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Testing the Effectiveness of The Welcome Basket Intervention

Primary Purpose

Psychosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Welcome Basket (WB)
Welcome Basket Brief (WBbr)
Treatment As Usual
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychosis focused on measuring Psychosis, Psychosis NOS, Schizophrenia, Hospital discharge, Inpatient psychiatry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Participants must have been referred to outpatient case management.
  4. 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.
  5. Proficiency in English.

Exclusion criteria:

1. Do not meet the above criteria.

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Welcome Basket Brief (WBbr)

Welcome Basket (WB)

Treatment As Usual

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Hospitalization
Number of rehospitalizations and lengths of stay captured through case manager report and verified through hospital electronic database if a CAMH hospitalization.
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).
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 in recovery engagement
The brief, 10-item version of the Personal Recovery Outcome Measure (Barbic et al., 2016).
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).
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.

Full Information

First Posted
October 12, 2016
Last Updated
February 5, 2021
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT02946255
Brief Title
Testing the Effectiveness of The Welcome Basket Intervention
Official Title
Testing the Effectiveness of a Brief, Peer Support Intervention to Facilitate Transition Form Psychiatric Hospitalization
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
Psychosis, Psychosis NOS, Schizophrenia, Hospital discharge, Inpatient psychiatry

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Welcome Basket Brief (WBbr)
Arm Type
Experimental
Arm Description
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.
Arm Title
Welcome Basket (WB)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Welcome Basket (WB)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Welcome Basket Brief (WBbr)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Adaptive Functioning
Description
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).
Time Frame
Change from baseline, 4 weeks post discharge and 6 month follow up
Secondary Outcome Measure Information:
Title
Hospitalization
Description
Number of rehospitalizations and lengths of stay captured through case manager report and verified through hospital electronic database if a CAMH hospitalization.
Time Frame
4 weeks post discharge and 6 months post discharge
Title
Change in quality of life
Description
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).
Time Frame
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
Title
Change in symptomology
Description
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.
Time Frame
Change from baseline, to 4 weeks post discharge and 6 months post discharge
Title
Change in recovery engagement
Description
The brief, 10-item version of the Personal Recovery Outcome Measure (Barbic et al., 2016).
Time Frame
Change from baseline, to 4 weeks post discharge and 6 months post discharge
Title
Change in community involvement
Description
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).
Time Frame
4 weeks post discharge and 6 months post discharge
Title
Descriptive Measures
Description
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.
Time Frame
Core demographic information: baseline only / Service use history: Change from baseline, to 4 weeks post discharge and 6 months post discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean A Kidd, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7956112
Citation
Barker S, Barron N, McFarland BH, Bigelow DA. A community ability scale for chronically mentally ill consumers: Part I. Reliability and validity. Community Ment Health J. 1994 Aug;30(4):363-83. doi: 10.1007/BF02207489.
Results Reference
background
Citation
Lee, K., Brekke, J., Yamada, A., & Chou, C. (2010). Longitudinal invariance of the satisfaction with life scale for individuals with schizophrenia. Research on Social Work Practice, 20(2), 234-241.
Results Reference
background
Citation
Derogatis, L.R.(1993). BSI Brief Symptom Inventory: Administration, Scoring, and Procedure Manual (4th Ed.). Minneapolis, MN: National Computer Systems.
Results Reference
background
Citation
Barbic, S., Kidd, SA, Backman, C., MacEwan, W.. Honer, W., & McKenzie, K. (2016). The development and testing of the Personal Recovery Outcome Measure (PROM) [in preparation].
Results Reference
background
PubMed Identifier
26176621
Citation
Stergiopoulos V, Gozdzik A, Misir V, Skosireva A, Connelly J, Sarang A, Whisler A, Hwang SW, O'Campo P, McKenzie K. Effectiveness of Housing First with Intensive Case Management in an Ethnically Diverse Sample of Homeless Adults with Mental Illness: A Randomized Controlled Trial. PLoS One. 2015 Jul 15;10(7):e0130281. doi: 10.1371/journal.pone.0130281. eCollection 2015.
Results Reference
background
Citation
First MB, William JBW, Karg RS, Spitzer RL: Structured Clinical Interview for DSM-5-Research Version (SCID-5 for DSM-5, Research Version; SCRID-5-RV). Arlington,VA, American Psychiatric-Association, 2015.
Results Reference
background
PubMed Identifier
2035047
Citation
Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.
Results Reference
background
PubMed Identifier
17182423
Citation
Dennis ML, Chan YF, Funk RR. Development and validation of the GAIN Short Screener (GSS) for internalizing, externalizing and substance use disorders and crime/violence problems among adolescents and adults. Am J Addict. 2006;15 Suppl 1(Suppl 1):80-91. doi: 10.1080/10550490601006055.
Results Reference
background
PubMed Identifier
2289094
Citation
Birchwood M, Smith J, Cochrane R, Wetton S, Copestake S. The Social Functioning Scale. The development and validation of a new scale of social adjustment for use in family intervention programmes with schizophrenic patients. Br J Psychiatry. 1990 Dec;157:853-9. doi: 10.1192/bjp.157.6.853.
Results Reference
background
Links:
URL
http://www.camh.ca/en/research/Pages/research.aspx
Description
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addictions teachings hospital.

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Testing the Effectiveness of The Welcome Basket Intervention

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