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

Study Overview
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Brief Summary
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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
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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: 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. 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. 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.

Official Title
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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

Conditions
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Psychotic Disorders, Schizophrenia, Schizoaffective Disorder, Medication Adherence, Medication Non-Adherence

Intervention / Treatment
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* Behavioral: CAE-L


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAE-L<br>Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end. | Behavioral: CAE-L<br>* Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.<br>* Other names: paliperidone palmitate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tablets Routine Questionnaire (TRQ, Past Week) From Screen to Week 25 Visit | The Tablets Routine Questionnaire (TRQ) determines the proportion of prescribed medication taken and is not dependent upon timing of medication provided that medication is consumed within the required day/24 hour period. This rating has demonstrated statistically significant association with past non-adherence, repeated past non-adherence, any non-adherence in the past month, and non-adherence in the past week. The TRQ format will be modified slightly to document all adherence values (an exact proportion) for each item. TRQ scores ranges from perfect adherence (0% missed) to missing all medication (100% missed). An average TRQ was calculated for individuals on more than one BD medication. | Screen, Week 25 | 
| Change in Tablets Routine Questionnaire (TRQ) (Past Month) From Screen to Week 25 | The Tablets Routine Questionnaire (TRQ) determines the proportion of prescribed medication taken and is not dependent upon timing of medication provided that medication is consumed within the required day/24 hour period. This rating has demonstrated statistically significant association with past non-adherence, repeated past non-adherence, any non-adherence in the past month, and non-adherence in the past week. The TRQ format will be modified slightly to document all adherence values (an exact proportion) for each item. TRQ scores ranges from perfect adherence (0% missed) to missing all medication (100% missed). An average TRQ was calculated for individuals on more than one BD medication. | Screen, Week 25 | 
| Long-acting Injection (LAI) Adherence | Long-acting injection (LAI) adherence will be determined as a proportion of LAI (paliperidone palmitate or haloperidol decanoate) injections received at the appropriate time (within 7 days of scheduled time). | Week 25 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in DAI (Drug Attitudes Index) From Screen to Week 25 | The DAI contains ten true-false items. Correct responses are scored as +1, while incorrect responses are scored as 0. The highest possible score is 10, while the lowest possible score is 0. Higher scores indicate better drug attitudes, while lower scores indicate worse drug attitudes. | Screen, Week 25 | 
| Change in AMSQ (Attitudes Toward Mood Stabilizers Questionnaire) From Screen to Week 25 | The AMSQ/AMQ is used to measure attitudes towards medications. The scale contains 19 items. Responses which suggest positive attitudes towards medications are scored 0, while responses which suggest negative attitudes towards medications are scored 1. The items scores are added for a total score. Total scores range from 0 to 19. Lower total scores suggest more positive attitudes, while higher scores suggest more negative attitudes. | Screen, Week 25 | 
| Change in PANSS (Positive and Negative Syndrome Scale; Positive Symptoms Scale) From Screen to Week 25 | The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The Positive Symptoms Subscale consists of 7 questions. Each item is rated on a scale of 1 (Absent) to 7 (Extreme). Total scores for the Positive Symptoms Subscale range from 7-49. Higher scores indicate more symptoms of psychopathology. There is no aggregate score for this measure, as the subscales are to be scored separately. | Screen, Week 25 | 
| Change in PANSS (Positive and Negative Syndrome Scale; Negative Symptoms Scale) From Screen to Week 25 | The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The Negative Symptoms Subscale consists of 7 questions. Each item is rated on a scale of 1 (Absent) to 7 (Extreme). Total scores for the Negative Symptoms Subscale range from 7-49. Higher scores indicate more symptoms of psychopathology. There is no aggregate score for this measure, as the subscales are to be scored separately. | Screen, Week 25 | 
| Change in PANSS (Positive and Negative Syndrome Scale; Composite Scale) From Screen to Week 25 | The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The Composite Scale is scored by subtracting the negative score from the positive score. This yields a bipolar index that ranges from -42 to +42. The bipolar composite scale simply expresses the direction and magnitude of difference between positive and negative syndromes. Scores >0 indicate there are more positive symptoms of schizophrenia endorsed, and scores <0 indicate there are more negative symptoms of schizophrenia endorsed. There is no aggregate score for this measure, as the subscales are to be scored separately. | Screen, Week 25 | 
