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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02258737
Other study ID # CMT
Secondary ID
Status Completed
Phase N/A
First received September 29, 2014
Last updated October 2, 2014
Start date October 2007
Est. completion date April 2009

Study information

Verified date October 2014
Source University of Lausanne Hospitals
Contact n/a
Is FDA regulated No
Health authority Switzerland: Commission cantonale (VD) d'éthique de la recherche sur l'être humain
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Transitional Case Management
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
Standard Care
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).

Locations

Country Name City State
Switzerland Social Psychiatry Section, Lausanne University Hospital Prilly VD

Sponsors (2)

Lead Sponsor Collaborator
University of Lausanne Hospitals Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence to outpatient care 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) one year No
Primary Working alliance 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) one year No
Primary Number of readmissions 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) one year No
Primary Degree of psychiatric symptoms 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) one year No
Primary Hopelessness 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) one year No
Primary Substance use Assessment of alcohol and drug consumption (prevalence and frequency) using an extract from " Cannabis and Substance Use Assessment Scale " (CASUAS) (Edwards et al., 2003) one year No
Primary Perceived Improvement Assessment of the patient's perception of clinical improvement using the Perceived Improvement questionnaire (Perreault, 2003) one year No
Primary Severity of mental health problems 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) one year No
Primary Global Assessment of Functioning 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) one year No
Primary Social and Occupational Functioning 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) one year No
Primary Social support 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) one year No
Primary Empowerment Measure of empowerment using the "Empowerment" questionnaire (Community Mental Health Evaluation Initiative, CMHEI, 2001) one year No
Primary Satisfaction Assessment of the degree of satisfaction of users of psychiatric services using the Client's Satisfaction Questionnaire (CSQ- 8) (Larsen, 1979; translation Chambon, 1992) one year No
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