Evaluating the Efficacy of a Late-Life Schizophrenia Integrated Care Pathway to Treat Acute Psychotic Symptoms
Information source: Centre for Addiction and Mental Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Late-life Schizophrenia ICP (Other); Treatment as Usual (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Centre for Addiction and Mental Health Official(s) and/or principal investigator(s): Petal Abdool, MD, Principal Investigator, Affiliation: Centre for Addiction and Mental Health
Overall contact: Petal Abdool, MD, Phone: 416-535-8501, Ext: 39404, Email: petal.abdool@camh.ca
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.
Clinical Details
Official title: Evaluating the Efficacy of a Late-Life Schizophrenia Integrated Care Pathway to Treat Acute Psychotic Symptoms
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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)
Secondary outcome: 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.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). Efficacy of an Integrated Care Pathway on functional outcome using the Multnomah Community Ability Scale (MCAS) for social fuctioning and Montreal Cognitive Assessment scale (MoCA) to test for cognition.
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. 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 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 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 are being cared for.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All races and ethnicity
- Meets DSM-V TR 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
Locations and Contacts
Petal Abdool, MD, Phone: 416-535-8501, Ext: 39404, Email: petal.abdool@camh.ca
Centre for Addiction and Mental Health, Toronto, Ontario M6J 1H4, Canada; Recruiting Petal Abdool, MD, Phone: 416-535-8501, Ext: 39404, Email: Petal.abdool@Camh.ca Tarek Rajji, MD, Phone: 416-535-8501, Ext: 33661, Email: Tarek.Rajji@camh.ca Petal Abdool, MD, Principal Investigator
Additional Information
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching
Starting date: August 2015
Last updated: August 18, 2015
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