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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

Page last updated: August 23, 2015

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