A Trial of "Opening Doors to Recovery" for Persons With Serious Mental Illnesses
Phase: NA
Conditions: Mental Disorders, Severe, Schizophrenia and Related Disorders, Bipolar Disorder, Depressive Disorder
Sponsor: New York State Psychiatric Institute

 
A Trial of “Opening Doors to Recovery” for Persons with Serious Mental Illnesses 
 
ClinicalTrials.gov: Identifier NCT04612777 
 
09/13/2022 
 
Revised 07/24/2024 
 
 

Methods 
Participants 
Enrollment will begin in December 2014 and continue until the target sample size is 
achieved, which is expected to take approximately three years. Adults with serious mental 
illnesses (SMI) will be recruited from three inpatient facilities: a state psychiatric hospital in 
Savannah, Georgia; a crisis stabilization unit (CSU) in Savannah; and a CSU in Brunswick, 
Georgia. 
Eligibility criteria will include: (1) 18–65 years of age; (2) English speaking; (3) diagnosis 
of a psychotic or mood disorder (confirmed with the Structured Clinical Interview for DSM-5 
Disorders (SCID-5);1 (4) two separate inpatient admissions, each for ≥2 days, in the past 12 
months; (5) absence of intellectual disability or dementia; (6) capacity to provide informed 
consent; (7) being discharged to reside within one of seven counties with case management 
(CM) services provided by the public mental health agency hosting the research; (8) not 
currently receiving assertive community treatment (ACT) or CM; and (9) eligible to receive CM; 
i.e., unable to complete daily living activities in at least two areas, despite caregiver or 
behavioral health staff support, and requires assistance in one or more areas of managing their 
illness.2 
Interventions 
Opening Doors to Recovery (ODR). The Community Navigation Specialist (CNS) team’s 
process of community navigation is a broader function than traditional CM as it includes 
mapping and connecting clients to all available local resources, which requires being embedded 
in the community. The CNSs benefits from commitments of diverse collaborative ODR partners 
(who convene as part of a “Blue Ribbon Taskforce”), including local treatment providers, law 
enforcement, employers, and housing programs. Those enrolled in ODR consent to information 
sharing that allow the CNSs to overcome communication barriers in pursuit of their clients’ 
recovery goals. One example of this is a novel Police–CNS Linkage System that allows law 
enforcement officers to talk directly to a CNS in the event of a police encounter—a component 
of ODR also being studied separately.3,4 The CNS team’s caseload will be capped at 40. Each 
CNS is expected to meet with the client at home or in community settings at least monthly, with 
the client having contact with at least one CNS weekly. 
Case Management (CM). For the control group, we considered both traditional CM and 
intensive case management (ICM) to be different enough from ODR for the purposes of testing 
hypotheses. Because we are limited to what is available locally for the control group, patients 
will receive CM if being discharged to reside in six of the counties, and they will receive ICM if 
living in Chatham County, the most urban/populous county, which offers ICM services. CM 
services, as defined by the State mental health agency, focus on assisting the individual with: 
developing natural supports to promote community integration, identifying service needs, linking 
to services/resources, and coordinating services to maximize integration and minimize service 
gaps.2 Outcome expectations include decreased hospitalizations and incarcerations, as well as 
increased housing stability, job-related activities, community engagement, and recovery.2 CM is 
provided by a licensed practitioner, whose caseload does not exceed 50. Contact must be made 
with the individual ≥2 times per month, at least one of which must be in-person, in a non-clinic 
setting. ICM is very similar, but four in-person visits are required monthly, at least 60% of total 
contacts must be face-to-face, and at least 50% must be delivered in non-clinic/community-
based settings.2 An ICM team includes nine professionals, and the team’s maximum case load 
is 200 (22 per team member). 
Referral, Assessment, and Randomization 
All procedures will be reviewed and approved by the university’s and the State’s 
Institutional Review Boards. Clinicians at the three sites will refer potentially eligible patients 
who will then be evaluated for their interest in taking part in the study and capacity to give 
informed consent. Trained research assessors will complete the initial/baseline assessment 

