Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03616990 |
| Other study ID # |
IRB16-0536 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 6, 2017 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
University of Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Supportive Release Center (SRC) is a collaboration between the University of Chicago
Urban Health Lab, Treatment Alternatives for Safe Communities, Heartland Alliance Health, and
the Cook County Sheriff's office. The aim of the SRC is to identify individuals with mental
illnesses, substance use disorders, and other vulnerabilities as they are released from the
Cook County Jail (CCJ), provide an improved environment to assess needs of these individuals,
and facilitate effective linkages with social services following release, including medical
care and substance use or mental health treatment. The SRC improves the current standard of
care offered at the CCJ by introducing mechanisms to facilitate engagement with post-release
services and address individuals' immediate acute needs. The primary objective of this
randomized controlled trial is to evaluate the impact of assignment to the SRC on the number
of arrests within one year of study enrollment among eligible men being released from the
Cook County Jail. Researchers hypothesize that the SRC is more effective than usual care at
facilitating and ensuring receipt of transition services and care, and that receipt of this
treatment will decrease the number of arrests within one year of study enrollment.
Description:
The University of Chicago Health Lab is working with service providers - Treatment
Alternatives for Safe Communities (TASC) and Heartland Alliance Health (HAH) - and the Cook
County Sheriff's Office (CCSO), to implement a randomized controlled trial of a Supportive
Release Center (SRC) compared to usual care for persons leaving the Cook County Jail (CCJ)
with mental health, substance use disorder, or acute health needs. The primary aim of this
randomized controlled trial is to evaluate the impact of assignment to the SRC, compared with
not being offered a placement at the SRC (and consequent usual care), on the number of
arrests within one year of study enrollment among eligible men being discharged from CCJ.
The recruitment strategy for the SRC intervention is integrated into the jail discharge
process. Individuals are discharged from the CCJ in groups, such that they may wait several
hours before being discharged. After being escorted to the discharge area, detained
individuals are consented to participate in the SRC study and asked to take a survey designed
to identify needs, vulnerabilities, and interest in receiving services. During consent,
individuals are informed that their CCJ Booking ID will be used to acquire data from the
CCSO, Chicago Police Department, Illinois Criminal Justice Information Authority, and
Illinois State Police to determine their history of arrest, time spent in jail, and instances
of re-arrest following study enrollment. In conjunction with demographic information linked
from CCSO, this ID can be used to track healthcare and social service utilization via
databases administered by Cook County Health and Hospital System (CCHHS), the Centers for
Medicare and Medicaid Services, the Illinois Department of Healthcare and Family Services,
the Illinois Department of Public Health, the Chicago Fire Department, and collaborating
service-providers (TASC and HAH).
Eligibility for the SRC intervention requires survey responses indicating both (1)
vulnerability, suggesting potential need for the SRC, and (2) interest in attending the SRC.
Vulnerability that suggests potential need for the SRC is ascertained by four independent
criteria: a response of "more than half the days" or "nearly every day" to questions (1) and
(2) from either the PHQ-9 depression or Generalized Anxiety Disorder (GAD)-7 modules, which
refer to problems experienced "over the past 2 weeks" (PHQ: 1. "little interest or pleasure
doing things", 2. "feeling down, depressed, and hopeless"; GAD: 1. "feeling nervous, anxious,
or on edge", 2. "not being able to stop or control worrying"); two or more previous instances
of incarceration over the past 12 months; history of substance use over the previous 12
months, indicated by weekly or more than weekly consumption of i) more than five alcoholic
drinks per day, or ii) prescription drugs for non-medical reasons, or iii) illegal drugs; or
affirmative response to questions asking about previous diagnosis by a health professional
for a mental health condition, existence of urgent needs for healthcare over the three weeks
following discharge, or concern about personal safety during discharge from the jail. Two
questions gauge respondent interest in attending the SRC: interest in having (i) a safe place
to stay upon discharge or (ii) a place to go to receive connections with social services upon
discharge. An individual who responds affirmatively to both "interest" questions is
automatically eligible for the SRC; to be eligible with an affirmative response to only one
"interest" question, the respondent must have at least one indicator of vulnerability.
Individuals who do not respond affirmatively to either question about interest are not
eligible for the SRC.
Detainees who are eligible and interested in services are then randomized to treatment and
control groups. Individuals who are randomized to treatment have individual meetings with
TASC social workers in a private office close to the discharge area, where the SRC is
explained and offered. TASC provides opportunities to interview and receive service-linkages
in the CCJ office for all randomized individuals. In addition to individuals randomized to
control, those randomized to treatment who choose not to visit the off-site SRC facility are
offered linkages during their private interview with TASC.
The SRC is located on the CCJ campus, one half mile from the point of CCJ discharge.
Participants accepting the SRC treatment are transported from the CCJ exit to the facility in
TASC vehicles. The facility has the capacity to provide an overnight stay, meal, and shower
to twelve individuals per night and provides a private environment where TASC case-workers
can meet with discharged individuals. This environment provides TASC staff an opportunity to
conduct a more intensive needs-screening to identify appropriate service-linkages, including
connection with organizations providing substance use treatment and mental health services.
An advanced practice nurse is available at the SRC to address immediate medical needs and
ensure continued access to necessary prescription medications. On pre-specified days HAH
recruits from the SRC to populate a non-SRC study; individuals recruited from the SRC and
individuals randomized to SRC control on days HAH is recruiting are excluded from the SRC
study.
Intention-to-treat (ITT) and treatment-on-treated (TOT) analyses will be conducted for
specified outcomes. In addition to an ITT group indicator, all models include covariates for
demographic information (age, race, Hispanic/Latino indicator) acquired from the CCSO, an
indicator variable for whether the individual could qualify for SRC treatment based on that
measure ("qualified" (1) vs. "not qualified" or "no response (0)), and an indicator for
whether that measure was missing ("no response" (1) vs. "not qualified"or "qualified" (0))
(i.e. PHQ/depression score, GAD anxiety score, previous mental health diagnosis, alcohol use,
prescription drug use, illegal drug use, acute health needs, or concern for personal safety).
Age (18-24, 25-35, 36-45, 46-55, over 55), race ("black", "white", "other", "unknown"), and
ethnicity ("Hispanic/Latino", "not Hispanic/Latino", "unknown") are coded as categorical
variables. All models will include an interaction term between age and ITT status. Arrest and
hospitalization outcomes will be measured using data from the Illinois State Police and
Illinois Department of Public Health acquired via probabilistic matching on demographic
identifiers. As a robustness check for count outcomes, researchers will evaluate sensitivity
of results to the inclusion of an offset representing the number of days individuals an
individual is vulnerable to the outcome. Unexposed time (invulnerable to re-arrest or
emergency department visit) is defined as time spent incarcerated or hospitalized.
