Testing the Effectiveness of The Welcome Basket Intervention

Study Overview
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Brief Summary
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The investigators propose to examine the effectiveness of a brief intervention that might better facilitate the transition into the community for people with schizophrenia or bipolar disorder with psychotic features. The intervention is called the Welcome Basket. It involves Peer Support Workers connecting with and supporting hospitalized individuals in the days before discharge and again in the community in the first month immediately following discharge. The investigators will compare the outcomes of discharge from hospital as usual with the full version of the welcome basket and a preliminary test of an abbreviated 2 visit version of the intervention.

Detailed Description
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Discharge from hospital has been highlighted as a critical time in the care of individuals with mental illness. The peak period of risk for readmission for individuals with severe mental illness is in the first month and the highest risk for post-discharge suicide is within the first 2 weeks with discontinuity of contact with providers highlighted as a key risk factor. One half of individuals with schizophrenia miss their first-scheduled outpatient appointment following discharge and this time is a key period of risk for medication non-compliance. Common problems that occur at the time of discharge from psychiatric care settings include poor communication between inpatient and outpatient providers and inadequate involvement and support of families. The research literature on effective practices linked with discharge is strikingly sparse given the evidence that this is a period of heightened risk. The investigators hypothesize that the Welcome Basket intervention will improve the discharge-related outcomes of individuals with schizophrenia or bipolar disorder with psychotic features compared to treatment as usual. Investigators will also explore the outcomes of an abbreviated, 2-visit version of the intervention. This study will employ a randomized, controlled trial design. Inpatient clients with a diagnosis of schizophrenia spectrum mental illness or bipolar disorder with psychotic features will be randomized with a 2:2:1 ratio to: treatment as usual, the full welcome basket intervention, and the abbreviated intervention. Measures will include re-hospitalization, symptomatology, quality of life, and community functioning. Assessments at baseline, 4 weeks post-discharge, and 6 months post-discharge will facilitate studies of relative effectiveness and sustainment of gains. This design will facilitate an examination of both overall outcomes as well as some preliminary dismantling of mechanisms of action.

Official Title
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Testing the Effectiveness of a Brief, Peer Support Intervention to Facilitate Transition Form Psychiatric Hospitalization

