Clinical trial NCT02085447: A Concierge Model of CAE Plus LAI in Individuals With Schizophrenia at Risk for Treatment Non-adherence and Homelessness
Official title: A Concierge Model of Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAL-C) in Individuals With Schizophrenia at Risk for Treatment Non-adherence and for Homelessness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Schizophrenia
Schizoaffective Disorder
Medication Adherence
Medication Non-Adherence
Keywords: Homelessness
Antipsychotic Drugs
Antipsychotics
Injectables
Long Acting Injectable Antipsychotic
Psychotic Disorders
Schizophrenia
Schizoaffective Disorder
Medication Adherence
Medication Non-Adherence
Community Mental Health Centers
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective study using a concierge model of customized adherence enhancement and long-acting injectable antipsychotic (CAL-Concierge) in 30 individuals with schizophrenia or schizoaffective disorder 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Tablets Routine Questionnaire (TRQ, Past Week) From Screen to Week 25 Visit
timeFrame: Screen, Week 25
measure: Change in Tablets Routine Questionnaire (TRQ) (Past Month) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Long-acting Injection (LAI) Adherence
timeFrame: Week 25
Secondary outcomes:
measure: Change in DAI (Drug Attitudes Index) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in AMSQ (Attitudes Toward Mood Stabilizers Questionnaire) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in PANSS (Positive and Negative Syndrome Scale; Positive Symptoms Scale) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in PANSS (Positive and Negative Syndrome Scale; Negative Symptoms Scale) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in PANSS (Positive and Negative Syndrome Scale; Composite Scale) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in PANSS (Positive and Negative Syndrome Scale; General Psychopathology) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in CGI (Clinical Global Impression) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in ASSIST GRS (Alcohol, Smoking and Substance Involvement Screening Test ) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in SOFAS (Social and Occupational Functioning Assessment Scale) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in AIMS (Abnormal Involuntary Movement Scale) From Baseline to Week 25
timeFrame: Baseline, Week 25
measure: Change in SAS (Simpson Angus Scale) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in BARS (Barnes Akathisia Rating Scale) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Parkinsonism) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dystonia) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dyskinesia) From Screen to Week 25
timeFrame: Screen, Week 25
measure: Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Akathisia)
timeFrame: Screen, Week 25
measure: Change in Hospitalizations (Psychiatric) in the Past 6 Months From Screen and Week 25
timeFrame: Screen, Week 25
measure: Change in Hospitalizations (Medical) in the Past 6 Months From Screen and Week 25
timeFrame: Screen, Week 25
measure: Percentage Change of Days of Sub-optimal Housing in the Past Six Months; Change From Screen to Week 25
timeFrame: Screen, Week 25
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References: