 12 Months
Time Frame: From enrollment through 12 months
|
Number of Emergency Department visits Number of behavioral health inpatient visits Number of behavioral health outpatient mental health (MH) visits
|
From enrollment through 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHA-IRB-22-23-156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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