Conditions
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Psychosis

Intervention / Treatment
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* Behavioral: Welcome Basket (WB)
* Behavioral: Welcome Basket Brief (WBbr)
* Behavioral: Treatment As Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be adults, 18 years of age or older, with a chart diagnosis of a schizophrenia spectrum mental illness or bipolar disorder with psychotic features confirmed by Module B (psychotic symptoms) of the Structured Clinical Interview for DSM-5 (SCID-5) (First, William, Karg, & Spitzer, 2015). All participants will be on CAMH inpatient units at the time of recruitment and will have been in continuous inpatient care for close to or more than 2 weeks. This timeframe is guided by the rationale and experience indicating that an overly brief period of hospitalization circumscribes the relevance of the intervention. Participants will be returning to places of residence in the Greater Toronto Area (catchment of CAMH) or can travel to the GTA if they will reside outside the catchment area. Participants must have been referred to outpatient case management. Proposed housing arrangements must be stable and conducive to the intervention. If homelessness or emergency shelter residence appears likely, or boarding home policy precludes any external staff from entering the premises, such individuals will be excluded. Proficiency in English. Exclusion criteria: 1. Do not meet the above criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Welcome Basket Brief (WBbr)<br>The brief version of the Welcome Basket (WBbr) was developed based upon the observation in feasibility testing that for some participants much of the benefit of this approach appeared to be centred upon the visits immediately prior and subsequent to discharge. In the WBbr the same core components will be present, albeit in an abbreviated form with one 30-60 minute visit in the week prior to discharge and a single, 3-hour visit in the week subsequent to discharge in which the welcome basket would be delivered, core CAT strategies discussed and implemented, and some basic orientation to community resources undertaken. This brief version of the intervention has not to date been studied. | Behavioral: Welcome Basket Brief (WBbr)<br>* The brief version of the Welcome Basket (WBbr) was developed based upon the observation in feasibility testing that for some participants much of the benefit of this approach appeared to be centred upon the visits immediately prior and subsequent to discharge. In the WBbr the same core components will be present, albeit in an abbreviated form with one 30-60 minute visit in the week prior to discharge and a single, 3-hour visit in the week subsequent to discharge in which the welcome basket would be delivered, core CAT strategies discussed and implemented, and some basic orientation to community resources undertaken. This brief version of the intervention has not to date been studied.<br>|
| Experimental: Welcome Basket (WB)<br>Peer Support Workers (PSWs) hold 1-2 meetings with clients (30-60 minutes) in the 2-week period before they are discharged from hospital. They describe the program and undertake an assessment. From this assessment the two core components of the intervention are initiated. First, a welcome basket is created for the client. The PSW also forms a plan with the client about tours of their neighbourhood to familiarize them with the local resources and support them in building confidence in accessing their local communities. These activities will take place through weekly visits (2 hours/visit) in the 4 weeks immediately following discharge. WB will be provided in combination with core Cognitive Adaptation Training (CAT) compensatory interventions. | Behavioral: Welcome Basket (WB)<br>* Peer Support Workers (PSWs) hold 1-2 meetings with clients (30-60 minutes) in the 2-week period before they are discharged from hospital. They describe the program and undertake an assessment. From this assessment the two core components of the intervention are initiated. First, a welcome basket is created for the client. The PSW also forms a plan with the client about tours of their neighbourhood to familiarize them with the local resources and support them in building confidence in accessing their local communities. These activities will take place through weekly visits (2 hours/visit) in the 4 weeks immediately following discharge. WB will be provided in combination with core Cognitive Adaptation Training (CAT) compensatory interventions.<br>|
| Active Comparator: Treatment As Usual<br>Treatment as usual (TAU) involves the typical discharge procedures for clients from Unit 2, Forensic and EPU wards at CAMH. It includes referral to outpatient psychiatric services and relevant community supports with the transition facilitated by inpatient social work staff. | Behavioral: Treatment As Usual<br>* Treatment as usual (TAU) involves the typical discharge procedures for clients from Unit 2, Forensic and EPU wards at CAMH. It includes referral to outpatient psychiatric services and relevant community supports with the transition facilitated by inpatient social work staff.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adaptive Functioning | Community Functioning will be assessed with the Multnomah Community Ability Scale (MCAS, Barker et al. 1994, a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants primary clinician (inpatient for baseline and case managers for post and follow up measures). | Change from baseline, 4 weeks post discharge and 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization | Number of rehospitalizations and lengths of stay captured through case manager report and verified through hospital electronic database if a CAMH hospitalization. | 4 weeks post discharge and 6 months post discharge | 
| Change in quality of life | The Satisfaction With Life scale (Lee et al., 2010), an 18-item scale that has subscales assessing living situation, social relationships, work, self and present life. QoL will be assessed post intervention and at follow up (would not be valid during inpatient stay due to contextual confounds with items). QoL will also be assessed using the Social Support Survey (Sherbourne & Stewart, 1991), a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction (all time points). | Satisfaction With Life Scale: 4 weeks post discharge and 6 months post discharge / Social Support Survey: Change from baseline, to 4 weeks post discharge and 6 months post discharge | 
| Change in symptomology | 53 item Brief Symptom Inventory (BSI) (Derogatis, 1993); this widely used instrument has extensively demonstrated validity and reliability properties and contains 53 items assessing a wide range of symptom areas with responses given on a 5 point scale of distress ranging from 'not at all' to 'a great deal'. The BSI includes 7 subscales; depression, hostility, phobic anxiety, obsessive compulsive, anxiety, paranoid ideation and interpersonal sensitivity. The 5 item GAIN Short Screener (Dennis, Chan, & Funk, 2006), will also be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. | Change from baseline, to 4 weeks post discharge and 6 months post discharge | 
| Change in recovery engagement | The brief, 10-item version of the Personal Recovery Outcome Measure (Barbic et al., 2016). | Change from baseline, to 4 weeks post discharge and 6 months post discharge | 
| Change in community involvement | The 11 item Community Integration Scale (Stergiopoulos et al., 2015) which was developed for the At Home study with a comparable population to assesses psychological and behavioural community engagement. Community Involvement will also be assessed with the Social Functioning Scale (Birchwood, Smith, Cochrane, Wetton, & Copestake, 1990). Community Involvement will be assessed post intervention and at follow up (would not be valid during inpatient stay due to contextual confounds with items). | 4 weeks post discharge and 6 months post discharge | 
| Descriptive Measures | Core demographic information (gender, ethnicity, sexual orientation, age, education, etc.) is collected at time 1. Service use history (history of hospitalization, physical and mental health service use, and community services) is also collected and updated at each contact. Amount of contact in hours per month with a person or persons (other than providers; e.g. family) regarded as important supports by participants will be captured to help determine if non-service supports are a relevant covariate in considering outcomes. | Core demographic information: baseline only / Service use history: Change from baseline, to 4 weeks post discharge and 6 months post discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosis, Psychosis NOS, Schizophrenia, Hospital discharge, Inpatient psychiatry