Clinical trial NCT02529163: Evaluating the Efficacy of a Late-Life Schizophrenia Integrated Care Pathway to Treat Acute Psychotic Symptoms
Official title: Evaluating the Efficacy of a Late-Life Schizophrenia Integrated Care Pathway to Treat Acute Psychotic Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Integrated Care Pathway
Acute Psychotic Episode
Randomised Control Trial
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 18 months
Secondary outcomes:
measure: 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.
timeFrame: 18 months
measure: 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).
timeFrame: 18 months
measure: 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.
timeFrame: 18 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Petal Abdool, MD
role: PRINCIPAL_INVESTIGATOR
References: