NCT02529163

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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
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.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-12-01
• Completion: 2019-07-01
• First posted: 2015-08-20
• Last updated: 2018-08-10

Locations

1 site across 1 country: Canada