Mental DisordersNCT02258737
Efficacy of Transitional Case Management Following Psychiatric Hospital Discharge
A study testing Transitional Case Management in people with Mental Disorders, run by University of Lausanne Hospitals at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Transitional Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are 18-65 years of age
- No immediate institutional follow up after discharge
- Independent living condition
Who cannot join
- Organic brain disease
- Clinically significant concurrent illnesses
- Poor understanding of French
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Social Psychiatry Section, Lausanne University Hospital
Prilly, Canton of Vaud, 1008
About this study
Official title: 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.
Read more
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.
- Conditions
- Mental Disorders
- Being tested
- Transitional Case Management, Standard Care
- Keywords
- Case management, psychiatric hospitalization, discharge
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional Case ManagementBehavioural
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 CareBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| transitional case management | Experimental | Not described Receives: Behavioral: Transitional Case Management |
| standard care | Active comparator | Not described Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one year
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)
Measured: one year
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)
Measured: one year
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)
Measured: one year
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)
Measured: one year
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)
Measured: one year
Perceived Improvement
Assessment of the patient's perception of clinical improvement using the Perceived Improvement questionnaire (Perreault, 2003)
Measured: one year
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)
Measured: one year
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)
Measured: one year
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)
Measured: one year
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)
Measured: one year
Empowerment
Measure of empowerment using the "Empowerment" questionnaire (Community Mental Health Evaluation Initiative, CMHEI, 2001)
Measured: one year
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)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Charles Bonsack, University of Lausanne Hospitals
- Investigators
- Charles Bonsack, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258737
- Sponsor's protocol ID
- CMT
- Status last verified
- Oct 2014
- First submitted
- 29 Sep 2014
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonsack C, Golay P, Gibellini Manetti S, Gebel S, Ferrari P, Besse C, Favrod J, Morandi S. Linking Primary and Secondary Care after Psychiatric Hospitalization: Comparison between Transitional Case Management Setting and Routine Care for Common Mental Disorders. Front Psychiatry. 2016 Jun 2;7:96. doi: 10.3389/fpsyt.2016.00096. eCollection 2016.
PubMed 27313547
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transitional Case Management Following Psychiatric Hospital Discharge: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02258737
- Acronym / sponsor ID
- CMT
- Conditions
- Mental Disorders
- Keywords
- Case management, psychiatric hospitalization, discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transitional case management | Experimental | Behavioral: Transitional Case Management |
| standard care | Active comparator | Behavioral: Standard Care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients are 18-65 years of age
- No immediate institutional follow up after discharge
- Independent living condition
Key exclusion criteria (3 listed)
- Organic brain disease
- Clinically significant concurrent illnesses
- Poor understanding of French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transitional Case ManagementThe 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 | Behavioural | transitional case management |
| Standard CareRoutine 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). | Behavioural | standard care |
Primary outcome
Adherence to outpatient care
Time frame: one year
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)
Working alliance
Time frame: one year
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)
Number of readmissions
Time frame: one year
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)
Degree of psychiatric symptoms
Time frame: one year
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)
Hopelessness
Time frame: one year
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)
Substance use
Time frame: one year
Assessment of alcohol and drug consumption (prevalence and frequency) using an extract from " Cannabis and Substance Use Assessment Scale " (CASUAS) (Edwards et al., 2003)
Perceived Improvement
Time frame: one year
Assessment of the patient's perception of clinical improvement using the Perceived Improvement questionnaire (Perreault, 2003)
Severity of mental health problems
Time frame: one year
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)
Global Assessment of Functioning
Time frame: one year
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)
Social and Occupational Functioning
Time frame: one year
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)
Social support
Time frame: one year
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)
Empowerment
Time frame: one year
Measure of empowerment using the "Empowerment" questionnaire (Community Mental Health Evaluation Initiative, CMHEI, 2001)
Satisfaction
Time frame: one year
Assessment of the degree of satisfaction of users of psychiatric services using the Client's Satisfaction Questionnaire (CSQ- 8) (Larsen, 1979; translation Chambon, 1992)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
- Derived from this study: PubMed 27313547Bonsack C, Golay P, Gibellini Manetti S, Gebel S, Ferrari P, Besse C, Favrod J, Morandi S. Linking Primary and Secondary Care after Psychiatric Hospitalization: Comparison between Transitional Case Management Setting and Routine Care for Common Mental Disorders. Front Psychiatry. 2016 Jun 2;7:96. doi: 10.3389/fpsyt.2016.00096. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Bonsack, MD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional Case Management in people with Mental Disorders, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to outpatient care (time frame: one year). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02258737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2014.