SchizophreniaLLS-ICPNCT02529163
Evaluating the Efficacy of a Late-Life Schizophrenia Integrated Care Pathway to Treat Acute Psychotic Symptoms
A study testing Late-life Schizophrenia ICP and Treatment as Usual in people with Schizophrenia and Schizoaffective Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Late-life Schizophrenia ICP and Treatment as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Late-life Schizophrenia ICP, Treatment as Usual
- Keywords
- Integrated Care Pathway, Acute Psychotic Episode, Randomised Control Trial
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Late-life Schizophrenia ICPOther
Also called LLS-ICP, Late-life Schizophrenia Integrative Care Pathway
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 UsualOther
Also called TAU
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Reduction in the rate and time to respond to medication during an acute psychotic episode measured by Clinical global impression - efficacy scale (4 item scale rated from 0 - 4 points with 0 being not assessed and 4 representing side effects outweighing therapeutic effect). This scale will be used to measure the efficacy of therapeutic response to the medication algorithm in the ICP against the standard treatment of care (TAU).
Measured: 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).
Reduction in the number and severity of medication side effects on participants. The SAS is a 10 item scale (0 stands for normal - 4 stands for exaggerated symptoms) used to assess Parkinsonian and extra-pyramidal side effects. BAS is a 4 item scale used to assess the severity of drug induced akathisia. AIMS is a 12 item scale (0 for normal - 4 for severe) used to assess dyskinesias. These scores will be aggregated to measure the side effect burden seen with use of atypical anti-psychotic medication used to treat schizophrenia. These scores will compare the side effect burden of the TAU group against the ICP group.
Measured: 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.
Increase in functional outcome to be assessed using the MCAS which measures adaptive functioning including health, adjustment to living, social competence and behavioral problems. It is a 17 item scale which graded from 1-6 where 1 represents extreme impairment, 5 represents normal and 6 representing unknown. The MoCA is a cognitive test that contains 12 items and is scored on a 30 point scale where 30 represents excellent cognitive function and 0 represents very poor cognitive function. Both scales will be aggregated to determine the relationship of the ICP and TAU to functional outcomes by measuring both cognitive and social functioning.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2017
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petal Abdool, Centre for Addiction and Mental Health
- Investigators
- Petal Abdool, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529163
- Sponsor's protocol ID
- 032/2015
- Acronym
- LLS-ICP
- Status last verified
- Aug 2018
- First submitted
- 11 Aug 2015
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: We do plan to share individual data at the completion of the study. Data will be shared only if the participant has agreed to do so as indicated on their informed consent document. Data that is expected to be shared will include all assessments from each visit, time to relapse, and which arm of the study each participant is affiliated with. In addition, research data gathered as part of this study may be shared and provided to investigators affiliated with GMHS (or other secondary investigators ) for the purpose of conducting secondary analyses about late-life mental illness. If subjects are enrolled in multiple studies in GMHS, their research data will be shared across studies to reduce participant burden and avoid duplication of procedures.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of a Late-Life Schizophrenia Integrated Care Pathway to Treat Acute Psychotic Symptoms
- ClinicalTrials.gov ID
- NCT02529163
- Acronym / sponsor ID
- LLS-ICP / 032/2015
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Integrated Care Pathway, Acute Psychotic Episode, Randomised Control Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jul 2019 (estimated)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Late-life Schizophrenia ICP | Active comparator | Other: Late-life Schizophrenia ICPThe 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 |
| Treatment as Usual (TAU) | Active comparator | Other: Treatment as UsualThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Late-life Schizophrenia ICPAlso: LLS-ICP, Late-life Schizophrenia Integrative Care PathwayThe 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 | Other | Late-life Schizophrenia ICP |
| Treatment as UsualAlso: TAUThe 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. | Other | Treatment as Usual (TAU) |
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)
Time frame: 18 months
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.
3 secondary outcomes
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.
Time frame: 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).
Time frame: 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.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teachingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We do plan to share individual data at the completion of the study. Data will be shared only if the participant has agreed to do so as indicated on their informed consent document. Data that is expected to be shared will include all assessments from each visit, time to relapse, and which arm of the study each participant is affiliated with. In addition, research data gathered as part of this study may be shared and provided to investigators affiliated with GMHS (or other secondary investigators ) for the purpose of conducting secondary analyses about late-life mental illness. If subjects are enrolled in multiple studies in GMHS, their research data will be shared across studies to reduce participant burden and avoid duplication of procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petal Abdool, MD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Late-life Schizophrenia ICP and Treatment as Usual in people with Schizophrenia and Schizoaffective Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.