| Change in PANSS (Positive and Negative Syndrome Scale; General Psychopathology) From Screen to Week 25 | The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The General Psychopathology Subscale consists of 16 questions. Each item is rated on a scale of 1 (Absent) to 7 (Extreme). Total scores range from 16-112 on the General Psychopathology scale. Higher scores indicate more symptoms of psychopathology. There is no aggregate score for this measure, as the subscales are to be scored separately. | Screen, Week 25 | 
| Change in CGI (Clinical Global Impression) From Screen to Week 25 | The CGI evaluates global psychopathology illness severity on a 7 point Likert Scale (minimum score = 1; maximum score = 7) with higher scores indicating worse pathology. | Screen, Week 25 | 
| Change in ASSIST GRS (Alcohol, Smoking and Substance Involvement Screening Test ) From Screen to Week 25 | The ASSIST was used to measure drug use. A total score is derived by combining item scores (minimum score = 0; maximum score = 382). Higher scores indicate higher risk of lifestyle problems, including health. | Screen, Week 25 | 
| Change in SOFAS (Social and Occupational Functioning Assessment Scale) From Screen to Week 25 | Evaluates social and occupational functioning on a scale of 0 (Inadequate information) to 100 (Superior functioning). It is a one-item measure. | Screen, Week 25 | 
| Change in AIMS (Abnormal Involuntary Movement Scale) From Baseline to Week 25 | The AIMS is used to monitor for the development of involuntary movements that may occur as a result of certain psychotropic medication. It contains 14 items, 10 of which are rated on a scale of 0 (None) to 4 (Severe). The remaining four items are yes or no questions. Items 1 thru 7 are added for a total score, while item 8 is used as an overall severity index. Total scores range from 0 to 28. Higher scores indicate more adverse outcomes.Items 9 thru 12 provide additional information that may be useful in determining lip, jaw, and tongue movements. | Baseline, Week 25 | 
| Change in SAS (Simpson Angus Scale) From Screen to Week 25 | The Simpson-Angus Scale is used to monitor for neurological and musculoskeletal side effects that may be a result of certain psychotropic medications. The scale consists of 10 questions which each can be rated on a scale of 0 to 4. Scores for each item are added to produce a total score. Total scores range from 0 to 40. Higher scores indicate more adverse outcomes. | Screen, Week 25 | 
| Change in BARS (Barnes Akathisia Rating Scale) From Screen to Week 25 | This scale is used to measure the presence of akathisia, as may result from use of certain psychotropic medications. The scale contains four items and the score for each item is added to produce the total score. Total scores range from 0 to 14. Higher scores indicate more adverse outcomes. | Screen, Week 25 | 
| Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Parkinsonism) From Screen to Week 25 | For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. The score for Parkinsonism (including akathisia), ranges from 0 to 102 (17 items), and is based on all items of the Parkinsonism examination: tremor (0-48), gait and posture (0-6), postural stability (0-6), rigidity (0-24), expressive automatic movements (0-6), bradykinesia (0-6), akathisia (0-6). Higher scores indicate more severity. | Screen, Week 25 | 
| Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dystonia) From Screen to Week 25 | For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. The score for dystonia ranges from 0 to 60 (10 items), and is formed by including both acute and chronic dystonia, based on the dystonia examination. Higher scores indicate more severity. | Screen, Week 25 | 
| Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dyskinesia) From Screen to Week 25 | For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. Score for TD, ranging from 0 to 42, is based on the sum of all seven items in the TD objective examination. Higher scores indicate more severe symptomology. | Screen, Week 25 | 
| Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Akathisia) | For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. The score for akathisia is separated from the Parkinsonism score and is based on the combined score of subjective akathisia (item 6 of the questionnaire) and objective akathisia (item 7 of the Parkinsonism/Akathisia objective examination). This subscore total ranges from 0 to 6. Higher scores indicate more severity. | Screen, Week 25 | 
| Change in Hospitalizations (Psychiatric) in the Past 6 Months From Screen and Week 25 | Change in number of psychiatric hospitalizations from the past 6 months from Screen and Week 25. This is calculated by subtracting the number of psychiatric hospitalizations at screen from the number of psychiatric hospitalizations at week 25. | Screen, Week 25 | 
| Change in Hospitalizations (Medical) in the Past 6 Months From Screen and Week 25 | Change in number of psychiatric hospitalizations from the past 6 months from Screen and Week 25. This is calculated by subtracting the number of psychiatric hospitalizations at screen from the number of psychiatric hospitalizations at week 25. | Screen, Week 25 | 
| Percentage Change of Days of Sub-optimal Housing in the Past Six Months; Change From Screen to Week 25 | Change in number of sub-optimal housing from the past 6 months from Screen and Week 25. This is calculated by subtracting the percent of sub-optimal housing at screen from the number of sub-optimal housing at week 25. | Screen, Week 25 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Homelessness, Antipsychotic Drugs, Antipsychotics, Injectables, Long Acting Injectable Antipsychotic, Psychotic Disorders, Schizophrenia, Schizoaffective Disorder, Medication Adherence, Medication Non-Adherence, Community Mental Health Centers