Substance Use DisordersNCT03551301
Transitional Case Management for Patients Suffering From Substance Use Disorders
An observational study of Substance Use Disorders, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Transitional Case Management
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2017to 1 Apr 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subgroup of high need users hospitalized in our addiction unit
Who may be able to join
- 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
Who cannot join
- Evidence of organic brain disease or learning disability based on the chart review.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Substance Use Disorders
- Being tested
- Transitional Case Management
- Keywords
- Substance Use Disorders, Case Management, Community Treatment, Hospital discharge
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional Case ManagementOther
TCM program is a type of very flexible community treatment in terms of frequency and intensity of care. This is facilitated by a small case load ratio per health care professional (1:10). The healthcare workers are specialised in SUD treatment. The intervention begins during hospitalisation and lasts around 4 weeks after discharge from the hospital.
The main aim of this intervention is to accompany the patient in the difficult phase of transition between hospital and outpatient care and ensure their adherence to the treatment program. The healthcare workers will explore specific patient needs and ensure that health and social services are better coordinated to fit their needs. Another important aim is to reduce the number of (unplanned) hospitalizations and emergency room visits.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital days
Number of days in hospital
Measured: at 12 months
Secondary outcomes (12)
Service use
Number of hospital admissions
Measured: at 12 months
Patient network
Number of persons in network
Measured: 0, 3, 6, 12 months
Time to first readmission to hospital
Number of days to first readmission
Measured: 0, 1, 3, 6, 12 months
Type of admission (planned versus unplanned)
Type of admission (planned versus unplanned) reviewed on patient file
Measured: 0, 1, 3, 6, 12 months
Number of ER visits
Number of ER visits reviewed on patient file
Measured: 0, 1, 3, 6, 12 months
Treatment adherence
percentage of attended outpatient appointments reviewed on patient file
Measured: 0, 1, 3, 6, 12 months
Number or Transitional Case Management interventions
Number or Transitional Case Management interventions
Measured: 0, 1, 3, 6, 12 months
Addictive behaviour
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST. V.3 French)
Measured: 0, 1, 3, 6, 12 months
General psychiatric symptoms
Health of Nation Outcome Scale - French version (HoNOS-F): scores 0 - 52 (higher score = more psychiatric symptoms)
Measured: 0, 1, 3, 6, 12 months
Global functioning
World Health Organization Disability Assessment Schedule (WHODAS)
Measured: 0, 1, 3, 6, 12 months
General life satisfaction
Satisfaction With Life Scale: scores 5 - 35 (higher score = higher life satisfaction)
Measured: 0, 1, 3, 6, 12 months
Advance directives written by the participants
Advance directives written by the participant (yes - no)
Measured: at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Sep 2017
- Primary completion4 Dec 2019
- Study completion1 Apr 2020
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 Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Penzenstadler, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551301
- Sponsor's protocol ID
- ID 2017-00733
- Status last verified
- Mar 2024
- First submitted
- 24 Apr 2018
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chatton A, Khazaal Y, Penzenstadler L. A 13-item Health of the Nation Outcome Scale (HoNOS-13): validation by item response theory (IRT) in patients with substance use disorder. Addict Sci Clin Pract. 2023 Oct 24;18(1):64. doi: 10.1186/s13722-023-00416-8.
PubMed 37876018
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitional Case Management for Patients Suffering From Substance Use Disorders
- ClinicalTrials.gov ID
- NCT03551301
- Acronym / sponsor ID
- ID 2017-00733
- Conditions
- Substance Use Disorders
- Keywords
- Substance Use Disorders, Case Management, Community Treatment, Hospital discharge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 11 Jun 2018 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subgroup of high need users hospitalized in our addiction unit
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Evidence of organic brain disease or learning disability based on the chart review.
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 ManagementTCM program is a type of very flexible community treatment in terms of frequency and intensity of care. This is facilitated by a small case load ratio per health care professional (1:10). The healthcare workers are specialised in SUD treatment. The intervention begins during hospitalisation and lasts around 4 weeks after discharge from the hospital. The main aim of this intervention is to accompany the patient in the difficult phase of transition between hospital and outpatient care and ensure their adherence to the treatment program. The healthcare workers will explore specific patient needs and ensure that health and social services are better coordinated to fit their needs. Another important aim is to reduce the number of (unplanned) hospitalizations and emergency room visits. | Other | – |
Primary outcome
Hospital days
Time frame: at 12 months
Number of days in hospital
12 secondary outcomes
Service use
Time frame: at 12 months
Patient network
Time frame: 0, 3, 6, 12 months
Time to first readmission to hospital
Time frame: 0, 1, 3, 6, 12 months
Type of admission (planned versus unplanned)
Time frame: 0, 1, 3, 6, 12 months
Number of ER visits
Time frame: 0, 1, 3, 6, 12 months
Treatment adherence
Time frame: 0, 1, 3, 6, 12 months
Number or Transitional Case Management interventions
Time frame: 0, 1, 3, 6, 12 months
Addictive behaviour
Time frame: 0, 1, 3, 6, 12 months
General psychiatric symptoms
Time frame: 0, 1, 3, 6, 12 months
Global functioning
Time frame: 0, 1, 3, 6, 12 months
General life satisfaction
Time frame: 0, 1, 3, 6, 12 months
Advance directives written by the participants
Time frame: at Baseline
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 20 Mar 2024.
- Derived from this study: PubMed 37876018Chatton A, Khazaal Y, Penzenstadler L. A 13-item Health of the Nation Outcome Scale (HoNOS-13): validation by item response theory (IRT) in patients with substance use disorder. Addict Sci Clin Pract. 2023 Oct 24;18(1):64. doi: 10.1186/s13722-023-00416-8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders, run by University Hospital, Geneva 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 8 inclusion and 1 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 20 Mar 2024. 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?
Hospital days (time frame: at 12 months). 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 NCT03551301, 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 20 Mar 2024.