A Concierge Model of CAE Plus LAI in Individuals With Schizophrenia at Risk for Treatment Non-adherence and Homelessness

Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia,
but rates of full or partial non-adherence exceed 60%. There is direct correlation between
non-adherence and rates of relapse in schizophrenia; on average, non-adherent patients have
a risk of relapse that is 3.7 times greater than their adherent counterparts. Long-acting
injectable antipsychotic (LAI) medication can improve adherence but needs to be combined
with a quality behavioral program to modify long-term attitudes and behaviors.

A recently completed study funded by the Reuter Foundation and conducted by these
investigators found that a novel customized psychosocial adherence enhancement intervention
paired with LAI (CAE-L) reduced rates of homelessness, improved psychiatric symptoms and
increased overall functioning in this very vulnerable group of individuals. CAE has been
manualized and appears very acceptable to homeless people with serious mental illness.
However, in spite of the very promising results, the CAE-L intervention has some important
limitations that are barriers to its wide-spread future use in public health settings. These
limitations are:

1. CAE-L used a PhD-level psychologist to deliver the behavioral part of the program. Many
public-sector clinical settings have a very limited number of such highly trained
individuals. As an alternative, social workers could be an efficient way to deliver
CAE.

2. CAE-L used only haloperidol decanoate as the injectable medication. Unfortunately,
akathisia-- a very distressing side effect, occurred in 40% of people. Use of a newer,
better tolerated medication option could improve the investigators approach.

3. Logistic barriers preventing people who were stabilized and doing well on CAE-L to
continue their improved functioning once they transitioned back to regular care
settings. It is clear that there needs to be a mechanism to facilitate the successful
"hand-off" of individuals who have benefitted from CAE-L into maintenance therapy. A
successful transition could have substantial financial and humanitarian cost-savings.

To address these obstacles and in preparation for a large-scale randomized controlled trial
of this novel, blended intervention the investigators propose to conduct a prospective study
using a concierge model of customized adherence enhancement combined with a long-acting
injectable antipsychotic (CAL-Concierge) in individuals with schizophrenia at risk for
treatment non-adherence and for homelessness. Like the CAE-L approach, CAL-Concierge is
expected to improve health outcomes among the most vulnerable of populations with
schizophrenia but even more importantly, will demonstrate that it can be used to improve the
efficiency and quality of care in typical practice settings.

Inclusion Criteria:

- Individuals age 18 and older with schizophrenia or schizoaffective disorder as
confirmed by the Mini International Psychiatric Inventory (MINI). The investigators
will use a DSM-5 concordant version of the MINI if it is available at the time that
the first study participant is enrolled.

- Individuals who are currently or have been recently homeless (within the past 12
months) as per revised federal definition of homelessness (Homeless Emergency
Assistance and Rapid Transition to Housing. In: Development DoHaU, ed2011.)

- Known to have medication treatment adherence problems as identified by the Treatment
Routines Questionnaire (TRQ, 20% or more missed medications in past week or past
month)

- Ability to be rated on psychiatric rating scales.

- Willingness to take long-acting injectable medication

- Currently in treatment at a Community Mental Health Clinic (CMHC) or other treatment
setting able to provide mental health care during and after study participation

- Able to provide written, informed consent to study participation.

Exclusion Criteria:

- Individuals on long-acting injectable antipsychotic medication immediately prior to
study enrollment.

- Prior or current treatment with clozapine

- Medical condition or illness, which in the opinion of the research psychiatrist,
would interfere with the patient's ability to participate in the trial

- Physical dependence on substances (alcohol or illicit drugs) likely to lead to
withdrawal reaction during the course of the study in the clinical opinion of the
treated research psychiatrist

- Immediate risk of harm to self or others

- Female who is currently pregnant or breastfeeding

- Individual who is already in permanent and supported housing that includes
comprehensive mental health services (i.e. Housing First)