within about a week before discharge. After eligibility screening, consent, and the assessment, 
the patient will be randomized at a 1:1 ratio to ODR or CM using a computer-generated 
algorithm. The study statistician will create the randomization list, by randomly alternating blocks 
of 2 or 4, and the resulting sequential treatment assignments will be sealed in opaque 
envelopes. After the patient is found to meet eligibility criteria, gives informed consent, and 
completes the baseline assessment, the research assessor will open the next envelope in the 
sequence and inform the ODR or CM provider of the treatment assignment. 
Outcome Data Collection 
Primary outcomes (hospitalizations and arrests). Hospitalization data will be collected 
from three sources: the Georgia Department of Behavioral Health and Developmental 
Disabilities (DBHDD, the State’s mental health agency), the CSU in Savannah, and the CSU in 
Brunswick. Because DBHDD operates all state psychiatric hospitals, they have complete 
admission and discharge data for the study timeframe. However, DBHDD only collected CSU 
data beginning in January 2017; as such, the two CSUs serving as referral sites will also 
provide admission and discharge data for the full study period. 
Arrest data will be provided by the Georgia Crime Information Center (GCIC), within the 
Georgia Bureau of Investigation (the lead state law enforcement agency), in the form of the 
participants’ record of arrests and prosecutions (RAP sheets). GCIC receives monthly arrest 
reports from >600 state and local law enforcement agencies; this information is stored in GCIC’s 
crime database and is summarized in the RAP sheet. To test our arrest-related hypotheses, we 
will extract all arrests for the 12 months after enrollment. Arrest data will be available for all 
participants. 
Secondary outcomes (housing and recovery). Data collection for the two secondary 
outcomes will be collected in-person, though retention is expected to be difficult based on the 
serious psychosocial impairment of the study sample and experience in the initial study.5 Two 
housing-related measures will be used. The Housing Satisfaction Scale (HSS)6 has 19 items 
covering choice, safety, privacy, and proximity.6–8 The Housing Instability Index (HII) is a sum of 
10 items that ask participants about their housing situations over the past six months;9 the time 
frame was adapted to four months for this study to match the follow-up timepoints. 
To thoroughly assess recovery, we will examine five measures of constructs aligned with 
recent conceptualizations of recovery and the goals of ODR. First, the Multnomah Community 
Ability Scale (MCAS) is a 17-item instrument that measures social and community functioning, 
with documented good inter-rater and test-retest reliability, and validity.10 We added five items 
covering several areas deemed important for the study’s purposes.  Second, the Maryland 
Assessment of Recovery in People with Serious Mental Illness (MARS) is a 25-item instrument 
addressing recovery experiences,11 with documented excellent internal consistency and test-
retest reliability, as well as construct validity and divergent validity.12 Third, the Herth Hope 
Scale (HHS) is a 30- item measure widely used to assess hope,13 and with well-documented 
psychometric properties. 14 Fourth, the Empowerment Scale (ES) is a 28-item measure 
assessing self-esteem, perceived power, optimism/control over the future, and related 
constructs, with documented reliability and validity.15–17 Finally, the 21-item Community 
Navigation Scale was developed for the initial and current study—preliminary psychometric 
research suggests good internal consistency reliability and construct validity.18 
Recovery Summary Score (RSS) 
Because the recovery measures are likely to be highly correlated, we will derive a summary 
measure to conserve power, which we call the overall Recovery Summary Score (RSS), using 
principal component analysis (PCA) with possible rotation, and then calculating a patient-
specific summary measure by standardizing each of the five measures and then averaging for 
each subject and timepoint. 
Data Analyses 

Between-group comparisons will rely on intention-to-treat analyses. Analyses involving 
hospitalizations and arrests will be performed using both binomial and Poisson generalized 
linear models for binary outcomes and counts, respectively. Analyses of change in housing and 
recovery measures will be performed using linear mixed models on all available data at each 
timepoint. Time in months will be used as a continuous predictor (growth curves) with measures 
at baseline, 4-, 8-, and 12-months. For the primary outcome analysis (12-month endpoint) the 
model structure will include group (ODR vs. CM), time, and group-by-time interactions, with a 
random intercept for subject. For those measures that indicate significant 2-group differences, 
we will compare ODR against ICM specifically, to further define effects (post-hoc analyses). For 
count/duration of hospitalizations and number of arrests, we will do conditional tests (comparing 
only those with non-zero values) to reduce the effects of zero inflation and get meaningful effect 
sizes across groups. 
 
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