Clinical trial NCT02946255: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: Psychosis
Psychosis NOS
Schizophrenia
Hospital discharge
Inpatient psychiatry
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Multnomah Community Ability Scale - Participant Interview Based
timeFrame: Baseline
measure: Multnomah Community Ability Scale - Participant Interview Based
timeFrame: 4 Week Follow-Up
measure: Multnomah Community Ability Scale - Participant Interview Based
timeFrame: 6 Month Follow-Up
measure: Multnomah Community Ability Scale - Clinician Based
timeFrame: Baseline
measure: Multnomah Community Ability Scale - Clinician Based
timeFrame: 4 Week Follow-Up
measure: Multnomah Community Ability Scale - Clinician Based
timeFrame: 6 Month Follow-Up
Secondary outcomes:
measure: Hospitalizations and Emergency Room Visits
timeFrame: Baseline to 6 Month Follow-Up
measure: The Satisfaction With Life Scale
timeFrame: 4 Week Follow-Up
measure: The Satisfaction With Life Scale
timeFrame: 6 Month Follow-Up
measure: Social Support Survey
timeFrame: Baseline
measure: Social Support Survey
timeFrame: 4 Week Follow-Up
measure: Social Support Survey
timeFrame: 6 Month Follow-Up
measure: Brief Symptom Inventory
timeFrame: Baseline
measure: Brief Symptom Inventory
timeFrame: 4 Week Follow-Up
measure: Brief Symptom Inventory
timeFrame: 6 Month Follow-Up
measure: Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale
timeFrame: Baseline
measure: Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale
timeFrame: 4 Week Follow-Up
measure: Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale
timeFrame: 6 Month Follow-Up
measure: Personal Recovery Outcome Measure
timeFrame: Baseline
measure: Personal Recovery Outcome Measure
timeFrame: 4 Week Follow-Up
measure: Personal Recovery Outcome Measure
timeFrame: 6 Month Follow-Up
measure: Community Integration Scale
timeFrame: 4 Week Follow-Up
measure: Community Integration Scale
timeFrame: 6 Month Follow-Up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Sean A Kidd, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.