- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03551301
Transitional Case Management for Patients Suffering From Substance Use Disorders
March 19, 2024 updated by: Louise Penzenstadler, University Hospital, Geneva
According to the World Health Organization the population suffering from addiction problems is increasing.
This population is characterized by multiple needs at the medico-psychosocial level.
However, some of these patients, a particular subgroup that we are going to be interested in the so-called "high need" user group, find it difficult to access and stay in outpatient treatment programs.
They often present a chaotic use of the health system, including a high number of hospitalizations in times of crisis.
They also show very low utilization of health care services, accompanied by social marginalization.
This can be related to relapses and poor social functioning.
A high number of relapses occur particularly at the end of hospitalization.
Interventions in the field of addiction, such as Transitional Case Management (TCM) should increase the adherence of these patients to treatment by accompanying them in the sensitive period following hospitalization.
One of the objectives of the study is to evaluate the impact of TCM on the number, duration and type of hospitalizations, as well as the number of emergency room visits.
The investigators will also measure the duration until the possible future hospitalization, after the TCM.
The secondary objectives of this study will be to see the effect of TCM on adherence to outpatient treatment.
The investigators will focus on the impact of follow-up on the participant's medico-psycho-social network, substance use and other psychological variables.
The investigators will also evaluate his or her psychiatric symptoms and global and social functioning.
Life satisfaction and satisfaction with the care received will also be measured.
The investigators will compare the population treated by the TCM with the other users of the addiction service who are hospitalized.
The study will investigate this through questionnaires at the beginning of care, at one month, three months, six months and 12 months after the start of TCM management.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Geneva, Switzerland, 1202
- Service d'addictologie HUG
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subgroup of high need users hospitalized in our addiction unit
Description
Inclusion Criteria:
- Substance use disorder
- Hospitalisation at recruitment
- Substance Use Disorder according to the DSM-5 and one of the following criteria:
- No preexisting outpatient follow-up care or regular follow-up care
- More than three emergency room visits during the last 12 months
- More than three hospitalizations in psychiatric hospital during the last 12 months
- More than 40 hospitalization's days during the last 12 months
- First hospitalization for a SUD
Exclusion Criteria:
- Evidence of organic brain disease or learning disability based on the chart review.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital days
Time Frame: at 12 months
|
Number of days in hospital
|
at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Service use
Time Frame: at 12 months
|
Number of hospital admissions
|
at 12 months
|
|
Patient network
Time Frame: 0, 3, 6, 12 months
|
Number of persons in network
|
0, 3, 6, 12 months
|
|
Time to first readmission to hospital
Time Frame: 0, 1, 3, 6, 12 months
|
Number of days to first readmission
|
0, 1, 3, 6, 12 months
|
|
Type of admission (planned versus unplanned)
Time Frame: 0, 1, 3, 6, 12 months
|
Type of admission (planned versus unplanned) reviewed on patient file
|
0, 1, 3, 6, 12 months
|
|
Number of ER visits
Time Frame: 0, 1, 3, 6, 12 months
|
Number of ER visits reviewed on patient file
|
0, 1, 3, 6, 12 months
|
|
Treatment adherence
Time Frame: 0, 1, 3, 6, 12 months
|
percentage of attended outpatient appointments reviewed on patient file
|
0, 1, 3, 6, 12 months
|
|
Number or Transitional Case Management interventions
Time Frame: 0, 1, 3, 6, 12 months
|
Number or Transitional Case Management interventions
|
0, 1, 3, 6, 12 months
|
|
Addictive behaviour
Time Frame: 0, 1, 3, 6, 12 months
|
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST.
V.3 French)
|
0, 1, 3, 6, 12 months
|
|
General psychiatric symptoms
Time Frame: 0, 1, 3, 6, 12 months
|
Health of Nation Outcome Scale - French version (HoNOS-F): scores 0 - 52 (higher score = more psychiatric symptoms)
|
0, 1, 3, 6, 12 months
|
|
Global functioning
Time Frame: 0, 1, 3, 6, 12 months
|
World Health Organization Disability Assessment Schedule (WHODAS)
|
0, 1, 3, 6, 12 months
|
|
General life satisfaction
Time Frame: 0, 1, 3, 6, 12 months
|
Satisfaction With Life Scale: scores 5 - 35 (higher score = higher life satisfaction)
|
0, 1, 3, 6, 12 months
|
|
Advance directives written by the participants
Time Frame: at Baseline
|
Advance directives written by the participant (yes - no)
|
at Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction with Transitional Case Management
Time Frame: at 1 month
|
Patient satisfaction with Transitional Case Management
|
at 1 month
|
|
Duration and intensity of Transitional Case Management intervention
Time Frame: at 1 month
|
Daily contact log (Relevé quotidien des contacts (RQC))
|
at 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
December 4, 2019
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
April 24, 2018
First Submitted That Met QC Criteria
May 28, 2018
First Posted (Actual)
June 11, 2018
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID 2017-00733
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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