- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02258737
Efficacy of Transitional Case Management Following Psychiatric Hospital Discharge
Efficacy of Transitional Case Management Following Psychiatric Hospital Discharge: a Randomized Trial
Efficacy of transitional case management following psychiatric hospital discharge: a randomized trial
Background The movement of deinstitutionalisation in Western societies has modified the role of psychiatric hospital, which has lost its asylum function to become a place for acute care.
Psychiatric stays are now shorter and close interactions with the outpatient care network is therefore more critical than before. The first weeks following discharge from psychiatric hospital represent a period of high risk for relapse, readmission or even suicide. Case management has a proven efficacy in facilitating patients' deinstitutionalisation after very long hospitalisations and in stabilizing high users of psychiatric care. In contrast, studies exploring the impact of time limited case management following discharge from short stays (transitional case management) in earlier phases of psychiatric disorders in connection with primary care are lacking.
Working Hypotheses The investigators hypothesize that transitional case management following hospital discharge decreases risk of readmission, improves adherence to outpatient care, facilitates recovery and improves patients' satisfaction with treatment as compared to routine care.
Specific Aims In this study, the investigators will compare the impact of both intervention on number of contact and level of adherence to outpatient care. The investigators will also compare both groups on number of readmission, risk of early aggravation of the disorders, level of functioning and satisfaction with care.
Methods This is a randomized single-blind study comparing transitional case management after discharge with routine post-hospitalization care for subjects living independently without institutional psychiatric follow-up. Demographic and clinical data will be gathered during hospitalization, and 1, 3, 6 and 12 months after discharge. Quantitative assessment of outcomes using validated instruments will be: contact and level of adherence to outpatient care (primary outcomes), as well as number of hospitalization days, number of readmissions, severity of illness and satisfaction with care (secondary outcomes).
Expected Value of the Proposed Project This study should improve psychiatric patients follow-up in collaboration with the different levels of care in the global context of deinstitutionalization.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
VD
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Prilly, VD, Switzerland, 1008
- Social Psychiatry Section, Lausanne University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients are 18-65 years of age
- No immediate institutional follow up after discharge
- Independent living condition
Exclusion Criteria:
- Organic brain disease
- Clinically significant concurrent illnesses
- Poor understanding of French
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: standard care
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Routine hospitalization care is broadly defined as the usual level of care in the context of the adult department of psychiatry of the CHUV (Centre Hospitalier Universitaire Vaudois).
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Experimental: transitional case management
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The case management activity deals with organizational and clinical aspects.
The objective is to focus on network's expectations during hospitalization and at discharge, and ensure contacts between hospital and patient' social network.
The aim is to support patient during the transition phase following discharge
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Adherence to outpatient care
Time Frame: one year
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Information on admission, diagnoses, notes on problems of compliance, preparation for hospital discharge and links with outpatient care using the Boyer Scale (Boyer, McAlpine, Pottick et al. 2000)
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one year
|
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Working alliance
Time Frame: one year
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Assessment of the relationship between patient and care provider uning the Working Alliance Inventory, short version (WAI-SRp) (Horvath, 1984; Hatcherr & Gillaspy, 2006; translation : Baillargeon & Leduc, 2000; de Roten, 2006)
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one year
|
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Number of readmissions
Time Frame: one year
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Socio-demographic assessment of service receipt (use of services, length of hospitalization and number of readmissions) and medication profile using the Client Socio-Demographic and Service Receipt Inventory (CSSRI - EU) (Chisholm et al., 2000)
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one year
|
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Degree of psychiatric symptoms
Time Frame: one year
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Assessment of psychiatric symptoms (global severity, diversity of symptoms and degree of discomfort) using the Symptom check-list (SCL-90 R) (Derogatis, 1977; French translation: Guelfi et Dreyfus,1984)
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one year
|
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Hopelessness
Time Frame: one year
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Assessment of the risks of suicide attempts or of suicide.
Assessment of pessimism using the Hopelessness Scale - Questionnaire H (Hopelessness scale) (Beck, 1974; translation Cottraux, 1985)
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one year
|
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Substance use
Time Frame: one year
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Assessment of alcohol and drug consumption (prevalence and frequency) using an extract from " Cannabis and Substance Use Assessment Scale " (CASUAS) (Edwards et al., 2003)
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one year
|
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Perceived Improvement
Time Frame: one year
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Assessment of the patient's perception of clinical improvement using the Perceived Improvement questionnaire (Perreault, 2003)
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one year
|
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Severity of mental health problems
Time Frame: one year
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Assessment of the severity of mental health problems (behavior, handicap, symptoms, social) using the Health of Nation Outcome Scale (HoNOS) (Wing & Curtis, 1996; Lauzon et al. 2001)
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one year
|
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Global Assessment of Functioning
Time Frame: one year
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Assessment of the patient's level of global functioning on a scale of 0 to 100 using the Global Assessment of Functioning (GAF), (Endicott, Spitzer et al 1976; translation Guelfi, Boyer, 1989)
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one year
|
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Social and Occupational Functioning
Time Frame: one year
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Assessment of the levels of social and professional functioning on a scale of 0 to 100 using the Social and Occupational Functioning Assessment Scale (SOFAS) (Goldman, Skodol et Lave, 1992)
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one year
|
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Social support
Time Frame: one year
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Assessment of the network's and of the patient's perception regarding availability using the " Social Support " questionnaire (Community Mental Health Evaluation Initiative, CMHEI, 2001)
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one year
|
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Empowerment
Time Frame: one year
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Measure of empowerment using the "Empowerment" questionnaire (Community Mental Health Evaluation Initiative, CMHEI, 2001)
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one year
|
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Satisfaction
Time Frame: one year
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Assessment of the degree of satisfaction of users of psychiatric services using the Client's Satisfaction Questionnaire (CSQ- 8) (Larsen, 1979; translation Chambon, 1992)
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one year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Charles Bonsack, MD, Lausanne University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMT
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