Testing the Effectiveness of The Welcome Basket Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02946255
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : August 16, 2017
Information provided by (Responsible Party):
Sean Kidd, Centre for Addiction and Mental Health

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. 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.

Condition or disease Intervention/treatment Phase
Psychosis Behavioral: Welcome Basket (WB) Behavioral: Welcome Basket Brief (WBbr) Behavioral: Treatment As Usual Not Applicable

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 full version of the Welcome Basket intervention will improve the discharge-related outcomes of individuals with schizophrenia. 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 schizophrenia spectrum diagnosis 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Testing the Effectiveness of a Brief, Peer Support Intervention to Facilitate Transition Form Psychiatric Hospitalization
Actual Study Start Date : May 16, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Welcome Basket Brief (WBbr) Behavioral: Welcome Basket Brief (WBbr)
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.

Experimental: Welcome Basket (WB) Behavioral: Welcome Basket (WB)
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 e.g. setting up and placement of a calendar, basic organization of living space.

Active Comparator: Treatment As Usual Behavioral: Treatment As Usual
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 Measures :
  1. Change in Adaptive Functioning [ Time Frame: Change from baseline, 4 weeks post discharge and 6 month follow up ]
    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 :
  1. Hospitalization [ Time Frame: 4 weeks post discharge and 6 months post discharge ]
    Number of rehospitalizations and lengths of stay captured through case manager report and verified through hospital electronic database if a CAMH hospitalization.

  2. Change in quality of life [ Time Frame: 4 weeks post discharge and 6 months post discharge ]
    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).

  3. Change in symptomology [ Time Frame: Change from baseline, to 4 weeks post discharge and 6 months post discharge ]
    53 item Brief Symptom Inventory (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 'extremely'. The BSI includes 7 subscales; depression, hostility, phobic anxiety, obsessive compulsive, anxiety, paranoid ideation and interpersonal sensitivity.

  4. Change in recovery engagement [ Time Frame: Change from baseline, to 4 weeks post discharge and 6 months post discharge ]
    The brief, 10-item version of the Personal Recovery Outcome Measure (Barbic et al., 2016).

  5. Change in community involvement [ Time Frame: Change from baseline, to 4 weeks post discharge and 6 months post discharge ]
    The 18 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 be assessed post intervention and at follow up (would not be valid during inpatient stay due to contextual confounds with items).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Participants will be adults, 18 years of age or older, with a chart diagnosis of a schizophrenia spectrum mental illness confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.15). All participants will be on CAMH inpatient units at the time of recruitment and will have been in continuous inpatient care for 2 or more 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).
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02946255

Contact: Sean A Kidd, PhD 416 535 8501 ext 36295
Contact: Gursharan K Virdee, DPsych 4165358501 ext 34065

Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5T 1R8
Contact: Sean A Kidd, Ph.D    4165358501 ext 36295   
Contact: Gursharan K Virdee, DPsych    4165358501 ext 34065   
Sponsors and Collaborators
Centre for Addiction and Mental Health
Principal Investigator: Sean A Kidd, PhD Centre for Addiction and Mental Health

Additional Information:
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.
Derogatis, L.R.(1993). BSI Brief Symptom Inventory: Administration, Scoring, and Procedure Manual (4th Ed.). Minneapolis, MN: National Computer Systems.
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].

Responsible Party: Sean Kidd, Independent Clinician Scientist, Centre for Addiction and Mental Health Identifier: NCT02946255     History of Changes
Other Study ID Numbers: 073/2016
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sean Kidd, Centre for Addiction and Mental Health:
Psychosis NOS
Hospital discharge
Inpatient psychiatry

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders