Evaluating the Efficacy of a Late-Life Schizophrenia Integrated Care Pathway to Treat Acute Psychotic Symptoms

Schizophrenia Clinical Trial

— LLS-ICP  

Official title:

Evaluating the Efficacy of a Late-Life Schizophrenia Integrated Care Pathway to Treat Acute Psychotic Symptoms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02529163
• Other study ID #: 032/2015
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2015
• Est. completion date: July 2019

Study information

• Verified date: August 2018
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As of late Integrated Care Pathways (ICPs) have been shown to improve quality of care in the medical field with special attention given to mental health in particular. One aspect of metal health that has not seen the incorporation of ICPs is in the area of schizophrenia. Late life Schizophrenia (LLS) is defined as suffering from schizophrenia and being 50 years of age or older. The LLS-ICP study will look at the efficacy of an ICP in late life schizophrenia versus treatment as usual (TAU). Participants with LLS and having psychotic symptoms above a predefined threshold will be randomly assigned to a TAU group or an ICP group. The primary outcome measure will be reduction in symptom severity as measured by clinical global impression severity scale (CGI-S) and brief psychiatric rating scale (BPRS). If successful, this study will provide strong evidence to implement LLS-ICP across different inpatient and outpatient settings.

Description:

This study aims to investigate whether a Late-Life Schizophrenia-Integrated Care Pathway (LLS-ICP) is superior to treatment as usual (TAU) in the treatment of psychotic symptoms of patients with schizophrenia or schizoaffective disorder. The investigators hypothesize that the LLS-ICP will be superior to TAU and result in 1.higher rates of response, 2. shorter times to response, 3. less side effects, 4. and better functional outcomes. The LLS-ICP study will be the first randomized controlled study to assess the efficacy of an ICP in patients with schizophrenia or schizoaffective disorder in this region. If successful, it will lead to the development of new and innovative approaches to health care delivery to patients with chronic schizophrenia or schizoaffective disorder not just within this institution but also at other sites in the community. The nature of ICPs as algorithmic and systematic in providing assessments and treatments render them ideal to be disseminated to medical practice outside of the institution of where they have been developed. These settings can include primary care clinics, supportive living environments, and long-term care homes where patients with chronic schizophrenia or schizoaffective disorder are being cared for.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: July 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• All races and ethnicity

• Meets DSM-IV TR (Diagnostic and Statistical Manual Version 4 Text Revision) criteria for a current diagnosis of Schizophrenia

• clinically unstable and in an acute episode as defined by a CGI severity score greater than 3 or a BPRS thought disorder sub-scale score higher than 6 (total score).

• Willingness and ability to speak English

• Willingness to provide informed consent or has a proxy who can do so

• Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.

Exclusion Criteria:

• Diagnosis of bipolar disorder, current major depressive episode or an acutely psychotic episode secondary to a non-schizophrenic disorder

• Meets diagnostic criteria for substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Other:
• Late-life Schizophrenia ICP
The ICP medication algorithms first trial begins with: Risperidone titrated to a max dose Failure to Risperidone will lead to a second trial with either: Quetiapine OR Aripiprazole If subject refuses or if this trial does not work, then offer: Ziprasidone or Loxapine Failure of 2 anti-psychotic trials results in: Clozapine trial If subject refuses a Clozapine trial then: Olanzapine offered titrations occur over 33-36 day period (inpatient) or 12 week period (out patient) with each 0.5 mg titration after the target dose requiring a CGI-E If compliance is an issue then a depot preparation: Paliperidone Risperidone Flupentixol Aripiprazole Physicians will be prompted for non-pharmacological interventions
• Treatment as Usual
The TAU group will be offered non-pharmacological interventions such as (but not limited to): metabolic monitoring skin hygiene pain management nutritional counseling family counselling Financial/housing support Group CBT (Cognitive Behavioral Therapy) Physicians treating this group will use their own discretion as they will not be prompted like the ICP group. Pharmacological interventions contain anti-psychotic medication selected at the discretion of the treating physician provided it fall under the current standard of care such as: Risperidone Aripiprazole Quetiapine Olanzapine Paliperidone Clozapine Ziprasidone Max dosing and the time to reach the target dose is done at the discretion of the treating physician.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of LLS-ICP using a medication algorithm and evaluating with the clinical global impression severity scale (CGI-S) and brief psychiatric rating scale (BPRS)	Reduction in symptom severity will be measured using CGI-S (1 item 7 point scale with 0 being not assessed and 7 being most extremely ill patient) and (BPRS) which will be used to measure psychiatric symptoms such as hallucinations, anxiety or depression. ( 24 question scale rated from 0 being not assessed and 7 being extremely severe). Both scores will be aggregated to determine the reduction in overall symptoms and their severity in relationship to ICP and TAU groups.	18 months
Secondary	Efficacy of an Integrated Care Pathway on rate and time of response needed to treat acute psychotic episode measured by CGI-E for therapeutic response and global improvement.	Reduction in the rate and time to respond to medication during an acute psychotic episode measured by Clinical global impression - efficacy scale (4 item scale rated from 0 - 4 points with 0 being not assessed and 4 representing side effects outweighing therapeutic effect). This scale will be used to measure the efficacy of therapeutic response to the medication algorithm in the ICP against the standard treatment of care (TAU).	18 months
Secondary	Efficacy of an Integrated Care Pathway on side effect burden using Simpson Angus Scale (SAS), Barnes Akathisia Scale (BAS/BARS), and Abnormal Involuntary Movement Scale (AIMS).	Reduction in the number and severity of medication side effects on participants. The SAS is a 10 item scale (0 stands for normal - 4 stands for exaggerated symptoms) used to assess Parkinsonian and extra-pyramidal side effects. BAS is a 4 item scale used to assess the severity of drug induced akathisia. AIMS is a 12 item scale (0 for normal - 4 for severe) used to assess dyskinesias. These scores will be aggregated to measure the side effect burden seen with use of atypical anti-psychotic medication used to treat schizophrenia. These scores will compare the side effect burden of the TAU group against the ICP group.	18 months
Secondary	Efficacy of an Integrated Care Pathway on functional outcome using the Multnomah Community Ability Scale (MCAS) for social functioning and Montreal Cognitive Assessment scale (MoCA) to test for cognition.	Increase in functional outcome to be assessed using the MCAS which measures adaptive functioning including health, adjustment to living, social competence and behavioral problems. It is a 17 item scale which graded from 1-6 where 1 represents extreme impairment, 5 represents normal and 6 representing unknown. The MoCA is a cognitive test that contains 12 items and is scored on a 30 point scale where 30 represents excellent cognitive function and 0 represents very poor cognitive function. Both scales will be aggregated to determine the relationship of the ICP and TAU to functional outcomes by measuring both cognitive and social functioning.	18 months

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