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

NCT ID: NCT02529163

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-07-31

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Late-life Schizophrenia ICP

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

Group Type: ACTIVE_COMPARATOR

Late-life Schizophrenia ICP

Intervention Type: 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

Treatment as Usual (TAU)

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: 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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

LLS-ICP; Late-life Schizophrenia Integrative Care Pathway; TAU

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Petal Abdool

Staff Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petal Abdool, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

Related Links

http://www.camh.net/research

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

Other Identifiers

032/2015

Identifier Type: -

Identifier Source: org_study_id