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

NCT02529163 | Unknown

• 1 other identifier: 032/2015
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Integrated Care Pathway; Acute Psychotic Episode; Randomised Control Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  18 months

• 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).

  18 months

• 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.

  18 months

Study Arms (2)

Late-life Schizophrenia ICP

ACTIVE COMPARATOR

The Late-Life Schizophrenia ICP arm will follow a medication algorithm composed of 3 trials and titration schedule with prompts. First trial is Risperidone (2- 4mg daily). Second trial: Quetiapine (100 - 400mg daily) OR Aripiprazole (100 - 200mg daily) OR OR Ziprasidone (80mg daily) OR Loxapine (100mg daily) Third trial: Clozapine (450mg daily) or Olanzapine (20mg daily) If non compliant depot preparation of: Paliperidone (50 - 150mg monthly), Risperidone (12.5 - 50mg q 2 weeks), Flupentixol (10 - 20mg q 2-3 weeks) or Aripiprazole ( up to 400mg monthly) Prompts will be given to for non-pharmacological interventions such as: * metabolic monitoring * skin hygiene * pain management * nutritional counseling * counseling

Other: Late-life Schizophrenia ICP

Treatment as Usual (TAU)

ACTIVE COMPARATOR

The TAU will not receive any prompts to follow a specific treatment. The TAU group will be treated according to the current standard of care by the treating physician. They will have an opportunity to be offered the same non-pharmacological interventions seen with the ICP group but at the discretion of the treating physician. Pharmacological interventions will include an anti-psychotic medication that is selected at the discretion of treating physician with no set titration schedule or timeline to meet a maximum dosage. Max dosage will be decided by the treating physician.

Other: Treatment as Usual

Interventions

Late-life Schizophrenia ICP OTHER

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

Also known as: LLS-ICP, Late-life Schizophrenia Integrative Care Pathway

Late-life Schizophrenia ICP

Treatment as Usual OTHER

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.

Also known as: TAU

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Petal Abdool, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychiatrist

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 20, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2019
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)